(Total Views: 604)
Posted On: 05/30/2025 7:58:15 AM
Post# of 153822
Quote:
someone here previously mentioned that since this trial is open label that the data would be more generally accessible throughout the process.
Open label just means everyone involved knows which patients are getting the drug being tested. In the mssCRC trial all patients are getting the drug so no blinding is necessary. But data sequestration would still be in place, otherwise the FDA would insist on adjusting the p value to a worse state. The more that data is seen at each time point the more the p value will be degraded. If the data is overwhelmingly good the DMSB may suggest the company look at the data and submit it to the FDA. In the case of Cytodyn's mssCRC trial it is unlikely they will do so. It's a small patient population with many starting out underdosed. Where our benefit will shine is in overall survival at the full 12 months of the trial and the longer the time period extends past that the better the results will be comparatively. In the TAS-102/bevacizumab mssCRC trial median overall survival was 9.1 months. I would expect our median overall survival to be well past the 12 month trial if the 350mg dose is expeditiously increased to 700mg.

