Greenwich Lifesciences Inc (NASDAQ:GLSI) shares are trading higher by 30.6% to $10.85 Wednesday afternoon after the company provided an update on the Phase III clinical trial, Flamingo-01. The Data Safety Monitoring Board recommended continuing the trial without modifications due to no serious adverse events related to GLSI-100 reported so far.
In the U.S., around 30 clinical sites are actively recruiting patients, with plans to add 10 more sites in 2024. In Europe, pending regulatory approval, contracts are in place to add over 100 sites, potentially increasing total trial sites to 140-160. The trial’s Steering Committee discussed expanding a trial arm based on encouraging data, aiming to enroll up to 250 patients.
Additionally, preparations for interim analysis and BLA submission in the US are underway. Plans for additional ...
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