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Re: flipper44 post# 605422

Wednesday, 06/28/2023 7:35:11 PM

Wednesday, June 28, 2023 7:35:11 PM

Post# of 711392
Ok with the ASM language and 1M+ pages they are in the process of submission so I’m ok that nwbo is answering questions and the app has been accepted or near accepting. I think nwbo PR’s MHRA approval similar to the PIP.
However, nwbo Strategy apparently changed slightly the MIA was a little late to approval and all of a sudden Nwbo can ship worldwide with the MIA. So it would seem the small delay in MIA was compensated by the worldwide shipping benefit bringing in more revenues faster. So here it seems they altered plans slightly to accommodate anticipated non UK demand…..MHRA even coughed up some extra dough helping UK GBM patients get treatment. I’m not surprised if there is a real backlog at Sawston.
Next we move to MAA, we know the timelines and a qualified expectation with the showers flowers thing and here we are. Is there an MAA delay? If Sawston is on backlog now, what happens with demand on MAA approval? Maybe the Sawston expansion completion is tied in here.
Across the pond, if Orbis is in play, When does Cognate get wrapped up?
So if there’s a delay in RA approvals, capacity constraints cannot be ruled out.
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