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Posted On: 12/10/2023 10:23:18 AM
Post# of 148863
Re: biloxiblues #139704
While Dr. Lalezari's response addressed the latter part of the question, he had noted his answer to the "timeline to hear back from the FDA" at the end of his presentation earlier:
00:25:36 Dr. Jay Lalezari:
I think that's a study that the FDA is going to have a hard time not wanting to see done. There is currently no therapy for immune activation in HIV. Half the patients we're going to enroll are going to be transgender women who have elevated activation markers because of the hormonal therapy they're taking. And in fact, what I had mentioned earlier was that the FDA, having received the protocol, has asked if they can cross-reference the IND file for NASH, which is exactly the right question to be asking is “what other evidence do we have that leronlimab is mediating inflammation and immune activation?”. So that we are waiting to hear. I believe the clock is ticking and that we're expecting to hear one way or another from the FDA in the next two weeks. And from there, it's either we're off clinical hold and we're raising the money and we're launching this study, or we're dealing with whatever else is being sent our way. And I think I will just stop there and happily answer any questions. Thank you all for listening.
This interview was apparently conducted on 11/21/23 ... so "in the next two weeks" would be roughly December 5th (with weekends - was not to be) or December 11th (without weekends) ... that's this coming Monday or some time this week hopefully?
And btw, many thanks to MGK and all of you who are providing such valuable information, making this board a pleasure to read.
00:25:36 Dr. Jay Lalezari:
I think that's a study that the FDA is going to have a hard time not wanting to see done. There is currently no therapy for immune activation in HIV. Half the patients we're going to enroll are going to be transgender women who have elevated activation markers because of the hormonal therapy they're taking. And in fact, what I had mentioned earlier was that the FDA, having received the protocol, has asked if they can cross-reference the IND file for NASH, which is exactly the right question to be asking is “what other evidence do we have that leronlimab is mediating inflammation and immune activation?”. So that we are waiting to hear. I believe the clock is ticking and that we're expecting to hear one way or another from the FDA in the next two weeks. And from there, it's either we're off clinical hold and we're raising the money and we're launching this study, or we're dealing with whatever else is being sent our way. And I think I will just stop there and happily answer any questions. Thank you all for listening.
This interview was apparently conducted on 11/21/23 ... so "in the next two weeks" would be roughly December 5th (with weekends - was not to be) or December 11th (without weekends) ... that's this coming Monday or some time this week hopefully?
And btw, many thanks to MGK and all of you who are providing such valuable information, making this board a pleasure to read.
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