Replies to post #216858 on Avid Bioservices Inc (CDMO)

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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. So, the ability to combine bavituximab with drugs like, Opdivo, and I’m sure Joe has talked about addl. trials that he’s thinking about. I’m sure in the future we’re going to see these types of combination trials come to fruition, and this will lead to label expansions and one of other very positive things for the development of bavituximab as an oncology agent.