Glad that Lykiri pointed out that this is not just LG, but NWBO as a company spinning this crap
“spinning this crap”. No ex, that is not my opinion. I agree with the court.
Chad A. LERNER, Plaintiff, v. NORTHWEST BIOTHERAPEUTICS, et al., Defendants.
United States District Court, D. Maryland, Southern Division.
Signed March 31, 2017.
v. Efficacy of DCVax Products Finally, Plaintiffs object to Defendants' statements made at the January 13, [273 F.Supp.3d 592] 2014 BioTech Showcase and, to a lesser extent, the January 12, 2015 BioTech Showcase regarding the efficacy of DCVax products in general. ECF No. 22 ¶¶ 50, 78. Plaintiffs claim that "neither DCVax-L nor DCVax-Direct had demonstrated an 80+% response rate in any well-designed clinical trial," and "neither DCVax-L nor DCVax-Direct had demonstrated a 1-½ year extension in median overall survival or progression free survival over standard of care in any well-designed clinical trial." ECF No. 22 ¶ 50. Plaintiffs further state that "NW Bio had no evidence from well-controlled trials showing any `extensions of the time to disease progression, progression free survival, and extensions of overall survival in the realm of years.'" Id. ¶ 79.
These claims are either flawed or suffer from a lack of clarity. If, for example, Plaintiffs are alleging that NW Bio falsely reported a greater-than-80% response rate for DCVax, Plaintiffs may have stated a claim. However, in their Opposition, Plaintiffs merely explain that "these representations were misleading not because of what they affirmatively stated, but because of the adverse interim Phase III results they omitted." ECF No. 28 at 40. Plaintiffs fail to show how this is an actionable omission, as they do not adequately plead facts demonstrating that an interim efficacy analysis took place or what such analysis revealed. Indeed, the only reasonable inference with respect to these allegations, as stated, is that Plaintiffs disagreed with Defendants' methodology, interpretation of the data, or expressions of optimism. In that regard, they fail to allege how these statements are false or misleading. See Padnes v. Scios Nova Inc., No. C 95-1693 MHP, 1996 WL 539711, at *5 (N.D. Cal. Sept. 18, 1996) (holding that "[t]he fact that plaintiffs disagree with the ... researchers and with defendants about the import of the ... data does not make defendants' summaries of the study false or misleading."); In re Pfizer, Inc. Sec. Litig., 538 F.Supp.2d 621, 631 (S.D.N.Y. 2008) (noting that "`corporate officials need not present an overly gloomy or cautious picture' so long as `public statements are consistent with reasonably available data.'"); ATSI Commc'ns. Inc. v. Shaar Fund. Ltd., 493 F.3d 87, 99 (2d Cir. 2007) (stating that allegations in securities fraud claims "that are conclusory or unsupported by factual assertions are insufficient.").
Plaintiffs additionally object to the following statement from Defendant CEO Powers: "In terms of efficacy, again, we are still in clinical trials, we have to see how the further trials read out there [are] no guarantees, but [what] we've seen up `til now has been quite encouraging.'" ECF No. 22 ¶ 78. This is quite unlike the defendant's statement in In re Medimmune. Inc., cited by Defendants, ECF No. 26-1 at 27. in which the company Vice President stated: "There's absolutely no question about efficacy," in regards to defendant's drug Respivir. There, the Court held:
It is one thing to declare enthusiasm about the results from this study and the implications for preventing this serious illness, ... [or] that a high dose of Respivir significantly reduced the severity of RSV and significantly reduced the frequency of RSV related hospitalizations. It is quite another thing to make a statement that falls into the second category of arguably false or misleading statements, i.e. that Respivir was unquestionably efficacious. In re Medimmune. Inc. Sec. Litig., 873 F.Supp. 953, 967 (D. Md. 1995). Here, Defendants did not represent that DCVax was "unquestionably efficacious," nor do Plaintiffs allege that the reported results in the presentation were false.
Therefore, the Court cannot find that Plaintiffs have stated a claim with respect to the efficacy of DCVax Products.
AI
