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07/10/22 9:16 PM

#493831 RE: beachhyena #493823

There actually is a reason not to announce the Eden validation. If you have a product that is not yet approved a mfg process validation is not relevant because the RA has not yet reviewed the submission to say the process is acceptable let alone its validation work. So, just to keep things on the straight and narrow, I think it is possible to have a validated process that is not announced as such. I would not PR the validation at this time but I would state it is under development because it officially is until there is a product approval. For what that is all worth.

GLTA