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Re: HGilS post# 363791

Monday, 12/27/2021 9:16:58 AM

Monday, December 27, 2021 9:16:58 AM

Post# of 403233
I've noticed over the years they have had a lot of approvals with no P/R, just go threw the approval page and you will see, puzzles me too, but most of the big boys don't bother unless it's a big launch.

https://www.accessdata.fda.gov/scripts/cder/daf/

or, it could be Kept on the down low, for some reason we are not privy to.
you see they must have applied at least 8 months ago and knew it could get approved, yet they extend the contract with Elite,
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