Replies to post #693204 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

The FDA says that changing the endponts based on information from the trial is a big no-no. And the results of an IA is huge wrt the likelyhood f the initial endpoints failing.

You are a liar you tell lies lies lies. And you are ignorant.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1852589/
When and How Can Endpoints Be Changed after Initiation of a Randomized Clinical Trial?

https://www.researchgate.net/publication/6385936_When_and_How_Can_Endpoints_Be_Changed_after_Initiation_of_a_Randomized_Clinical_Trial

https://www.clinicaltrialsarena.com/features/changing-primary-endpoints-in-clinical-trials-proceed-with-caution/?cf-view
If the original primary endpoint is no longer the most appropriate endpoint due to new knowledge or events, then changing the endpoint may be appropriate, Booth elaborates. However, the reevaluation should occur in conjunction with a data safety monitoring committee and input from trial leadership.

[hope4patients]

FALSE

[biosectinvestor]

No, it was a safety IA, but more importantly and more critical, the results and changes were made by an external, completely blinded, expert team of epidemiologists abd statisticians who created the new protocol and ECA. There was a very meticulous effort to exclude any bias. It was clearly, very painstakingly done and took considerable time.

Moreover, that court case you hate said two important things, that up to the time you always claimed there had already been such an IA, there had not been, it was for safety. Up to that point. Further, and MORE importantly, such an IA would not unblind.

https://casetext.com/case/lerner-v-nw-biotherapeutics

“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.”

All one has to do is to thoroughly read that case to see how absolutely nuts, bat s/it crazy shorts were to make all manner of false and misleading assertions that had zero basis in fact but they had just enough to IMPLY bad faith. Heck, filing the lawsuit and waiting for it to resolve allowed them to go on for YEARS implying false and misleading and nasty things about the company, management and DCVax-L as well as about Dr. Liau, and get away with it.

Shorts are, and if it is not obvious to observers, it should be by now, filled with crazy hot air because as success becomes more and more apparent, they realize that they literally have nothing BUT hot air and implied allegations without basis in substantial truth. Implied allegations always rely on some nut of fact, not necessarily proving the claim, but something upon which they can IMPLY something nasty or unpleasant.

But time and time again. Shorts are wrong.

https://wapo.st/3Ke1J1g

https://www.uclahealth.org/news/article/fda-approval-brain-cancer-alzheimers

[drugrunner]

lol NWBO was never in possession of INTERIM TRIAL DATA..

Another falsehood perpetuated by EX