Synaptogenix Inc (SNPX)

[InTheTrenches]

Post-marketing safety studies are done all the time for long-term safety. (besides which, we HAVE long-term safety: administered to 1500 cancer patients, some for long-term).

If we see clear reversal of symptoms (SIB scores, MMSE scores, ADLs) and reasonable safety over 3 months in the Phase 2b results, there is a distinct possibility that the FDA may suggest to NTRP that they submit an NDA, with the possibility of conditional approval of Bryostatin for moderate-to-severe Alzheimer's.

The approval would be conditional that NTRP will start a Phase IV post-marketing safety trial of Bryostatin within a reasonable amount of time, and marketing of Bryostatin could be revoked if there are any major long-term safety concerns.

Phase 2b reversal of Alzheimer's would have to be convincing, and the FDA would have to be reasonably comfortable with the safety data from the Phase 2b, Phase 2a, compassionate-use patients, and prior cancer trials (1500 patients, some for long-term use).

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The FDA has recently shown flexibility in conditionally approving drugs for diseases where no drug is available to directly treat the cause of the disease: e.g., Eteplirsen for Duchenne Muscular Distrophy (Sarepta Therapeutics).

Further, Scott Gottlieb, who will be the new FDA director, is much more open to getting effective drugs to market ASAP, compared to his predecessors.