- The FDA has issued a Complete Response Letter (CRL) regarding Verrica Pharmaceuticals Inc's (NASDAQ:VRCA) marketing application for VP-102 for molluscum contagiosum.
- The only deficiency listed in the CRL was related to the deficiencies identified at a general reinspection of Sterling Pharmaceuticals Services LLC, the contract manufacturing organization that manufactures Verrica's bulk solution drug product.
- Sterling advised Verrica on May 20 that it received notice that it is on Official Action Indicated (OAI) status. Sterling's OAI classification resulted from a reinspection of the CMO conducted by the FDA in February 2022.
- Also See: Verrica Pharma Shares Slide After Response Letter From FDA.
- The reinspection was conducted approximately 90 days after the Agency initially classified Sterling as VAI (Voluntary Action Indicated) on November 17, 2021.
- Verrica understood that the VAI classification did not indicate that a reinspection was required.
- The CRL did not identify any other deficiencies.
- In July 2020, the company received the first CRL for VP-102, noted deficiencies that precluded discussion of labeling and post-marketing requirements/commitments.
- Verrica intends to file a Type A meeting request by the end of this week.
- VRCA said it is working collaboratively to help Sterling present multiple options to the Agency to satisfy the deficiencies. Concurrently, Verrica is engaging an additional CMO to serve as an alternative supplier of VP-102's bulk solution.
- Price Action: VRCA shares are down 55% at $2.50 during the premarket session on the last check Wednesday.
