have you invested or worked in biotech sector before?
if you had, you’d already know the answers to your questions.
no, the US fda will usually expect a pivotal trial for a device like this, which means a larger randomised controlled trial, which is what OSL is supposed to be working on, but haven’t started. Fda doesn’t accept CE mark.
no, treated patients in Europe/SEA aren’t the same as ‘test’ subjects for fda.
have you invested or worked in biotech sector before? if you...
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