Avid Bioservices Inc (CDMO)

[Protector]

biopharm, the strange thing is that STOPPING SUNRISE now, from an FDA perspective if not different from stopping it in DEC 2016.

PPHM may do the BLA if they want. If they can CONVINCE the FDA of the anomaly and show the Bavi arm performed as planned and sta. sig. they will get approved. That is why the IDMC only gives advice. If it would have been a STOP for efficacy then also approval is not guaranteed, the sponsor must always go through the BLA procedure.

With the PII being a registrational trial and PPHM under the Fast Track being able to discuss the PII part of the BLA (incl. salvaging data), it is well possible that the FDA agrees with some form of confirmation data from SUNRISE.

I think that the phrase in the PR that Bavituximab performed as per trial design is NOT by coincidence. That plus PII results could be sufficient for the BLA to pass.

But in all cases I keep believing PPHM accepted this STOP advice so easy that I cannot undo myself from the impression that they only wanted to break in early in the SUNRISE data.