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

To: tuck who wrote (11153)	6/29/2017 5:44:47 PM
From: tuck	Read Replies (1) \| Respond to of 12215

CARA: Miljenko posted on the firesafe thread: "I think that trial failed, 39% and 35% reduction is misleading! What is placebo respond?" If you don't want to bother listening to the call, one can find some of the pertinent info on the accompanying slide deck here: CARA P2b OA pain trial Note the completion rate differences and arm size differences between knee and hip, with the knee being by far the bigger arm. Note also that the two populations were prospectively defined. They did get a higher placebo effect in the knee, almost 2 points on the primary. They expect to use higher doses in the upcoming adaptive trial (5, 7.5, and 10, perhaps). They say they got decent receptor occupancy at 5mg, but not saturation. They think that 10 mg should about saturate them. Bioavailability makes it hard to figure at first, and apparently they went too low here for unequivocal efficacy. The AE profile suggests they have room to do so, at least, or this really would be a failure. Also, the curves appeared to still be separating at the end of the treatment period, so they expect to do a longer adaptive trial: 4 weeks titration again, but an 8 week maintenance period. That should also help achieve an analgesic effect in all OA populations. But no doubt, there is still some risk with that. They hope to start by year end. It wasn't clear to me if they were talking about talking with the FDA about next steps or actually starting the trial. I would guess, the trial doesn't start till next year. We'll see what tomorrow brings. Since it wasn't a complete flop, it may stabilize in the high teens. I expect most of the volatility will go out of my puts, and I won't get much insurance out of them, but fortunately I didn't need at a really high level of insurance. My inclination is to hold. But I'm open to more bearish interpretations of these results if well founded. Cheers, Tuck