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by s1artibartfast
883 days ago
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That is a bad quote out of context. The original drug was a prodrug, agreed upon with the FDA. "To create a usable medication
from tenofovir, Gilead was required to develop an alternative
form of the chemical, known generally as a “prodrug,” that would
be safe and effective when administered orally.
Gilead eventually created TDF, a prodrug form of tenofovir,
and focused its development efforts on that compound. TDF was
approved by the FDA for sale as a treatment for HIV/AIDS
in 2001. At some point during its work, Gilead developed a second
prodrug form of tenofovir, TAF, that also showed promise in the
treatment of HIV/AIDS" The FDA does not engage in horse trading like saying we will approve this Dangerous Drug if you promise to develop a safer one in the future. Drugs either meet clearly established legal criteria, or they don't. |
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