Piper/Sandler Reiterate Buy / FDA Inspection Assigned.
While we were disappointed to see UNC Y receive a second CRL related to deficiencies previously identified at a third party manufacturing vendor management provided thoughtful commentary which instills us with confidence specifically during review dialogue the agency told unsi that the third party inspection could occur up to the last few weeks of the June 29th deadline unfortunately during the last hour the FDA informed UNCY that the inspection had not occurred and the only way for the agency to push the date was through a CRL. Notably management highlighted the inspection has now been assigned where they are prepared to resubmit OLC once the inspection is complete and the third party vendor is deemed to compliance UNCY can resubmit OC under type 1 NDA so the new PD UFA date should occur much quicker in three to four months october 2026 d Piper/Sandlers response.
Per management, the FDA has communicated the inspection assignment to the vendor in writing, and management expects it to occur within weeks, given the agency's typical unnaounced scheduling for these visits. Once completed, the path to resubmission and a final decision is expected to be short, consistent with Class 1 type turnaround rather than a new cycle.