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Thursday, April 27, 2017 3:40:32 AM
It seems vehicle, that is the placebo, had greater than expected effect, while 0.5% dose still showed superior statistical significance. I don't know how Aldeyra have arrived at 0.1% as the control arm for establishing minimum effective dose (as required by the FDA), but we must assume they have previously determined some form of dose response curve to make them confident that 0.1% is high enough to show effect against even a strong placebo effect.
Then Tom Brady is adding that, all that being correct, establishing minimum effective dose is all they are missing to potentially have the FDA agree the P2b trial and results leading directly to a P3 registration trial.
Understand your concern on how Aldeyra chose 0.1% and why they feel confident about that being a minimum effective dose. Hopefully IR will eventually provide a reply to you (let us know), but I guess we just have to decide if we trust Tom Brady and crew on the science.
I might double or quadruple down. If successful the rest of the pipeline, not least ADX-102 in SLS with Orphan Drug Designation, is awesome.
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