Verrica Pharmaceuticals · VP-102 · Nov 2021 – May 2022

What changed between Verrica's second and third FDA letters?

November 2021: “voluntary action indicated,” inspection closed. May 2022: a “general reinspection,” “Official Action Indicated” status and a third letter. This time the filing named the manufacturer: Sterling.

EphemerisX Research · Published · 7 source documents · 2 min read

Short answer

By Verrica's account, both letters turned on a contract manufacturer's facility rather than on VP-102 itself. What Verrica reported about the inspections changed: in November 2021, a “voluntary action indicated” classification for “the CMO”; in May 2022, a “general reinspection” of a facility of Sterling Pharmaceutical Services, “Official Action Indicated” status, and a letter that, Verrica says, identified no other deficiency.

What the evidence shows

The 8-K of May 25, 2022 says the letter came as a direct result of deficiencies identified at a general reinspection of a facility of Sterling Pharmaceutical Services, LLC 8-K · May 25, 2022, and that Sterling advised the Company that it received notice on May 19, 2022 8-K · May 25, 2022 that it was on Official Action Indicated 8-K · May 25, 2022 status. The CRL did not identify any other deficiencies. 8-K · May 25, 2022

It adds: The Company was informed by the FDA that it had completed its review of the NDA and product label, there were no open questions on the NDA review, and the VP-102 label was ready to be communicated. 8-K · May 25, 2022

The letter itself is signed 05/23/2022 FDA · May 23, 2022 · p. 6. Its searchable pages hold its standard sections, including the name: This name was found acceptable pending approval of the application in the current review cycle. FDA · May 23, 2022 · p. 3

The September 2022 presentation describes Sterling as a contract manufacturing organization (CMO) that manufactured the bulk solution for VP-102 8-K · Sep 14, 2022, and adds that a pre-approval inspection (PAI) was also conducted on VP-102 at Sterling with no observations 8-K · Sep 14, 2022.

What changed

The inspection outcomes Verrica reported. November 2021: “voluntary action indicated” (“VAI”), is now closed 8-K · Nov 12, 2021. May 2022: Official Action Indicated 8-K · May 25, 2022. The May 25, 2022 8-K does not mention the earlier “voluntary action indicated” classification. 8-K · searched

The name. In 2021, a facility of a contract manufacturing organization 8-K · Sep 20, 2021. None of Verrica's five 2021 filings on the second letter (September 20 to November 29) mentions Sterling. 8-K · searched In May 2022, Sterling Pharmaceutical Services, LLC 8-K · May 25, 2022.

The scope, as Verrica put it. 2021: do not specifically relate to the manufacturing of VP-102 8-K · Sep 20, 2021. 2022: None of the issues identified by FDA during the reinspection were specific to the manufacturing of VP-102. 8-K · May 25, 2022

What followed. After the second letter: Verrica resubmitted the NDA for VP-102 on November 24, 2021 8-K · Nov 29, 2021. After the third, its board approved a plan to reduce its workforce by terminating 20 employees 8-K · Jun 3, 2022, and Verrica moved the bulk solution elsewhere: How did VP-102 get from a third FDA letter to approval?

Follow the thread

This investigation connects to

The documents, by date

Verrica Pharmaceuticals Form 8-K, filed September 20, 20218-K · Sep 20, 2021Verrica Pharmaceuticals Form 8-K, filed November 12, 20218-K · Nov 12, 2021Verrica Pharmaceuticals Form 8-K, filed November 29, 20218-K · Nov 29, 2021FDA Complete Response Letter, May 23, 2022FDA letter · May 23, 2022Verrica Pharmaceuticals Form 8-K, filed May 25, 20228-K · May 25, 2022Verrica Pharmaceuticals Form 8-K, filed June 3, 20228-K · Jun 3, 2022Verrica Pharmaceuticals Form 8-K, filed September 14, 20228-K · Sep 14, 2022

The passages quoted

Verrica Pharmaceuticals Form 8-K, filed September 20, 2021

None of Verrica's five 2021 filings on the second letter (September 20 to November 29) mentions Sterling.

Searched the whole document for: Sterling. None found.

