FDA FASTTRACK PROVISION:
NNVC's drug has shown very strong evidence of a high probability of qualifying for an FDA fasttrack. Amazingly enough, not only has no one even once used the term fasttrack, everyone appeared to be disparaging the very PR that gave the strongest evidence for it.
(When your drug is SO low toxicity that you must do preliminary trials to determine what range to do the tox tests in, that's a strong indication of fast track potential at least for the low toxicity criteria (i.e.: no significant toxicity even at a dose 100 X the therapeutic dose).
I deliberately avoided the use of the term "fast track" to see what would happen and NOT ONE SINGLE PERSON MENTIONED IT! (which confirms my impression of this board)
FROM THE FDA WEBSITE:
Fast Track
Fast Track, which was developed by FDA, and codified into law in 2007, is a process designed to facilitate the development and expedite the review of drugs to treat serious or life-threatening diseases that will fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious diseases, including AIDS, Alzheimer’s disease, cancer, epilepsy, and diabetes. Filling an unmet medical need is defined as providing a therapy where none exists or one that may be potentially superior to an existing therapy. [[ALL of the IVPR MGD applications should qualify : a one shot cure, 100% effective, constant protein levels (vs high variatons with other methods, etc]]
Once a drug receives Fast Track designation, FDA offers the sponsor early and frequent communications to facilitate an efficient development program. The frequency of communications ensures that questions and issues are resolved in a timely manner, often leading to earlier drug approval. Fast Track drug sponsors are also eligible for "rolling review" of applications, allowing earlier submission and initiation of review. More than a third (12/35) of the 35 drugs were given a Fast Track designation. Of the 12 drugs that received a Fast Track designation, 9 (75%) were approved in the first review cycle. Of the 10 Fast Track drugs for which FDA was able to make comparisons to approvals in other countries, 100% were approved in the U.S first.
