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Posted On: 09/29/2021 5:35:53 PM
Post# of 148892
biggest takeaway today brain metastasis
revealed today that 6 mTNBC patients had brain metastasis, AND THEY ALL BEAT SOC and the other drug recently approved. huge huge huge.
and this is what baffles me about the FDA and their by the book processes. clearly there is a breakthrough here, clearly they want to get it right, but in the meantime, they will choke a new drug like leronlimab and keep it from patients who want the right to try. mTNBC kills quickly, and if i heard this data today and couldnt get my hands on LL as i was dying, as many are right this second, id be fuming, and dying.
the official protocol is they have to go through a blinded trial which guarantees that patients in placebo will die. in life or death trials, we already know what the SOC numbers are. i dont understand why there is not a constant accurate record of current SOC data for all mTNBC patients, so we can call these people the "placebo" SOC group for the next drug. i guess its just too expensive, its just terrible that, as janet woodcock put it..."People say they want placebo-controlled trials, but I always ask them would you be willing to die to give a p-value?"
revealed today that 6 mTNBC patients had brain metastasis, AND THEY ALL BEAT SOC and the other drug recently approved. huge huge huge.
and this is what baffles me about the FDA and their by the book processes. clearly there is a breakthrough here, clearly they want to get it right, but in the meantime, they will choke a new drug like leronlimab and keep it from patients who want the right to try. mTNBC kills quickly, and if i heard this data today and couldnt get my hands on LL as i was dying, as many are right this second, id be fuming, and dying.
the official protocol is they have to go through a blinded trial which guarantees that patients in placebo will die. in life or death trials, we already know what the SOC numbers are. i dont understand why there is not a constant accurate record of current SOC data for all mTNBC patients, so we can call these people the "placebo" SOC group for the next drug. i guess its just too expensive, its just terrible that, as janet woodcock put it..."People say they want placebo-controlled trials, but I always ask them would you be willing to die to give a p-value?"
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