That article says if the FDA isn't satisfied with the toxicity and dosing then there will be a delay. But if you have been following biotech stocks as long as I have very rarely does the FDA refuse an IND application.
The only way for refusal is if the dosing is way off and the treatment is toxic. But since the company is using edothelial cells to spur the bone morrow naturally to create red blood cells I don't see how toxicity plays a role hardly at all.
It's all speculation and never a sure thing, but more likely than not they will get IND approval!
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