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by refurb
1675 days ago
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It doesn't make for a very compelling news story, but the real reason why Glybera failed is because it's not that great of a drug and it loses effect over time and you can't redose with the same AAV vector. They also relied a surrogate endpoint versus actual clinical measures (as those were to confounded by the small sample size and patient variability). It just barely got approved by the EMA and based on feedback the company didn't bother to pursue FDA approval. |
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