“If they go by 60 day reviews, today is 60 days “ !
On July 31, 2017, Kitov Pharmaceuticals Holdings Ltd. (the “Company”) announced that it had submitted a New Drug Application to the U.S. Food and Drug Administration for KIT-302, its lead drug candidate. On July 31, 2017, the Company issued a press release in connection with its submission of the New Drug Application, “ Kitov Submits New Drug Application to FDA for KIT-302 ”, which is attached hereto as Exhibit 99.1
Googled this info below ~~>
How long for NDA approval?
Once a NDA application is filed, the U.S. FDA has 60 days to decide whether it intends to file it or reject it. If the application is deemed as incomplete, it can reject or request for more information within the first 60 days.
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