[Ed. Note: “Orphan” drugs are used for specific, small percentage diseases, like MS. Which makes them massively expensive.]
by Doug Hornig, Casey Research:
The Food and Drug Administration (FDA) has had a long and checkered history, from the day in 1906 when President Roosevelt signed the act that created the tiny new Food, Drug, and Insecticide Organization to the present, when the agency wields enormous regulatory authority that can make or break a company in the blink of an eye.
As investors in biotech know all too well, a modest investment can turn into a small fortune or burn to ashes, depending upon whether the FDA turns its collective thumb up or down after a new drug’s trial results.
To get that new drug approved today means running a gantlet that stretches over a painstakingly long time and requires the expenditure of hundreds of millions of dollars or more. Final approval now usually comes after more than a decade of testing. Compare that to the seven months it averaged prior to 1960.
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