What would it take for the FDA to not support a company applying for accelerated approval?
In what circumstances would they say "don't apply".
I honestly don't know.
I assume as long as the condition they are intending to treat is serious and fills an unmet medical need, as per the FDA website, then they would support, or allow, an application.
So, is the supporting of an application ONLY based on the condition they are hoping to treat? If so, this is a pretty nothing announcement, right?
It has no bearing on the likelihood of accelerated approval, of whether or not the product is likely to work, or whether there is any substantial evidence of efficacy.
Maybe I'm interpreting this incorrectly, would love some insights into this from those who have done their DD.
What would it take for the FDA to not support a company applying...
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