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K-V Pharmaceutical Announces Resubmission to New Drug Application for Gestiva™
Date:7/13/2010

isclosed, will not be sufficient to fund our operations beyond such quarter unless we are able to raise additional capital by selling assets or through external financing;
  • the consent decree between the Company and the FDA and the Company's suspension of the production and shipment of all of the products that it manufactures and the related nationwide recall affecting all of the products that it manufactures, as well as the related material adverse effect on its revenue, assets and liquidity and capital resources, as more fully described in Part I, Item 2 – "Management's Discussion and Analysis of Financial Condition and Results of Operations – Background – Discontinuation of Manufacturing and Distribution; Product Recalls; and the FDA Consent Decree" in the Form 10-Q;
  • the possibility of further reducing the Company's operations, including further reductions of its employee base and significantly curtailing some or all of its efforts to meet the consent decree's requirements and return its approved products to market in order to maintain and attempt to increase its limited cash and financial resources, and related costs and accounting charges from taking such actions;
  • the plea agreement between the Company and the U.S. Department of Justice and the Company's obligations therewith, as well as the related material adverse effect, if any, on its revenue, assets and liquidity and capital resources, as more fully described in Note 20 – "Subsequent Events" of the Notes to the Consolidated Financial Statements in the Form 10-Q;
  • changes in the current and future business environment, including interest rates and capital and consumer spending;
  • the difficulty of predicting FDA approvals, including timing, and that any period of exclusivity may not be realized;
  • the possibility of not obtaining FDA approvals or delay in obtaining FDA approvals, including with respect to Gestiva™;
  • acceptance of
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    • SOURCE K-V Pharmaceutical Company
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