(Total Views: 482)
Posted On: 12/15/2023 10:53:01 AM
Post# of 154725
Now let's clarify what he said!
Okay, thank you for that question, and I do realize that it is confusing to get a letter that both removes one hold and imposes another hold. I'm not sure that that's ever happened at the FDA before.
But the hold that was in place for the last 22 months that required CytoDyn to address annual reports, update the investigator brochure, provide the FDA with an integrated safety database, all of those conditions have been met, and FDA acknowledges them as a complete response, retiring and removing that clinical hold.
The hold that they put in place does not relate to anything in the past and is entirely a function of our submitting to them a new protocol and what is, frankly, a new indication and challenge for CytoDyn.
And that hold, I think, can be described as temporary, while we incorporate FDA's suggestions into our clinical protocol, get it back to them, give them another opportunity to review and comment, and then move forward. So I am, as I indicated, I'm very grateful to FDA. for the thoughtful comments and deep thinking they did about how CytoDyn should approach immune activation with leronlimab.
Okay, thank you for that question, and I do realize that it is confusing to get a letter that both removes one hold and imposes another hold. I'm not sure that that's ever happened at the FDA before.
But the hold that was in place for the last 22 months that required CytoDyn to address annual reports, update the investigator brochure, provide the FDA with an integrated safety database, all of those conditions have been met, and FDA acknowledges them as a complete response, retiring and removing that clinical hold.
The hold that they put in place does not relate to anything in the past and is entirely a function of our submitting to them a new protocol and what is, frankly, a new indication and challenge for CytoDyn.
And that hold, I think, can be described as temporary, while we incorporate FDA's suggestions into our clinical protocol, get it back to them, give them another opportunity to review and comment, and then move forward. So I am, as I indicated, I'm very grateful to FDA. for the thoughtful comments and deep thinking they did about how CytoDyn should approach immune activation with leronlimab.
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