News Focus
News Focus
icon url

Doc logic

08/01/22 10:41 PM

#500225 RE: meirluc #500190

meirluc,

I believe the 17 missing SOC/placebo make it more likely that many of those 35 were censored early crossovers from after the halt that they do not want to discuss yet because of what their outcomes might imply about the ramifications of potential combo use or other. That kind of data, if brought into consideration, would have a tendency to indicate things that go beyond the scope of this trial and possibly present an absolute need for ECAs. FDA needs to be presented data that can not be used to say their hand was forced into doing something and that, I believe, may have put NWBO and it’s investors in the position we currently face. I believe that the top line data we have received falls far short of explaining critical details about this trial that are being carefully protected to prevent potential litigation of “the process” by those who are watching for any slip up they might utilize to challenge results and conclusions. Best wishes.
icon url

antihama

08/02/22 5:46 PM

#500536 RE: meirluc #500190

That's good food for thought meirluc but wouldn't it be more advantageous for NWBO/Statistical Significance if they used all of the ITT placebo group including, as you point out, the 33 that are probably sicker than the 64 who crossed over? So I don't think they are trying to pull the wool over the Journal's eyes. And the External Controls were pre-specified in the SAP which I assume was discussed with the Regulatory Authorities.
icon url

biosectinvestor

08/02/22 11:30 PM

#500599 RE: meirluc #500190

I don’t think it would make sense to include those patients as treated patients when they never received any DCVax-L. They were placebo arm and I would expect they would be used as a kind of additional measure against the ECA, and not counted with the actually treated patients.