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Saturday, April 09, 2016 12:01:09 PM
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To repeat the obvious if Bavi is so promising, Peregrine should be able to get a favorable partnering deal. If they can't, very likely we amateurs are wrong about Bavi
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There was a 2 billion deal with AbbVie that was derailed by the sabotage. Does that prove that there will never be another deal?
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I'd rather see them lay off the entire development staff and make a profitable future from Avid.
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I think they are trying to get Sunrise approved which would explain why they are not laying off. Is that even possible? How many believed at that time that a failed or sabotaged phase II trial would be good enough to get you into the next phase?
If Bavi performed as expected in Sunrise according to King and then it can be proven that the dramatical outperformance of the control arm was a fluke and you compare Bavi's performance to the historical performance of Doce OR if it is found that there was interference in the control arm that led to its abnormal and unexpected performance then maybe Bavi might get approved. We just don't know.
The FDA, according to his mission statement "is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation."
If the FDA follows his mission then it could conclude that Bavi is more efficient and safer than chemo and Opdivo with its 9 months OS which they are very proud of enough and was approved by the FDA because its control arm had only a 6 months OS. PPHM can then proceed with the commercialization of Bavi or sell it to BP for a huge chunk of money. BP can then choose to either sell Bavi+chemo and charge as much as they would with I/O drugs like Opdivo, shelf it and proceed with they new I/O drugs by themselves or add Bavi into the mix if it helps.
On the other hand, the FDA which is controlled by BP to some extent ( we don't know how large) might bow to BP and then Bavi is not approved. At this point, PPHM can let BP into the fold and see if Bavi can improve the efficacy and safety of I/O drugs like Opdivo. You only need one BP to do this. AZ please step up to the plate or the long suffering shareholders will lose big time. But PPHM management will lose the most because they have by far the most shares.
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