so if leronlimab hits and matches single digit SOC ORR, and also has no side effects, doesnt that make it a better candidate for use by doctors than SOC? what am i missing here? does the FDA consider side effects when making approval decisions or are side effects kind of ignored? because if no side effects were a bonus over using an approved SOC drug with exact ORR that had bad side effects, why wouldnt the FDA approve leronlimab immediately? maybe side effects dont matter and most cancer drugs now all have bad side effects but just the way it is. the patients live longer by a few months and thats all that matters, even if those extra months are miserable because of bad side effects.
so if leronlimab hits 20% ORR with no side effects to be comfortable, or hits 30%+ ORR with no side effects to exceed and gain leverage, does this make it a blockbuster ? or are bad side effects kind of ignored as a non issue when compared to drugs owned by powerful big pharma ? does big pharma want the side effects issue to be a minor inconvenience when all other metrics are equal? sounds like it
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leron just needs to soundly beat the single digit SOC ORR to be on solid ground. 20% to be comfortable i would say? but 30%+ would provide a lot more leverage and be comparable to anything that i can find in development.