Full opinion text
OPINION & ORDER PAUL A. ENGELMAYER, District Judge: In these related cases brought under the securities laws, plaintiffs claim that the pharmaceutical company Sanofi, its predecessor Genzyme, and three company executives (collectively, “defendants,” “Sanofi,” or “the company”) made false and misleading statements about Lemtrada, a multiple sclerosis (“MS”) drug, while it was under review by the U.S. Food and Drug Administration (“FDA”). Although plaintiffs find multiple faults with Sanofi’s public pronouncements, their core allegation is that defendants failed to disclose concerns the FDA had expressed about the “single-blind” design used in Lemtrada’s clinical trials, and that this omission made Sanofi’s public statements about Lemtrada false and misleading. Plaintiffs allege violations of §§ 10(b), 18, and 20(a) of the Securities Exchange Act of 1934, 15 U.S.C. §§ 78a et seq. (the “Exchange Act”); §§ 11 and 12 of the Securities Act of 1933, 15 U.S.C. § 77a et seq. (the “Securities Act”); and state blue sky laws. Pending now are defendants’ motions to dismiss both complaints for failure to state a claim, under Federal Rules of Civil Procedure 12(b)(6) and 9(b). For the following reasons, the Court grants these motions in full and dismisses both complaints. I. Background Sanofi, based in Paris, is the fifth largest pharmaceutical group in the world. CAC ¶¶ 2, 39; AGC ¶¶ 14, 21. In 2011, Sanofi acquired Genzyme, a pharmaceutical company based in Cambridge, Massachusetts. CAC ¶ 8; AGC ¶¶ 15, 25. At the time, Genzyme was in the process of developing and testing a MS drug called alemtuzu-mab, commonly known as “Lemtrada.” CAC ¶ 6; AGC ¶ 22. Largely because Sanofi and Genzyme could not agree on a valuation of Lemtra-da, Sanofi issued contingent value rights (“CVRs”) to all Genzyme shareholders as part of the acquisition. CAC ¶ 9; AGC ¶ 24. The CVRs were tradable on the open market. CAC ¶ 39; AGC ¶ 3. They entitled holders to cash payments upon the achievement of certain milestones. One important milestone was obtaining FDA approval for Lemtrada by March 31, 2014. CAC ¶ 10; AGC ¶ 26. After completing the Genzyme acquisition, Sanofi continued to move Lemtrada forward in the clinical testing and FDA approval process. See CAC ¶¶ 12, 15; AGC ¶ 52. On November 8, 2013, the FDA Advisory Committee on Peripheral and Central Nervous System Drugs (“Advisory Committee”) issued a briefing report that “sharply criticized” Sanofi’s application for FDA approval of Lemtrada. CAC ¶ 19; see also AGC ¶ 55. Based on the Report, it was apparent that the FDA would not approve Sanofi’s application. See id. That day, the price of the CVRs declined from $2.00 to $0.77 per share. CAC ¶ 22; AGC ¶ 57. Soon after, the FDA formally rejected Sanofi’s application. CAC ¶ 25; AGC ¶ 58. The price of the CVRs thereafter declined to $0.32 per share. CAC ¶ 26; AGC ¶ 58. On November 14, 2014, however, well after the filing of these lawsuits, the FDA reversed its initial decision and approved Lemtrada for use by certain MS patients. See 13 Civ. 8806, Dkt. 55. Plaintiffs are individuals and corporations that purchased CVRs before November 8, 2013. CAC ¶ 1; AGC ¶5. They allege that, before the release of the November 8, 2013 FDA Report that triggered a sharp drop in the CVRs’ price, defendants made misleading and incomplete statements about the likelihood of obtaining timely FDA approval for Lemtrada, the drug’s safety and efficacy, and the results of the ongoing clinical trials. See CAC ¶ 13; ÁGC ¶ 2. Most centrally, plaintiffs claim that the FDA had conveyed to Genzyme executives that the single-blind design of Lemtrada’s clinical trials could bias the study, such that the trial results would have to be particularly robust to overcome that design impediment, see, e.g., CAC ¶ 23; AGC ¶ 36, and that Genzyme’s and later Sanofi’s failure to disclose that interim feedback made its encouraging statements about the drug’s prospects misleading, see CAC ¶ 21; AGC ¶ 37. Plaintiffs allege that they relied on defendants’ statements in deciding to acquire CVRs. CAC ¶¶ 92-97, 106; AGC ¶¶ 53-54. Based on these factual allegations, plaintiffs assert various violations of federal and state securities laws. CAC ¶¶ 100-15; AGC ¶¶ 61-106. A. Factual Background 1. Genzyme Develops Lemtrada MS is “a potentially debilitating autoimmune disease that affects the brain and central nervous system- of an estimated 400,000 people in the United States and 2.5 million worldwide.” CAC ¶ 78 (quoting a Boston Globe article). In the early 2000s, a non-party company, ILEX, began developing Lemtrada as a drug to combat MS. See AGC ¶ 36(a). In 2002, clinical trials of Lemtrada began. See CAC ¶30; AGC ¶ 36(a). In 2004, while Lemtrada was in the second of three phases of clinical trials, Genzyme acquired ILEX. See AGC ¶ 36(a). Genzyme continued the Lemtrada studies and released safety and efficacy updates on an annual basis. See Def. Decl. Exs. 14 (2005), 15 (2006), 16 (2007), 18 (2010). One of Lemtrada’s primary benefits is its unique treatment regimen: While many MS drugs must be taken daily or weekly, Lemtrada is administered intravenously during two annual courses of treatment. CAC ¶ 7. In part for this reason, in 2010, Lemtrada had an estimated value of $14 billion worldwide. Id. ¶ 6. However, Lem-trada’s distinctive method of administration made it difficult or impossible to conduct “double-blind” studies — ones in which the nature of the treatment being administered is concealed from both subjects and investigators. See Def. Decl. Ex. 9, at 4 (“FDA Guidance for Industry”). The Lemtrada studies therefore had a single-blind design: The investigators were not aware of each subject’s assigned treatment, but the subjects knew whether they were receiving Lemtrada or a competitor drug commonly known as Rebif. The fact that the single-blind design was being used was reported in various publicly available sources. See Def. Decl. Exs. 12,13, 17, 22, 28-29. As early as 2002, the year the Lemtrada clinical trials began, the FDA expressed concerns about the single-blind design of the study. CAC ¶ 23; AGC ¶ 36. In that year, the FDA advised ILEX and Gen-zyme that the Lemtrada clinical trials “will not provide substantial support” for a license application. AGC ¶ 36(a); see also id. ¶¶ 36(b)-(c). Defendants did not publicly disclose this interim feedback. See, e.g., CAC ¶ 13; AGC ¶ 35. In 2005, a patient who had received Lemtrada died of sepsis, and the FDA placed the clinical trial on hold for approximately 10 months. CAC ¶ 31; AGC ¶ 36(d). Genzyme disclosed information about the hold in a press release. Def. Decl. Ex. 14, at 3, 4. A confidential witness (“CW”) employed by Genzyme between 2002 and 2012 reported that, even when the FDA lifted the hold, Genzyme employees remained concerned about Lemtrada’s safety profile. CAC ¶¶ 29-32. Additionally, a Steering Committee composed of high-level Genzyme executives was “hypersensitive” to concerns about Lemtrada’s safety and the potential impact of the reported adverse events on Lemtrada’s commercial viability. Id. ¶ 32. By 2006, however, the FDA’s position had shifted. On November 21, 2006, for example, Genzyme met with the FDA and included the following in the minutes of the meeting: FDA responded that a rater blinded (but patient not blinded) study may be adequate if the effect is large. However, a totally blinded study is more likely