Hey MSBlasters, I came across this YT clip
https://www.youtube.com/live/k33d4h-CpGU?si=TMbmY2J-phCmb4V1
Buddy the patient rep is a star. He doesn’t mince his words.
Peter Marks is in it & discusses working with companies.
It’s about accelerated approval for Duchenne Muscular Dystrophy. Buddy discusses the ethical dilemma of use of placebo. It’s a very interesting watch. FDA & some of their experts are left looking as though they lack clear direction/understanding/ knowledge of current best practice. It is crazy to watch one lady get given the facts by the company but still refuse to believe them.
Glad to say that the drug had an 8 to 6 yes vote & was granted an AA.
Buddy is awesome!
I think MSB Team deserve medals for having to teach the FDA.
Cell Therapy News/Articles, page-17489
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