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Posted On: 08/19/2020 3:32:43 PM
Post# of 148936
It does seem odd that the FDA has now had a full week to review the M/M trial results (I believe they were transmitted last Wednesday) and we shareholders have not heard a peep.
Surely the folks charged with this task don't take weekends off in the middle of a pandemic when there is a potential game-changing therapeutic requesting an Unmet Need EUA (but maybe they don't consider analyzing Phase 2 trial results as being as high a priority).
Therefore, I have to assume there are conversations taking place between CytoDyn and the FDA -- with the FDA seeking clarification, or requesting additional information, or discussing the particulars of the next step -- which could be Phase 3 Registrational, Phase 4 Confirmational, or EUA.
If the outcome is a Phase 4 Confirmational or EUA I would expect we'd know about it immediately.
Alternatively, if it is a Phase 3, maybe Dr.NP is strategically using the four business days the SEC allows before a material disclosure must be made public to allow Mexico or the UK pull the trigger without learning of the FDA's decision.
Surely the folks charged with this task don't take weekends off in the middle of a pandemic when there is a potential game-changing therapeutic requesting an Unmet Need EUA (but maybe they don't consider analyzing Phase 2 trial results as being as high a priority).
Therefore, I have to assume there are conversations taking place between CytoDyn and the FDA -- with the FDA seeking clarification, or requesting additional information, or discussing the particulars of the next step -- which could be Phase 3 Registrational, Phase 4 Confirmational, or EUA.
If the outcome is a Phase 4 Confirmational or EUA I would expect we'd know about it immediately.
Alternatively, if it is a Phase 3, maybe Dr.NP is strategically using the four business days the SEC allows before a material disclosure must be made public to allow Mexico or the UK pull the trigger without learning of the FDA's decision.
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