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Re: HyGro post# 543365

Sunday, 12/04/2022 2:43:31 PM

Sunday, December 04, 2022 2:43:31 PM

Post# of 726127
I would argue that the FDA is the best source for learning about the FDA’s processes. There are videos available online featuring physicians and FDA officials commenting on the approval process.

The unmet need for rGBM in particular is highly relevant. Safety and the availability or unavailability of other therapies are also highly relevant. For rGBM (recurrent) in particular, these considerations would be crucial for any advisory board.

https://www.fda.gov/drugs/development-approval-process-drugs



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