Cit­ing lin­ger­ing con­cerns, FDA stops Evoke at the 10-yard line a month be­fore PDU­FA date

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.”

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