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DewDiligence

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DewDiligence

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Re: north40000 post# 188299

Thursday, 04/07/2016 5:55:17 PM

Thursday, April 07, 2016 5:55:17 PM

Post# of 252233
DRRX -20%/AH on FDA-mandated change to phase-3 trial design:

http://finance.yahoo.com/news/durect-announces-posimir-program-210000595.html

DURECT Corporation today announced that after the PERSIST Phase 3 trial for POSIMIR was underway and enrolling patients at multiple sites, the Company received a letter from FDA advising the Company to make a number of amendments to the PERSIST trial. One of the recommendations was to incorporate standard bupivacaine HCl as an active control. The Company had a follow-up call with the FDA this week to discuss the advice letter, as a result of which the Company has decided to implement the FDA's recommendations.

This change will add to the time and cost to complete the PERSIST trial…

No kidding.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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