“Based on the guidance provided by the DSMC, wil
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Posted On: 10/20/2020 9:10:13 AM
“Based on the guidance provided by the DSMC, will Cytodyn request from the FDA either an immediate EUA or in the weeks to come ?”
The DSMC’s recommendation is to continue the trial to full enrollment and conduct another interim analysis at 293 patients. This doesn’t indicate to me that the DSMC felt the data was strong enough at this time to warrant halting the trial and recommending to CYDY that the company file for EUA. The PR is clear on the path forward and CYDY even states in the PR that they are going to focus on increasing enrollment, which tells me they need to get to 293 before another opportunity at a halt and EUA is considered.
The DSMC’s recommendation is to continue the trial to full enrollment and conduct another interim analysis at 293 patients. This doesn’t indicate to me that the DSMC felt the data was strong enough at this time to warrant halting the trial and recommending to CYDY that the company file for EUA. The PR is clear on the path forward and CYDY even states in the PR that they are going to focus on increasing enrollment, which tells me they need to get to 293 before another opportunity at a halt and EUA is considered.
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