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Re: teetertodder post# 227511

Sunday, 07/26/2015 12:52:35 PM

Sunday, July 26, 2015 12:52:35 PM

Post# of 346183

2. and has a primary endpoint of response rate, which should be able to measured quickly based on blood chemistry and microenvironment changes per BAVI's MOA


Response rate for solid cancers is measured by looking at the tumors and seeing they have shrunk by a defined amount. This concept that Bavi could be approved based on a measured change in some markers and a purported MOA is pure nonsense.

IF we see results similar to pre-clinical (200-300% improvement), why wouldn't that be good enough for approval??


The trial will have a primary endpoint (presumably ORR of Bavi+Opdivo being stat sig vs Opdivo alone). If that hits when the trial is over then approval is reasonable. They will most certainly not just be looking at the results as they come in and say "Look at that immune response!".
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