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Re: RCH68 post# 1656

Thursday, 03/26/2015 1:54:43 PM

Thursday, March 26, 2015 1:54:43 PM

Post# of 2206
I understand your concern. However, they can only prepare each patient so much before the actual dosing needs to take place. Until that point they have to make sure that the lab values are all in check. That can't happen necessarily immediately and expectedly when positive news comes back from the DSMB about the previous cohort. Liver function tests can fluctuate with people who have hep c, and it is not necessarily anticipated that the 4th and 5th patients would be dosed exactly the same day, or even the same week. There is latitude there that is dependent on each participants status at the time of the green light. Parallel means they don't have to wait for safety data from patient 4 to dose patient 5. That's it. This is not a major reason for concern, it's just an annoying, but understandable part of the process. I am, however, disappointed that other trial sites have not opened up, but again, we don't know the complete criteria being used to evaluate which sites will open and which will not. We had a delay before, and the cause was not what everybody thought it was. Be patient, and let's let the trial run it's course. The next trial should have more relaxed criteria. But we seriously want to nail this one right, not only because it is our first trial, but because it can set a precedence for ddRNAi that we do not want to screw up.
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