Monday, July 15, 2024 9:54:34 AM
First of all, he said she "implied" it. She said
Getting regulatory interest is not equal to getting regulatory approval. And she says that happens AFTER the company release the patient level data which they have not, and probably never will to a competitor anyway.
I'm actually hoping that our publication uh and the discussions around it will spur the sponsors of these clinical trials to publicly release their individual patient data so that we as a field can further innovate and get regulatory interest in the use of external control arms in neurology and oncology trials
Getting regulatory interest is not equal to getting regulatory approval. And she says that happens AFTER the company release the patient level data which they have not, and probably never will to a competitor anyway.
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