Basking Ridge, N.J.-based ElectroCore asked for an expanded 510(k) indication covering prevention of migraine with ElectroCore, a non-invasive vagus nerve stimulator. Today the company said the federal safety watchdog asked for “more information and analysis of the clinical data” backing the 510(K) submission.
“Although the company has 180 days to respond to FDA’s request, the company expects to meet with the FDA in the fourth quarter to discuss the information request,” according to a press release.
“We look forward to meeting soon with the FDA to discuss our 510(k) submission and are committed to working with the agency to address their questions as quickly as possible,” CMO Tony Fiorino said in prepared remarks. “Meanwhile we continue to recruit subjects into the Premium 2 study which we anticipate will further define the clinical utility of GammaCore in the migraine space.”
The news pushed ECOR shares down -3.3% to $3.25 apiece today in pre-market trading. The stock was off -10.1% to $3.02 in early trading.