Avid Bioservices Inc (CDMO)

[nuke661]

windandsea,

can't sleep tonight. I must be way too excited about Rudolph Garnick leading Santa King's sleigh to the island of misfit biotechs' trials so he can distribute Peregrine's Sunrise trial to the world .

I thought I'd but in here. First, I think MD meant months not weeks, but he'd have to answer that for himself. The thing I wanted to chime in on was the Opdivo trial that your post seems to imply is a standard which Bavituximab has to be measured against.

It was made crystal clear in the call and followed up by posts on this board, that Opdivo was approved based on squamos cell lung cancer trial results.

From the call transript provided by CJ-Post 209953

Steve King: Yes, we did get some questions on the comments that he made. There are few things to keep in mind. One is that he was specifically referring to Squamous NSCLC - in fact, those patients are actually excluded from our study, so, we’re in Non-Squamous NSCLC. So, we don’t expect that that will have any overriding impact on enrollment in our study whatsoever. In the broader scheme of things, the question is, does this somehow affect our trial design or in some way impact our overall program? We’re very confident that, and the way we’re going about things, is to focus on the things that we can control, #1. Not that nothing else is going to happen in the marketplace, because you never know, but basically this was the reason we had an End-of-Ph2-meeting with the FDA. We got clearly their buy-off on the trial design which included the comparator arm. So, we’re very confident from our standpoint that we’re on track, and if we have statistically significant positive results in our study, that we should be in a great position for approval.
Rob Garnick: I totally agree, I know Dr. Pazdur pretty well. I’ve worked with him in the past, and I think his comments on the Squamous NSCLC trial with Opdivo are right on. However, as Steve said, we are in the Non-Squamous population, which is a totally different disease. Our agreements with FDA on the Phase III trial design are something that typically FDA is not going to go back on and make changes and disagree with the end-point and trial design. So I think we’re in a very strong position that should the trial be positive, as we would expect, that we will be able to obtain a good approval, relatively rapid because approval for the product because we do have the fast-track designation. So, I’m not worried about that and I also agree that it will have absolutely no effect on the accrual of patients in the trial itself. I do think that with the really great results that have been reported for Opdivo, it makes me particularly interested in combination trails with bavituximab because one of the real advantages of bavituximab is that it has an extremely good safety profile, which is actually highly unusual both in immuno-oncology drugs as well as in chemotherapy drugs in general.

Opdivo Trial Summary

Squamos cell cancers are somewhere in the neighborhood of 30% of the non small cell lung cancers.
Squamos Cell Cancer Info

Bavituximab trials are for NON-Squamos, Non Small Cell Lung Cancers and squamos cell cancers are excluded from the Bavi Sunrise trials.
see trial exclusion criteria

So in summary, Bavituximab is not competing in the same SOC field for NSCLC as Opdivo. Also,Bavituximab's target population is ~70% of the NSCLC population and Opdivo's is ~30% of the NSCLC population. So, Bavituximab+Docetaxel market potential is in no way threatened by Opdivo. Peregrine apparently desires to do a combination trial with Opdivo because Bavi pre-clinical data is starting to make a significant number of researches believe that adding a little Bavi is much mo better than no Bavi at all.

You should also remember (if not remember, should now note) that the PII bavituximab trial (you know, the one the nefarious character Dakota Bitch purposefully messed with) was working towards an MOS of over 12 months until the overly conservative regrouping of trial arms brought it down to 11.7 months.

Hope this answers your main concern.