Avid Bioservices Inc (CDMO)

[Protector]

exwannabe, I don't follow the logic here on PPHM's SUNRISE clinical trial.

First look in H1/2016
Second Look in as of H2/2016
Unblinding DEC 2016

While the first two are event driven, the unblinding (which is end of trial) is planned as a fix event and probably only depends on timely enrolment of the 582 SUNRISE patients in the 161 world-wide centers in DEC 2015.

If the second look-in would be a "continue" advice then what the IDMC actually says is: You didn't reach the end-points yet, BUT continue because there is a good case that you will reach them as planned. Otherwise, if that chance doesn't exists and the IDMC see it is hopeless they'll say FUTILITY and not CONTINUE.

The # of events for unblinding is very possibly around 67%. With the hockey stick enrolment and a planning of 3 to 6 months difference between 1st and 2nd look-in on a total difference of 50-33=17% events, the distance to unblinding (67-50=17% too) can never suddenly be 1 year in the future. This last 17% can be reached MUCH faster then the first 17% given the larger number of patients in play thanks to the hockey stick enrolment.


So in a WORSE case this will delay the trial a couple of months, say 3, IMO.

I don't know what it is but I detect, in general, a BIG EFFORT to make the board think all events related to PPHM and SUNRISE and APPROVAL and related PPHM PPS appreciations are FAAAAAAAAAAAR in the future. But OK that changes from the former Bavituximab doesn't work, SUNRISE will never enrol, etc and it makes me believe things may be evolving much faster then we all think on here.