Replies to post #437086 on NorthWest Biotherapeutics Inc (NWBO)
01/20/22 1:34 PM
01/20/22 1:39 PM
01/20/22 1:40 PM
01/20/22 1:43 PM
What happened back in 2015 was likely
01/20/22 1:45 PM
01/20/22 2:58 PM
01/20/22 4:29 PM
Plaintiffs' additional argument that Defendants were trying to "bury" interim efficacy results is undercut by the record itself. A review of the record in its entirety leaves as the only reasonable inference that the data monitoring committee had reviewed only safety data from the Phase III trials, not efficacy data. ECF No. 22 at 34 ("We had a safety-only evaluation . . . by the Data Safety Monitoring Committee"): 35 ("Up to now. the assessments have only been safety, so this will be the first assessment for efficacy"). Plaintiffs do not establish how Defendants deliberately withheld or concealed information with respect to the interim review.
Accordingly. Plaintiffs" claims related to the Interim Analysis of the DCVax-L Phase III Trial by the are dismissed.
B) Whatever happened then, NWBO knows it. If the FDA had said anything to the effect that the trial doing so well no new patients are needed then NWBO would know they had a home run with the trial as of then. They would not been changing it to alternative endpoints and dragging in on 5+ years past when TLD would have been expected (even without an early efficacy halt). [/I]
C) Companies PR home run TLD as fast as they can for good reason. It does a lot more for advertising than tote bags. There is a reason why nobody has found a concrete example of a dev stage bio with positive P3 data not shouting it at withing a few months.
D) The attempt to change endpoints is post-hoc. Some here think that datalock is some hardline. It is not that simple. Changes to endpoints cannot be based on information from the trial. NWBO has significant data from the trial. The FDA action is huge. The blended data. The crossover numbers (that could worry them that the arm-arm OS comp would have problems). And that is only the certain known data.
E) Related to A), the fact that NWBO has been in a 7 year quiet period wrt the planned 2015 IA. NWBO had no problem going to war when they accused of hiding a bad rec in 2014. They had no problem subsequently talking of an efficacy IA in 2015. Then radio silence.
iii. Interim Analysis of DCVax-L Phase III Trial by
Plaintiffs next allege that Defendants" statements made in the March 7. 2014 press release. April 1,2014 annual report on Form 10-K. and December 10. 2014 Oppenheimer 25th Annual Health Conference regarding the interim analysis by the were materially false or misleading. ECF No. 22 ¶¶ 54, 56, 76. Plaintiffs allege that "the review of efficacy data by the DSMB was not pending and would easily have been completed" and Defendants "omitted that the Company did not need a formal interim analysis to make a ballpark assessment of efficacy."' ¶ 52. Plaintiffs further state that "the assertion that the analysis remained 'outstanding* falsely implied that it was in the process of being completed, when in fact it was either completed and buried, or the had been directed not to complete it." Id. | 57. Plaintiffs also claim, with respect to the January 12. 2015 remarks, that "the interim review was not scheduled to commence in 2015 but in fact had commenced in 2013 and required only a few weeks to complete." Id. 1 79.
It first bears noting that Plaintiffs cite to a December 13. 2013 press release which explicitly states, "The Company does not participate in the interim analysis process or the assessment, and both the Company and the clinical trial sites remain completely blinded." ECF No. 26-6 at 5. Thus, it is unclear from the Complaint how Plaintiffs attribute the alleged shortcomings of the safety board review to Defendants given their stated lack of involvement. But more importantly. Plaintiffs rely on the unfounded "expert" opinion of Dr. Richard A. Guarino for their contention that "there is absolutely no reason why an interim analysis could not be completed within a few weeks." ECF No. 22 \ Al. Plaintiffs may not substitute factual allegations with the speculation of their expert witness. See Fin. Acquisition Partners LP v. Blackwell 440 F.3d 278. 285-86 (5th Cir. 2006) ("allowing plaintiffs to rely on an expert's opinion in order to state securities claims requires a court to 'confront a myriad of complex evidentiary issues not generally capable of resolution at the pleading stage.* In addition, considering such opinions might require ruling on the expert's qualifications."): DeMarco v. DepoTech Corp.. 149 F.Supp.2d 1212. 1222 (S.D. Cal. 2001) ("Conclusory allegations and speculation carry no additional weight merely because a plaintiff placed them within the affidavit of a retained expert.").
The gravamen of Plaintiffs' objections regarding the interim review by DSMB appears to be that it took too long, or that Defendants somehow delayed announcing conclusive results, or concealed the results altogether. But ""Defendants, like any other company wishing to publicly discuss the results of a scientific study, had to make a judgment as to which specific bits of information about the study and its conclusions to disclose." Padiies v. Scios Nova Inc., No. C 95-1693 MHP. 1996 WL 539711. at *5 (N.D. Cal. Sept. 18. 1996): see also In re Human Genome Scis. Inc. Sec. Litig, 933 F. Supp. 2d 751. 761 (D. Md. 2013) (noting that "[w]hile it is possible to infer that. .. executives deliberately omitted facts ... in order to hoodwink investors, it is just as plausible, indeed more so. to infer that they only offered vague details about the study because it was ongoing."). Plaintiffs here do not "plead facts sufficient to explain why the defendants' summaries [or lack thereof| of the study were false or misleading." //; re Rigel. 697 F.3d at 979. Plaintiffs' additional argument that Defendants were trying to "bury" interim efficacy results is undercut by the record itself. A review of the record in its entirety leaves as the only reasonable inference that the data monitoring committee had reviewed only safety data from the Phase III trials, not efficacy data. ECF No. 22 at 34 ("We had a safety-only evaluation . . . by the Data Safety Monitoring Committee"): 35 ("Up to now. the assessments have only been safety, so this will be the first assessment for efficacy"). Plaintiffs do not establish how Defendants deliberately withheld or concealed information with respect to the interim review.
Accordingly. Plaintiffs" claims related to the Interim Analysis of the DCVax-L Phase III Trial by the are dismissed.
v. Efficacy of DCVax Products
Finally. Plaintiffs object to Defendants' statements made at the January 13. 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 fflf 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 1-1/2 year extension in median overall survival or progression free survival over standard of care in any well-designed clinical trial." ECF No. 22 11 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.
"The Company remains blinded to all Trial data, and is only receiving and reporting updates on a blinded basis."
When Data Lock is reached, the independent statisticians will be given access to the unblinded dataset. The Company will remain blinded while the statisticians make the computations, converting the mass of raw data from the trial into formal tables and listings, and survival and progression measures, to report the trial results.
The bull argument always winds up with stuff like secret FDA actions, being afraid of the bears, setting traps for shorts and afraid of big bad BP.
01/20/22 9:45 PM
Additional details of the interim analyses will be provided in the DMC Charter and the statistical analysis plan (SAP). If significance is between 0.01 one-sided and 0.05 two-sided, this will be considered as very strong evidence of benefit conferred by DCVax-L.
“Hypotheses and analytic methods for these endpoints are specified in the Statistical Analysis Plan (SAP).”
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