Question - How does it work with interim looks, Data Monitoring Commitees timing, Press Releases, etc. If a trial is designed to have 2 interim looks based on the number of deaths in the total trial population - 1) is there a lag in time before the DMC looks at the data?, 2) is the Company obligated to make a PR stating that the interim death number was reached and the results so far indicate that the trial should continue or be halted?, 3) is it cut and dry - the trial achieves specific results dictated by an SPA - is the trial halted or does the DMC ordinarily side on caution and recommend that trial continue to the end?, and 4) are there lag times in when an interim look is expected and co. PRs or DMC meetings? Thanks for any insight you can provide.
