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Posted On: 02/26/2025 2:36:31 AM
Post# of 150687
The Oct. 28th, 2022 puzzle
Oct. 28th, 2022:
"The Company is of the opinion that FDA approval for the HIV-MDR indication is not feasible without significant additional investment to remedy the issues."
This press release & date shows Cytodyn hiring KOL's & consultants is before Cytodyn filed the lawsuit. The data showed Leronlimab hit Primary End Point on HIV-MDR.
Cytodyn said data was being withheld.
So reads like "significant additional investment", was a $$ cost estimate from KOL's to format what data they had, then give the BLA submission a shot:
but Cytodyn was broke.
How can you hit Primary & not have data??
Remember, the DOJ said there were over 100 deficiencies in the BLA.
Which leads to Feb. 24th, 2025:
Feb. 24th, 2025:
Following the resolution of the Company’s dispute with its former CRO, CytoDyn obtained follow-up records from patients treated with leronlimab during the Company’s prior clinical trials in oncology.
Court resolution was July 09, 2024.
Did Amarex also turn over additional HIV-MDR records?
Can Cytodyn now also have in progress HIV-MDR BLA?
?????
If so, it could still be the fastest route to FDA approval.
With what we've seen since Feb. 2024, I personally can't rule it out....
Oct. 28th, 2022:
"The Company is of the opinion that FDA approval for the HIV-MDR indication is not feasible without significant additional investment to remedy the issues."
This press release & date shows Cytodyn hiring KOL's & consultants is before Cytodyn filed the lawsuit. The data showed Leronlimab hit Primary End Point on HIV-MDR.
Cytodyn said data was being withheld.
So reads like "significant additional investment", was a $$ cost estimate from KOL's to format what data they had, then give the BLA submission a shot:
but Cytodyn was broke.
How can you hit Primary & not have data??
Remember, the DOJ said there were over 100 deficiencies in the BLA.
Which leads to Feb. 24th, 2025:
Feb. 24th, 2025:
Following the resolution of the Company’s dispute with its former CRO, CytoDyn obtained follow-up records from patients treated with leronlimab during the Company’s prior clinical trials in oncology.
Court resolution was July 09, 2024.
Did Amarex also turn over additional HIV-MDR records?
Can Cytodyn now also have in progress HIV-MDR BLA?
?????
If so, it could still be the fastest route to FDA approval.
With what we've seen since Feb. 2024, I personally can't rule it out....
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