Intersect ENT (NSDQ:XENT) said today that the FDA performed a pre-approval inspection of the company’s Menlo Park facility as part of the new drug application for the its Sinuva steroid-releasing sinus implant.
Although the FDA issued a form 483 with four inspection-related observations, the company said it doesn’t expect these notes to impact its Jan. 7 decision date set by the FDA for Sinuva.
“We appreciate the FDA’s close review and are committed to fully addressing the agency’s observations within the 15-day response timeframe,” president & CEO Lisa Earnhardt said in prepared remarks. “We are excited to have completed another important milestone as we continue to advance Sinuva through the NDA process.”
“We remain confident this does not have any implications for Sinuva’s approval prospects or approval timing (and our sense is that the observations are relatively benign in nature – i.e., more process oriented),” Leerink analysts Richard Newitter and Jaime Morgan wrote in a note to investors.
“There may even be reason to be encouraged by the outcome of the PAI in that this is the first major step of the approval process now behind the company – and no major issues identified – thus it could be read as a positive (required) milestone has now been met now and brings Sinuva one step closer to approval.”