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Re: Gulfbreeze post# 575

Friday, 12/13/2013 2:37:53 PM

Friday, December 13, 2013 2:37:53 PM

Post# of 9944
When they have their meeting....if they haven't had it already....they will get some sort of guidance.

1.)Outright Approval
2.)Accelerated Approval
3.)Single Arm Trial
4.)Your not ready

If they are given some sort of blessing then PVCT has to file a NDA. Around 60 days or sooner after the FDA receives the NDA the FDA sends an official letter back...and then we find out what exactly was the blessing PVCT got. They will know soon during the BTD meeting what NDA they will file but they are not telling until the FDA sends the approval letter.

I had hoped to hear what nod the FDA gives next week maybe. But it looks like a couple of months. If I see them out and they are dancing an Irish Jig then I will have an idea. Let us look at the press release Tuesday...
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