Replies to post #267924 on Avid Bioservices Inc (CDMO)

[vinmantoo]

cj, thanks, as always. do you really think the FDA is going to approve a drug for a given indication when the trial for that indication was stopped "for futility"? I am not saying it is impossible, but I am saying that I would not buy any more stock on that premise.

You don't have to hedge. It is impossible. The FDA would NEVER approve ANY drug for an indication where the pivotal phase III trial was stopped for futility at the first look in. How in the world can this still be a topic of discussion?

[JamesGMS]

Hello Ent, I think we've touched on this topic before - the following is excerpted in relevant part from your post to CJ:

cj, thanks, as always. do you really think the FDA is going to approve a drug for a given indication when the trial for that indication was stopped "for futility"? I am not saying it is impossible, but I am saying that I would not buy any more stock on that premise. Lightening can strike almost anywhere (but California). IMO there is an extremely slim chance Bavituimab is going to be used OR approved for treatment of advanced lung cancer. It simply does not make sense to me.

Advances in the treatment of cancer - at least when discussing what a BP can sell - are almost always {at least so far} measured in "very small" incremental MOS steps - which equates to months - sometimes only weeks - or sometimes even just an improved AE profile with no real increase in overall survival.

That is why a drug such as Opdivo can be approved - and on an accelerated basis - with just a two month MOS increase over best historical SOC results. So of course Opdivo presents "no cure" for the malady - in this case lung cancer - but rather, just an incremental increase in overall survival - with its own set of AE's - and only for that small footprint of lucky folks who actually respond to the treatment.

So if Bavi "performed as expected" as CJ reiterated, and achieving that expectation was designed by Dr. Garnick to allow the FDA to grant approval - as CJ also reiterated - then Bavi most certainly should be approved.

Re your "futility" statement above: If the Sunrise trial had simply seen a control arm result {9.4 months} exactly the same as seen in the Opdivo trial, do you have any doubt that Bavi would not be approved RIGHT NOW ?

Ent - I can understand your reticence to buy any more stock at this juncture given your concerns, but let me correct you on one important point - lighting can indeed strike almost anywhere - including California. I've lived in California all my life and have watched in awe many times as lighting fills the skies over the entire Bay Area - and as a very young man I've even watched a bolt of lighting strike a swimming pool just a mere twenty yards from where I was standing - and just seconds after my parents had instructed myself, and about four other kids, to get out of the pool. I'm glad they were paying attention : )

Enjoy the rest of your weekend.

James