Yes that is true, but the FDA doesn't work that way. They would rather 10,000 die of no treatment than 1 person die because of a new treatment that saved 10,o00.
No matter the stupidity of this, them is the rules the game is played by and you have to give the FDA what it wants. They want extended use data with new HIV drugs and so you have to give it to them.
Ann: Letter to Shareholders, page-250
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