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Posted On: 05/23/2021 11:02:40 AM
Post# of 148903
Good question. I would like to see a response by Cytodyn to the FDA along the lines of:
in regards the letter of May 19, we appreciate that the FDA has documented their decision to not issue an EUA at this time. As to the sentiment in the letter, we have for the last month been working with the world renowned Albert Einstein Institute in Brazil to initiate two new trials. These trials as we have said will build upon the strong results of Leronlimab for treating critical patients of CD12 which showed that 82% of those patients survived after 14 days with two doses of Leronlimab. The new trial will use our preferred four doses of Leronlimab. We will measure among other endpoints if this dosage enables the patients to sustain their fight against the disease after 28 days We are beginning this trial as soon as possible in order to provide these patients with an effective drug where none currently exists and reduce the abhorrent toll of so many deaths.
Not new Information, but supports that CytoDyn believes in the drug, has already moved forward and damns the FDA with feint praise.
Just my thoughts
in regards the letter of May 19, we appreciate that the FDA has documented their decision to not issue an EUA at this time. As to the sentiment in the letter, we have for the last month been working with the world renowned Albert Einstein Institute in Brazil to initiate two new trials. These trials as we have said will build upon the strong results of Leronlimab for treating critical patients of CD12 which showed that 82% of those patients survived after 14 days with two doses of Leronlimab. The new trial will use our preferred four doses of Leronlimab. We will measure among other endpoints if this dosage enables the patients to sustain their fight against the disease after 28 days We are beginning this trial as soon as possible in order to provide these patients with an effective drug where none currently exists and reduce the abhorrent toll of so many deaths.
Not new Information, but supports that CytoDyn believes in the drug, has already moved forward and damns the FDA with feint praise.
Just my thoughts
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