(Total Views: 480)
Posted On: 05/16/2025 1:35:38 PM
Post# of 154969
Re: KenChowder #153074
so the FDA is narrow minded. seems like they are more in the business of denial more than approval. i guess they dont have friends or family in need of such life saving possibilities that are currently taking keytruda or similar.. but rules are rules.
if they are holding the belief that a drug that enhances the effectiveness of another drug is NOT treating disease, then we (the world) have a major problem. if a ship is sinking and you can only toss them inflatable life preservers (conveniently only made by the ships company), will you not be allowed to inflate them? are the air pumps left onshore because air pumps (made by a different manufacturer of course) dont save people from drowning, only life preservers do? this is the logic i am seeing here. and im not even remotely surprised.
we saw how the FDA treated cytodyn during covid - only the "declared" "endpoints" werent "met" but there was clear evidence that something astounding was happening otherwise - so off the cliff you go! lose on a technicality! "anecdotal"!!!! off you go! big pharma only need apply!!!!!!!!!
whats your favorite color? blue, no yellow - off you go!!!
we saw how the FDA treated cytodyn with HIV - "declared" "endpoints" not "met" even though HIV patients were on the drug for years with no side effects doing way better than otherwise, but that doesnt matter...off you go! lose on a technicality! data was compromised (sabotaged) so....sucks to be you!
man those blinders are on extra special tight. might not see that life preserver im about to toss ya.
raising PL-L1 cant (currently) be an endpoint unto itself? reducing CTCs cant (currently) be an endpoint? it may take years to coax the FDA into allowing these endpoints? change is painfully slow? got it. silly me. i must be new here.
just tell that to a faithful keytruda customer
but its coming -
FDA - what is the airspeed of an unladen swallow?
cytodyn - african or european?
if they are holding the belief that a drug that enhances the effectiveness of another drug is NOT treating disease, then we (the world) have a major problem. if a ship is sinking and you can only toss them inflatable life preservers (conveniently only made by the ships company), will you not be allowed to inflate them? are the air pumps left onshore because air pumps (made by a different manufacturer of course) dont save people from drowning, only life preservers do? this is the logic i am seeing here. and im not even remotely surprised.
we saw how the FDA treated cytodyn during covid - only the "declared" "endpoints" werent "met" but there was clear evidence that something astounding was happening otherwise - so off the cliff you go! lose on a technicality! "anecdotal"!!!! off you go! big pharma only need apply!!!!!!!!!
whats your favorite color? blue, no yellow - off you go!!!
we saw how the FDA treated cytodyn with HIV - "declared" "endpoints" not "met" even though HIV patients were on the drug for years with no side effects doing way better than otherwise, but that doesnt matter...off you go! lose on a technicality! data was compromised (sabotaged) so....sucks to be you!
man those blinders are on extra special tight. might not see that life preserver im about to toss ya.
raising PL-L1 cant (currently) be an endpoint unto itself? reducing CTCs cant (currently) be an endpoint? it may take years to coax the FDA into allowing these endpoints? change is painfully slow? got it. silly me. i must be new here.
just tell that to a faithful keytruda customer
but its coming -
FDA - what is the airspeed of an unladen swallow?
cytodyn - african or european?
Quote:
It is true that approvals are for treating diseases, but not that long ago the FDA took the position that accelerated approval could be granted if appropriate surrogate endpoints were reached. Raising PD-L1 would not be such an endpoint, but shrinking tumors could, I think. I wonder if reducing CAMLs and CTCs (circulating cancer cells) might be such a surrogate endpoint? Especially since the poster clearly showed that reduction after Leron was given.
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