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Posted On: 08/17/2020 4:24:07 PM
Post# of 148892
Still very slow with the CD12 enrollment (~2/week). Really hope that picks-up dramatically -- at least back to the ~2/day we had seen in the past.
I find it interesting that CytoDyn is promoting their intention to apply for ex-US approvals -- but they have not disclosed how they would handle said distribution.
This morning's PR indicated that the results had been sent only to Mexico -- and not the other countries.
Also interesting how Israel was disclosed in last week's call, but omitted from this morning's PR, and is now included in the latest Proactive video.
If these ex-US applications are designed to function only as leverage to nudge the FDA in the right direction, then I guess little else need be done.
Alternatively, if one or more ex-US countries does approve, and the FDA drags their feet, then I would assume CytoDyn would need to announce some kind of global distribution agreement (which may have already been negotiated).
I suppose it's possible that one or more of these countries may have indicated to CytoDyn that they would be willing to be responsible for the entire supply chain of the product, and that CytoDyn need only ship leronlimab to one in-country location. But that strikes me as being less probable than having a global distribution partner.
I find it interesting that CytoDyn is promoting their intention to apply for ex-US approvals -- but they have not disclosed how they would handle said distribution.
This morning's PR indicated that the results had been sent only to Mexico -- and not the other countries.
Quote:
In addition, CytoDyn has sent its Top-line Report of the Phase 2, mild-to-moderate COVID-19 population, to the regulatory authorities in Mexico and hopes to obtain emergency use approval from the MHRA in the U.K., EMA in the European Union, as well as the regulatory authorities in the Philippines.
Also interesting how Israel was disclosed in last week's call, but omitted from this morning's PR, and is now included in the latest Proactive video.
If these ex-US applications are designed to function only as leverage to nudge the FDA in the right direction, then I guess little else need be done.
Alternatively, if one or more ex-US countries does approve, and the FDA drags their feet, then I would assume CytoDyn would need to announce some kind of global distribution agreement (which may have already been negotiated).
I suppose it's possible that one or more of these countries may have indicated to CytoDyn that they would be willing to be responsible for the entire supply chain of the product, and that CytoDyn need only ship leronlimab to one in-country location. But that strikes me as being less probable than having a global distribution partner.
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