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Re: Coolec78 post# 3089

Saturday, 05/20/2017 8:30:30 AM

Saturday, May 20, 2017 8:30:30 AM

Post# of 3833
I, of course, am only speculating. Maybe the end points of the Galt study are being met for possible provisional approval.

It has reported that GALT is due out with its topline NASH (Nonalcoholic Steatohepatitis) CX trial results in December this year. The company has hinted at the possibility of a Breakthrough Therapy designation if they meet their regulatory endpoints on Hepatic Venous Pressure Gradient (HVPG) and Fibrosis. There seems to be a feeling that there may be a pathway toward provisional approval as they outlined their plans to break the patient groups up into subsets for a follow on phase 3 trial. My understanding is that a few points of improvement in HVPG may result in provisional approval.

The company will need the cash to ramp up and market if it obtains provisional approval. Again, this is absolutely pure speculation, but I cannot think of any other reason for this large offering.
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