Replies to post #12909 on FDA Plays

[oldberkeley]

I could not agree more and I'm not happy with their management.

It comes down to data gathered after the NDA submission. Is there an actual protocol for submitting this type of data? Give the FDA a call and say, "Hey, we have some more data, we're sending it over?"

Not bashing the FDA, didn't mean for it to sound that way.