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

Item 2— "Management's Discussion and Analysis of Financial Condition and Results of Operations—Discontinuation of Manufacturing and Distribution; Product Recalls; and the FDA Consent Decree" of our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2011, including:
  1. the consent decree between the Company and the FDA and the Company's suspension in 2008 and 2009 of the production and shipment and the nationwide recall of all of the products that it formerly manufactured, as well as the related material adverse effect on our revenue, assets and liquidity and capital resources;
  2. the agreement between the Company and the Office of Inspector General of the U.S. Department of Health and Human Services ("HHS OIG") to resolve the risk of potential exclusion of the Company from participation in federal healthcare programs; and
  3. our ability to comply with the plea agreement between a  now-dissolved subsidiary of the Company and the U.S. Department of Justice;
  • the availability of raw materials and/or products manufactured for the Company under contract manufacturing agreements with third parties;
  • risks that the Company may not ultimately prevail in, or that insurance proceeds, if any, will be insufficient to cover potential losses that may arise from, litigation discussed in Note 16—"Commitments and Contingencies—Litigation and Governmental Inquiries" of the Notes to the Consolidated Financial Statements included in Part I, Item 1 of our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2011, including:
    1. the series of putative class action lawsuits alleging violations of the federal securities laws by the Company and certain individuals;  
    2. product liability lawsuits;
    3. lawsuits pertaining to indemnification and employment agreement obligations involving the Company and its former C
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    SOURCE Ther-Rx Corporation
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