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


To: tuck who wrote (11078)3/28/2017 12:55:44 PM
From: scaram(o)uche1 Recommendation

Recommended By
Biotech Jim

  Read Replies (3) | Respond to of 12215
 
"Sufficient receptor occupancy"??

Sounds familiar......

Message 30562788

Over the years at S.I., we've had some great calls, sufficiently researched. Probably fifty, give or take. Rare, these days.

Together with your subsequent post to the valuation thread, GREAT CALL Jim. Can't thank you enough for bringing it here. Best! Rick



To: tuck who wrote (11078)5/4/2017 9:16:21 PM
From: tuck  Respond to of 12215
 
Cara 1Q CC notes (some of this already known, perhaps, and is given as confirmation):

End of P2 FDA meeting for UP likely in third quarter.

Expect two 12 week P3 trials for OA, plus one open label safety trial of 52 weeks. Not likely to start until 2018.

The raise is in part to fund an expanded pruritus program.

Beyond HD, that program would look at non HD CKD, chronic liver disease, atopic dermatitis, and related diseases. The latter, especially, is also a big population/market. All these latter indications would likely be addressed by oral formulations.

Power analysis for IV pain. Coming in June. DMC will unblind but will only tell the company if they have sufficient power at 125 patients per arm, or if they need to enroll more (up to 150; beyond that would need approval from FDA) or drop an arm, etc. Secondary endpoint nausea and vomiting, opioid usage tertiary. Stoppage for efficacy is also a possibility, but management downplays the likelihood of that.

Company wants to retain US rights to all programs, but would partner ex-US.

Thinks they can get reimbursement from CMS without being in the bundle, as there are no alternatives. Cites the precedent of Amgen's calcimimetic, which is a similar situation.

Welcome comments from anyone else who listened.

Currently holding a pretty substantial sold put position, mostly May 15s and a few 17.5s. Also some shares in the IRA. Feeling fairly comfortable with it, in spite of the post raise weakness.

Cheers, Tuck