All such forward-looking statements are based on our current beliefs and expectations, and should not be regarded as a representation that our plans will be achieved. Our actual results may differ materially due to the risks and uncertainties inherent in the our business, which include, the potential that the FDA may not approve OFIRMEV; our dependence on the success of OFIRMEV, which is our only product candidate; the potential that the FDA may require additional data or information as part of its review of the our NDA for OFIRMEV or that's the review will not be completed within the expected timeframe, our reliance on our third-party manufacturer to address any deficiencies related to the manufacture of OFIRMEV; the risk that further FDA scrutiny of the manufacturing site for OFIRMEV may raise additional issues that must be resolved prior to approval, the potential that we will require substantial additional financing in order to obtain regulatory approval for and commercialize OFIRMEV, and do exercise our option to acquire Incline, the risk that we may not be able to raise sufficient capital when needed, or at all; the risk that delays in obtaining approval for and commercially launching OFIRMEV will enable competitors to further entrench their existing products or bring new products to market before OFIRMEV; and our ability to comply with the terms of our loan agreement.
These and other risks are detailed in our prior press releases and periodic public filings with the Securities and Exchange Commission. You are cautioned not to unduly rely on these forward-looking statements, and we undertake no obligation to revise or update such statements. All forward-looking statements are qualified by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
If anyone has not seen our press release issued earlier today, you can access it on our website at www.cadencepharm.com. Additionally, this conference call is being webcast through the company's website and will be archived there for future reference. Ted?