Monday, August 02, 2021 4:39:07 PM
When SYMJEPI went to the FDA for Approval...for the 3rd iteration, it was submitted on January 19, 2017: Ahead of the 6-month PDUFA Date, FDA approved on June 15, 2017. (Just under 5 Months)
I see a similar pattern going on with ZIMHI...submitted for FDA approval on 3rd iteration on May 17, 2021: PDUFA Date November 15th?....FDA may approve by October 13, 2021. (Again, just under 5 months)
One can only hope it is sooner, but my speculation is by mid October at the latest.
In My Own Personal Opinion Of Course!
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