AI
Saturday, March 29, 2025 5:30:57 PM
ex,
Thanks for asking 😶
No, I was referring to your conspiracy theory about the choice to pursue the MAA before a BLA with the FDA, and I think you’re taking her comment out of context as if it reflects the sum and total of her perspective — I believe she also said that the FDA required the crossover, that the FDA is becoming more open to ECA data, and that nothing would ever be approved for GBM if RTC design were required in all trials (suggesting that placebo participants must have access to the best available therapy).
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
It is also noteworthy that FDA approved the pembrolizumab combo trial design with DCVax-L (which is a RCT as you would prefer):
https://www.clinicaltrials.gov/study/NCT04201873
Thanks for asking 😶
No, I was referring to your conspiracy theory about the choice to pursue the MAA before a BLA with the FDA, and I think you’re taking her comment out of context as if it reflects the sum and total of her perspective — I believe she also said that the FDA required the crossover, that the FDA is becoming more open to ECA data, and that nothing would ever be approved for GBM if RTC design were required in all trials (suggesting that placebo participants must have access to the best available therapy).
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
It is also noteworthy that FDA approved the pembrolizumab combo trial design with DCVax-L (which is a RCT as you would prefer):
https://www.clinicaltrials.gov/study/NCT04201873
Bullish
Believe carefully. This is the greatest and most powerful lesson that I have learned since arriving on Earth. Examine what you believe about yourself most importantly, and then believe carefully as you interact with the world.
