Wednesday, August 24, 2022 2:07:20 AM
Hi. Good morning, and thanks for taking the questions. I just wanted to dig into AXS-07 a little bit. Where are you with respect to addressing the CMC questions detailed in the CRL? And when do you think you could resubmit the NDA?
Mark Jacobson -- Chief Operating Officer
Hey, Matt. It's Mark. So as you can imagine, the team is doing its work in the background. The CMC team is doing its work following the CRL.
And this morning, we did announce that we've requested and submitted a request for a Type A meeting with FDA. And what we plan to do is once that meeting is held, which we would expect this quarter -- we'd expect it to be held this quarter. Once it's held, then we'll be able to -- we'll be in a position to provide a clear update for our expectations around timing of the resubmission and if there are any nuances about the package or anything like that. But right now, it's status quo in terms of the last update where we think everything is addressable, and that we either have the information on hand or are able to -- in a position to provide it prior to our, or in connection with, our resubmission.
So we'll hopefully have more for you in the not-too-distant future.
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