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ndforlife

05/21/19 11:04 PM

#55455 RE: Martymook #55454

Sounds like they want to have the package submitted by 2020. Once submitted the FDA has 180 days to respond.

elkonig

05/22/19 10:42 AM

#55459 RE: Martymook #55454

Well its been eleven or twelve years so far since the applications first went in. At least three FDA denials for safety reasons have been issued.
Your guess is as good as any ones.