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antihama

09/09/21 5:59 PM

#401048 RE: FeMike #400892

Well, if there are observations/483s that the MHRA found, it will be in NWBOs court to take care of before getting certification. Since NWBO doesn't have to tell us if there was a delay to take care of any issues that has come up (it's not like they're getting a CRL), the only was we'll know if there is a problem is if we don't hear from them till Oct/Nov and beyond. Hopefully, the issues found are the sort like revising an SOP which could be taken care of before the inspectors leave the facility.