RE: Edison23 Mar 2023 13:27
Potnak, I agree we shouldn’t whitewash over MHRA’s request. However I’m inclined to agree that it doesn’t have anything to do with the quality of the submission. The following statement was issued by the MHRA inspectorate, incidentally on the 8th Nov 2022, the same day that SAR released the RNS:
“ Throughout the pandemic we have taken a pragmatic approach to the 'expiry' of GMP Certificates, with these initially extended to the end of 2021 and then to the end of 2022. I can confirm that the 'expiry' of GMP certificates will again be extended until the end of 2023.8 Nov 2022”
I think it’s possible that due to the expiry of certification, MHRA may well have been requesting the review of data as a back stop. Just a thought.