The time to use of rescue treatment within 12 hours was the primary outcome of the trial. The trial included 126 administrations of KVD900 and 55 of placebo. KVD900 has received Fast Track designation from the FDA. All reported adverse events have been mild and no subjects withdrew from the trial. & This excessive activation leads to inflammation, edema, and pain. The FDA may also request to inspect a foreign clinical study site to confirm compliance. The FDA may grant full or partial waivers, or deferrals, for submission of data. In addition, the statutory exceptions and regulatory safe harbors are subject to change. 8226; We will need substantial additional funding. The risks and uncertainties described below are not the only ones we face. We have incurred significant losses since our inception. We cannot eliminate the risk of contamination or injury from these materials. The full impact on our business of these automatic cuts is uncertain. The terms of any collaborations may also have impacts on other aspects of our business. We rely on third-party manufacturers to produce and process our product candidates. Any adverse determination in litigation could also subject us to significant liabilities. Shareholder Activism Could Cause Material Disruption to Our Business. Our NOLs may also be impaired under state law.
