FOI release

Freedom of Information request on Study synopsis and Clinical summary for Study 09 and Clinical summary for Table 4 and 5 (FOI 21/1293)

Published 31 May 2022

FOI 21/1293

22nd December 2021

Dear

With regards to the below request for information, please see attached the:

  • Study synopsis for Study 09
  • Clinical summary Table 4
  • Clinical summary Table 5
  • Clinical summary for Study 09

Redactions have been made to this information, under Section 40 (Personal information), Section 41 (Information provided in confidence) and Section 43 (Commercial interests).

Section 40 and 41 are absolute exemptions and no consideration of the 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 public interest argument that outweighs the commercial harm in divulging commercial know-how/secrets to competitors that can be used to their commercial advantage. Examples of public interest arguments would be a major public health risk or a major procedural failure or irregularity.

Best regards
The FOI Licensing Team