BLA Submission
BLA Submission. Submission to the FDA of the Company's biologics license application with respect to OTL-200 for the treatment of metachromatic leukodystrophy. For clarity, in the event the Company elects to initiate a rolling biologics license application, "BLA Submission" shall be deemed to occur upon the Company's initial submission of information to the FDA for such purpose
All Definitions
Found in
Orchard Therapeutics plc contract