Steven M. Skolnick Partner | One Lowenstein Drive Roseland, New Jersey 07068 | |
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+ | T: 973 597 2476 F: 973 597 2477 E: sskolnick@lowenstein.com | |
August 6, 2020
Division of Corporation Finance
Office of Life Sciences
United States Securities and Exchange Commission
Mail Stop 3030
Washington, DC 20549
Attention: Frank Wyman
| Re: | Provention Bio, Inc. |
| | Form 10-K for the fiscal year ended December 31, 2019 |
| | Filed March 12, 2020 |
| | File No. 001-38552 |
Dear Mr. Wyman:
On behalf of Provention Bio, Inc. (the “Company”), we are hereby responding to the letter, dated July 15, 2020 (the “Comment Letter”), regarding the Company’s Form 10-K for the fiscal year ended December 31, 2019 submitted March 12, 2020 (the “Annual Report”). In response to the Comment Letter and to update certain information in the Annual Report and the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, the Company is filing Amendment No. 2 to the Annual Report on Form 10-K with the Commission (the “Second Amendment”) and Amendment No. 1 to the Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 (the “Quarterly Amendment”). For ease of reference, set forth below in bold are the comments of the Staff in response to the Annual Report, as reflected in the Comment Letter. The Company’s response is set forth below each comment.
Frank Wyman
August 6, 2020
Page 2
The Company has authorized us to respond to the Comment Letter as follows:
Form 10-K for the fiscal year ended December 31, 2019
Section 302 Certifications in Exhibits 31.1 and 31.2, page 92
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1. | Please amend your filing on Form 10-K with revised Section 302 certifications that expand the fourth paragraph to cover management’s responsibility for establishing and maintaining a system of internal control over financial reporting in addition to its responsibility for disclosure control and procedures. Please note this additional language became effective for your first annual report and all periodic reports filed thereafter, which are required to contain management’s report on internal control over financial reporting. We refer you to the guidance under Compliance and Disclosure Interpretations (C&DI) for Regulation S-K, Question 246.13. This comment is also applicable to your Form 10-Q for fiscal quarter ended March 31, 2020. |
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| Response: |
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| The Company respectfully acknowledges the Staff’s comment and has filed the Second Amendment and the Quarterly Amendment with revised Section 302 certifications. |
Any questions regarding the contents of this letter should be addressed to the undersigned at (973) 597-2476.
Very truly yours,
Steven M. Skolnick
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