to be found persuasive if the treatment effect is relatively small.... The FDA again noted that they prefer double-blinded, controlled studies, especially for the pivotal trials. CAC ¶ 23(a). In other words, the FDA determined that it would accept data from the clinical trials, but the treatment effect would have to be “large” to win FDA approval. Similarly, a June 29, 2007 letter from the FDA reiterated the agency’s position regarding the study design: FDA strongly recommends that you use a double-dummy placebo control in your pivotal trials. The acceptability of your rater-blinded study will be a matter of review. If your study results reveal an extremely large effect, then FDA may potentially accept this rater-blinded design for the pivotal trials. Id. ¶ 23(b); AGC ¶ 36(e). The FDA permitted Lemtrada to enter Phase III clinical trials in September 2007 with a single-blind design. See CAC ¶ 12; AGC ¶¶ 43, 44, 46; see also Def. Decl. Ex. 20, at 2. On October 23, 2008, physicians involved in the Lemtrada studies published full results of the Phase II clinical trial in The New England Journal of Medicine. Def. Decl. Ex 17. This publication described the single-blind design of the study and disclosed every adverse event that had been observed to date. Id. It did not, however, disclose the FDA’s stated concerns about the single-blind design of the Lemtrada studies. CAC ¶ 27; AGC ¶¶ 35, 37. The FDA continued to express concerns about the design of the Lemtrada studies during the Phase III trials. Minutes from a March 17, 2010 meeting with Genzyme officials reflect that the FDA was: concerned by the potential bias introduced by the absence of blinding of patients, the possibility of unblinding of EDSS raters, the initiation of alternative MS therapies after the first relapse, and the elimination of censoring. The interpretation of the results from the statistical analysis will be challenging, and extremely robust findings will be necessary to overcome these issues.... Blinding procedures were discussed in detail. For EDSS and relapse reporting, the bias introduced by unblinding of physicians and patients remains a significant problem which will cause serious difficulties in interpreting the results of the trial. CAC ¶ 23(c); AGC ¶ 36(f). Notwithstanding these issues, Sanofi reported that the FDA had placed the Phase III Lemtrada studies on a fast track. AGC ¶ 42; Def. Decl. Ex. 32, at 12. The fast-track procedure is “designed to expedite the development, evaluation, and marketing of new therapies intended to treat persons with life-threatening and severely-debilitating illnesses.” 21 C.F.R. § 312.80. On January 24, 2011, the FDA again noted its concerns about the single-blind design of the Lemtrada study, during a meeting with Genzyme officials: The lack of blinding remains a major concern. We note that, despite these previous concerns that have been communicated to you, there was little discussion of the unblinded design of the trials in the meeting material. We emphasize the importance of presenting a full discussion and analysis of the impact of having the patients and treating physicians unblinded. CAC ¶ 23(d); AGC ¶ 36(g). 2. Sanofi Acquires Genzyme and Issues the CVRs In mid-2010, Sanofi initiated efforts to acquire Genzyme. CAC ¶ 8; AGC ¶ 22. The two companies negotiated for several months and reached a final agreement on February 16, 2011. CAC ¶ 8; AGC ¶¶ 24-25. Under their agreement, Sanofi acquired Genzyme for more than $20 billion. CAC ¶ 8. However, largely because Sanofi and Genzyme could not agree on an exact valuation of Lemtrada, Sanofi also consented to issue one CVR for each share of Genzyme. Id. ¶ 9; AGC ¶¶ 24, 26. In total, Sanofi issued more than 200 million CVRs. See AGC ¶ 5. The CVRs, which were tradable on the open market, derived their value from cash payments Sanofi would make if the company achieved certain milestones. CAC ¶ 10; AGC ¶ 26. One milestone entitled CVR holders to $1 per CVR if Lem-trada received FDA approval by March 31, 2014. Four other milestones entitled CVR holders to as much as $13 per CVR if Lemtrada reached certain sales targets. Id. Although Sanofi is a global company, regulatory approval within the United States (ie., by the FDA) “was a critical first step” to achieving the sales milestones because the U.S. “accounts for 20% of MS patients worldwide.” CAC ¶ 11. A final milestone entitled CVR holders to payments of $1 per share if two other Genzyme drugs met production milestones. AGC ¶ 28. If all six milestones had been reached, Sanofi would have paid an additional $3.8 billion in connection with the acquisition of Genzyme. CAC ¶ 9. On March 7, 2011, Genzyme filed a Schedule 14D-9 with the SEC. Def. Decl. Ex. 31 (“Genzyme 14D-9”).' The 14D-9 was used to persuade Genzyme shareholders to accept Sanofi’s offer. AGC ¶ 29. In it, Genzyme projected a 90% likelihood. that Lemtrada would be approved by March 31, 2014, fulfilling the first payment-triggering milestone. Id. ¶¶ 30, 40; Genzyme 14D-9, at 45. Genzyme also stated in the 14D-9, as on other occasions, that it “anticipates product approval in the United States in the second half of 2012” AGC ¶¶ 40, 42, 43, 44. ■ As to the Lemtra-da sales milestones, Genzyme projected an 80% likelihood of reaching the first, a 54% likelihood of reaching the second, a 50% likelihood of reaching the third, and a 16% likelihood of reaching the fourth. Id. ¶ 30; Genzyme 14D-9, at 45. These “projections were accompanied with boilerplate caveats” but did not reveal, the negative feedback Genzyme had received from the FDA regarding the single-blind study design. AGC ¶¶ 31, 34, 43, 44. With the approval of Genzyme shareholders, Sanofi completed the acquisition of Genzyme on April 8, 2011. See id. ¶ 33. 3. Sanofi Continues Testing Lemtrada After acquiring Genzyme, Sanofi continued the Lemtrada clinical trials and made numerous statements about the drug in press releases, earnings conference calls with analysts, and SEC filings. See CAC ¶¶ 45-73; AGC ¶¶ 45-52. Like its predecessor Genzyme, Sanofi released annual updates about Lemtrada. Def. Decl. Exs. 24-26 (2011), 27 (2012), 30 (2013). It also disclosed complete Phase III trial results, including all reported adverse effects, in two research articles published in The Lancet in November 2012. Def. Decl. Exs. 28-29. The Form 20-F Sanofi submitted on March 6, 2012 is representative of the statements defendants made in SEC filings between 2011 and 2013. It reported, inter alia, that “two Phase III studies demonstrating the safety and efficacy of [Lemtrada] were completed in 2011.” CAC ¶ 45; AGC ■ ¶ 47. Those studies “demonstrated- strong and robust treatment effect” and a “significantly reduced” relapse rate as compared to Rebif, the leading competitor. Additionally, the Form 20-F stated, the “safety results were consistent with previous [Lemtrada] use in MS, and adverse events continued to be manageable.” Id. During a conference call with' analysts on April 27, 2012,- Sanofi’s CEO, Christopher Viehbacher, characterized the results of the Phase III studies as “nothing short of stunning.” CAC ¶49. In describing safety concerns associated with Lemtrada, Viehbacher stated: “People are concerned about safety, but I don’t see the reason for that. We’ve seen higher incidence on impact for thyroid, but thyroid conditions are not uncommon in this population and indeed others and are pretty easily treated with standard therapy. The ITP [an immune disorder] has not been as severe as we’ve seen outside there the population and is [sic] all been reversed.” Id. ¶ 50. On June 12, 2012, Sanofi issued a press release announcing its submission of a supplemental Biologies License Application (“sBLA”) to the FDA. Id. ¶¶ 15, 52; AGC ¶49. Under the Public Health Service Act, firms must obtain licenses before marketing and selling pharmaceuticals in interstate commerce. 