Avid Bioservices Inc (CDMO)

[RRdog]

Entdoc,
IMHO the key is partnering needs. The FDA does not historically stand in the way of phase III if all safety and efficacy requirements were met in phase I and II in a disease that is a deadly unmet need.

Since this can not be a randomized, placeboed trial which is the gold standard, PPHM must have very clearly delineated guidelines from the FDA and preferably an SPA to make the kind of partnering deal they want.

Let them take their time and get it right

Just my opinion

RRdog