It took Evoke Pharma two years and a couple rounds of fundraising to slice and pull the data for an NDA of its only drug out of a Phase III wreckage. But just a month before the FDA was slated to give its verdict, the biotech reported that the effort might not have been enough after all.
The agency has seen deficiencies during the initial stage of its review, Evoke said on Monday, in three critical sections of the NDA. Although the comments outlined in the multi-disciplinary review are preliminary, the company conceded that ?approval of Gimoti by the PDUFA date of April 1, 2019 is uncertain given the letter.?