The excuse the FDA would have for needing RO is ei
Post# of 153826
(Total Views: 442)
Posted On: 03/11/2021 12:52:50 AM
The excuse the FDA would have for needing RO is either proof of MOA or in setting the correct dosage. Either would be proven by the efficacy and they already chose the 700mg dose. Since there were much fewer patients in monotherapy on the 700mg dose and more were added later as proof of safety that's obviously the group they wanted RO from.
The initial group of 700mg patients would have used a standard fluorescent tagged flow cytometry test. When they asked for additional 700mg patients around July 2019 would have been the same time that Dr. Patterson would have started using his test. So it's an easy inference that when Nader said the FDA didn't accept Dr. BP's test he's telling the truth. The non-acceptance could be as simple as it was a new test that had no generalized use yet.
Since the Dr. BP test's were done in 2019 it would seem most likely that samples still exist and those samples are the property of Cytodyn.
If I remember correctly they wanted around 70 new patients for safety. Which would be around the equivalent number of patients they had at 525mg in the monotherapy trial. A fix if one can not be obtained otherwise (but an unpalatable one) would be to run a 70 person, 700mg trial to establish RO vs efficacy.
The initial group of 700mg patients would have used a standard fluorescent tagged flow cytometry test. When they asked for additional 700mg patients around July 2019 would have been the same time that Dr. Patterson would have started using his test. So it's an easy inference that when Nader said the FDA didn't accept Dr. BP's test he's telling the truth. The non-acceptance could be as simple as it was a new test that had no generalized use yet.
Since the Dr. BP test's were done in 2019 it would seem most likely that samples still exist and those samples are the property of Cytodyn.
If I remember correctly they wanted around 70 new patients for safety. Which would be around the equivalent number of patients they had at 525mg in the monotherapy trial. A fix if one can not be obtained otherwise (but an unpalatable one) would be to run a 70 person, 700mg trial to establish RO vs efficacy.
(6)
(0)