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Biotech / Medical : biotech binary events

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To: semi_infinite who wrote (289)9/26/2017 1:10:22 PM
From: tuck  Read Replies (1) of 295
 
It's currently trading for a bit north of 2x cash. I expect a dead cat bounce into the $7s tomorrow, and I might reload. I will check the theta of the October calls and possibly sell. My guess on the P2b is fail or minuscule benefit, but I doubt data will come in before October or even November expiration. Note that this P3 was highly powered to try and pick up that minuscule benefit seen in P2 (stat sig by a whisker in CIBIC) and failed to find it in spectacular fashion.

Again there are a couple of primary endpoints and a couple of secondary endpoints. They could hit one, providing enough hope to slightly burn greedy shorts. So far as I can tell, Glaxo never tested it in DLB. They are trying a higher dose, too: one arm will have twice the dose tested in the AD trial, and without the donepezil. 240 patients randomized to 3 arms, 1:1:1. So they could see results at this higher dose.

The bigger risk to the selling October calls strategy is a near term read out of the gait and balance study. This is the 35mg dose but for 3 months, not six. Animal data is all we have here, and it's equivocal:

Reducing falls in Parkinson's disease: Interactions between donepezil and the 5-HT6 receptor antagonist idalopirdine on falls in a rat model of impaired cognitive control of complex movements

Note this is a slightly different drug, but same target. It's a small trial, with 40 patients randomized 1:1, so they'd need a big signal. But it's a somewhat different crossover design, with both cohorts receiving treatment and placebo in different sequences, so they are giving drug to 40 patients, but for less than 12 weeks. See:

Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With Dementia

Given the size/ dosing of the trial and the animal data, I'm not optimistic on this outcome, either, though it would be nice if it worked, as falls are definitely a cause of morbidity. The company doesn't seem to be hyping it much.

Cheers, Tuck
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