BLA is one of several start-ups offering individuals an opportunity to bankroll young athletes in exchange for a portion of their earnings -- a new and perfectly legal market that has some sports agents wringing their hands.

Source: https://www.legit.ng/business-economy/1537424-for-small-time-investors-bankrolling-a-young-athlete-pay-off/

The reason why it will be able to file a BLA for this gene therapy for the treatment of this patient population is because of positive results it had obtained from the phase 3 VITAL study.

Source: https://seekingalpha.com/article/4596633-abeona-bla-submission-eb-101-several-preclinical-presentations-expected?source=feed_all_articles

THOUSAND OAKS, Calif. /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Company's Biologics License Application (BLA) for tarlatamab.

Source: https://www.marketscreener.com/quote/stock/AMGEN-INC-4847/news/FDA-Grants-Priority-Review-to-Amgen-s-Tarlatamab-Application-for-Advanced-Small-Cell-Lung-Cancer-45563652/?utm_medium=RSS&utm_content=20231213

We don't see that as an impediment this year and we plan on filing our BLA second half of this year for the coming years.

Source: https://seekingalpha.com/article/4604374-novavax-inc-nvax-presents-bofa-securities-2023-health-care-conference?source=feed_all_articles

What did occur is that we said in connection with the BLA submission that we should all assume there's going to be an Adcom.

Source: https://seekingalpha.com/article/4583155-sarepta-therapeutics-inc-srpt-q4-2022-earnings-call-transcript?source=feed_all_articles