Maverick0408, if the BLA submission is a rolling submission in the UK, or it was submitted under the FDA Real Time Oncology Review (RTOR) in the US, NWBio would not be able to PR the submission until all modules / parts of the application are submitted to, and accepted by the relevant regulatory authority.
Orbis requires a different level of manufacturing capacity. Level 1 (pre data lock) Level 2 (post data lock 1-2021 Cognate doubling manufacturing announcement) Level 3 (Charles River Labs (multinational) purchases Cognate and promised extra expansion of manufacturing 2-2021 coupled with recent (2022) hiring at Memphis site for expansion and new product comparability oversight) Level 4 (2-2022 PR touting 1st patient treated and anticipated manufacturing changes after Flaskworks upgrade beyond Microden patents granted) Seeing a pattern here? Best wishes.
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