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FDA Approves Makena™, the First and Only Treatment to Reduce the Risk of Preterm Birth in Women With a Singleton Pregnancy Who Have a History of Singleton Spontaneous Preterm Birth
Date:2/4/2011

ve and negative covenants and conditions that must be met in order to avoid default and/or to qualify for additional loan tranches, and there are substantial risks of triggering defaults with respect to such covenants and/or the occurrence or non-occurrence of conditions that would preclude the Company from being able to draw down additional loan tranches, which could materially adversely impact the Company, lead to foreclosure on the Company assets acting as collateral for the loan agreement, and adversely affect the Company's ability to operate, including the acquisition and launch of Makena;
  • the possibility of not obtaining FDA approvals or delay in obtaining FDA approvals;
  • new product development and launch, including the possibility that any product launch may be delayed or unsuccessful, including with respect to Makena™;
  • acceptance of and demand for the Company's new pharmaceutical products, including Makena™, and for our current products upon their return to the marketplace, as well as the number of preterm births for which Makena™ may be prescribed and its safety profile and side effects profile;
  • the possibility that any period of exclusivity may not be realized, including with respect to Makena™, a designated Orphan Drug;
  • the satisfaction or waiver of the terms and conditions for the acquisition of the full U.S. and worldwide rights to Makena™ set forth in the previously disclosed Makena™ acquisition agreement, as amended;
  • the consent decree between the Company and the U.S. Food and Drug Administration ("FDA") and the Company's suspension of the production and shipment of all of the products that it manufactures (other than the Potassium Chloride ER Capsule products that are the subject of the FDA letter received September 8, 2010 allowing the return of those products to the marketplace) and the related nationwide recall affecting all of the other products that it manufactu
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