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Re: Lemoncat post# 256482

Saturday, 02/16/2019 4:17:13 PM

Saturday, February 16, 2019 4:17:13 PM

Post# of 403280
Yes, that was not a likely concern. A likely FDA concern, given the FDA requirement on repeating the Cisplatin qw arm, is that the Phase 2A showed B made SOM more likely in that care protocol, if its placebo group was statistically valid. Of course this result is unlikely and insensible; the FDA is simply saying "do it again." The FDA, and we, want another shot at seeing results that can be positive, reliable, and sensible.

(Note: I'm not saying "B not working is insensible". I'm saying that B making SOM more likely compared to placebo is insensible, especially given the results of the successful arm. And for my fellow longs: no, the fact that B's result in the qw arm was still an improvement over historical SOM rates is not proof of anything. We can't cherry pick. We're still left with the fact that its placebo group was better. Scientific knowledge isn't based on what we want to believe but what we can reliably prove.)
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