Lvegun, You stated that a phase 3 study will no
Post# of 153887
(Total Views: 531)
Posted On: 08/12/2020 8:30:54 PM
Lvegun,
You stated that a phase 3 study will not enroll quickly, "No. It will be larger than the past trial and while site locations are already set up, that doesn't speak to the pace of enrollment... as we're witnessing with the severe trial."
Phase 2 trials are designed as a proof of concept where the ranking of endpoints into primary and secondary is arbitrary. Cytodyn has already achieved requisite clinical and statistical significance in NEW2 progression.
If asked to conduct a phase 3, progression of NEWS2 can be selected as the primary endpoint.
Phase 3 trial run with the same 84 patient population, will achieve statistically significant improvement in the primary endpoint (NEWS2!) and the required results for approval.
It should be substantially easier to enroll 84 patients the second time around considering the increased number of infections and growing recognition that Leronlimab is the answer to covid infection.
You stated that a phase 3 study will not enroll quickly, "No. It will be larger than the past trial and while site locations are already set up, that doesn't speak to the pace of enrollment... as we're witnessing with the severe trial."
Phase 2 trials are designed as a proof of concept where the ranking of endpoints into primary and secondary is arbitrary. Cytodyn has already achieved requisite clinical and statistical significance in NEW2 progression.
If asked to conduct a phase 3, progression of NEWS2 can be selected as the primary endpoint.
Phase 3 trial run with the same 84 patient population, will achieve statistically significant improvement in the primary endpoint (NEWS2!) and the required results for approval.
It should be substantially easier to enroll 84 patients the second time around considering the increased number of infections and growing recognition that Leronlimab is the answer to covid infection.
(2)
(0)