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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 8:16:15 PM
From: HardToFind1 Recommendation

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hpgrant

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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.
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