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Re: DewDiligence post# 1809

Thursday, 09/26/2019 5:47:55 PM

Thursday, September 26, 2019 5:47:55 PM

Post# of 2933
I'm certainly not as up to speed as w/ HCV, nor with you or others that have a greater depth of understanding than do I.

I think that based on the market most would agree that there might be better compounds or MOA's
STILL...Luly did seem to reiterate that he believed in FXR. I'll have to listen again.

I'm not saying that Luly doubled down on the higher dose 2.5mg (I really thought it was out of the picture), but he also seemed to be interested in higher dose (what if it were 2.mg?) for heavier lifting, but also the lower dose (1. or .75mg hypothetically) for a longer term or with coupled with a 2nd partnered agent.
The words he said made me think they would go ahead; but middle of next year gives one pause; not like we are starting enrollment next week. : )

So far as "surprise"; if you have about a 50% discontinuation rate at 2.5 and even a 2% discontinuation rate at 1.mg, some element is not a surprise; but yes, perhaps a surprise you've known about for a while.

Here's the thing.
When Vertex started phase 2a trials in what would become Telaprevir/Incivek caused severe rash- SJS (Stevens-Johnson syndrome). I met a guy in a trial that showed up in the ER, and it scared the hell out of the staff; like initial reaction as if the guy had ebola. : )
In time it became something that they would anticipate, and "try to stay ahead of". Same happened w/ simeprevir. This a a far more mild rash, and when people understand it won't kill them they may be less likely to drop out. Even doctors can get spooked. Rates can change when people know it's safer than their fears.

There may be ways to augment or modify TX where they can improve response without throwing out the compound.
(which is why other trials continue, subpar as they may be)

AND.... what if one of ENTA's other follow on compounds could be partnered? Luly and ENTA know a lot more about their cards than investors. They may even also know something about the other cards in other players hands.

I realize I'm spinning this to be positive on a down day. I may not be as far along as you are on wanting them to stop. Their best judgement is far better than mine. : )
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