BLA Submission definition

BLA Submission means an application and all amendments and supplements thereto filed with the Regulatory Authority, including all documents, data, and other information concerning a pharmaceutical product which are necessary for gaining Regulatory Approval to market and sell such pharmaceutical product.
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BLA Submission means 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.
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BLA Submission is Lenders’ receipt of evidence satisfactory to Lenders that Borrower has submitted the BLA for Borrower’s product candidate, TOCA 511, to the FDA.
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Examples of BLA Submission in a sentence

  • BLA Submission A BLA will be submitted to the FDA upon obtaining sufficient clinical data, FDA meetings to support BLA, submission planning support for the CMC team, BLA strategy and meeting support, and submission preparation support activities, will all be completed.

  • January, 2011 Cancer type in development 25 BLA Submission for 2nd Cancer Type Developed 25.

  • Upon receipt of such BLA Submission Notice, Immunomedics shall have sixty days (60) days to exercise the Co-Promotion Option ***.

  • If Immunomedics declines to exercise the Co-Promotion Option within sixty days (60) after receipt of the BLA Submission Notice for ITP, the Co-Promotion Option shall not become exercisable again.

  • January, 2009 type to be developed 22 BLA Submission for Renal Cell Cancer 22.