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Biotech / Medical : NNVC - NanoViricides, Inc. -- Ignore unavailable to you. Want to Upgrade?

To: drkaz who wrote (12112)4/16/2019 5:53:39 PM
From: HardToFind  Read Replies (2) | Respond to of 12871
 
Putting this into perspective:
  1. The Pre-IND meeting is optional, but from a risk perspective, highly recommended.
  2. We have the prior experience of FluCide, in which we were informed that we needed to produce 2.5 kg of drug, and test for efficacy in numerous other types of flu viruses (still in progress with a third party).
  3. Presuming the FDA comes back with no unexpected demands in this pre-IND meeting,
  4. and we get our GLP test results back,
  5. and we comply with their pre-IND requests by the time of our IND,
  6. we will likely meet no further resistance and 30 days after submitting the IND we will be cleared to perform Phase I human testing,
  7. Diwan gets 500,000 series-A preferred shares...and maybe the company even formally agrees with Diwan on VZV licensing terms.
  8. Then we need to find a medical (research) institution that will approve our testing by their IRB (internal review board).
  9. Then we start the Phase I testing (administered by a contract research organization)
  10. Assuming that goes without incident, we report
  11. We prepare test protocols (and drug material) for Phase II or IIa testing.
  12. Then we find medical (research) institutions that will approve our Phase II or IIa testing by their IRB (internal review board).
  13. yada, yada, yada...
  14. After Phase III we collect all of our data.
  15. We prepare an NDA (new drug application) for approval by the FDA
  16. We wait up to 2.5 years for FDA approval or rejection


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