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Re: Steady_T post# 456552

Saturday, 04/13/2024 4:13:17 PM

Saturday, April 13, 2024 4:13:17 PM

Post# of 468388
You said:

Consider that if the Rett trial had not had such a strong response in the placebo group there would be an NDA filed by now


Hint!

Walter E Kaufmann, MD, Chief Scientific Officer of Anavex commented, “We believe that a high placebo response may have masked the therapeutic effect of this innovative orally available molecule. High placebo responses are well documented especially in pediatric clinical studies. Although data analysis is ongoing, the early conclusion is that the placebo rate could have been higher in the study due to a slight imbalance in disease severity at baseline, across the treatment arms, and the 2 to 1 drug to placebo randomization ratio. We intend to further assess the collective results and discuss with the regulatory authorities next steps.”


There is a lot misunderstandings on this MB on placebo response and discussions comparing the place response from the trofinetide to the EXCELLENCE trials, which is nonsense. It has nothing to do with Type 1 and 2 errors.

The longer we wait, the sooner we will get rich!

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