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Biotech / Medical : momo-T/FIF -- Ignore unavailable to you. Want to Upgrade?

To: Biotech Jim who wrote (11123)	6/6/2017 3:44:17 PM
From: tuck	Read Replies (2) \| Respond to of 12215

OK, starting to kick tires. I know little about NASH space. I gather that fibrosis leads to bad CV related mortality, and thus it is desirable to improve that metric, as well as achieving "NASH resolution." Endpoints seem fluid, particularly in early stage trials. For what FDA might be looking at, I found this: Endpoints and Populations and Trial Designs for Clinical Trials in NASH Indications But against that is the news from Intercept this February . . . CEO Mark Pruzanski: “First, we are amending our co-primary endpoint from fibrosis improvement and NASH resolution to fibrosis improvement or NASH resolution." Actual fibrosis improvement should be a significant marketing advantage if not a requirement for approval. Looking at CNAT's pan-caspase inhibitor for openers. Emricasan appears very safe, but reduction in liver transaminases looks inferior to 3196. CNAT doesn't seem to have actual human fibrosis data yet, but current P2s are testing for it as part of composite endpoint. ALT is part of a secondary endpoint. Genfit's PARP agonist doesn't worsen fibrosis, and in it's P3 trial now recruiting, improvement is only a secondary endpoint. Data from Phase 2b trial of GENFIT’s Elafibranor published in Gastroenterology Intercept's OCA (FXR agonist) has an inferior AE and efficacy profile. But it will be first to market (is approved in Canada now). NASH space very crowded. This is a good place to look at it (don't know if there are any biases from the guy running this website): NASH biotechs He didn't think much of OCA (or ICPT handling of histology), but that was over a year ago. Allergan and GILD also with advanced programs I haven't looked at. BJ, how much of a look have you taken at competitors, endpoints, and marketability? Who's the serious competition in your eyes? Cheers, Tuck

To: Biotech Jim who wrote (11123)	6/7/2017 12:00:35 AM
From: scaram(o)uche	4 Recommendations Recommended By Biotech Jim Doc Bones pgo-neil Thehammer Respond to of 12215

>> the board is in some semi-hibernative state << Yeah, sarcopenia is a bitch, no off season. Afraid I'm just permanently distracted. Most masters T&F awards are age group specific, i.e. made within 30-34, 35-39, ......, 80-84, etc. This is my first that crosses all age groups. There are 12 given each year, and the Pacific Assn. is the largest of USATF associations. For 2016, there were world record holders and an ex-Olympian among the recipients. Again.... decades on couch and in dark rooms with migraines, found triptan. BJ, Nigel, rkrw, others know how improbable this has been. BJ would make a great shot putter. ;-) In honor of Mary Peterson, Guru, who cared about Cincinnati and friends. .

To: Biotech Jim who wrote (11123)	6/7/2017 12:10:27 AM
From: scaram(o)uche	Respond to of 12215

It's just so cool that you bring leads here. We're all experienced, no downside even if there's downside. Thanks! Rick