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Re: fishhunter post# 1850

Saturday, 05/19/2018 8:39:37 PM

Saturday, May 19, 2018 8:39:37 PM

Post# of 2104
In essence if the ENCORE-PH meets the primary endpoint with stat sig, and the data is really good then Conatus can move straight to filing for FDA approval on an accelerated approval basis. That's because the FDA has stated that HVPG acts as a surrogate endpoint (meaning there is a clear biomarker that shows efficacy of the drug early on).

From there, the FDA would approve emricasan after phase 2 when it files the NDA, and it could run a phase 3 after FDA approval. So in essence the FDA would approve the drug and then conatus still would run a phase 3 anyways. But it would get emricasan for NASH cirrhosis patients with portal hypertension approved early.

That means if the primary endpoint HVPG hits, the stock will explode upwards.