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FatCat_Banker

02/16/14 12:38 AM

#4478 RE: RRRichmond #4477

The negative possibility is that it is terminated due to futility.

I'm not sure what else you want as the good possibilities range boundlessly, and the negative is terminal and singular.

These studies could prove to be inconclusive. Even in such an event, a continuation could still be recommended as safety, the primary consideration, is a foregone conclusion at this point.

If you track these posts prior, they detail the consistency of the trials. It is complex in nature, as it should be, and will have responsiveness seen in aspects and not in others. This is due, as noted by prior posts, to the ambiguous nature of GBM. It will be the majority that rules. Mind you, a third of prior efficacy needs to be seen for a positive ruling and the DMC is likely to rule in favor, within the ethics guidelines, in severe conditions such as these.

I'm sorry for your loss.
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longusa

02/16/14 2:16 PM

#4487 RE: RRRichmond #4477

RRR, so sorry for your loss. I can't imagine how difficult that must be.

Your post is wise. I also have had experiences good and bad that have taught me to not be fully invested into an FDA decision. On this 1st interim, though, the risks I think are minimal (hope this does not come back to bite me), since the only negative outcome is a halt for obvious futility. I don't think we see this as IMUC saw a 'continue' for ICT-107, which turned out to not meet the primary endpoint, though did see stat sig 2 mo PFS benefit. So I think DCVax-L will be doing at least as well as ICT-107.
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flipper44

02/17/14 7:16 AM

#4503 RE: RRRichmond #4477

RRRichmond.


I am very sorry for your loss. Thank you so much for sharing your thoughts with this board.