Oct. 23 at 11:22 PM
$IOBT Seeing DOR graph (about 42% of ITT population stll in response at 18 months and curve already flat in Cyl. arm) you see that OS can be stat. sig or very very close to it, even with the few number of events pre-specified in protocol. Market has seen that. Don't think at all that the Company will end bankrupt.
BUT this trial has three issues. Two that we know (narrowly missed stat. sig in PE, and just 17 US patients). And a third one that I see clearly appearing now. Hassel said it in an interview, and it was also stated in a paper @badprecog posted. MOA is not fully clear, translational analysis needed: how did the effect happen in PDL1-? It wasn't clear in Phase 1/2. And, why did it work so bad in PDL1+ if in H&N has worked so well in PDL1+ -even lung has been better?
Too much noise and two subgroups to extract in a new trial: pretreated (9% of patients) and acral-mucosal (ab 5% of patients).
If OS hits, may be Conditional marketing by EMA with a confirmatory trial.
