Freedom of Information request (FOI 22/914)
Published 17 January 2024
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FOI 22/914
16th September 2022
Dear
Thank you for your email where you have asked for one document - Study KEYNOTE-189 Appendix 16.1.2 (latest sample CRF),
As the study is ongoing and the CSR is not yet available, there is no information we can provide at this time and the Case Report Form would be exempt from disclosure under S41/S43 of the FOIA.
S41 is an absolute exemption and no consideration of the public interest is required, except to state that we would consider the release of this information to be an actionable breach of confidence. S43 is a conditional exemption and requires a consideration of the public interest. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in alerting competitors to whether a competitor is close to obtaining a marketing authorisation or not.
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Yours sincerely
MHRA Customer Experience Centre