“Yet they delay us by asking for an HIV protocol
Post# of 155052
(Total Views: 758)
Posted On: 10/16/2023 2:51:37 PM
“Yet they delay us by asking for an HIV protocol when we are not pursuing an HIV trial. I would consider that unnecessary.”
On the face of it I agree, however, Spock logic has suggested this FDA move might be a chiropractic adjustment to the Leronlimab trajectory for HIV approval. The FDA, knowing the safety, and the efficacy, with crisp documentation, perhaps in Cytodyn’s best interests, possibly even as a face saving move by the FDA as people will at some point recognize and trumpet the lunacy of this hold…might they be inclined toward a phase 4 study involving a sub population and with well defined end point that sticks the landing? Maybe HIV really is in play and potentially with more of a fast track toward approval. Only the company and the FDA know for sure and they aren’t talking. That said I suspect the company will be talking soon.
This speculation is born from a view which believes there may be some within higher levels of the bureaucracy with connections to BP that might surreptitiously try some blocking and tackling maneuvers but the larger swaths of employees, many highly educated with advanced degrees, are just trying to do their jobs with some level of intellectual honesty but perhaps biased by the overly cautious stance of the organization as a whole that has never been known to move at warp speed. We’ve been moving at sub-light speed for long enough maybe we hit space dock soon.
On the face of it I agree, however, Spock logic has suggested this FDA move might be a chiropractic adjustment to the Leronlimab trajectory for HIV approval. The FDA, knowing the safety, and the efficacy, with crisp documentation, perhaps in Cytodyn’s best interests, possibly even as a face saving move by the FDA as people will at some point recognize and trumpet the lunacy of this hold…might they be inclined toward a phase 4 study involving a sub population and with well defined end point that sticks the landing? Maybe HIV really is in play and potentially with more of a fast track toward approval. Only the company and the FDA know for sure and they aren’t talking. That said I suspect the company will be talking soon.
This speculation is born from a view which believes there may be some within higher levels of the bureaucracy with connections to BP that might surreptitiously try some blocking and tackling maneuvers but the larger swaths of employees, many highly educated with advanced degrees, are just trying to do their jobs with some level of intellectual honesty but perhaps biased by the overly cautious stance of the organization as a whole that has never been known to move at warp speed. We’ve been moving at sub-light speed for long enough maybe we hit space dock soon.
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