(2) For purposes of paragraph (1), the term "rare disease or condition'' means any disease or condition which (A) affects less than 200,000 persons in the United States, or (B) affects more than 200,000 in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will recovered from sales in the United States of such drug. Determinations under the preceding sentence with respect to any drug shall be made on the basis of the facts and circumstances as of the date the request for designation of the drug under this subsection is made.
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/Overview/ucm119477.htm
Estimated new cases and deaths from ovarian cancer in the United States in 2009:
New cases: 21,550
Deaths: 14,600
http://www.cancer.gov/cancertopics/types/ovarian
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