EISid18, I'll try, but it is Friday :)
Actually your question or observation is one of the more interesting. I never gave that a tough, although in several posts I have been mentioning the provision or pro-active behaviour of PPHM in relation to either outperforming control arms or impact of a SOC change during the SUNRISE trial.
I am going to do a HUGE SPECULATION because I have no other way to respond to this question because only PPHM knows the exact details.
If PPHM had a sub-group just in case the control arm would outperform (Shan) and they anticipate a SOC change during SUNRISE (Garnick) then:
1) Garnick will NOT have anticipated a SOC change WITHOUT ALSO being able to say WHAT drug would be the cause or would probably be able to become the SOC. Today for us, and maybe already in the past for the real pro's like Garnick that was Opdivo (On ASCO 2013 I personally thought of it as a hype but I think everybody will agree that it was not a hype AT ALL. It is there, it is approved and it is sold and on billboard from the ASCO to the airport (North :).
2) 1st ln NSCLC is a clinical trial that must have surprised PPHM (and everybody else) because Bavituximab puts down a world record and, coincidentally, so does the control arm. I remember that at the time Shan was the most 'hit' by that in "unbelieve". So I can understand that they learned and pro-actively did something for SUNRISE.
3) The dose switching may certainly have been the catalyst followed by AGAIN a 4th anomaly with the randomising of Pancreatic. If you'd want to do that randomising over again statisticians will tell you that it is very unlikely that you manage to create such a drastic imbalance in sick patients in the Bavi arm and healthier patients in the control arm again. So after 3 MAJOR incidents in which Bavituximab performs perfectly and your clinical trial gets messed up every time because of some anomaly or advantage for the control arm I figure Garnick, but also the leyman, must have sniffed that something is STATISTICALLY WRONG.
4) I think that in the MASTER PLAN PPHM should have been out of business since along time. Actually Q4/2012 or H1/2013. But ATM and later Avid revenue and PPHMP saved the day. If PPHM does a REVERSE SPLIT and the SHELF REMAINS (=is not split) then BP knows they will NEVER STOP them again because PPHM will pre-fund and then AstraZeneca will be the game-breaker with Durvalumab. AZ has NOTHING to loose. They already LOST part I of the Immuno-Oncology Muli-billion dollar market to BMY/Merck. Actually BP has ALL interest that PPHM could NOT reverse split by bringing the PPS to 2 or 3$ but the question is can they produce that kind of multi-dimensional forward thinking? BP is conservative and used the remedies they know.
So my conclusion given all the above is that the SUB-GROUPS as well as the SOC CHANGE provision in the SUNRISE trial took into account the eventuality of these events. And my theory is that you do not build a door on the hen-house to keep the fox out and then leave the door continuously open during the night.
And I know I got much criticism on my theory about a BLA request for the NSCLC study AFTER the SUNRISE stop ...BUT... the sub-groups and the in-FDA SUNRISE protocol approved SOC change provisions are THE DOOR OF THE HEN-HOUSE. Why are they there when, if the eventuality occurs, it is not to use them? Then PPHM might as well not have included all those pro-active measures.
So the ONE SENTENCE REPLY to your question is: PPHM anticipated control arm out-performance and SOC change and build in UPFRONT counter measures in the FDA protocol and got them approved.
If PPHM does/would NOT use these provisions than it is for pure strategic/commercial reasons AND IMO (In My Opinion, an ASSUMPTION, SPECULATION) because they have a BETTER ALTERNATIVE on the table. Whatever that might be because that could be MANY things :)
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