(Total Views: 308)
Posted On: 09/07/2019 4:24:27 AM
Post# of 145915
Yes, that's right. My point is just that the FDA sometimes acts arbitrarily and on the last minute while violating their own special designations and guidelines. And that CRL is ridiculous in itself: if they argue like this, they need to ban all IV products; and toxicity at a 10x Dose - I mean: if you drink 20l of water instead of 2 per day, it'll be toxic too. I'm not familiar with Sarepta either, but I suspect something else bothered the FDA here.
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