SpringWorks fixes ‘minor data handling error’ after March Form 483 for trial site linked to upcoming PDUFA

The FDA is­sued Spring­Works Ther­a­peu­tics a Form 483 on March 31, say­ing that the com­pa­ny’s own clin­i­cal tri­al pro­to­cols were not fol­lowed.

But Spring­Works COO Badred­din Edris told End­points News in a phone in­ter­view on Mon­day that “it was a mi­nor da­ta han­dling er­ror on an ex­plorato­ry end­point that was cor­rect­ed with­in a week in March and re­sult­ed in no im­pact on the da­ta” that formed the ba­sis of the com­pa­ny’s ap­pli­ca­tion for its first “pipeline-in-a-prod­uct” on­col­o­gy treat­ment, the oral gam­ma sec­re­tase in­hibitor, dubbed nirogace­s­tat, or Og­siveo.

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