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Posted On: 04/19/2021 1:37:49 AM
Post# of 148936
In the conference call announcing the CD12 data, after the Company had had extensive talks with the FDA, Nader talked about how quick he was to say Cytodyn would be happy to have another trial, no, two more trials to nail down results and endpoints that would gain statistical significance.
In the last CC, altho 2 more weeks had passed, his tone of urgency about more trials was muted. Why? I believe it was because the FDA said something like, "That may not be necessary."
I don't think that the FDA would be on the right side of ethical behavior to deny a company's right to conduct trials that would prove its drug's efficacy. The FDA must have given Cytodyn some sort of assurance that they would be given "a path forward." The murkiness of that guidance is puzzling.
Perhaps they said, "Continue with the OLE and see if you can get approval from the MHRA. If they approve you, we will give you an EUA or an approval - but only if you manufacture more Leronlimab with Samsung."
It could happen.
In the last CC, altho 2 more weeks had passed, his tone of urgency about more trials was muted. Why? I believe it was because the FDA said something like, "That may not be necessary."
I don't think that the FDA would be on the right side of ethical behavior to deny a company's right to conduct trials that would prove its drug's efficacy. The FDA must have given Cytodyn some sort of assurance that they would be given "a path forward." The murkiness of that guidance is puzzling.
Perhaps they said, "Continue with the OLE and see if you can get approval from the MHRA. If they approve you, we will give you an EUA or an approval - but only if you manufacture more Leronlimab with Samsung."
It could happen.
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