Avid Bioservices Inc (CDMO)

[biopharm]

So a pair of economists from MIT write an article about how THEY think the FDA should change. Based on that you hang your hat on it as the basis for thinking Sunrise might yet be used for FDA approval. Seriously???

Vinmantoo, you are correct. The FDA is and has been in transition, especially the politics and how they will be approving drugs moving forward. We have already seen the beginning stages of this.... as with BTD and there is more to come but if you know some at the top of CALICO such as Art Levinson maybe you can ask him if that is part of the reason why he leaves Roche : )

Anyhow, I mainly wanted to make you think twice about the role of the FDA. I'll repost your entire post in what I originally responded to and again, I disagree 100% and since the FDA is in transition, how on earth could any new rules of the FDA be disclosed on this board.... when future rule changes would only be known by some with non-disclosure rules. I guess we will have to agree to disagree of the role of the FDA, because their role is not static and ever changing.

You seem to be confused as to the role of the FDA.

The FDA is in transition

My comment was that it would have been prudent for PPHM to rerun another phase II trial was based on the best use of its capital. The phase II trial was corrupted, had a small number of patients and a high number of dropouts. It would have been prudent of PPHM to rerun the trial instead of scaling up and spending a boatload of money on a gamble.

The FDA disagrees with you and so do I. The FDA approved Phase III and Sunrise was given FastTrack. Also... the FDA and Peregrine has learned much more regarding their trials and a BLA filing with over 100,000 pages filed many months ago. We will not hear about the rest until a later time.

I was proven correct as the trial was stopped at the first look. The FDA doesn't care if companies waste their money on long shots or weak premises. Both Sunrise arms had Docetaxel, and no obvious safety issues were known by adding Bavi so the FDA wouldn't block the trial.

You were not proven correct as you seem to be ignorant of the facts of the reasons why Sunrise was stopped. Name 1 trial that a Docetaxel arm exceeded historic norms and the respective biotech drug arm going up against Docetaxel "performed as expected..". Once some light is shed further on those details, then are proven wrong again.

As far as Garnick, it is irrelevant what he said since he was proven wrong.

Again, you were not proven correct so Garnick was not proven wrong.

Besides, the company decided to move forward. Did you expect him to say anything less than glowing and keep his job? So why hasn't he stepped forward to express his confidence in Bavi now? where is he hiding?

We will have to wait for Robert Garnick to step into the spotlight next to find out....

some can say hiding.... some can say working on a masterpiece

I'll finish on this: Do you find it strange that some spend hours just to say bad things and don't look at the positives? I remember Genentech did not even win all their matches and Bristol Myers Squibb losing much top talent to AstraZeneca, maybe we hear of another this week