42 U.S.C. § 262(a). The sBLA provided specific information about Lemtrada to allow the FDA to determine whether to issue a license. See 21 C.F.R. § 601.20(d). The press release quoted Genzyme’s President and CEO, David Meeker, as stating that Lemtrada “has the potential to transform the lives of patients with Multiple Sclerosis.” CAC ¶ 52. On July 26, 2012, Sanofi CEO Vieh-bacher similarly told analysts that Lemtra-da “is a potential game changer.” Id. ¶ 54. On August 27, 2012, Sanofi announced that it had received a “Refuse to File” letter from the FDA. Id. ¶ 16. “The filing of an application means that FDA has made a threshold determination that the application is sufficiently complete to permit a substantive review.” 21 C.F.R. § 314.101(a). The FDA may refuse to file an application in a number of circumstances, including because “[t]he application does not contain a completed application form” or “does not on its face contain information required under” applicable law. Id. § 314.101(d). Sanofi’s announcement reported that the FDA had merely asked Sanofi to modify its presentation of the data “to enable the agency to better navigate the application.” CAC ¶ 16. After receiving the “Refuse to File” letter, Sanofi continued to make optimistic statements about Lemtrada’s prospects. During a conference call on October 25, 2012, for example, Sanofi’s CFO, Jerome Contamine, told analysts that the financial results “will continue and probably somewhat amplify in the coming quarters as we prepare for the launch of Lyxumia, thereafter for the launch of Lemtrada.” Id. ¶ 56. During the same call, Viehbacher said that he was “actually very satisfied with where the progress is going.” Id. ¶ 57. Plaintiffs understood these statements to suggest that the Lemtrada launch was imminent. Id. On January 28, 2013, Sanofi announced that the FDA had accepted its sBLA seeking approval for Lemtrada. Id. ¶¶ 18, 61; AGC ¶ 50. Sanofi stated that it expected the FDA to make a final decision as to Lemtrada during the second half of 2013. CAC ¶ 18. Soon after, on February 7, 2013, Vieh-bacher told analysts that Sanofi “should be in a good position to launch Lemtrada. It is obviously a huge opportunity that we have to be able to put two significant new medicines” — Lemtrada and another Sanofi drug, Aubagio — “into an important area like MS. This is a market of some $14 billion worldwide.” Id. ¶ 63. Sanofi executives made similarly optimistic statements over the next several months. On October 30, 2013, for example, Viehbacher told analysts “quite honestly, I’m feeling pretty relaxed because if I look at our Phase III pipeline, there’s an awful lot of really good stuff in there .... We’ve got Aubagio and Lemtrada rolling out.” Id. ¶ 73. By early 2014, Lemtrada had been approved for marketing and distribution in the European Union, Canada, Australia, Mexico, and Brazil, a total of more than 30 countries. Def. Decl. Exs. 45, 48-51. 4. The FDA Denies Approval of Lemtrada On November 8, 2013, the FDA Advisory Committee issued a report on Lemtra-da. CAC ¶¶ 19, 75; AGC ¶ 55. The FDA Report “sharply criticized” Sanofi’s submissions and stated that “significant concerns exist regarding the safety profile of [Lemtrada] and the adequacy of the efficacy data.” CAC ¶¶ 19, 75; see also AGC ¶ 56. All three doctors involved in the FDA Report recommended against approving Lemtrada. Dr. Evelyn Mentari, who examined the safety of Lemtrada, found “serious and potentially fatal” safety concerns including autoimmune diseases and thyroid disorders; she therefore recommended against approval “unless substantial clinical benefit exists.” CAC ¶¶ 76; AGC ¶ 56. Dr. John Marler, who assessed the efficacy of Lemtrada, expressed “grave concerns” regarding “the failure to blind patients and treating physicians”; he therefore concluded that Sanofi “ha[d] not submitted evidence from adequate and well-controlled studies to support the effectiveness of [Lemtrada].” Id. Dr. Sharon Yan, who reviewed the statistical analysis presented by Sanofi, likewise found “that troublesome design issues and the presence of bias in the trials prevents reliance on their results.” Id. Following the release of the FDA Report, the market price of the CVRs declined nearly 62%, from $2.00 to $0.77 per share. CAC ¶¶ 22, 77; AGC ¶¶ 3, 57. Five days later, on November 13, 2013, the FDA Advisory Committee released a “Background Package” on Lemtrada. CAC ¶ 23. It noted the concerns that the FDA had expressed to Genzyme between 2006 and 2011. Id. The same day, an FDA panel “took a series of seemingly contradictory votes.” Id. ¶ 78 (quoting a Boston Globe article). These votes were purely advisory and were not binding on the FDA. Id. By a vote of 11 to 6, the panel adopted the view that the Lemtrada studies were biased because the patients had not been blinded. But by a vote of 12 to 6, the same panel accepted that Sanofi had provided substantial evidence of Lemtra-da’s efficacy. Additionally, by a 17 to 0 vote, the panel affirmed that safety concerns should not preclude FDA approval of Lemtrada for patients for whom other drugs have not been effective. At the same time, however, the panel voted 16 to 0 that Lemtrada should not be approved as a “first-line treatment” for newly diagnosed MS patients. Id. On December 27, 2013, the FDA notified Sanofi that the sBLA for Lemtrada had been rejected. CAC ¶ 25. Soon after, on December 30, 2013, Sanofi issued a press release stating that “Sanofi does not anticipate that the CVR milestone of U.S. approval of Lemtrada by March 31, 2014 will be met.” Id. ¶ 26; AGC ¶58. The press release explained that the “FDA has taken the position that Genzyme has not submitted evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects.” AGC ¶ 58. That day, the market price of the CVRs dropped from $0.77 to $0.32 per share. CAC ¶ 26; AGC ¶ 58. On January 23, 2014, Viehbacher gave an interview on Bloomberg Television in which he stated that the FDA rejection “wasn’t a total surprise.” CAC ¶ 27; AGC ¶¶ 5, 59. He explained that “when we acquired Genzyme, we actually created a contingent value right, recognizing that it was not going to be an easy thing to bring Lemtrada to the market. This is a drug that’s been in development for quite some time. That having been said, this is a drug that’s been approved by 30 countries in the world.” Def. Deck Ex. 55, at 2. 5. Sanofi Announces FDA Approval of Lemtrada On April 7, 2014, following the filing of these lawsuits, Sanofi issued a press release stating that after “constructive discussions” with the FDA, it intended to resubmit the Lemtrada application. CAC ¶ 80. On May 30, 2014, the company issued another press release stating that the FDA had accepted a resubmitted sBLA “based on data from the same clinical studies included in the original sBLA.” Def. Decl. Ex. 53, at 2. Over the next several months, Sanofi submitted more than two dozen amendments to its application. See 13 Civ. 8806, Dkt. 55, at 12. Finally, on November 14, 2014, Sanofi announced that the FDA had approved Lemtrada for the treatment of certain MS patients, again based on data from the same clinical trials included in the original licensing application. Id. at 3, 7. B. Procedural History On December 11, 2013, plaintiff John Solak filed a Complaint on behalf of himself and all others similarly situated. 