"I was just pointing out that QIDP related speeding up also occurs during drug development."
As I understand it that is only true if Fast Track was applied for and approved. 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. It was applied for and approved for B-OM...here's why: FDA on Fast Track criteria: "Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy. Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need."
CTIX PR: "There are no FDA approved drugs for the prevention of oral mucositis."
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.
That leaves an open question as to what this really means: "The company is also eligible for Fast Track and Priority Review under QIDP." This is the quote from the company release of 12/8/14.....I have also seen very similar language in other literature. "Receiving QIDP designation means that Brilacidin is now eligible for additional FDA incentives in the approval and marketing path, including Fast Track designation and Priority Review for development and a five-year extension of market exclusivity. - See more at: http://cellceutix.com/cellceutix-antibiotic-brilacidin-receives-qidp-designation-from-fda/#sthash.XzrG2Xym.dpuf
It's not clear to me how the QIDP designation makes the drug eligible for Fast Track, however. Maybe someone else can document the connection, assuming there is one.
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