Replies to post #275839 on Avid Bioservices Inc (CDMO)

[biopharm]

Looks to me that the FDA GAVE THEM PERMISSION to "data mine" for bio markers ( one of which was B2GP1 } - WHY WOULD THEY DO THAT if not to further an approval process for the Sunrise trial ?

The FDA certainly knew before hand what Peregrines intentions were and the FDA is on a new path to shorten trials, reduce patients in trials as much as possible, increase safety and efficacy and it looks like the FDA has a perfect opportunity here to do all that with PS Targeting biomarkers that allows a blood test to check for a biomarker that would help 30% of all lung cancer patients, just for starters till betabodies comes online and sounds like CP will be correct .

...With the biomarker PPHM could single out about 30% of them (about 70,000) and offer them a better solution then SOC and where overlap with Opdivo a better/safer solution then Opdivo alone. For patients as well as insurance companies a Docetaxel + the ASSUMED 30K$ for Bavituximab would be a Hillary-grade acceptable treatment price compared to the 150K$ for Opdivo, the almost guaranteed relapse withing 2 years (hence all the criticising on those Opdivo commercials and a EU unwillingness to largely approve it). On the contrary, Bavituximab will help prevent relapse.
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It is my personal believe that PPHM will adjust the BLA filing to get approved for the 30% of ß2GP1 identifiable patients and that they will not file for the complete target population because Sunrise didn't confirm PII for that population due to the over-performing control arm. I do however NOT exclude that they'll file a BLA for it ones it is established what the cause of the out performance was and depending on what provision Dr. Garnick has put in the FDA approved Sunrise protocol as PPHM has disclosed.

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