wow strong argument. So according to you NWBO could switch from manual Grade-B aseptic processing to Eden/Flaskworks closed automation to making DCVax-L in a garden shed using tomato sauce as buffer and the MHRA would still approve the old process in the dossier?
You can’t switch the engine mid-flight and then tell the regulator “just approve the old one for now.” But hey, if tomato sauce is now apparently a valid CMC strategy under UK ATMP law, then I guess Flip just solved global oncology.
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