YMAB -23%/AH on RTF: http://www.globenewswire.com/news-release/2020/10/05/2103818/0/en/Y-mAbs-Provides-Regulatory-Update-on-Omburtamab-for-the-Treatment-of-Patients-with-Neuroblastoma.html Upon preliminary review, the FDA determined that certain parts of the Chemistry, Manufacturing and Control (“CMC”) module and the Clinical module of the BLA require further detail. No additional non-clinical data have been requested or are required.