jbainseky, although I also think they will communicate the 1st look-in I do not agree that they have too if the DMC advice does NOT impact the projected planning.
1) CONTINUE: Would change nothing for investors. We have been told End of Trial in DEC 2016 and as long as that goes PPHM has no/is under no obligation to give us progress reports.
2) STOP ORDER: For ethical or safety reason on the other hand would ALL change what PPHM has announced, namely End of Trail in DEC 2016. So that WOULD BE material events that investors need to know because it speeds up apporval or makes approval impossible.
3) STOP ADVICE: For futility or efficacy is at PPHM's choice. If they IGNORE the advice and continue the trial then no need to communicate. Nothing changes. If however they take the advice and stop the trial then that again is a material event that changes DEC 2016 that they announced.
PPHM could ignore a futility advice because they know about Bavi's latency in some conditions and want to give it time or increase patients as some BP's have done in the past. Or they could ignore an efficacy advice because they want to establish a stronger new SOC by letting the trial run to the end. They probably will never ever do either but just as an example.
So there is no straight answers, IMO, as to when PPHM must communicate the first look-in. It all depends on what it is and what they do with it.
They may consider NOT communicating a first look-in to be a strategic advantage by which they could surprise their competition who is waiting for the 1st look-in thinking that one will never be a STOP advice.
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