Evoke Pharma responds to DR letter for Gimoti NDA, requests meeting with FDA

Evoke Pharma announced that it has submitted its response to the FDA multi-disciplinary review, or DR, letter that was received on March 1 in association with the Gimoti 505 new drug application, or NDA. In addition, the company requested a meeting with the FDA prior to the Prescription Drug User Fee Act action date of April 1. The meeting was granted and will be held on March 21. The purpose of this meeting is to obtain FDA’s feedback on the company’s responses.
https://thefly.com/landingPageNews.php?id=2879193