Avid Bioservices Inc (CDMO)

[exwannabe]

JJ, or anyone, can the salvaged data from Sunrise be used with the FDA? Obviously management will use what they can when working with collaborators, but will the FDA even regard the data?

No.

Sometimes a company will go to the FDA after a failed P3 trial to discuss a path forward in the indication. In such a case it is more like the end of phase 2 meeting where they are discussing how to design a new P3 based on what they saw.

But in this case, PPHM has made it fairly clear that the particular pathway (chemo + Bavi in NSCLC) is dead. No need to discuss with the FDA how to not proceed.

The dataset would be used for safety purposes with the FDA if they manage to have success down the road.

BTW, it would not be "salvaged" data. It is just data from a trial whose primary endpoint failed.