Yes, that's right. My point is just that the FDA s

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.