clarity please on "second hold" - dr j says the FD
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Posted On: 12/14/2023 10:53:55 PM
clarity please on "second hold" - dr j says the FDA never did THAT before, and, most likely, he is correct. never did this before for any company or drug ever. ever.
of course cytodyn is first here....lifting a hold and instating a new one makes no sense to me whatsoever. why "hold" anything back at all? is safety even remotely a concern or is the truth that a hold was never about safety anyway, just a punishment for being chaotic cytodyn?
a new "protocol"? which means they will question the new protocol details for months or longer while still more other drugs get approved and remove any prospect of an "unmet need" needed to approve a new drug ... this is bonkers...correct me if im wrong - but isnt an effective drug with less/no side effects compared to a current drug on market fulfilling the "unmet need" criteria?
are we to believe the reason mono therapy is off the table because of "blips"? do other approved drugs have "blips"? why are we only hearing of "blips" now, never heard this before, when was this known and why have i not heard of this before? what is the hard data on "blips"?....is the real purpose of approval for montherapy have the high bar of being non-transmissible? i doubt any approved HIV drugs guarantee zero transmission, that would be impossible. would you have sex with that person? me not.
also refuse to believe new hold is "temporary" as our previous one was "temporary" and here it is 22 months later. will not celebrate one iota until this "new" hold is lifted. kinda like "youre getting out of jail, but first you have to go to this other jail" means youre still in jail and not in a remote island bar with women, weed, whites, and wine. apologies to robbie robertson.
dr j is the man and always has been. one of the few sane voices in the room for a very long time, ecstatic that he is our ceo. hope he has the balls and skin that it takes, i think he does. sheer knowledge and common sense garners enough confidence that he may be able to go head to head with the FDA and get this over the finish line. hopefully to go head to head with any BP partners that undoubtedly try to pull some very serious shit in the near future. i believe he is as frustrated with the FDA as we are on some levels, but also is aware of the nonsense they had to deal with working with nader et al. hope has the actual desire to take all this on also.
the FDA will still slow walk as much as they can, BP is their demon master, never forget this. the same FDA approved alzheimers aduhelm amidst huge internal protests (10 out of 11 on FDA panel disapproved the drug) as it was painfully obvious the approval was a blatant sham. did FDA heads roll? no. at least biogens ceo got fired.
biggest day in years. tomorrow is going to be fun.
of course cytodyn is first here....lifting a hold and instating a new one makes no sense to me whatsoever. why "hold" anything back at all? is safety even remotely a concern or is the truth that a hold was never about safety anyway, just a punishment for being chaotic cytodyn?
a new "protocol"? which means they will question the new protocol details for months or longer while still more other drugs get approved and remove any prospect of an "unmet need" needed to approve a new drug ... this is bonkers...correct me if im wrong - but isnt an effective drug with less/no side effects compared to a current drug on market fulfilling the "unmet need" criteria?
are we to believe the reason mono therapy is off the table because of "blips"? do other approved drugs have "blips"? why are we only hearing of "blips" now, never heard this before, when was this known and why have i not heard of this before? what is the hard data on "blips"?....is the real purpose of approval for montherapy have the high bar of being non-transmissible? i doubt any approved HIV drugs guarantee zero transmission, that would be impossible. would you have sex with that person? me not.
also refuse to believe new hold is "temporary" as our previous one was "temporary" and here it is 22 months later. will not celebrate one iota until this "new" hold is lifted. kinda like "youre getting out of jail, but first you have to go to this other jail" means youre still in jail and not in a remote island bar with women, weed, whites, and wine. apologies to robbie robertson.
dr j is the man and always has been. one of the few sane voices in the room for a very long time, ecstatic that he is our ceo. hope he has the balls and skin that it takes, i think he does. sheer knowledge and common sense garners enough confidence that he may be able to go head to head with the FDA and get this over the finish line. hopefully to go head to head with any BP partners that undoubtedly try to pull some very serious shit in the near future. i believe he is as frustrated with the FDA as we are on some levels, but also is aware of the nonsense they had to deal with working with nader et al. hope has the actual desire to take all this on also.
the FDA will still slow walk as much as they can, BP is their demon master, never forget this. the same FDA approved alzheimers aduhelm amidst huge internal protests (10 out of 11 on FDA panel disapproved the drug) as it was painfully obvious the approval was a blatant sham. did FDA heads roll? no. at least biogens ceo got fired.
biggest day in years. tomorrow is going to be fun.
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