Quick note re FDA submission for clinical trial. M

Quick note re FDA submission for clinical trial. My wife works in clinical research for neuroscience and has made two FDA submissions for trial approval in the past months. She made several noteworthy comments: while the FDA has had their own share of staff shrinkage they were consummate professionals and provided very useful protocol adjustments and timely feedback, one a fairly glaring oversight representing what amounts to an important exclusion criteria missed by the principal investigator. In short they were very responsive and a collaborative cross check to ensure the trial is well designed and in accordance with FDA standards. She also commented on how well designed the website interface was; assuming all information is at hand one can easily submit in one go. Once submitted it is a fact that if there is no FDA feedback in 30 days the trial can start even if no positive affirmation by the FDA. The IRB submission for approval to proceed can be done before or after FDA approval but often beforehand in order to obviate FDA amendments to protocol that might have been forced by the IRB.

Key point is Leronlimab is coming for Alzheimer’s…the Cornell study is funded and approved in principal to proceed, just needs IRB and FDA approval but don’t think of those as necessarily taking Herculean efforts or time. While we wait for news on that it appears there is front page worthy communication imminent from the ESMO conference.