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ZincFinger

10/17/13 11:17 AM

#75428 RE: JG36 #75414

You are dead wrong and evidence has been repeatedly presented to show that and you have repeatedly ignored it without addressing it in any way.

I made a technical error in referring to a Phase I/IIa as a "Phase I" (which is really a variation of a Phase I but it's not worth going there). that misstatement was very rapidly corrected but you have repeatedly ignored the corrections

NNVC is planning a Phase I/IIa (please LOOK IT UP if you don'tknow what it means)

A phase I/IIa is (as has been explained repeatedly before in excruciating detail (which apparently is not enough for some people) a COMBINED Phase I and II which is FAR FASTER than doing a Phase I and then a Phase II (because it is all planned from the begining because the THERAPEUTIC DOSE is known BEFORE the Phase I even starts (because the toxicity does NOT limit the dose as it does it the usual case (translation: you can use the theoretically optimum dose instead of having to settle for a lower dose that patients can tolerate).

A combined Phase I/IIa avoids the need to WAIT after completing phase I to analyze the phase I data to determine the therapeutic dose THEN plan the Phase II THEN submmit it to the FDA and WAIT for them to approve it. NONE of that is needed with a combined Phase I/IIa because you can just pick the optimal therapeutic dose in planning th ecombined study because of the low toxicity.

If that is STILL not clear to you I would suggest that a lot of DD on general background is in order