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Re: wrinklesobw post# 169759

Tuesday, 01/16/2024 10:17:59 PM

Tuesday, January 16, 2024 10:17:59 PM

Post# of 178331
If I had to take a guess, the FDA reused the original submission. The only reason why they were denied was due to lack of historical data or whatever. Basically lack of recognized testing. That was taken care of with the EFS program.


The EFS program could of also lead them into the BDD. Again these are complete guesses.
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