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Independent Laboratory Testing Demonstrates Important Quality Differences Between FDA-Approved Makena® and Compounded 17P Formulations
Date:11/8/2011

hief Executive Officer;
  • the possibility that the pending lawsuits and investigation by HHS OIG regarding potential false claims under Title 42 of the U.S. Code could result in significant civil fines or penalties, including exclusion from participation in federal healthcare programs such as Medicare and Medicaid and the possibility; and
  • challenges to our intellectual property rights by actual or potential competitors and challenges to other companies' introduction or potential introduction of generic or competing products by third parties against products sold by the Company;  
  • the possibility that our current estimates of the financial effect of previously announced product recalls could prove to be incorrect;
  • risks related to the Company's highly leveraged capital structure discussed in Part I, Item 2— "Management's Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources" of our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2011, including:
    1. the risk that the maturities of our debt obligations may be accelerated due to our inability to comply with covenants and restrictions contained in our loan agreements, including as a result of unanticipated delays in filing restated financial statements and related reports;
    2. restrictions on the ability to increase our revenues through certain transactions, including the acquisition or in-licensing of  products; and
    3. risks that present or future changes in the Board of Directors may lead to an acceleration of the maturities of the Company's debt;
  • the risks of unexpected delays in our ability to file restated financial statements and related reports;
  • the risk that we may not be able to satisfy the quantitative listing standards of the New York Stock Exchange, including with respect to minimum share price and public flo
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