InvestorsHub Logo
Followers 0
Posts 1587
Boards Moderated 0
Alias Born 08/09/2015

Re: DewDiligence post# 95

Thursday, 01/05/2017 9:51:31 AM

Thursday, January 05, 2017 9:51:31 AM

Post# of 196
DD, you are basing the FDA rejection on the .054 p value for cohort #1, which was requested by the FDA in an attempt to identify the high risk patient category, where the company has centralized lab data to qualify it and knowing the larger cohort data is fine, and, understanding the PK/PD advantages of Betrixiban on top of the fact that the FDA has confirmed this drug still has fast track designation and accepted the NDA under a priority review status? It seems to me there is a lot to lean on to expect approval, though I understand your point.