My thoughts and opinions on what could be happenin
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Posted On: 09/13/2020 11:24:55 AM
My thoughts and opinions on what could be happening with our P2 m-m data:
(1) FDA is very satisfied with our phase 2 m-m results (so no P3 is required);
(2) FDA and NP are concerned about prompt acceptance by the medical community and by the public at large because: (a) previous FDA covid-related therapeutic mistakes and missteps, (b) only a phase 2 was done for Leronlimab, and (3) less than 100 patients tested in phase 2;
(3) FDA and NP are very confident about upcoming P3 results for severe to critical;
(4) Because of their confidence in P3, FDA and NP agree that the best course of action is to wait for the P3 data, thereby making available great safety (and efficacy) data for a thousand patients (ie. HIV patients, covid P2 trial patients, covid P3 trial patients);
(5) Leronlimab receives simultaneous EUAs (or perhaps full FDA approvals) for any and all covid patients, once P3 data becomes available;
(6) MHRA - see and apply 1 through 5 above.
I would expect to hear about #4 above at Wednesday's cc.
(1) FDA is very satisfied with our phase 2 m-m results (so no P3 is required);
(2) FDA and NP are concerned about prompt acceptance by the medical community and by the public at large because: (a) previous FDA covid-related therapeutic mistakes and missteps, (b) only a phase 2 was done for Leronlimab, and (3) less than 100 patients tested in phase 2;
(3) FDA and NP are very confident about upcoming P3 results for severe to critical;
(4) Because of their confidence in P3, FDA and NP agree that the best course of action is to wait for the P3 data, thereby making available great safety (and efficacy) data for a thousand patients (ie. HIV patients, covid P2 trial patients, covid P3 trial patients);
(5) Leronlimab receives simultaneous EUAs (or perhaps full FDA approvals) for any and all covid patients, once P3 data becomes available;
(6) MHRA - see and apply 1 through 5 above.
I would expect to hear about #4 above at Wednesday's cc.
(6)
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