"I think that there’s a lack of really trusting that this pathway that’s commercially viable for individualized medicine is really going to open up. If investors don’t believe in it, there are no companies in this space. The companies won’t last."
Julia Vitarello, patient advocate and founder, EveryONE Medicines
The FDA recently described a new regulatory framework that would let personalized medicines with a “plausible mechanism” of action bypass randomized clinical trials.
But recent decisions about rare disease drug applications raise doubts about what the pathway means for patients.
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