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Biotech / Medical : Provectus Pharmaceuticals Inc. -- Ignore unavailable to you. Want to Upgrade?


To: Mammon who wrote (11171)4/24/2012 11:26:59 AM
From: NTTG2 Recommendations  Read Replies (2) | Respond to of 13111
 
I think this is the first time you have read 'Using the recommendations that we received from senior FDA officials regarding patient population and primary endpoint, we are requesting SPA review of our protocol. While the review process could occur in as little as 45 days from the date of submission, we expect it will be an iterative process, and thus, more time may be required to work with the FDA on a study design agreement.'

Since the SPA is an all-or-none review process, MGT is clearly signaling that they are not confident that they will get the SPA on first submission.