Friday, September 13, 2024 12:03:41 PM
I agree for the most part - Dr. Jin will have invaluable input into the study design - especially endpoints, power calculations to decide N, and the statistical hierarchy and how the endpoints will be evaluated but will not actually design the trial. Power calculations are done without much budget consideration. N and cost of the trial are related and the final decision will be up to Missling. However, though I would not consider Dr. Jin to be an AD or PD or Rett expert, I would consider him to be an expert in neurologic clinical trial design and their analysis. He has personally seen many dozen neurology trials and their associated strengths and weaknesses. He will be in charge of the SAP . If Anavex had not hired Dr. Jin they would be spending just as much on consultants (as they likely did with Dr. Ette)
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