Replies to post #75399 on NanoViricides Inc. (NNVC)

[BonelessCat]

Before you post such outdated and rigid positions for your views regarding clinical trials, you might want to read this and then look up "breakthrough designation" and "unmet need."
http://www.raps.org/focus-online/news/news-article-view/article/2853/woodcock-fda-to-consider-approving-some-drugs-using-just-one-phase-i-clinical-t.aspx

[ZincFinger]

Totally true but totally irrelevant! That the Phase I/IIa are combined is highly significant despite that they are sequential.

Ordinarily, a company does not begin designing a Phase II until after a Phase I is completed. That's because for most phase I's you won't know what doses will or can be used in the phase II until you have the data from the Phase I. Most drugs have toxicity high enough that the therapeutic dose is limited to far below what the ideal dose would be because of toxicity.

So with standard Phase I and then an (uncombined) Phase II there is a considerable gap in time from the completion of the Phase I until the Phase II can be begun: the Phase I must be analyzed and then the Phase II planned with appropriate doses. Then the plan must be submitted to the FDA and then there's a wait for approval. NONE of that delay is necessary with a commbined PhaseI/IIa: the entire combined trials are preplanned at the start. They can be, because the toxicity is so low that what will be the therapeutic does in the Phase IIa is already known in the planning stage in Phase I BECAUSE THE THERAPEUTIC DOES WILL NOT BE LIMITED BY TOXICITY.

So your point is totally true and totally irrelevant. The Phase I and the Phase IIa in a combined Phase I/IIA are, indeed, sequential. But the combination is FAR faster than a standard Phase I, Phase II. PLUS the Phase I/IIa has a very high chance of early approval (because of the exceptionally low toxicity).