Below is a summary of clinical and corporate activities identified from the Shareholder Letter released on January 11, 2021:
- Phase 3 enabling animal studies - 8 completed, 2 in progress
- CMC and tablet production - in progress
- Submission of FDA IND application - completed and approved
- Initiate Phase 3 trials - anticipated to begin H2 calendar 2021
- Enhanced 6-week AME study to provide pharmacokinetic data and de-risk dose selection - set to begin Q1 calendar 2021
- ATB-352 - currently in IND-enabling studies, with human trials slated for late calendar 2021 (per March 2021 Corporate Presentation)
- IBD candidate identified
- Launch of large market partnering - in progress
- Unify IP - in progress
- Upgrade to OTC QX - completed Feb 16
Subsequent to January 11, 2021 Shareholder Letter, the following announcements have been made:
- Nuance Deal - Feb 9
- Bought Deal - Feb 17/24
- Investor conferences - Mar 8-17
- FDA clearance of IND application - Mar 29
Guesses on what's the next big news release? I personally would like an update on the IP unification, and the AME study. I have a feeling they won't say anything about the AME study though. Antibe is a bit stingy with the news releases. Many biotech companies would've had an announcement along the lines of "Antibe Submits Investigational New Drug (IND) Application with U.S. FDA" before the announcement of the IND approval.
Of course, I certainly wouldn't complain if the next news release was Pfizer buying us out for $4 billion USD....