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Thursday, December 15, 2022 10:03:21 PM
The fact that the fda keeps the whole approval process going forward, albeit at sub snail pace, tells me that they believe theres something there worth pursuing.
The fda could easily end the issue by simply reviewing the data and issuing a hard yes or no but for some strange reason are prolonging what should be a relatively simple decision imo.
Would be interesting if any previous ep changes had to undergo these steps as revive does.......seems revive is a ground breaker of sorts re the fda as this is not the first issue where they have been given ""special"" treatment.
I personally believe that these unnecessary delays are by design, but for what reason, only the fda really knows.
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