GREY:ATBPF - Post by User
Comment by
RunningofdBullson Jul 27, 2021 9:29am
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Post# 33609379
RE:Corp Update
RE:Corp Updateyou forgot the best part though..."
we are now interacting with pharmaceutical companies around the globe, with several conversations having reached the confidential stage" WalkOverTheStrt wrote: Key takeaways
- On Track- "associated CMC (chemistry, manufacturing and controls) activities are on schedule"
- On track - IND-opening single-dose detailed pharmacokinetics/ pharmacodynamics study dosed.
- On track - AME study "Following the anticipated completion of this study in the upcoming quarter, we will request a meeting with the FDA; that meeting will be the last key milestone before Phase III initiation."
- Good - Building the bench and expertise - "retained a former chair of the U.S. FDA’s Advisory Committee on Anesthesia, Critical Care and Addiction Products for ongoing advice / process of selecting three physicians to constitute the Independent Data Monitoring Committee (“IDMC”) / hiring of Dr. Ana Stegic as our Director of Clinical Operations
- Unclear - "more than two years of runway and fully funds the "initial" Phase III trial" what is meant by intial?
- Never Too Late But Surprised this wasn't finalized months ago / potential covid delay to tour facilities or? "currently evaluating proposals from leading global contract research organizations (“CROs”) "
- Not Great - IMO this is a delay as I would have expected enrollement Q4 from all their previous statements - "efficacy trial is planned for approximately 50 sites in the U.S. and Canada, with enrollment set to commence in Q1 2022"