FOI release

Freedom of Information request on CTA submission package (FOI 21-192)

Published 7 May 2021

Thank you for your information request, dated 18 February 2021 where you asked for the following:

1. Electronic copies of the CTA submission package (e.g. study protocol, investigator brochure) received by the MHRA in relation to the JNJ-73763989/JNJ-56136379 Phase 2 study, with EudraCT Number 2019-004475-39. All appropriately redacted to remove any personal or data protection material.

I am pleased to provide you with some of the information requested, attached to this email.

These documents are provided with any personal information redacted, as well as any information specific to the structure or molecular formula and manufacturing process or considered commercially sensitive, under Section 40 (Personal Information), Section 41 (Information Provided in Confidence) and Section 43 (Commercial Interests) of the Freedom of Information (FOI) Act.

Other application documentation has not been provided as the information was provided to us in confidence, with the expectation that it will not be released, and is therefore exempt from disclosure under Section 41 of the Freedom of Information Act. Disclosure would also likely prejudice commercial interests and, therefore, exemption under Section 43 also applies.

Section 41 is an absolute exemption and no consideration of the balance of public interest is required. Section 43 is a qualified exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any overriding argument for releasing the information that outweighs the commercial harm by providing potential competitors with an insight into the product development and design of this study.

The Freedom of Information Act only entitles you to access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Yours sincerely,

MHRA Customer Services

MHRACustomerServices@mhra.gov.uk

Copyright notice

The information supplied in response to your request is the copyright of MHRA and/or a third party or

parties, and has been supplied for your personal use only. You may not sell, resell or otherwise use

any information provided without prior agreement from the copyright holder. For full details on our

copyright policy please visit: https://www.nationalarchives.gov.uk/information-management/re-usingpublic-

sector-information/copyright/crown-copyright/ or e-mail the MHRA Information Centre.