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Biotech / Medical : NNVC - NanoViricides, Inc.
NNVC 0.880+3.5%Feb 6 9:30 AM EST
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To: old 'n cranky who wrote (10051)4/10/2018 11:53:37 AM
From: HardToFind1 Recommendation

Recommended By
hpgrant

  Read Replies (1) of 12873
 
You make good points, and we're largely on the same page.

If a company wants to get multiple indications, I've seen it done both ways. The more common approach is to get approval for the easiest indication, then follow with the second, etc. Formal animal tox and Phase I (human tox) typically don't have to be repeated.

The process of drug development is (as I see it):
  1. Come up with a theory.
  2. Develop a candidate "molecule"
  3. Produce candidate drug material.
  4. Test for efficacy in cell cultures.
  5. Test for efficacy in animals (or Moffat's cadaver models).
  6. Test again in anther lab to repeat the results in animals (if possible).
  7. Do informal tox testing in rats.
  8. Produce enough drug to do formal tox testing.
  9. Do formal tox tests in rats.
  10. Do formal tox tests in dogs.
  11. Generate a human trial proposal.
  12. Phase I human trials
  13. Phase II human trials
  14. Phase III human trials
I threw in two caveats in my statement (in case you missed it):
  • for shingles
  • anytime soon
If they go for multiple indications all at once in a single new candidate (or multiple new candidates) it sadly won't be anytime soon. If the company has new drugs, it's a bit of work to get them to step #7 (informal tox) because they will also want to re-check it against shingles...which only happens at Moffat's lab, and last time took a year or more to test. In my opinion the right thing to do is to initially pursue approval for one indication, the furthest along and easiest to get, then to submit for the rest after that. It appears that one indication should be shingles. I have no idea if the company's management agrees and still has that "laser-like focus" that Seymour claimed it had earlier.
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