13 Civ. 8806, Dkt. 1. It alleged that Sanofi, through its executives, misrepresented the safety and efficacy of Lemtrada and failed to disclose flaws in the clinical trials that decreased the likelihood of obtaining timely FDA approval. Id. ¶¶ 9, 37. As a result of these materially misleading statements, Solak claimed, he and other members of the purported class had bought CVRs at artificially inflated prices, then lost money when the FDA issued its briefing report and the value of the CVRs declined. Id. ¶53. On this basis, Solak asserted claims under § 10b-5 and § 20(a) of the Exchange Act. Id. ¶¶ 54-69. On December 18, 2013, Vincent Stasiu-lewicz filed a separate Complaint on behalf of himself and all others similarly situated. 13 Civ. 8991, Dkt. 1. Stasiulewicz’s Complaint was substantially similar to Solak’s: It alleged that Sanofi misled investors regarding Lemtrada’s safety and efficacy, the design of the clinical trials, and the likelihood of timely FDA approval. Id. 1T9. Sanofi thereby caused Stasiulewiez and other members of the purported class to purchase CVRs at artificially inflated prices. Id. ¶ 47. Like Solak, Stasiulewiez brought claims under claims under § 10b-5 and § 20(a) of the Exchange Act. Id. ¶¶ 45-60. The Court accepted Stasiulew-icz’s case as related to Solak’s on January 23, 2014. On February 10, 2014, Solak moved to consolidate the two cases. 13 Civ. 8806, Dkt. 8-10; 13 Civ. 8891, Dkt. 3-5. On March 3, 2014, the Court granted the motion and consolidated the cases under the caption “In Re Sanofi Securities Litigation.” 13 Civ. 8806, Dkt. 27; 13 Civ. 8891, Dkt. 12. On April 28, 2014, these plaintiffs filed a Consolidated Amended Complaint. 13 Civ. 8806, Dkt. 44 (“CAC”). The putative class consists of all persons, other than defendants, who purchased CVRs between March 6, 2012 and November 7, 2013. Id. ¶ 1. The CAC asserts claims under § 10b-5 and § 20(a) of the Exchange Act. Id.- ¶¶ 100-15. As defendants, it names Sano-fi, Viehbacher, Meeker, and Contamine. Id. ¶¶ 39-42. On March 28, 2014, a group of 32 corporations (the “AG Funds plaintiffs”) filed a separate Complaint whose claims arose from the same events. 14 Civ..2211, Dkt. 2 (“AGC”). The AG Funds plaintiffs either opted out of the class or acquired CVRs prior to the class period. Id. ¶¶ 7-13. The Court accepted this case as related to the pending consolidated class action. Like the CAC, the AGC brings claims under § 10(b) and § 20(a) of the Exchange Act. Id. ¶¶ 77-87. It also brings claims under § 18 of the Exchange Act, §§ 11 and 12 of the Securities Act, and various state blue sky laws. Id. ¶¶ 61-76, 88-106. The AGC names as defendants Sanofi, Genzyme, Viehbacher, Meeker, and Conta-mine (collectively, the “defendants”). Id. ¶¶ 14-18. On June 27, 2014, defendants filed motions to dismiss both complaints, along with memoranda of law and supporting declarations. 13 Civ. 8806, Dkt. 48, 49 (“Def. Br.”), 50 (“Def. Decl.”); 14 Civ. 2211, Dkt. 17, 18, 19. Defendants argue, inter alia, that plaintiffs failed to identify an actionable misstatement or material omission and to adequately plead scienter. They argue that their statements were not misleading, but rather were either non-actionable expressions of historical fact, forward-looking statements accompanied by meaningful cautionary language, permissible corporate puffery, or declarations of opinion that were sincerely and reasonably held. On August 26, 2014, plaintiffs filed their opposition to the motions to dismiss. 13 Civ. 8806, Dkt. 51 (“CA Br.”); 14 Civ. 2211, Dkt. 20 (“AG Br.”). On October 10, 2014, defendants filed replies. 13 Civ. 8806, Dkt. 52 (“Def. CA Reply”); 14 Civ. 2211, Dkt.- 21 (“Def. AG Reply”). On October 31, 2014, the Court held argument. 14 Civ. 2211, Dkt. 24 (“Tr”). On November 17, 2014, defendants submitted a letter informing the Court that the FDA had approved Lemtrada. 13 Civ. 8806, Dkt. 55. On November 18, 2014, plaintiffs filed letters in reply. 13 Civ. 8806, Dkt. 56; 14 Civ. 2211, Dkt. 26. II. Applicable Legal Principles A. Standard for Resolving the Motion to Dismiss To survive a motion- to dismiss under Rule 12(b)(6), a complaint must plead “enough facts to state a claim to relief that is plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). A claim will only have “facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). A complaint is properly dismissed, where, as a matter of law, “the allegations in a complaint, however true, could not raise a claim of entitlement to relief.” Twombly, 550 U.S. at 558, 127 S.Ct. 1955. Although the court must accept as true all well-pled factual allegations in the complaint and draw all reasonable inferences in the plaintiffs favor, Steginsky v. Xcelera Inc., 741 F.3d 365, 368 (2d Cir.2014), that tenet “is inapplicable to legal conclusions,” Iqbal, 556 U.S. at 678, 129 S.Ct. 1937. “Securities fraud claims are subject to heightened pleading requirements that the plaintiff must meet to survive a motion to dismiss.” ATSI Commc’ns, Inc. v. Shaar Fund, Ltd., 493 F.3d 87, 99 (2d Cir.2007); see also Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308, 321-23, 127 S.Ct. 2499, 168 L.Ed.2d 179 (2007). First, a complaint alleging securities fraud must meet the requirements of Federal Rule of Civil Procedure 9(b). See ECA & Local 134 IBEW Joint Pension Trust of Chi. v. JP Morgan Chase Co., 553 F.3d 187, 196 (2d Cir.2009). Rule 9(b) states that “[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.” Fed.R.Civ.P. 9(b). “Allegations that are conclusory or unsupported by factual assertions are insufficient.” ATSI, 493 F.3d at 99. Second, such a complaint must comply with the pleading requirements of the Private Securities Litigation Reform Act (“PSLRA”), 15 U.S.C. § 78u-4(b). See ECA 553 F.3d at 196. In particular, where a plaintiffs claims depend upon allegations that the defendant has made an untrue statement of material fact or that the defendant omitted a material fact necessary to make a statement not misleading, the plaintiff “shall specify each statement alleged to have been misleading [and] the reason or reasons why the statement is misleading.” 15 U.S.C. § 78u-4(b)(1). Thus, in order to plead a claim of securities fraud, plaintiffs “must do more than say that the statements ... were false and misleading; they must demonstrate with specificity why and how that is so.” Rombach v. Chang, 355 F.3d 164, 174 (2d Cir.2004). In addition, the plaintiff “shall, with respect to each act or omission ... state with particularity facts giving rise to a strong inference that the defendant acted with the required state of mind.” 15 U.S.C. § 78u-4(b)(2). “For an inference of scienter to be strong, ‘a reasonable person [must] deem [it] cogent and at least as compelling as any opposing inference one could draw from the facts alleged.’ ” ATSI, 493 F.3d at 99 (quoting Tellabs, 551 U.S. at 324, 127 S.Ct. 2499) (alteration and emphasis in original). B. Elements of Plaintiffs’ Claims The class-action plaintiffs assert claims under §§ 10(b) and 20(a) of the Exchange Act. CAC ¶¶ 100-15. The AG Funds plaintiffs assert claims under those sections as well as § 18 of the Exchange Act, §§ 11 and 12(a)(2) of the Securities Act, and the blue sky laws of California, Massachusetts, and Minnesota. AGC ¶¶ 61-106. To state a claim under § 10(b) of the Exchange Act, a plaintiff must adequately plead “(1) a material misrepresentation or omission by the defendant; (2) scienter; (3) a connection between the misrepresentation or omission and the purchase or sale of a security; (4) reliance upon the misrepresentation or omission; (5) economic loss; and (6) loss causation.” Matrixx Initiatives, Inc. v. Siracusano, 563 U.S. 27, 131 S.Ct. 1309, 1317, 179 L.Ed.2d 398 (2011) (citation omitted). To state a claim under § 18 of the Exchange Act, a plaintiff must adequately plead that: “(1) the defendant made or caused to be made a statement of material fact that was false or misleading at the time and in light of the circumstances under which it was made, (2) the statement was contained in a document filed pursuant to the Exchange Act or any rule or regulation thereunder, (3) reliance on the false statement, and (4) resulting loss to the plaintiff.” In re Adelphia Commc’ns Corp. Sec. & Derivative Litig., 542 F.Supp.2d 266, 268 (S.D.N.Y.2008) (citation omitted). Claims brought under §§ 11 and 12(a)(2) of the Securities Act involve “roughly parallel elements.” In re Morgan Stanley Info. Fund Sec. Litig., 592 F.3d 347, 359 (2d Cir.2010). “Section 11 imposes liability on issuers and other signatories of a registration statement that ‘contained an untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary to make the statements therein not misleading.’ 15 U.S.C. § 77k(a). Section 12(a)(2) imposes liability under similar circumstances with respect to, inter alia, prospectuses. Id. § 771(a)(2).” Fait v. Regions Fin. Corp., 655 F.3d 105, 109 (2d Cir.2011). Finally, to state a claim under § 20(a) of the Exchange Act, “ ‘a plaintiff must show (1) a primary violation by the controlled person, (2) control of the primary violator by the defendant, and (3) that the defendant was, in some meaningful sense, a culpable participant in the controlled person’s fraud.’ ” Carpenters Pension Trust Fund of St. Louis v. Barclays PLC, 750 F.3d 227, 236 (2d Cir.2014) (quoting ATSI, 493 F.3d at 108). If plaintiffs have not adequately alleged a primary violation, i.e., a viable claim under another provision of the Securities Act or Exchange Act, then the § 20(a) claims must be dismissed. Thus, common to all of plaintiffs’ claims — indeed, the central element — is the existence of a false or misleading statement or omission of material fact. See City of Omaha, Neb. Civilian Employees’ Ret. Sys. v. CBS Corp., 679 F.3d 64, 67-68 (2d Cir.2012) (“[T]hese claims all share a material misstatement or omission element.”). Additionally, scienter is an element of plaintiffs’ § 10(b) and § 20(a) claims under the Exchange Act. The Court highlights, and below addresses the allegations as to, these two elements because consideration of them is sufficient to establish that neither the CAC nor the AGO states a claim. 1. False or Misleading Statement or Omission As noted, for any of plaintiffs’ claims to survive the motions to dismiss, plaintiffs must have adequately pled “that the defendant made a statement that was ‘misleading as to a material fact.’ ” Matrixx Initiatives, 131 S.Ct. at 1318 (quoting Basic Inc. v. Levinson, 485 U.S. 224, 238, 108 S.Ct. 978, 99 L.Ed.2d 194 (1988)) (emphasis omitted). Federal securities law “do[es] not create an affirmative duty to disclose any and all material information.” Id. at 1321. “Disclosure of information is not required ... simply because it may be relevant or of interest to a reasonable investor.” Resnik v. Swartz, 303 F.3d 147, 154 (2d Cir.2002). Instead, an omission is actionable only when disclosure of information is “necessary ‘to make ... statements made, in the light of the circumstances under which they were made, not misleading.’” Matrixx Initiatives, 131 S.Ct. at 1321 (quoting 17 C.F.R. § 240.10b-5(b)) (ellipses in original). As for the materiality requirement, it “is satisfied when there is ‘a substantial likelihood that the disclosure of the omitted fact would have been viewed by the reasonable investor as having significantly altered the total mix of information made available.’ ” Id. at 1318 (quoting Basic, 485 U.S. at 231-32, 108 S.Ct. 978). As the Supreme Court has explained, a lower standard — such as defining a “material fact” as any “fact which a reasonable shareholder might consider important” — would lead corporations to “bury the shareholders in an avalanche of trivial information[,] a result that is hardly conducive to informed decisionmaking.” TSC Indus., Inc. v. Northway, Inc., 426 U.S. 438, 448-49, 96 S.Ct. 2126, 48 L.Ed.2d 757 (1976). The “materiality hurdle” is, therefore, “a meaningful pleading obstacle.” In re ProShares Trust Sec. Litig., 728 F.3d 96, 102 (2d Cir.2013). However, because of the fact-intensive nature of the materiality inquiry, the Court may not dismiss a complaint “on the ground that the alleged misstatements or omissions are not material unless they are so obviously unimportant to a reasonable investor that reasonable minds could not differ on the question of their importance.” Carpenters Pension Trust Fund, 750 F.3d at 235 (quoting ECA, 553 F.3d at 197). In contrast to objective statements of material fact, subjective statements of opinion are generally not actionable as fraud. See, e.g., In re Nevsun Res. Ltd., No. 12 Civ. 1845(PGG), 2013 WL 6017402, at *9 (S.D.N.Y. Sept. 27, 2013). “Subjective statements can be actionable only if the ‘defendant’s opinions were both false arid not honestly believed when they were made.’ ” Kleinman v. Elan Corp., 706 F.3d 145, 153 (2d Cir.2013) (quoting Fait, 655 F.3d at 113); see also, e.g., City of Omaha, 679 F.3d at 67-68 (holding that this standard applies to claims brought under §§ 11, 12, 10(b), and 20(a) because they “all share a material misstatement or omission element”); Freidus v. ING Groep N.V., 736 F.Supp.2d 816, 836 (S.D.N.Y.2010) (“That opinion can be false or misleading only if the opinion-giver ... did not truly believe it to be the case at the time it was issued.”); Fait v. Regions Fin. Corp., 712 F.Supp.2d 117, 125 n. 55 (S.D.N.Y.2010) aff'd, 655 F.3d 105 (2d Cir.2011) (collecting cases). “It is not sufficient for these purposes to allege that an opinion was unreasonable, irrational, excessively optimistic, [or] not borne out by subsequent events.” In re Salomon Analyst Level 3 Litig., 350 F.Supp.2d 477, 489 (S.D.N.Y.2004). “The Second Circuit has firmly rejected this ‘fraud by hindsight’ approach.” Podany v. Robertson Stephens, Inc., 318 F.Supp.2d 146, 156 (S.D.N.Y.2004) (citing Stevelman v. Alias Research, Inc., 174 F.3d 79, 85 (2d Cir.1999)). Rather, plaintiffs “must allege “with particularity’ ‘provable facts’ to demonstrate that the statement of opinion is both objectively and subjectively false.” Bond Opportunity Fund v. Unilab Corp., No. 99 Civ. 11074(JSM), 2003 WL 21058251, at *5 (S.D.N.Y. May 9, 2003), aff'd 87 Fed.Appx. 772 (2d Cir.2004) (summary order) (quoting Va. Bankshares v. Sandberg, 501 U.S. 1083, 1093-98, 111 S.Ct. 2749, 115 L.Ed.2d 929 (1991)). 