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Re: Gulfbreeze post# 6967

Wednesday, 11/12/2014 9:25:44 AM

Wednesday, November 12, 2014 9:25:44 AM

Post# of 9944
Not going to get in a great debate. Nobody has a crystal ball. Again my concern is that the management of PVCT is simplistic and somewhat naive. I totally agree referring back to the BTD disaster is simply rehashing old news and is rather redundant. However given the lack of success of larger pharma corporations to obtain a BTD designation why did the mgmt. of PVCT think they would be successful? It gives the appearance that PVCT management was trying to score a touchdown on fourth and long. Even if the FDA had told PVCT to go for it if that was what PVCT wanted maybe PVCT management should have rethought the odds against them and discussed with the FDA the path to a protocal for a phase three study.
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