Misleading statements and lies from the 13d letter -
Correction to the BLA and submittal of justification letter. 2 Covid trials submitted to ANVISA with appropriate dosages and endpoints. Successful phase 2 longhaulers trial. NASH trial fully enrolled with results in 2020. Cancer trials completing enrollment with possible results 2020.
The 13d crew seem to be unaware that the FDA limited us to 2 doses. If they are that unaware woe to the shareholders if they take over.
The expectations from the FDA seem to be that Cytodyn will roll over and play dead. Why would anyone think this comes from management rather than other considerations held by FDA employees.
The FDA has done all in it's power to block approval for HIV. Insisting on a 700mg dose then making the company jump through hoops to prove it's the right dosage. Using the excuse of receptor occupancy when other HIV drugs have not been held to that standard and the correct predictor of dosage is safety and efficacy.
In CD12 a four dose regimen was requested and the FDA insisted on two. There was absolutely no reason for the FDA to insist on 2 doses in a 4 week trial.
The FDA has never refused a trial or leronlimab's use in any application. They screwed us on the protocol but the trial still went forward. Maybe they're thinking of Cytolin.
Actions by the FDA in the last few years show it's the FDA that needs to restore it's own credibility.
Doesn't 13d think that leronlimab will push Cytodyn into a triple digit stock? They must not be aware of the 65+ indications for leronlimab. Maybe they have a buyout waiting in the wings for a tiny price.
The FDA has been very specific that it was pushback from the public that resulted in the letter.
Drexel University trial was Withdrawn (Lack of enrollment) originally started under Progenics in 2011, Cytodyn pivoted to monotherapy. Georgetown University metastatic colorectal cancer trial substituted with cancer basket trial. Scripps pre-clinical study for PrEP unknown.
This includes warrants and options exercised and sold many that were awarded earlier and he has held for years. Quite misleading and bandied about quite widely by those with an agenda.
Quote:Over the recent months, it has become clear that the Company has made virtually no progress in addressing the significant managerial and operational deficiencies that have destroyed stockholder value and led to unacceptable delays in receiving regulatory approval.
Correction to the BLA and submittal of justification letter. 2 Covid trials submitted to ANVISA with appropriate dosages and endpoints. Successful phase 2 longhaulers trial. NASH trial fully enrolled with results in 2020. Cancer trials completing enrollment with possible results 2020.
Quote:In 2020, CYDY ran two clinical trials for Leronlimab, both of which were unsuccessful due to management’s and the board’s poor execution.
The 13d crew seem to be unaware that the FDA limited us to 2 doses. If they are that unaware woe to the shareholders if they take over.
Quote:Dr. Pourhassan’s and Dr. Kelly’s tenures at CYDY have been marked by a consistent failure to meet FDA expectations leading to a poor and unsalvageable relationship.
The expectations from the FDA seem to be that Cytodyn will roll over and play dead. Why would anyone think this comes from management rather than other considerations held by FDA employees.
The FDA has done all in it's power to block approval for HIV. Insisting on a 700mg dose then making the company jump through hoops to prove it's the right dosage. Using the excuse of receptor occupancy when other HIV drugs have not been held to that standard and the correct predictor of dosage is safety and efficacy.
In CD12 a four dose regimen was requested and the FDA insisted on two. There was absolutely no reason for the FDA to insist on 2 doses in a 4 week trial.
Quote:The FDA has repeatedly refused to authorize CYDY-led clinical trials or even authorize applications, putting the Company in an extremely precarious position from an operational and financial perspective.
The FDA has never refused a trial or leronlimab's use in any application. They screwed us on the protocol but the trial still went forward. Maybe they're thinking of Cytolin.
Quote:Put simply, CYDY needs to restore its credibility with the FDA
Actions by the FDA in the last few years show it's the FDA that needs to restore it's own credibility.
Quote:Dr. Pourhassan claimed that CYDY would be a three-digit share price company after the results of the CD12 trial were unpublished but known internally.
Doesn't 13d think that leronlimab will push Cytodyn into a triple digit stock? They must not be aware of the 65+ indications for leronlimab. Maybe they have a buyout waiting in the wings for a tiny price.
Quote:This behavior, in part, led to an unusual public rebuke of CYDY by the FDA.
The FDA has been very specific that it was pushback from the public that resulted in the letter.
Quote:CYDY has in the past boasted and issued news releases about collaborations with reputable research institutions and labs. These alleged collaborations included Drexel University, the Scripps Research Institute, and Georgetown Medical Center.
Drexel University trial was Withdrawn (Lack of enrollment) originally started under Progenics in 2011, Cytodyn pivoted to monotherapy. Georgetown University metastatic colorectal cancer trial substituted with cancer basket trial. Scripps pre-clinical study for PrEP unknown.
Quote:Dr. Pourhassan made $9,971,254 in total compensation in 2020
This includes warrants and options exercised and sold many that were awarded earlier and he has held for years. Quite misleading and bandied about quite widely by those with an agenda.
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