FOI release

Freedom of Information request on the Electronic copies of the CTA submission package relating to Selgantolimod Phase 2 study (FOI 22/681)

Published 22 March 2023

FOI 22/681

31 May 2022

Re: FOIA request: Selgantolimod Phase 2 study

Dear

Thank you for your information request, dated 8th May 2022 where you asked for the following:

1. Electronic copies of the CTA submission package (including the study protocol, investigator brochure(s) and other relevant study documents) received by the MHRA in relation to the Selgantolimod Phase 2 study GS-US-465-4439 (ClinicalTrials.gov: NCT04891770, EudraCT: 2021-000672-11). 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, 41 and 43 of the Freedom of Information Act.

Other application documentation has not been provided as the information was submitted 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.

In addition, some of the information you have requested is due to be published upon study completion. Section 22 is a qualified exemption and public interest has been taken into consideration. We consider that the public interest will be better served by general publication of this information, when it is in its complete form, rather than the Agency releasing an incomplete version of the document prematurely.

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