IND NDA question
From CC
That is the forward-looking statement, so I’ll share with you my experience. If you file a bad NDA, the FDA will give you a refusal [ph]. If the FDA asks you for certain things and you don’t do them because you disagree with them or you think they are scientifically, they are not justified the FDA will refuse your application. So the smartest thing to do is what you’ve been doing, you open what’s called IND and through the IND you communicate with them back and forth. You send them letters, this is what I’ve done, does the FDA agree? They’ll come back with yes or no, or we agree, but we want to do something else. And you adjust all of that to get to the point where you need to file the final NDA.
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