Avid Bioservices Inc (CDMO)

[ststephensrevenge]

+++I would argue it set us back 3-4 years.

As it stands today, that appears to be a reasonable assessment.

What bothers me most is that PPHM IR was stated as saying that the "FDA was lending a sympathetic ear" and yet only awarded Peregrine a vanilla Phase III go ahead.

-No AA
-No Breakthrough Designation
-Not even an early look...someone correct me if I am wrong on this one

The FDA had/has an opportunity to rectify the damage that this one individual has wrought and chooses to sit on their hands.

If we know all there is to know about the Phase III protocol as we currently understand it, then the outfit behind what occurred hit a grand slam. I have a big problem with that given the fact that the FDA could have and should have employed a reasonable amount of logic, looked at the results objectively of this very sick patent population and said...."You know what, given the safety profile, survival outlook and results of the 3mg group...go ahead and start helping people now while you run our agreed upon Phase III.

That apparently hasn't happened...and that bugs me beyond belief.

Did Garnick and King not even lobby for this? I can't imagine why they wouldn't.

Maybe it is in the making, but as usual we are kept in the dark.