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Re: seventhwave post# 21

Thursday, 04/27/2017 5:55:34 PM

Thursday, April 27, 2017 5:55:34 PM

Post# of 134
Have seen the unexpected strong placebo effect too. In a U.K. cat allergy trial the reduction in allergic reaction was 60% and exactly 60% too for the placebo arm in phase 3 study. In the phase 2 studies the drug had proven superior statistical significance.

I do agree that the ALDX choice of 0.1% solution is worrisome, particularly as I have seen no dose response data or explanation of this assumed minimum response dose.

As you said, nor is it clear what ALDX have agreed with the FDA. Is it confirmation of statistical significance against placebo for the 0.5% dose, while simply accepting whatever minimal dose effect we get. Or is there some set expectation from the 0.1% arm.

I don't know, but CEO Brady seems to think it is all Dandy. I guess only time will tell.

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