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Re: Pyrrhonian post# 53409

Thursday, 02/11/2016 12:07:15 PM

Thursday, February 11, 2016 12:07:15 PM

Post# of 826312
Quote:

So even if you are not of the opinion that PFS & OS diff will be very robust .... just hypothetically in the case that PFS & OS diff are very robust .... then, in that instance, do you think the odds of approval would be favorable?



It's not obviously yes? Of course! But what is very robust? FDA has expressed "a doubling of PFS."

If this placebo group will do a little better than IMUC's (10.1 months mPFS), say around 12 months mPFS, DCVax-L group will need to be 24 months mPFS. You actually think that's reasonable to expect?

What are the odds of that if the therapy is ineffectual (my assertion)? Like 1 in 100,000. --- Pyr



I think it is obvious that OS is doing well in this trial, from Dr Liau comment that "everyone is living longer". So I think OS is robust. (Probably even "very robust" in certain subgroups).

Do I think mPFS of 24 is reasonable to expect? Hard to say, but I think it is feasible. Might land somewhere between 16 to 24? Perhaps better than 24.

Your assertion is that the therapy is "ineffectual"? As in: the treatment would have no effect whatsoever?? That is a pretty negative view (especially considering what you thought about the treatment just mere months & years ago). Zero effect? Really? I think your assertion of "zero effect" has odds of perhaps 1 in 100,000.

(RUSL .... interesting).
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