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Msg  47572 of 47891  at  8/15/2022 3:12:32 PM  by

noluckrequired


refile or not argument

two birds of the same stripe- if it technically has to refile but that refile is the same application with deficiencies corrected re CMO and heparin supply then it is the same end effect- i.e the FDA is not going to go back to square 1 and 6 month review but rather pick up the application at the manufacturing approval item. That should lend it self to late 2022 or early 2023 for approval just the same. Now of course we must assume the CMO did in fect correct all deficiencies.


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Msg # Subject Author Recs Date Posted
47573 Re: refile or not argument noluckrequired 1 8/15/2022 3:27:36 PM




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