[BostonCard]

I'd probably take it, it at least seems safe and maybe could help a bit.



I wonder BC, have you seen many drugs get FDA approval when the efficacy data is this poor?

In the oncology space, a number of drugs have gotten "accelerated approval" from the FDA.  A recent JAMA article (https://jamanetwork.com/journals/jamaint...le/2733561) found that only about 1/5 of them had confirmatory trials that showed a survival advantage.

Conclusions and Relevance  Confirmatory trials for one-fifth (n = 19 of 93) of cancer drug indications approved via the FDA’s accelerated approval pathway demonstrated improvements in overall patient survival. Reassessment of the requirements for confirmatory trials may be necessary to obtain more clinically meaningful information.

BC

[BostonCard]

I'd probably take it, it at least seems safe and maybe could help a bit.



I wonder BC, have you seen many drugs get FDA approval when the efficacy data is this poor?

In the oncology space, a number of drugs have gotten "accelerated approval" from the FDA.  A recent JAMA article (https://jamanetwork.com/journals/jamaint...le/2733561) found that only about 1/5 of them had confirmatory trials that showed a survival advantage.

Conclusions and Relevance  Confirmatory trials for one-fifth (n = 19 of 93) of cancer drug indications approved via the FDA’s accelerated approval pathway demonstrated improvements in overall patient survival. Reassessment of the requirements for confirmatory trials may be necessary to obtain more clinically meaningful information.

BC