The critical importance of the Phase 2b/3 enrollme
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Posted On: 04/22/2020 12:23:45 PM
The critical importance of the Phase 2b/3 enrollment was my understanding as well as far as getting initial data to the FDA and having any hope of early approval.
Per CYDY PR on 4/15:
"Patients enrolled in this trial are expected to be administered leronlimab for two weeks with the primary endpoint being the mortality rate at 28 days and a secondary endpoint of mortality rate at 14 days. The Company will perform an interim analysis on the data from 50 patients."
So, we had our first Phase 2b/3 enrollee on 4/15. We need 49 more patients enrolled. Then wait 14 days. Then send interim analysis data to FDA.
Until then, FDA and/or Fauci has no reason to mention CYDY. It's all about enrollment now.
Unless I misunderstood something...
Per CYDY PR on 4/15:
"Patients enrolled in this trial are expected to be administered leronlimab for two weeks with the primary endpoint being the mortality rate at 28 days and a secondary endpoint of mortality rate at 14 days. The Company will perform an interim analysis on the data from 50 patients."
So, we had our first Phase 2b/3 enrollee on 4/15. We need 49 more patients enrolled. Then wait 14 days. Then send interim analysis data to FDA.
Until then, FDA and/or Fauci has no reason to mention CYDY. It's all about enrollment now.
Unless I misunderstood something...
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