GREY:ATBPF - Post by User
Comment by
Pandoraon Jul 27, 2021 10:28am
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Post# 33609734
RE:Corp Update
RE:Corp UpdateWalkOverTheStrt 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"
Yes, after all this time, who would have expected another delay from Antibe. :-)) Most everybody?