Also curious if any company has ever received auth to manufacture and distribute under a specials approval, then received subsequent commercial manufacturing approval but then later get hold up from receiving commercial marketing approval?? We should scream this from the highest mountain that historically this means we are good to go and could and should happen within X time frame.
I’m gonna be the FUDster again, but it’s important to remember the specials and the commercial license are not specific to DCVax. DCVax manufacturing is allowed under them, yes, but they are not specific to just DCVax. Plenty of other things can be produced under this license. The MHRA did not review DCVax or it’s likelihood to be approved as any part of this process.