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Re: None

Wednesday, 12/05/2018 8:39:41 PM

Wednesday, December 05, 2018 8:39:41 PM

Post# of 2104
Highlighted points that I took away from the CC:

1) Mean HVPG in ALL emricasan dose groups DECREASED in ALL compensated cohorts while mean HVPG in the placebo cohort INCREASED. Get it? Consistent Decreases in Emricasan groups vs Consistent Increases with Placebo groups. Emricasan was never touted to be a single drug therapy. Regardless that the arbitrarily set "endpoint" did not get reached, the drug, none the less, did and is doing what it was meant to do. And then # 2...

2) There was a short blurb in which they did not go into details about but only made reference too (until later in the Q&A session):
Consistent Improvement in Mechanism Related Biomarkers. (I.e., Liver enzymes). Now this did NOT get any press and rightfully so as it was not part of the trial. However, it was significant enough to catch someones attention- In essence, not only is there consistent improvement in HVPG accros the board, but it also appears there is an equally consistent corresponding improvement in the "related biomarkers" or liver enzymes - in other words, the liver appears to be able to heal as well. Now, they can't and wouldn't elaborate on this topic at that time and moved on rather quickly. However, later on in the Q&A, it was also made known that the- "vast majority of patients in this study are ALSO now in the extension trial which goes on for an additional 6 months."
Here's the twist- at the end of this trial, which is the current group that today's results were derived from, this group is also being treated for an additional 6 months, but the benchmark is no longer based on HVPG- it will be based on "liver function" and "clinical outcomes"- Think about that. Somebody else already is.

... the findings ... support additional investigation of this compound for those with compensated cirrhosis due to NASH and ... at greatest risk of clinical decompensation for whom there are no alternate approved therapies.
– Arun Sanyal, M.B.B.S., M.D.


Lastly, #3
3) Mento or moderator (I don't recall) during Q&A with a direct question about Novartis's drug combo involvement, "I didn't say we weren't going to see any information about combo studies with Novartis....and I'm not prepared to comment further"

And that, IMO, is where this whole thing hinges. On Novartis.

Emricasan is doing exactly what it is supposed to do... albeit perhaps not at the magnitude they had hoped. However, it IS, none the less, consistent across ALL groups which means it's NOT a fluke. Therefore, again IMO, it only makes sense that emricasan will and should be combo'd up with another drug- after all as I stated earlier, emricasan was never considered as a single drug therapy to begin with.

So I'm going to let the market do its thing for awhile- maybe even trade the whipsaw as those without a clue as to why they bought to begin with, bail. And in addition, just keep my eyes on Novartis. They will ultimately decide CNAT's fate and direction IMO.

Theo ;-)