- Last Study Visits (LSV) will commence immediately. All actively participating patients, still receiving the Investigational Product (IP) or statin, will be contacted to schedule visits to their particular site for a last visit or treatment visit. Those sites with the most patients enrolled will commence first, followed by the others. This will allow additional time to build the overall MACE events to about 260 or greater while not slowing down the trial’s move towards final database lock.
- Database Lock (DBL) will occur after the last patient’s final visit and the last query is resolved.
- Approximately two weeks after DBL, the primary endpoint and additional secondary and exploratory endpoints are expected to be announced.
Curious if anyone has a good read on when the company is expected to announce top line results.
Is it simply a function of the final LSV + ~ 2weeks or is there more to it?