FDA throws up an­oth­er road­block to Car­diome, 9 years af­ter re­ject­ing its drug

Nine years af­ter the FDA threw Car­diome $CRME for a loop, re­ject­ing its IV atri­al fib­ril­la­tion drug Brinavess (ver­nakalant), the biotech is no clos­er to chang­ing the agency’s de­ci­sion.

Back in 2008 reg­u­la­tors de­mand­ed more da­ta on heart fail­ure, in­clud­ing ad­di­tion­al safe­ty work. Then, in 2012, Mer­ck dropped its rights in the drug and left the pen­ny stock biotech to mar­ket the drug in Eu­rope and Latin Amer­i­ca on its own.

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