Thursday, June 30, 2016 10:45:01 AM
IF the FDA had needed an AdCom for SequestOx, it would have been scheduled in Apr, May, Jun 2016 which is ample time before their scheduled PDUFA Jul 14, 2016.
A Pharma makes Commercial decisions and plannings that are scheduled for the FDA mandated PDUFA date. For these FDA guidelines to be violated by the FDA would be detrimental against the FDA. Especially when the FDA knew everything about SequestOx in Jan 2016 and nothing changed in the way of any new data since Jan, 2016.
Savvy investors are planning for the FDA SequestOx Commercial approval, with Commercial label on Jul 14,2016!
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