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Re: exwannabe post# 391709

Tuesday, 07/27/2021 5:16:07 PM

Tuesday, July 27, 2021 5:16:07 PM

Post# of 688929
I did not say Sawston is the singular holdup. I agree with posters that the FDA likely would not consider an application well considered without its production fully articulated and established initially in a manner that is easily expanded as necessary.

I do think they need to have worldwide production set and that will probably be most critical for Europe. But CRL as Cognate’s successor in all contracts, will likely be contracted to manufacture in North America, the US and Canada, as per the discussion in some of their financial reports. I do not think that has changed. There are milestones that will need to be met for that circumstance to be triggered. That is my view. And CRL can likely be contracted as necessary in other locations.
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