Go back and listen to Dr Jay’s updates from Dece
Post# of 153776
(Total Views: 909)
Posted On: 04/21/2024 3:19:16 PM
Go back and listen to Dr Jay’s updates from December and March, it is clear to him for the reason that LL will not (in its current form) be approved for HIV monotherapy; he cites a moderate log drop in viral load (not terrible but not great either).
The current market for HTE/MDR (highly treatment experienced/Multi drug resistant) HIV patients has become crowded in the last few years - If you are going to Bring a drug to market, The FDA wants it to show a marked difference from what is already on the market- But I think Dr. Jay alluded to the concept that LL could be used in Combination with other drugs for MDR patients. Regarding monotherapy, the FDA may be wary because of the “moderate” log drop relative to other drugs on the market and the occurrence of some blips.
That is not to say that a clinical trial could not be designed where a patient starts out on combination therapy including LL, gets through the blips, and then continues on with just LL monotherapy. The comparator arm could be patients who remain on combination therapy with the chosen regimen, plus LL throughout the duration of the trial. The good news is this would include a partnership. I don’t know if the FDA would have the fortitude to approve such a trial and so taking it to macaques with Dr. Sacha Might be required first. But all of this is moot Because Long acting LL (LALL) Is already in the works. If LALL is showing similar blips then adding It as combination therapy as almost a loading regimen in the first month might be an order.
But I digress…
I don’t know if the drug where Murray ended up advising is any good or how different it is from SOC (Standard of care ) but I don’t think that is the reason for him going there. I think he enjoys the salary and the company enjoys him advising them through FDA Waters. I don’t think it has anything to do with LL.
The current market for HTE/MDR (highly treatment experienced/Multi drug resistant) HIV patients has become crowded in the last few years - If you are going to Bring a drug to market, The FDA wants it to show a marked difference from what is already on the market- But I think Dr. Jay alluded to the concept that LL could be used in Combination with other drugs for MDR patients. Regarding monotherapy, the FDA may be wary because of the “moderate” log drop relative to other drugs on the market and the occurrence of some blips.
That is not to say that a clinical trial could not be designed where a patient starts out on combination therapy including LL, gets through the blips, and then continues on with just LL monotherapy. The comparator arm could be patients who remain on combination therapy with the chosen regimen, plus LL throughout the duration of the trial. The good news is this would include a partnership. I don’t know if the FDA would have the fortitude to approve such a trial and so taking it to macaques with Dr. Sacha Might be required first. But all of this is moot Because Long acting LL (LALL) Is already in the works. If LALL is showing similar blips then adding It as combination therapy as almost a loading regimen in the first month might be an order.
But I digress…
I don’t know if the drug where Murray ended up advising is any good or how different it is from SOC (Standard of care ) but I don’t think that is the reason for him going there. I think he enjoys the salary and the company enjoys him advising them through FDA Waters. I don’t think it has anything to do with LL.
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