AI
Sunday, December 11, 2022 6:12:26 PM
Thanks for your opinion—Yes, the FDA is always circumspect in their decisions.
Beyond the significance of years of clinical survival data from three separate clinical trials, there are two other crucial factors to consider before approval can be awarded:
1. Safety Profile/Benefit-Risk Analysis
2. Unmet Medical Need
Then, perhaps further consider its use in combo based on interim survival data:
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
https://www.uspto.gov/about-us/news-updates/uspto-announces-cancer-moonshot-expedited-examination-pilot-program
Beyond the significance of years of clinical survival data from three separate clinical trials, there are two other crucial factors to consider before approval can be awarded:
1. Safety Profile/Benefit-Risk Analysis
2. Unmet Medical Need
Then, perhaps further consider its use in combo based on interim survival data:
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
https://www.uspto.gov/about-us/news-updates/uspto-announces-cancer-moonshot-expedited-examination-pilot-program
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.
