yes you got it right, and that is the current object of the game just like you stated it - improving ICI effectiveness dramatically with LL would warrent an approval of a combo.
BUT its even better than that.....leronlimab improves the patients condition enough on its own that when combined with a keytruda, the patients' other metrics improve regardless of enhanced ICI effectiveness. one could call it a win-win. im just not sure how those metrics are proven since the clinical trial focuses only on the primary endpoint, which could be turning the tumor from cold to hot, and the already hot to hotter BUT not any the secondary benefits. unless specifically stated (and paid for of course)
say an upcoming CRC trial patient is also a behaviorally HIV high risk patient (use your imagination) - and LL apparently acts astonishingly well as a PrEP and the patient never contracts HIV even though the patient is trying as hard as he can to contract HIV - would this be recorded and recognized in the trial ? no. could it be determined later? yes. we just mined old data in search of other objectives.
questions have been asked before - the previous 8-9 years of 1000 or so drastically ill street living level chronically ill HIV patients taking LL have any of the secondary benefits, like maybe lower cases of covid (or other lung issues for that matter living on the street?) or cancers during that time, for example? no idea. wasnt recorded and the blood samples are gone.
isnt this what hosed us on the covid cd10/cd12 trials? where the endpoints werent "stated properly", so they were "missed"? even though covid patients were dosed for two weeks, improved the first two weeks - dramatically - , the final measurements were at the end of four weeks (final two weeks undosed because FDA wanted it that way) so the numbers went back down and LL was considered ineffective on a technicality? thats the clownshow i remember.
the FDA basically said that yes, the brakes on you car worked the first two weeks, but since you hit the brick wall the second two weeks because we removed the brakes, the brakes never worked. oh and by the way, the other company that likes to stop the car like fred flintstone does, were going with those guys, because, well, because.
so it seems to me that additional benefits in any trial going forward could just as easily be ignored if endpoints are not "worded properly" or if those metrics are even recorded (its expensive) or blood samples are preserved for later analysis (thats expensive too) . so somebody please assure me that the clownshow wont rear its ugly head again and the FDA doesnt play funny with the trials and bust us on a "technicality" again. the brakes work, dont tell me differently.
BUT its even better than that.....leronlimab improves the patients condition enough on its own that when combined with a keytruda, the patients' other metrics improve regardless of enhanced ICI effectiveness. one could call it a win-win. im just not sure how those metrics are proven since the clinical trial focuses only on the primary endpoint, which could be turning the tumor from cold to hot, and the already hot to hotter BUT not any the secondary benefits. unless specifically stated (and paid for of course)
say an upcoming CRC trial patient is also a behaviorally HIV high risk patient (use your imagination) - and LL apparently acts astonishingly well as a PrEP and the patient never contracts HIV even though the patient is trying as hard as he can to contract HIV - would this be recorded and recognized in the trial ? no. could it be determined later? yes. we just mined old data in search of other objectives.
questions have been asked before - the previous 8-9 years of 1000 or so drastically ill street living level chronically ill HIV patients taking LL have any of the secondary benefits, like maybe lower cases of covid (or other lung issues for that matter living on the street?) or cancers during that time, for example? no idea. wasnt recorded and the blood samples are gone.
isnt this what hosed us on the covid cd10/cd12 trials? where the endpoints werent "stated properly", so they were "missed"? even though covid patients were dosed for two weeks, improved the first two weeks - dramatically - , the final measurements were at the end of four weeks (final two weeks undosed because FDA wanted it that way) so the numbers went back down and LL was considered ineffective on a technicality? thats the clownshow i remember.
the FDA basically said that yes, the brakes on you car worked the first two weeks, but since you hit the brick wall the second two weeks because we removed the brakes, the brakes never worked. oh and by the way, the other company that likes to stop the car like fred flintstone does, were going with those guys, because, well, because.
so it seems to me that additional benefits in any trial going forward could just as easily be ignored if endpoints are not "worded properly" or if those metrics are even recorded (its expensive) or blood samples are preserved for later analysis (thats expensive too) . so somebody please assure me that the clownshow wont rear its ugly head again and the FDA doesnt play funny with the trials and bust us on a "technicality" again. the brakes work, dont tell me differently.
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