Replies to post #258456 on Avid Bioservices Inc (CDMO)

[biopharm]

The sabotage by CSM in Fargo in ND may have settled the lawsuit and yet, get rewarded for a job well done. Lots of IO trials running through this network now

March 9, 2016
CSM Announces Partnership With IMP to Deliver Clinical Trial Supply Services Globally

http://www.prweb.com/releases/2016/03/prweb13254119.htm

[pphmtoolong]

JamesGMS, believe me I am much poorer due to the Sunrise results. I don't characterize the results as a flop with any pleasure whatsoever.

However, I have to call it the way the IDMC calls it. In this second line NSCLC Phase III trial, Bavi did not help patients enough to merit continuing the trial.

So, at this point there is no evidence that Bavi will get FDA approval for anything. No approval, no sales. No sales, no value.

Bavi is not done yet, but it has not proved the anti-PS approach has any practical value. So neither does the IP.

In view of that Peregrine is in crisis mode. Not enough money to fully fund the company for the additional years now required to prove Bavi and the anti-PS platform have value.

I am very happy to point out that Avid may have the potential to carry Bavi and Peregrine until we get irrefutably good news from the clinic.

If Peregrine management has the sense to drastically reduce development expenses until an expanded Avid can carry the load, we may be OK. I don't like to think about the devastating dilution if they don't.

Paul

[entdoc]

James, you wrote, "Sunrise most certainly did not flop in any way, shape, or form. The Treatment Arm performed as expected - while the Control Arm blew away all expectations and historical norms going back decades..."
We need some real numbers to establish your assertions here, and I have no recollection of seeing those numbers. I don't remember the "blow away, and going back decades". Without specifics it maybe can be assumed that Bavi performed a couple months better than historical norms for Doce (which makes that part of the pr true) but it did not (apparently) perform better than placebo (which is probably also the case).
It is known that other placebo trials are now "outperforming" THEIR historic norms. That is, for some reason placebos are performing better than ever, and the more convincing the blinding of the placebo controlled study; the more "therapeutic" the treatment environment (e.g. IVs, modern medical equipment); and the more scientific the treatment environment appears to the patient, the better placebo groups seem to do. Finding a difference in the background and therapeutic milieu between Bavi-treated and Doce + placebo will not be easy, and finding Bavi in the placebo is truly a case of lightening striking twice.
If you recall, "spare-the-mice" left this board at about the time we had a healthy discussion here about the possible futility of using an immuno-stimulant such as Bavi with a cytotoxin such as Docetaxel. How can one expect activated monocytes (for instance) to reproduce when cell division is being discouraged and actively reproducing cells are being poisoned? Some stockholders have sat back and said maybe they will be right for all the wrong reasons, which often happens. It was a long shot from the beginning IMO. I'm waiting for Bavi + irradiation; and Bavi-labeled imaging agents, to mention only a couple realistic application for the science.