2. Scienter To sustain their § 10(b) and § 20(a) claims, plaintiffs must also adequately plead scienter. See Matrixx Initiatives, 131 S.Ct. at 1317; Carpenters Pension Trust Fund, 750 F.3d at 236. As noted, Rule 9(b) and the PSLRA require plaintiffs to “state with particularity facts giving rise to a strong inference that the defendant acted with the required state of mind.” 15 U.S.C. § 78u-4(b)(2). “For an inference of scienter to be strong, ‘a reasonable person [must] deem [it] cogent and at least as compelling as any opposing inference one could draw from the facts alleged.’ ” ATSI, 493 F.3d at 99 (quoting Tellabs, 551 U.S. at 324, 127 S.Ct. 2499) (alteration and emphasis in original). The requisite mental state is one “embracing intent to deceive, manipulate, or defraud.” Tellabs, 551 U.S. at 319, 127 S.Ct. 2499. Plaintiffs “may satisfy this requirement by alleging facts (1) showing that the defendants had both motive and opportunity to commit the fraud or (2) constituting strong circumstantial evidence of conscious misbehavior or recklessness.” ATSI, 493 F.3d at 99. Recklessness is “a state of mind approximating actual intent, and not merely a heightened form of negligence.” S. Cherry St., LLC v. Hennessee Grp. LLC, 573 F.3d 98, 109 (2d Cir.2009) (citation and emphasis omitted). To qualify as reckless, defendants’ conduct must have been “ ‘highly unreasonable’ ” and “ ‘an extreme departure from the standards of ordinary care.’ ” Novak v. Kasaks, 216 F.3d 300, 311 (2d Cir.2000) (quoting Rolf v. Blyth, Eastman Dillon & Co., 570 F.2d 38, 47 (2d Cir.1978)). An alleged “refusal to see the obvious, or to investigate the doubtful” must be “egregious” to be actionable. Chill v. Gen. Elec. Co., 101 F.3d 263, 269 (2d Cir.1996) (citation omitted). Further, where, as here, plaintiffs do not allege that defendants had a motive to defraud the public, they “must produce a stronger inference of recklessness.” Kalnit v. Eichler, 264 F.3d 131, 143 (2d Cir.2001). More concretely, plaintiffs can establish recklessness by adequately alleging that “defendants knew facts or had access to non-public information contradicting their public statements” and therefore “knew or should have known they were misrepresenting’ material facts.” In re Scholastic Corp. Sec. Litig., 252 F.3d 63, 76 (2d Cir.2001) (citing Novak, 216 F.3d at 308). “The key, of course, is the honest belief of the management in the truth of information issued to the public. If the management knows that certain facts will necessarily prevent the regulatory approval ... and conceals these facts from the investing public, then there is scienter.” In re AstraZeneca Sec. Litig., 559 F.Supp.2d 453, 470 (S.D.N.Y.2008) aff'd sub nom. State Univ. Ret. Sys. of Ill. v. Astrazeneca PLC, 334 Fed.Appx. 404 (2d Cir.2009) (summary order). Similarly, there is scienter “if the management is reckless in dealing with such adverse facts.” Id. If, on the other hand, “the management of the company releases positive reports about the drug to the public along the way which the management honestly believes to be true, and where there is no reckless disregard for truth, then that is not securities fraud.” Id.; see also id. (collecting cases). C. PSLRA Safe Harbor The PSLRA amended both the Securities Act and the Exchange Act to provide a safe harbor for forward-looking statements. See 15 U.S.C. § 77z-2 (Securities Act); 15 U.S.C. § 78u-5(e) (Exchange Act). Forward-looking statements are defined as those that contain, among other things, “a projection of revenues, income, [or] earnings,” “plans and objectives of management for future operations,” or “a statement of future economic performance.” Id. Under these parallel statutory provisions, a forward-looking statement is not actionable if it “is identified and accompanied by meaningful cautionary language or is immaterial or the plaintiff fails to prove that it was made with actual knowledge that it was false or misleading.” Slayton v. Am. Exp. Co., 604 F.3d 758, 766 (2d Cir.2010). Because the statute is written in the disjunctive, statements are protected by the safe harbor if they satisfy any one of these three categories. Id. Materiality is defined above; the other two categories are defined as follows: Meaningful cautionary language: To qualify as “meaningful,” cautionary language “must convey substantive information about factors that realistically could cause' results to differ materially from those projected in the forward-looking statements.” Id. at 771 (citing H.R. Conf. Rep. 104-369, at 43 (1995), 1995 U.S.C.C.A.N. 730, 742). Language that is “vague” or “mere boilerplate” does not suffice. Id. at 772. “To determine whether cautionary language is meaningful, courts must first ‘identify the allegedly undisclosed risk’ and then ‘read the allegedly fraudulent materials — including the cautionary language — to determine if a reasonable investor could have been misled into thinking that the risk that materialized and resulted in his loss did not actually exist.’ ” In re Delcath Sys., Inc. Sec. Litig., 36 F.Supp.3d 320, 333 (S.D.N.Y.2014) (quoting Halperin v. eBanker USA com, Inc., 295 F.3d 352, 359 (2d Cir.2002)). Plaintiffs may establish that cautionary language is not meaningful “by showing, for example, that the cautionary language did not expressly warn of or did not directly relate to the risk that brought about plaintiffs’ loss.” Halperin, 295 F.3d at 359. Actual knowledge: The scienter requirement for forward-looking statements — actual knowledge — is “stricter than for statements of current fact. Whereas liability for the latter requires a showing of either knowing falsity or recklessness, liability for the former attaches only upon proof of knowing falsity.” Slayton, 604 F.3d at 773 (quoting Inst. Invs. Grp. v. Avaya, Inc., 564 F.3d 242, 274 (3d Cir.2009)). And under the heightened pleading standards, which apply to both scienter requirements, plaintiffs must “state with particularity facts giving rise to a strong inference that the defendant acted with the required state of mind.” 15 U.S.C. § 78u-4(b)(2). “For an inference of scienter to be strong, ‘a reasonable person [must] deem [it] cogent and at least as compelling as any opposing inference one could draw from the facts alleged.’ ” ATSI, 493 F.3d at 99 (quoting Tellabs, 551 U.S. at 324, 127 S.Ct. 2499) (alteration and emphasis in original). III. Analysis The two Complaints identify a total of 26 statements that plaintiffs allege are false or misleading. Broadly speaking, these statements address four subjects: (1) the company’s view of the prospects of timely FDA approval of Lemtrada, (2) the timing of the anticipated launch of Lemtrada, (3) the results of the ongoing clinical trials, and (4) Lemtrada’s adverse effects on patients. Plaintiffs’ central grievance — the absence of any specific disclosure of the FDA’s concerns about the single-blind design of the Lemtrada clinical trials and the correspondingly heightened burden for obtaining FDA approval — is germane to most of these categories. For the reasons that follow, the Court holds that the statements in the first two categories are not actionable because they are statements of opinion, and plaintiffs have not adequately pled that they were other than genuinely held when made. Such statements are therefore neither false nor misleading, nor made with scien-ter; they are also protected by the PSLRA safe harbor. The statements in the third and fourth categories are not actionable because they were not misleading as to material facts, and