Replies to post #139633 on Innovation Pharmaceuticals Inc (IPIX)

[slcimmuno]

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.

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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/

[Waverunner1]

The company has stated the request would be made once the Phase III trial sites are set up, which has not been completed quite yet. Approval is a mere formality via QIDP, but it still has to be requested.

I would have expected that to have been reported if it happened and I would have expected it to happen by now if it was going to happen at all.

I suspect that Fast Track was either not applied for or not granted for B-ABSSSI because it was felt that it didn't meet the above criteria.