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Re: loanranger post# 139633

Wednesday, 02/10/2016 6:58:14 PM

Wednesday, February 10, 2016 6:58:14 PM

Post# of 402606
From an FDA blog post - essentially FT for B-ABSSSI, under QIDP, is theirs for the taking. Cellceutix just has to apply for it, when not if.

Btw, would appreciate it, if doable, if you could link to todays full Sullivan filing like you've done in the past. I'd love to read the dets.

//

Provisions in a law passed a little over two years ago, commonly known as the GAIN Act, or the Generating Antibiotics Incentives Now Act, is helping to stimulate the development of new antibiotics. Under GAIN, certain antibacterial or antifungal drugs intended to treat serious or life-threatening infections can be designated “Qualified Infectious Disease Products” (QIDPs). **As part of its QIDP designation, a drug receives priority review and can also receive fast track designation at the sponsor’s request.**

http://blogs.fda.gov/fdavoice/index.php/2014/07/fdas-multi-pronged-approach-helps-meet-the-challenge-of-bringing-new-and-innovative-antibiotics-to-patients-who-need-them/
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