Now, to be clear, CytoDyn was again placed on a new clinical hold for the immune activation study while we incorporate FDA feedback and prepare a revised protocol. I want to stress that this new clinical hold is often a normal part of the FDA review process on newly submitted protocols. The hold does not raise any new regulatory or safety concerns and it will be removed after we respond to FDA's guidance concerning our protocol design, primary and secondary endpoints, and stopping rule. We're reviewing the FDA guidance now with our key consultants and expect to submit our revised protocol in January.
00:05:40, Dr. Jacob Lalezari:
So, just to summarize and be clear, the partial clinical hold over the last 22 months has been removed and all past issues have been completely addressed. We expect the new hold to be lifted after we incorporate FDA's recent suggestions and submit our revised immune activation protocol in January. After that resubmission, the FDA will have 30 days to respond to comments. I know that the simultaneous removal of one hold and the imposition of a new hold can seem confusing. But I want to assure everyone today that this is all very good news for CytoDyn, and we are excited to be turning the page and moving forward.
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.
00:05:40, Dr. Jacob Lalezari:
So, just to summarize and be clear, the partial clinical hold over the last 22 months has been removed and all past issues have been completely addressed. We expect the new hold to be lifted after we incorporate FDA's recent suggestions and submit our revised immune activation protocol in January. After that resubmission, the FDA will have 30 days to respond to comments. I know that the simultaneous removal of one hold and the imposition of a new hold can seem confusing. But I want to assure everyone today that this is all very good news for CytoDyn, and we are excited to be turning the page and moving forward.
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.
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