theorysuit:Could it be that the MHRA invited the FDA to have both agencies conduct concurrent inspections ?
Re: skitahoe post# 523608
Thursday, October 20, 2022 5:53:02 PM
Post# 523618 of 523646 The mfg facility can be outside of the US for US NDA/BLA. And the FDA will inspect the facilities and not rely on any other RAs. GMDA and SPPI are two examples.
The total emphasis on manufacturing became apparent after unblinding with Cognate gearing up and CRL buying Cognate and expanding even more in early 2021 which is coming up on 2 years ago. Hardly a new shift even if you couldn’t accept it as apparent when pointed to back then. Up until that point a slower approach forward looked like it might be the plan. After that point, Project Orbis may have come into the discussions or a potential partnership deal or even just a manufacturing agreement might have been made to be contingent/structured upon manufacturing readiness and timing of it. NWBO has talked about lots of moving parts and just because we don’t see everything clearly doesn’t mean at least some of us can’t imagine, based purely on the potential of the results we have seen to date, what those moving parts might include based on the actions not only of NWBO but especially on their contract manufacturers. All those saying CRL doesn’t have an up to date agreement in place with NWBO, please spare us all time wasted reading your response to this post by reading the above message again ; ). Best wishes.
Market Data 
Markets 
AI
