Replies to post #132684 on Avid Bioservices Inc (CDMO)

[sulaco]

EBS, we'll get there because

Bavi plays too well with other regimens. In my exposure to the nuances of BP, this fits the oncology field well.

The oncology field is essentially a conservative one. Believe it or not, they don't like change. OK, maybe a little, and I better get more money out of it. If it helps patients (a little), then that's good, too.

Oncology is all about SOC. It takes a while to change SOC. It takes a while to change attitudes. It doesn't happen overnight. Doctors are a conservative bunch. Oncology doctors are a super conservative bunch.

I doubt very much it'll take your time frame for Bavi to take off. Immunologicals are the "newest" addition to SOC that can fit right in to established regimens. They don't steal the show, they just make it more expensive, and do help patients. In other words, they're perfect.

Best,

Joe

[geocappy1]

I somewhat agree. Some talked about the FDA sympathizing but I am not so sure. They approved our phIII but if there is no accelerated pathway they worked hand and hand with BP to stall us what could be up to 3-4 years. So everybody says thanks for the approval FDA but unreality if we don't get a lookin then they screwed us in favor of BP. IMO it would be typical government/big business corruption.

[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.