Avid Bioservices Inc (CDMO)

[Protector]

krug, if you unblind the trail stops (incl. the MOS table build-up) and all patients that are not death (evented) are censored.

So if you have many survivals at the moment that you end the trial you will have a large group of censored patients. That doesn't mean anything because you don't know if those patients were enrolled a few weeks before end of trial or two years before end of trial.

PPHM can then follow up further, such as start look-in in detailed data that was not available to them before unblinding, etc. With that they can start making final results and finish their BLA. They have a fast Track, so ALL bavituximab history that needs to be in the BLA could be filed starting in Q1/2013 (when they got the fast track - by memory) and FDA accepted. So the last data of SUNRISE (the results) need to go in their. The FDA has 6 months to approve UNLESS we get an accelerated review (then it is 2 months). We do NOT have an AR now and the next window to apply would be at unblinding (or unblinding due to an early halt). FDA replies within 6 weeks. We have seen lately they can do it in 3 days also :)

So your official MOS table stops when the trial is unblinded.