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Tuesday, 01/02/2024 11:46:09 AM

Tuesday, January 02, 2024 11:46:09 AM

Post# of 461943
Avatar adult trial highly significant, Excellence pediatric trial not so.

“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.”



It sounds as if they will argue that the kids overreacted to attention. I wonder if there is a pick up in the Excellence OLE whether that might be enough combined with Avatar.

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