All statements that address expectations or projections about the future, including without limitation, product development, product launches, regulatory approvals, market position, acquisitions, sale of assets, revenues, expenditures, resumption of manufacturing and distribution of products and the impact of the recall and suspension of shipments on revenues, and other financial results, are forward-looking statements.
All forward-looking statements are based on current expectations and are subject to risk and uncertainties. In connection with the "safe harbor" provisions, the Company provides the following cautionary statements identifying important economic, political and technological factors, which among others, could cause actual results or events to differ materially from those set forth or implied by the forward-looking statements and related assumptions.
Such factors include (but are not limited to) the following: (1) the ability to continue as a going concern; (2) changes in the current and future business environment, including interest rates and capital and consumer spending; (3) the difficulty of predicting FDA approvals, including timing, and that any period of exclusivity may not be realized; (4) the possibility of not obtaining FDA approvals or delay in obtaining FDA approvals; (5) acceptance and demand for new pharmaceutical products; (6) the introduction and impact of competitive products and pricing, including as a result of so-called authorized-generic drugs; (7) new product development and launch, including the possibility that any product launch may be delayed or that product acceptance may be less than anticipated; (8) reliance on key strategic alliances; (9) the availability of raw materials and/or products manufactured for the Company under contract manufacturing arrangements with third parties; (10) the regulatory environment, including regulatory agency an
|SOURCE KV Pharmaceutical Company|
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