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Re: austinmediainc post# 56972

Wednesday, 03/16/2016 9:15:32 AM

Wednesday, March 16, 2016 9:15:32 AM

Post# of 720626
Yeah, good point. And as AVII mentioned first I believe, "screening" in this trial extends all the way to just before being randomized. Patients return just before ranodmization and have all sorts of screening done (k score, blood work, scanned for PD again, etc). That IS screening. When screening was halted, all patients in the "pipeline," yes who had vaccine made, could not get into the trial. A partial hold has a simple meaning--patient who are ON therapy who show no significant SAE can remain on therapy, ALL others cannot. If a patient has not begun a course of the experimental tx, and a partial hold ensues, they cannot them get it, regardless of where in the SOC process they are.

The interesting thing though (because a hold is related to the IND, not a trial per se) is that the expanded access apparently continued unhindered--or perhaps WAS on hold for a time and then wasn't. I don't know, but it seems now it's all a go. I'm not SURE that would be allowed under a partial hold if safety related and imposed by FDA/EMA. I may be wrong though.

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