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Also, it is hard for me to imagine that prior FDA meetings did not address this given it has received breakthrough designation.

Oh, well THAT'S reassuring! 🤣🤣🤣


https://jamanetwork.com/journals/jamainternalmedicine/articl...

Surely you've seen this gem which places some egg on the FDA?

"Of (accelerated approvals), 6 (21%) approvals showed overall survival benefit,"

Yikes. Not totally apples to apples, but faster without solid trials doesn't make an open & shut efficacy case post approval!

But hey, we still give placebo but with more bleeding for strokes (tpa); so what do I know... 🤷???
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