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Posted On: 02/26/2021 12:44:41 PM
Post# of 153937
Re: MD VIROLOGIST #80098
Perhaps Cytodyn is trying to get data for 42 and 60 days, or perhaps they are in discussions of the available with 28 day primary and secondary endpoints.
Were the data to be poor, with need for 42/60 day data (as for Relief/aviptadil), I doubt that Cytodyn would be in the midst of confidential, simultaneous discussions with FDA, MHRA and Health Canada
and
It seems that obtaining that data, completing analysis, AND the discussions with all three agencies in a 2-3 week timeframe is less likely than completing these discussions based on the trial as designed and completed.
IMO they are scrambling to finish negations and deliver Leronlimab to patients in need.
Were the data to be poor, with need for 42/60 day data (as for Relief/aviptadil), I doubt that Cytodyn would be in the midst of confidential, simultaneous discussions with FDA, MHRA and Health Canada
and
Quote:.
expects to release CD12 data and complete discussions with various regulatory agencies within 2 to 3 weeks
It seems that obtaining that data, completing analysis, AND the discussions with all three agencies in a 2-3 week timeframe is less likely than completing these discussions based on the trial as designed and completed.
Quote:
.Exactly, IMO they are scrambling to get that data.
IMO they are scrambling to finish negations and deliver Leronlimab to patients in need.
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