FDA slaps back small-cap's bid to repurpose 50-year-old chemotherapy
When the German drugmaker Medac handed off a decades-old cancer compound to their US subsidiary in February, it thought it would be smooth sailing to market. After all, the drug had recently been approved in Europe and was available in Canada.
On Tuesday, though, Medac and that publicly traded subsidiary, Medexus, announced the FDA had rejected the compound, telling the company they would need to get new data and reanalyze their Phase III trial before marketing it in the US.
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