Open the document →

Verrica Pharmaceuticals Form 8-K, filed September 20, 2021

announced that it received a complete response letter from the U.S. Food and Drug Administration (the “ FDA ”) identifying deficiencies at a facility of a contract manufacturing organization for its New Drug Application (the “ NDA ”) for VP-102 for the treatment of molluscum contagiosum. The identified deficiencies do not specifically relate to the manufacturing of VP-102, but instead raise general quality issues at the facility. The FDA did not identify any clinical, safety or product specific chemistry, manufacturing, and controls deficiencies related to the NDA.
Open at the source →

Verrica Pharmaceuticals Form 8-K, filed November 12, 2021

On November 5, 2021, Verrica was notified that the inspection of the CMO has been classified as “voluntary action indicated” (“VAI”), is now closed and that the VAI classification will not directly negatively impact FDA’s assessment of the Company’s NDA regarding this CMO. With the satisfactory resolution of the facility inspection, Verrica has engaged the FDA to determine the next steps toward the potential approval of VP-102 for the treatment of molluscum.
Open at the source →

Verrica Pharmaceuticals Form 8-K, filed November 29, 2021

Verrica received a Complete Response Letter (CRL) from the FDA on September 17, 2021 due to open general inspection items at a contract manufacturer (CMO) that were not specific to VP-102. The Company received a General Advice Letter (GAL) from the FDA on September 22, 2021 with recommendations to improve VP-102’s user interface. On November 5, 2021 Verrica was notified that the inspection of the CMO was classified as “voluntary action indicated” (“VAI”), is now closed and that the VAI classification will not directly negatively impact FDA’s assessment of the Company’s NDA. Verrica resubmitted the NDA for VP-102 on November 24, 2021; the resubmission is limited to address the successful resolution of inspection deficiencies identified at the CMO in the CRL, as well as the recommendations included in the General Advice Letter.
Open at the source →

FDA Complete Response Letter, May 23, 2022 · page 3

CARTON AND CONTAINER LABELING (2) We reserve comment on the proposed labeling until the application is otherwise adequate. PROPRIETARY NAME Please refer to correspondence dated, March 23, 2021, which addresses the proposed proprietary name, Ycanth. This name was found acceptable pending approval of the application in the current review cycle. Please resubmit the proposed proprietary name when you respond to the application deficiencies.
Open at the source →

FDA Complete Response Letter, May 23, 2022 · page 6

KENDALL A MARCUS 05/23/2022 08:27:37 AM
Open at the source →

Verrica Pharmaceuticals Form 8-K, filed May 25, 2022

The May 25, 2022 8-K does not mention the earlier “voluntary action indicated” classification.

Searched the whole document for: VAI, voluntary action. None found.

Open the document →

Verrica Pharmaceuticals Form 8-K, filed May 25, 2022

announced that it received a complete response letter (“ CRL ”) from the U.S. Food and Drug Administration (the “ FDA ”) as a direct result of deficiencies identified at a general reinspection of a facility of Sterling Pharmaceutical Services, LLC (“ Sterling ”), a contract manufacturing organization for its New Drug Application (the “ NDA ”) for VP-102 for the treatment of molluscum contagiosum. The CRL did not identify any other deficiencies. Sterling advised the Company that it received notice on May 19, 2022 that it is on Official Action Indicated (“ OAI ”) status. None of the issues identified by FDA during the reinspection were specific to the manufacturing of VP-102. The Company was informed by the FDA that it had completed its review of the NDA and product label, there were no open questions on the NDA review, and the VP-102 label was ready to be communicated.
Open at the source →

Verrica Pharmaceuticals Form 8-K, filed June 3, 2022

On May 31, 2022, the board of directors (the “Board”) of Verrica Pharmaceuticals Inc. (the “Company”), in order to streamline operations and reduce costs, approved a plan to reduce its workforce by terminating 20 employees, which the Company expects to be completed by June 3, 2022. The decision followed the Company’s announcement on May 24, 2022 of the receipt by the Company of a complete response letter for its new drug application for VP-102.
Open at the source →

Verrica Pharmaceuticals Form 8-K, filed September 14, 2022

Verrica received a Complete Response Letter (CRL) from the FDA in May 2022 as a direct result of deficiencies identified at a general reinspection of a facility of Sterling Pharmaceuticals Services, LLC (Sterling) a contract manufacturing organization (CMO) that manufactured the bulk solution for VP-102. None of the issues identified by the FDA during the reinspection were specific to the manufacturing of VP-102; a pre-approval inspection (PAI) was also conducted on VP-102 at Sterling with no observations. The FDA confirmed in a Type A meeting on June 27, 2022 that the NDA for VP-102 for molluscum contagiosum was fully reviewed and there were no other deficiencies in the NDA; label comments were completed by the FDA and were ready to be communicated.
Open at the source →

Prepared from public FDA letters and SEC filings: every quoted passage is matched to the original document, and every “not in” statement comes from a search of the whole document, before it is published. Questions, summaries and connecting sentences are EphemerisX’s wording. Not investment advice. How this research works → · Ask the FDA and SEC Ephemeris →