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

To: old 'n cranky who wrote (10051)	4/10/2018 11:53:37 AM
From: HardToFind	1 Recommendation Recommended By hpgrant Read Replies (1) \| Respond to 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): Come up with a theory. Develop a candidate "molecule" Produce candidate drug material. Test for efficacy in cell cultures. Test for efficacy in animals (or Moffat's cadaver models). Test again in anther lab to repeat the results in animals (if possible). Do informal tox testing in rats. Produce enough drug to do formal tox testing. Do formal tox tests in rats. Do formal tox tests in dogs. Generate a human trial proposal. Phase I human trials Phase II human trials 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.

To: old 'n cranky who wrote (10051)	4/10/2018 8:16:15 PM
From: HardToFind	1 Recommendation Recommended By hpgrant Read Replies (1) \| Respond to of 12873

Have you ever seen a Phase 1 clinical trial testing a drug candidate for multiple indications at the same time? With Phase I [Safety & Dosage] (I'd guess 30-50 participants for one indication) you're trying to find some efficacy with minimal toxicity. Sometimes it's done with healthy patients, sometimes with diseased, sometimes both. You're looking for a sweet spot of efficacy (or a target dosing level) without unacceptable toxicity levels. If the treatment modality is the same or similar for multiple indications, one test could work for multiple indications. The test may be modified to gather efficacy information for those multiple indications. But I wouldn't hold up Phase I shingles testing to wait for pre-clinical data for the rest. The first indication should inform the rest on the toxicity side, but we wouldn't mind getting some efficacy data on each of the would-be indications early on and relatively inexpensively. For Phase II [Efficacy & Side Effects] (I'd guess 200-300 participants) this is where I'd wait for shingles to complete before continuing with the rest (unless I was really flush with cash and had very promising efficacy data from Phase I). For Phase III [Efficacy & Adverse Reactions] (I'd guess 400-1200 participants) we're really applying the law of large numbers to see if our safety & efficacy findings are consistently positive.