BLA Event

BLA Event. (i) receipt of the Pre-BLA Meeting Minutes, which minutes do not expressly advise the Company not to proceed with a BLA Submission, and (ii) the Company's public announcement of its intention to file a BLA Submission following the receipt of such minutes. For the avoidance of doubt, in the event the Pre-BLA Meeting Minutes reflect any disagreement or concern regarding any aspect of the Company's proposed BLA Submission, or that certain aspects of the Company's proposed BLA Submission will be... review issues, that portion of the "BLA Event" criteria set forth in clause (i) in the immediately preceding sentence will be deemed to be satisfied unless the Pre-BLA Meeting Minutes expressly advise the Company not to proceed with a BLA Submission View More