plaintiffs have not adequately alleged scienter, i.e., that defendants either had a motive and opportunity to commit fraud or were reckless in making those statements. A. Statements Regarding the Prospect of FDA Approval of Lemtra-da The AGC challenges six statements made in Genzyme’s or Sanofi’s SEC filings that address FDA approval of Lemtrada. See AGC ¶¶ 30, 40, 42, 43, 44, 52. Each statement is to the effect that the company expects the FDA to approve Lemtrada prior to March 31, 2014, the cutoff date for the first CVR payment milestone. Five of these statements are substantively identical: They represent that Genzyme “anticipates” or “expects” FDA approval of Lem-trada “in the second half of 2012” or, in one instance, that Sanofi “expects action” in 2013. See id. ¶¶ 40, 42, 43, 44, 52. The sixth statement goes further: It forecasts a 90% likelihood of reaching the FDA approval milestone, an 80% likelihood of reaching the first sales milestone, a 54% likelihood of reaching the second sales milestone, and a 50% likelihood of reaching the third sales milestone. Id. ¶ 30. The AGC alleges that these statements were “misleading” because they “were not accompanied by any mention of the concerns the FDA had expressed about the trials or Lemtrada’s approval prospects.” AGC ¶¶ 30, 40, 42, 43, 44, 52. 1. False or Misleading Statement or Omission These six statements are statements of opinion- — -they express Sanofi’s expectations for the future rather than presently existing, objective facts. See, e.g., In re Bank of Am. Corp. Sec., Derivative, & Employee Ret. Income Sec. Act (ERISA) Litig., No. 09 MD 2058(PKC), 2013 WL 6504801, at *16 (S.D.N.Y. Dec. 11, 2013) (prediction of a company’s future performance is a statement of opinion); In re MF Global Holdings Ltd. Sec. Litig., 982 F.Supp.2d 277, 312 (S.D.N.Y.2013) (statement that a target is “more likely than not to be realized” is a statement of opinion). Accordingly, the statements are “actionable only if the ‘defendant’s opinions were both false and not honestly believed when they were made.’ ” Kleinman, 706 F.3d at 153 (quoting Fait, 655 F.3d at 113). On the facts pled and properly considered on a motion to dismiss, there is no basis to conclude that defendants did not genuinely believe what they were saying at the time they said it. Defendants’ business decisions strongly indicate that they regarded Lemtrada as a promising new drug: Sanofi paid $20 billion to acquire Genzyme, CAC ¶ 8, in large part due to Genzyme’s ownership of Lemtrada, see CAC ¶ 6. And the two companies conducted the Lemtrada clinical trials over the course of a decade, presumably at significant cost. See AGC ¶ 36; CAC ¶ 23. Indeed, Sanofi told analysts that it continued to invest in Lemtrada even as it was “struggling to fund everything [it had] in development” and “killed” other projects. Def. Decl. Ex. 61, at 17. Plaintiffs recite no facts indicating that defendants did not in fact expect FDA approval within the timeframe their statements articulated. And, absent concretely pled facts to this effect, the inference that the AG Funds plaintiffs ask the Court to draw — that Sanofi acquired Genzyme and continued to fund the Lemtrada clinical trials while secretly believing that FDA approval was unlikely, impossible, or, if achievable, only on a delinquent time schedule — is implausible and conjectural. Cf. City of Edin burgh Council v. Pfizer, Inc., 754 F.3d 159, 170 (3d Cir.2014) (citing Kleinman,. 706 F.3d at 153) (“[T]he initiation of Phase 3 cost millions of dollars and required FDA approval, rendering it improbable that defendants would have continued if they did not believe their interpretation of the interim results or if they thought the drug a complete failure”); Davidoff v. Farina, No. 04 Civ. 7617(NRB), 2005 WL 2030501, at *11 n. 19 (S.D.N.Y. Aug. 22, 2005) (“[I]t would have made no economic sense for defendants to invest literally billions of dollars in a venture that they knew would fail.”). Seeking to sustain their position, the AG Funds plaintiffs focus on a single purported admission by one individual defendant: Sanofi CEO Viehbacher’s January 23, 2014 statement that the FDA’s decision to reject Lemtrada “wasn’t a total surprise.” AGC ¶¶ 5, 59; CAC ¶¶21, 27-29, 84. But Viehbacher’s asserted lack of “total surprise” is not inconsistent with defendants’ statements that they expected timely FDA approval. Cf. In re Bristol-Myers Squibb Sec. Litig., 312 F.Supp.2d 549, 558 (S.D.N.Y.2004) (“Given the uncertainty inherent in any application for FDA approval, Defendants’ alleged ‘inkling’ ” that the FDA might not approve the drug “is reasonable and entirely consistent with Defendants’ public statements.”). In fact, as pled, defendants projected a 10% likelihood that the FDA would not approve Lemtrada by March 31, 2014. See AGC ¶¶ 30, 34. An event or circumstance with a 10% possibility of coming to pass can be fairly described as “not a total surprise”: Good examples from daily life include a rainout of a baseball game, a one-hour flight delay, or a first-place finish by a racehorse whose odds of winning had been 9:1. Thus, the AGC not only fails to afford a basis to infer that defendants did not sincerely believe their projections when they made them; it also indicates that defendants affirmatively put the market on notice of what they perceived to be a 10% chance that the FDA would not approve Lemtrada by the cutoff date for the milestone payment. Additionally, examination of Viehbacher’s statement in the context in which it was made belies plaintiffs’ characterization of it as an admission that, before the FDA acted, he had viewed the likelihood of non-approval as higher than the company had forecast: SCHATZKER: Lemtrada was a drug that you hoped to use to gain a fair amount of share, I think it’s fair to say, in the multiple sclerosis business. The FDA rejected it. How much of a letdown was the for you? VIEHBACHER: Well, it’s actually something that wasn’t a total surprise, because when we acquired Genzyme, we actually created a contingent value right, recognizing that it was not going to be an easy thing to bring Lemtrada to the market. This is a drug that’s been in development for quite some time. That having been said, this is a drug that’s been approved by 30 countries in the world. We’re seeing patients who have gone five years without a relapse. So we believe that the drug actually is working and it’s important for patients, and that’s why for the first time in my 25 years in this industry, we’re thinking about doing an appeal with the FDA. Def. Decl. Ex. 55, at 2. Read in context, Viehbacher’s statement does not concede that he (and the company) knew all along that the FDA would reject Lemtrada. Rather, the statement admits no more than that the company regarded FDA approval as uncertain. That proposition is consistent with Sanofi’s public statements about Lemtrada’s prospects. The CAC also recites statements attributed to a confidential witness (“CW”) who was employéd by Genzyme between 2002 and 2012. See CAC ¶¶ 29-32. Although these statements are not alleged in the AGC, in the interest of completeness, the Court considers them in evaluating the AG Funds plaintiffs’ claim of falsity. The CAC alleges that, according to the CW, Genzyme and Sanofi employees were “aware of Lemtrada’s (and the trials’) shortcomings” and “were hypersensitive to reported adverse events” and