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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