Edwards Lifesciences (NYSE:EW) expects the FDA to approve its Sapien heart valve “any day now,” according to CEO Michael Mussallem.
Edwards has been hanging fire since July, when an FDA advisory panel recommended that the federal watchdog agency approve the Sapien device, which is a transcatheter aortic valve replacement.
Yesterday Mussallem told analysts on a conference call that Edwards believes it’s “at the end of the line” for approval.
“We really do believe that there aren’t any outstanding questions at this point. We believe all issues have been resolved. We’ve been in extensive discussions with the FDA and we really believe that we’re at the end of the line here. And that’s why we gave the indication of ‘any day now,'” Mussallem said. “I haven’t done a great job of predicting exactly approvals, Mike, so I don’t want to go out and be precise on the day. We said we expect it any day. That’s probably about as close as I want to get.”
Earlier this week EW shares took a dive on a rumor that FDA approval could be delayed. The sell-off started after Wells Fargo analyst Larry Biegelsen reported that a member of the FDA advisory panel that recommended approval of Sapien said the device wouldn’t get a green light until April 2012. Edwards denied the rumor, saying it’s still banking on approval this month.
EW shares were up more than 5.2 percent to $71.32 as of about noon today.