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Re: exwannabe post# 423413

Thursday, 12/02/2021 2:16:15 PM

Thursday, December 02, 2021 2:16:15 PM

Post# of 818022
They actually have a contract with CRL (CRL steps into Cognate’s position if they dissolve Cognate into CRL, effectively and Cognate still exists I believe, so the contract still is there), the old one has not expired. And it is subject to FDA approval for the new one, not really a huge worry and then lastly they have Flaskworks in process, which likely they would need to figure out if they were going to license out.

I won’t comment on the BLA already in process, but I do not think they need to have a new contract with CRL, I think more likely, and only if the FDA needs more reassurance, they can have an already negotiated contract pending approval that they would NOT have to PR, with a confidential letter of intent or similar structure to confirm only with the FDA that they have what they need ready upon FDA approval.

And of course they have everything else in process via Sawston and Flaskworks.
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