the implications “for Lemtrada’s ultimate commercial viability.” CAC ¶29. The CW further reported that a Steering Committee composed of high-level Genzyme executives was “concerned with Lemtrada’s safety profile.” CAC ¶ 31. These allegations, however, are far too generic to give rise to a plausible inference that defendants did not believe their public predictions. Any responsible corporate executive would be “aware of’ ongoing clinical trial results, “concerned” about adverse events, and “sensitive” to the possibility of FDA non-approval, whether its likelihood was appraised at 10%, higher, or lower. There is no inconsistency between a pharmaceutical company executive’s concern about adverse events and the possibility of a negative FDA reaction to a proposed drug, and his sincere optimism that the FDA was likely to approve the drug. Even assuming the AG Funds plaintiffs had adequately pled subjective falsity, the statements in question also have to be objectively false to be actionable. Fait, 655 F.3d at 110. In arguing that defendants’ stated optimism was incompatible with the facts known to them, the AG Funds plaintiffs emphasize that the FDA had repeatedly criticized the single-blind design of the Lemtrada clinical trials — a critique that defendants never publicly disclosed. AG Br. 1-2; see also CA Br. 1. But again, viewed in context, the FDA’s statements to the company could readily be squared with the company’s publicly anticipated timetable for approval. As pled, in expressing misgivings about a single-blind methodology, the FDA did not state that it would refuse to approve Lemtrada were this methodology used. It stated instead that, to obtain approval, Lemtrada’s demonstrated “treatment effect” would have to be large — i.e., the company would carry a heavier burden of proof than if a double-blind approach had been used — to compensate for the bias potentially introduced by a single-blind methodology. See AGC ¶ 36; CAC ¶ 23; see also Def. Decl. Ex. 11 (FDA briefing report). Further, a series of actions by the FDA, as reflected in plaintiffs’ pleadings and in public filings, communicated that timely agency approval was possible. Despite the concerns the FDA had expressed about the design of the clinical trials, it allowed those trials to proceed. Had the FDA at any point concluded that there were “serious defects in study design that would render the study incapable of producing valid evidence of safety and effectiveness,” it had “authority to issue a clinical hold.” 52 Fed.Reg. 8798. Clinical holds protect human subjects from exposure to flawed and therefore scientifically worthless studies. Id. Indeed, after a patient died of sepsis in 2005, the FDA had placed Lemtrada’s Phase II clinical trials on hold. See AGC ¶ 36(d); CAC ¶31. But, approximately 10 months later, the FDA removed that hold and at no later point halted the Lemtrada studies. See AGC ¶ 36(e); CAC ¶ 31. On the contrary, the FDA permitted Genzyme to commence Phase III studies. See AGC ¶¶43, 44, 46; CAC ¶ 12. Phase III trials may be performed only “after preliminary evidence suggesting effectiveness of the drug has been obtained.” 21 C.F.R. § 312.21(c). Accordingly, this step “can only be taken after there have been positive Phase 2 results sufficient to satisfy both business and regulatory interests.” Kleinman, 706 F.3d at 163. The FDA then placed the Phase III studies on a fast track. AGC ¶ 42; Def. Deck Ex. 32, at 12. This procedure, too, was consistent with Sanofi’s stated perception that timely FDA approval was likely, as it is “designed to expedite the development, evaluation, and marketing of new therapies intended to treat persons with life-threatening and severely debilitating illnesses.” 21 C.F.R. § 312.80. Finally, in January 2013, the FDA accepted Sanofi’s sBLA seeking approval for Lemtrada. AGC ¶ 50; CAC ¶¶ 18, 61. In light of these actions, and the absence of allegations of concrete facts that put defendants on notice that timely FDA approval was unlikely, the AG Funds plaintiffs have failed to adequately plead that defendants’ stated opinion that timely FDA approval was likely was “objectively false.” Fait, 655 F.3d at 110. 2. Scienter As Judge Lynch has aptly observed, where plaintiffs allege a false statement of opinion, “the falsity and scienter requirements are essentially identical” because “a material misstatement of opinion is by its nature a false statement, not about the objective world, but about the defendant’s own belief.” Podany, 318 F.Supp.2d at 154. Thus, defendants act with scienter “[i]f the management knows that certain facts will necessarily prevent the regulatory approval ... and conceals these facts from the investing public.” AstraZeneca, 559 F.Supp.2d at 470. But there is no scienter if “the management of the company releases positive reports about the drug to the public along the way which the management honestly believes to be true, and where there is no reckless disregard for truth.” Id. Here, for much the same reasons that the AG Funds plaintiffs have failed to adequately plead falsity with respect to defendants’ projections about FDA approval, they- also fail to adequately plead scienter. The AG Funds plaintiffs emphasize that defendants knew about the design shortcomings in the Lemtrada clinical trials and the heightened burden of proof that followed from it, yet failed to disclose that interim feedback, and were aware or recklessly failed to appreciate that the absence of such a disclosure made their optimistic projections about FDA approval false and misleading. See AGC ¶¶ 79-80; CAC ¶¶ 81-84. But the inference of scienter does not follow from the fact of nondisclosure. The law did not impose an affirmative duty to disclose the FDA’s interim feedback just because it would be of interest to investors, see Resnik, 303 F.3d at 154, and “[t]he mere allegation that defendants failed to disclose [relevant information] does not in and of itself constitute strong evidence that they did so with scienter,” Fort Worth Employers’ Ret. Fund v. Biovail Corp., 615 F.Supp.2d 218, 226 (S.D.N.Y.2009). Instead, to adequately plead scienter, plaintiffs must also provide sufficient factual allegations to indicate that defendants understood that their public statements were inaccurate, or were “highly unreasonable” in failing to appreciate that possibility. Novak, 216 F.3d at 308. For the reasons noted earlier, the AGC and CAC do not clear this hurdle. The complaints do not plead a factual basis on which the Court can infer that defendants did not believe their statements about the likelihood of timely FDA approval. And the FDA’s statements and actions known to defendants were by no means inconsistent with defendants’ stated optimism. Viewing the circumstances, as pled, in totality, an inference of scienter is not plausible, and the inference that defendants intended to mislead is not “at least as compelling” as the alternative inference, namely, “that defendants did not know, and had no reason to know, that the FDA would initially” reject the sBLA for Lemtrada. Biovail, 615 F.Supp.2d at 228. 3. PSLRA Safe Harbor The PSLRA safe harbor presents a final barrier to sustaining the AG Funds plaintiffs’ challenge to this first category of statements. The six statements about FDA approval are classically forward-looking — they address what defendants expected to occur in the future. See Kovtun v. VIVUS, Inc., No. 10 Civ.