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Saturday, December 02, 2017 1:39:52 PM
= ie 67% get it
(pretty close to historical rates of 70-75%)
Your 18/30 on active w/o SOM =
= ie only 40% get it
(If I’m reading your numbers correctly)
That def would be a big success ... a close to 30pt spread active vs placebo
Put differently — one would have a 2 in 3 or 3 in 4 chance of getting SOM w/o B compared to a 2 in 5 chance when on B — much better odds at preventing SOM
My thinking:
An active vs control spread of 15 (Low) or 30 (Mid) or 45 (High) — all would be a success, though the higher the spread the louder IPIX would be able to toot the Efficacy horn
Also recall B OM is targeting prevention (not reduction of symptoms) and that it is so easily administered... aspects of the drug that further set it apart
Something missing from your analysis is Dropout / Exclusion rates, unlikely all 61 will be evaluable so the Ns will change
When I have time I’ll try and dig up some comps in other OM trials as to Dropout rates
Anyway — good stuff
I’d be surp if we match the 50pt spread seen at Interim, but 20 or 30pt spread and we should be good... arguably “blowout” results — makings of first potentially approvable drug in preventing SOM
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