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Re: Saltz post# 18945

Friday, 12/15/2017 6:26:38 PM

Friday, December 15, 2017 6:26:38 PM

Post# of 232191
It really is that complex and also add into the mix the limited resources that BP would have to ramp up the screening process. This was/is a very difficult trial to enroll.

That is fine. However, management should have given us at least a 6 month error time line. If the trial has that many restrictions, then management should have factored this into their projection time lines (Golden Quarter, Tony..Big wig)). Not to mention thousands of candidates are out there. If this product has potential I sure hope IF it hits the market, they will not have to be screened like this for utilization. I still believe, even with approval, a N=50 validation will put them at the end of the CCR5 algorithm. especially with a less than 4% discontinuation rate and exeptible efficacy. Perhaps a niche product. IMO I am sorry, please do not blame the FDA, an experienced company should know their demands. We are out over a year in expected results..that demonstrates real concerns..or ..maybe that's just me.
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