The FDA is keep­ing its par­tial hold on Re­pros’ Proellex

Re­pros Ther­a­peu­tics $RPRX says that the FDA plans to main­tain the par­tial clin­i­cal hold on Proellex so reg­u­la­tors can take ex­tra time in con­sult­ing with agency ex­perts on the liv­er ef­fects spot­ted in the clin­ic. But they ex­pect to be able to an­swer the agency’s re­quest for in­for­ma­tion and of­fer a planned pro­to­col in a mat­ter of weeks.

Re­pros had told in­vestors their meet­ing with the FDA would be an end of Phase II sit-down. But that changed to a guid­ance ses­sion on this drug.

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