I believe this peer reviewed article ( https://pubmed.ncbi.nlm.nih.gov/37429704/ may be extremely impt because it speaks a language, Bayes, or Bayesian statistics, which has a high credibility among FDA statisticians. I do not pretend to understand Bayesian stats, but my take away is that it has grown in acceptance within the FDA and has in recent years allowed a significant number of device/drug approvals due to the fact that it employs what I think is more qualitative factors and data, rather than simply traditional quantitative data.
Again, I am not a stat person, but I believe that the FDA's growing appreciation for Bayesian stats grew these last decades out of the FDA device division stat folks who pioneered its application in clinical trials. The 10 July article does include the one person who is a stat expert working for a stat company. He is the 4th person, not an employee of Anavex, and from a stat company of experts
This article should receive a high level of acceptance within the FDA evaluators and the broader medical community.
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