ODX / MHRA Update24 Sep 2020 11:52
Anyone who knows my credentials from GDR will agree I do my research and I dont ramp. This is what I have managed to find out from ODX.
Post Ulster, the data was first reviewed internally, then reports were written up, checked and approved, before they were submitted to MHRA.
These reports are not tick boxes.
Post receipt of these reports MHRA ask questions, and they review the technical data. The consortium believe what they have submitted is good enough but you cant guarantee what questions will be asked.
The point is we are now at the point where MHRA have everything.
BBI are working on the app - it was supposed to be their own app, CK is unaware if there is integration between BBI and NHSX as its not his area, but he said it was an interesting question and that he will bring it up. I'm a stickler for detail, he mentioned weekly call (mentioned this is the briefing). So that means even now the consortium is having weekly update calls.
The Mologic Antigen LFT (Heathrow) is still in development. Once complete ODX will do a tech transfer for that. YES Its ODX bound. As long as Mologic are not late to the party, this test is a gamechanger for them and us.
Mologic Antibody LFT Test, tech transfer done. Ready to manufacture now.
AbC-19 Antibody Test, tech transfer underway. Ready to manufacture in October.
Dido Harding stating no science for Antibody, this was correct at the time according to CK, however since then they believe there has been a shift in the government tone, see Abi tweet and Colin also mentioned they are engaged with the DoH to help prove the science. Hence you may have noticed that recently there has been a shift in the government tone using immunity and antibody in the same sentence.
Capacity this month is 100k pw, yes they can make 100k tests
Capacity next month is 200k pw
I asked why there has been a delay in manufacturing, Colin accepted and apologised that he/UK-RTC didn't foresee a delay from the Government.
All of the above is from CK - Yes i mailed him.