Oct 06, 2020 / 01:00PM GMT
Operator
Greetings, and welcome to the Y-mAbs Conference Call. (Operator Instructions) As a reminder, this conference is being recorded.
It is now my pleasure to introduce your host for today's conference, Dr. Claus Møller. Thank you, Doctor. Please go ahead.
Claus Juan Møller San Pedro - Y-mAbs Therapeutics, Inc. - CEO & Director
Thank you very much. Good morning, everybody, and thanks for joining us today. I'm joined today by Y-mAbs Founder, Chairman and President, Thomas Gad; and our Chief Financial Officer, Bo Kruse. We are holding this call to provide an update of securing regulatory status for omburtamab. We completed the rolling submission for the BLA for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma in August this year. And late on Friday, October 2, we received refusal -- a refusal to file a letter from the FDA.
Upon its preliminary review, the FDA determined that certain parts of the CMC module and the clinical module of the BLA required further detail to
Y-mAbs Therapeutics, Inc. - Special Call Transcript
Oct 06, 2020
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