Unless you know the issue behind the approvable letter I can't see how you can say that odds that they can get it approved without another study are nil.
The FDA gave Encysive a class one response which according to their own guidlines means that the issue wouhld be fairly minor.
The FDA went through and made suggestions about the risk map that Encysive put together which would only go into effect after approval. If they had no intention of approving the drug why would they have done that?
The safety and efficacy of the drug has been shown to be better than the already approved drug.
I don't know the odds but I don't believe they are nil
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