X4 Pharmaceuticals, Inc. (NASDAQ:XFOR) Q4 2022 Earnings Call Transcript

Kristen Kluska: Thank you. Looking forward to seeing some of the presentations this year.

Paula Ragan: Thanks, Kristen.

Operator: Our next question comes from RK of H.C. Wainwright. Please go ahead.

Swayampakula Ramakanth: Thank you. Good morning, Paula. I think most of my questions have been answered. Just trying to understand, in this next meeting that you want to have the FDA before you file, what sort of clarifications are you trying to get? So that you’re well equipped when you file?

Paula Ragan: Thanks, RK. Murray, would you like to take that?

Murray Stewart: Yes, so this is a standard pre NDA meeting. So most companies work that all companies have to have a pre NDA meeting, and we make sure we clarify the most appropriate things. So we covered all areas. So are they comfortable with the non-clinical data, are they comfortable that the data actually is shows the drug is effective and safe and has a positive risk benefit. We discuss whether there are any CMC issues and the whole point of the pre NDA meeting is so when we move ahead to file the FDA are not surprised by anything, and we’re not surprised by anything.

Swayampakula Ramakanth: Thanks.

Operator: This concludes the question and answer session. I would like to turn the conference back over to Paula Ragan for any closing remarks.

Paula Ragan: Thank you, operator. Well, as you can hopefully hear from all of our tones today, we’re very excited about the year ahead and the road beyond. We thank you again for joining us today and hope you all have a wonderful day. Thank you.

Operator: This concludes today’s conference call. You may disconnect your lines. Thank you for participating and have a pleasant day.