FDA last week accepted for filing an NDA for Arca biopharma Inc.'s beta blocker, Gencaro bucindolol. But the company has an interesting circle to square. It is hoping the agency approves bucindolol to treat the entire heart failure population based mainly on a Phase III trial that did not show significance on the primary endpoint, but did show significance in a post hoc analysis of a genetic subgroup.
If the script plays out as hoped, the company will be able to use the $50 million it will pick up in a reverse merger with Nuvelo Inc., also announced last week, to launch the beta blocker.
The Phase III