Replies to post #277198 on Avid Bioservices Inc (CDMO)

[Protector]

Wernaaa, not sure if you had the news of the PPHM Annual and the composition of the data set on which the disclosed results were based?

You are siting one of my posts from BEFORE the Annual and before we came to learn that PPHMs new composed data set was not only based on the data obtained in the blinded part of the clinical trial but also AFTER. This makes the data 'not fileable'. Not for the 30% (because it isn't stat.sig. if you only used the data till first look-in) and not for the complete set because whatever provisions may have been in the Sunrise protocol for control arms, the data isn't stat. sig. either if you may only consider the blinded part.

So the BLA for the 2nd ln NSCLC will certainly be filed at some point BUT PPHM will have to do something extra. Possibly a confirmational trial if that is in the plans or partner NSCLC and let the partner do the confirmational trial.

Since the data is GOOD for PPHM to make decision and to know that Bavituximab works, while not for the FDA due to the fact that part of the data was obtained after unblinding, the data is ALSO good for partner negotiations.