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ATLnsider

07/19/23 3:32 PM

#611663 RE: Chiugray #611631

Chiugray, the other thing to keep in mind is that some of us believe that NWBio has a rolling submission with most or all of the relevant regulatory authorities.

As a result, it’s possible that some of the 27 modules were completed and submitted over a year ago, or at least several months ago, and the regulatory authorities have already reviewed most of the 27 modules already.

It is possible that only a few of the remaining 27 modules are left to be finalized, submitted and reviewed. These remaining few modules would likely include the CMC (Chemistry, Manufacturing and Controls) module.