It's a good sign if the FDA doesn't require any further information/clarification.
If the application meets primary endpoints, show efficacy, shows that efficacy benefits outweighs the side effects, shows that the drug can be produced to a consistent standard, then approval is in the bag.
Also the fact that we didn't require an expert panel to review the application is a good sign, means this application is straightforward enough FDA reviewer to understand.
It's a good sign if the FDA doesn't require any further...
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