'Bedaquiline kills more than 5 times as many subjects as the placebo does, so what do you think the FDA will do? If you think they’ll ban it, you’ll be mistaken. A committee recommends fast-tracking it.'
'Would you take a drug that trials have shown kills 5 times as many patients as a placebo simply because there are no other drugs to treat your condition? No? Apparently, the FDA thinks you have the wrong attitude, because they’re on the verge of fast-tracking a deadly tuberculosis drug with precisely that same danger.
In its favor, there is no other drug for multi-drug resistant tuberculosis. Does that convince you to take it?
Also in its favor, the drug meets the endpoint defined by the studies. Now are you convinced to give it a try?
Those are the reasons cited by the FDA’s advisory committee for placing bedaquiline on fast track approval. Seriously!
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