(Total Views: 566)
Posted On: 12/10/2023 6:27:59 AM
Post# of 148870
Thank you. So the next question ties to your response directly. What is the timeline to hear back from the FDA regarding the lift, and what are the next steps if the hold is not lifted?
Dr. Jacob Lalezari:
Yeah. Well, that's a question I've been dreading. And I fully expect them to approve this protocol. There's no reason for them not to. There are no safety issues in the ambulatory HIV population. There's a completely unmet medical need. And so I don't see a reason why they would reject this. And I am not really prepared to discuss what Plan B looks like. CytoDyn does have some options under that scenario. But I prefer to think positively and think that this is giving FDA the very thing they wanted to get CytoDyn off hold. They asked CytoDyn to identify an HIV population to use leronlimab in that was not multi-drug resistant. resistant where there was no unmet need. So I think CytoDyn has done a good job identifying this population and getting it to FDA. I don't see any reason why they have to reject it.
Dr. Jacob Lalezari:
Yeah. Well, that's a question I've been dreading. And I fully expect them to approve this protocol. There's no reason for them not to. There are no safety issues in the ambulatory HIV population. There's a completely unmet medical need. And so I don't see a reason why they would reject this. And I am not really prepared to discuss what Plan B looks like. CytoDyn does have some options under that scenario. But I prefer to think positively and think that this is giving FDA the very thing they wanted to get CytoDyn off hold. They asked CytoDyn to identify an HIV population to use leronlimab in that was not multi-drug resistant. resistant where there was no unmet need. So I think CytoDyn has done a good job identifying this population and getting it to FDA. I don't see any reason why they have to reject it.
(8)
(0)
Scroll down for more posts ▼