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marketing? the FDA clearly does not put safety first, every new drug on the market has a list of problems so long it takes up more than 50% of the ad just to tell us death or cancer or limb loss is a side effect for psoriasis. or a new drug has horrific side effects and the trial results show that it adds 5 months to a patients' lifespan, but deafness or blindness or heart attacks or stroke are somehow worth it. so i am not convinced that all things being equal, even if leronlimab is equally effective as a current drug with serious side effects, leronlimabs safety record could push it past SOC on certain indications, when i believe it should get approval in such a scenario.
for instance, if leronlimab is nearly identical to maravirocs' MOA, why isnt it considered for approval already and maraviroc taken off the market as obsolete? my complaint is leronlmab will have to get astounding results and blow the doors off of ORR, PFS, and OS in order to get the attention from the FDA it deserves. im wondering if the current cold to hot trial would be strong enough if the improvement on a combo ICI is as low as say 10-20% (it will be far better than that). you know, the incremental improvement that some new drugs achieve in a crowded market that is far from having an "unmet need", and still get approved. how have other drugs inched past approval without astounding results and minimal improvement while inflicting chronic side effects? this is a mystery to me.
so now here we are with the "cold to hot" trial, and given historical trial results that have been rewarded with approval, what would be the lowest acceptable improvement by percentage that would result in an approval? what would be the threshold for "accelerated approval"?
for instance, if leronlimab is nearly identical to maravirocs' MOA, why isnt it considered for approval already and maraviroc taken off the market as obsolete? my complaint is leronlmab will have to get astounding results and blow the doors off of ORR, PFS, and OS in order to get the attention from the FDA it deserves. im wondering if the current cold to hot trial would be strong enough if the improvement on a combo ICI is as low as say 10-20% (it will be far better than that). you know, the incremental improvement that some new drugs achieve in a crowded market that is far from having an "unmet need", and still get approved. how have other drugs inched past approval without astounding results and minimal improvement while inflicting chronic side effects? this is a mystery to me.
so now here we are with the "cold to hot" trial, and given historical trial results that have been rewarded with approval, what would be the lowest acceptable improvement by percentage that would result in an approval? what would be the threshold for "accelerated approval"?
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