[Ip-health] Gilead's remdesivir wins orphan drug status for coronavirus - Gilead Sciences, Inc. (NASDAQ:GILD) | Seeking Alpha
james.love at keionline.org
Mon Mar 23 14:04:49 PDT 2020
This deserves a challenge.
Here is the legal definition of "rare disease".. (and we wish COVID-19 was
DESIGNATION OF DRUGS FOR RARE DISEASES OR CONDITIONS
SEC. 526 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT [21 USC 360bb].
(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.
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