Series B Milestone Event means the Company releases final topline data from the MIRACLE trial and documented a statistically significant improvement in the primary efficacy endpoint.
Series B Milestone Event means the occurrence of the Company receiving positive Phase I Part 3 data readout for DA-1726.
Series B Milestone Event means the occurrence of the Company filing with the FDA for approval for AllocetraTM’s osteoarthritis related indication.
More Definitions of Series B Milestone Event
Series B Milestone Event means the occurrence of the Company filing with the FDA for approval for AllocetraTM’s osteoarthritis related indication. “Series B Ordinary Warrants” means, collectively, the Series B Ordinary Shares purchase warrants delivered to the Purchasers at the Closing in accordance
Series B Milestone Event means the occurrence of the Company or another Person receiving the first FDA approval of a product, technology, or process in the human space utilizing the Company’s intellectual property, provided, however, that the FDA’s approval of a protocol for a clinical trial of a product, technology or process in the human space, or the FDA’s acceptance of data from in vitro trials or in vivo animal trials, shall not constitute “FDA approval” for purposes of this definition.
Series B Milestone Event means the occurrence of the Company or another Person receiving the first FDA approval of a product, technology, or process in the human space utilizing the Company’s intellectual property, provided, however, that the FDA’s approval of a protocol for a clinical trial of a product, technology or process in the human space, or the FDA’s acceptance of data from in vitro trials or in vivo animal trials, shall not constitute “FDA approval” for purposes of this definition. “FDA” means the U.S. Food and Drug Administration.
Series B Milestone Event means the occurrence of the Company receiving FDA (as defined herein) clearance for an optical genome mapping system for any indication.
Series B Milestone Event means the occurrence of the earlier of (i) the successful completion of a registrational trial for Niyad, as defined by achieving the primary endpoint per the trial protocol or (ii) the Company receiving “pre-marketing approval” by the FDA of Niyad.
Series B Milestone Event means the occurrence of the earlier of (i) the successful completion of a registrational trial for Xxxxx, as defined by achieving the primary endpoint per the trial protocol or (ii) the Company receiving “pre-marketing approval” by the FDA of Niyad.
Series B Milestone Event means the public announcement via press release or the filing of a Current Report on Form 8-K of: (i) the enrollment of at least fifteen (15) patients with a 30-day mortality rate less than 30% in the Company’s SZN-043 Phase 1b clinical trial for the treatment of severe alcohol-associated hepatitis, with no recommended changes by the Safety Review Committee to the study design including changes related to dose or schedule and (ii) Safety Review Committee approval for the Company to advance to a higher dose cohort.