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Re: danielboog2 post# 406988

Tuesday, 10/05/2021 5:35:06 PM

Tuesday, October 05, 2021 5:35:06 PM

Post# of 827469
danielboog2,

The other validation route is to wait for manufacturing certification with BLA waiting with fill in the blanks for prior art and closed system options available to insert. Either way, certification starts increased Specials manufacturing output and that brings validation too.
NWBO pointed to initial treatments being done under the old method but if there has been a safety push by regulators then maybe they can get certification with Flaskworks done before the BLA submission. Will the national priority designation help in this regard? I don’t know but maybe. Best wishes.
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