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Re: akblack post# 429836

Tuesday, 12/28/2021 5:31:30 PM

Tuesday, December 28, 2021 5:31:30 PM

Post# of 700880
Things are moving slowly with the implementation of the 21st Century Cures Act at FDA. It may be due to COVID. Whatever the cause, the FDA likely is not focused on slowing NWBO down. I think absolutely to the contrary. But people approving applications are not the same people implementing and finalizing policy. So, you can’t make announcements based on regulations and policies not yet finalized by your primary regulator. The reforms have been outlined and announced in great detail. The process is molasses. All IMHO.
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