Well as waggs has said before...and I agree with it...
Except you get multiple shots at it with the FDA. It's unusual for the FDA to deny a Phase 1 IND, but it can happen. Then the company addresses the FDA's concerns, and resubmits it.
The first time it was suggested everything had to be perfect for the mythical IND submission it was on this forum. Kenny then picked up on it, and regurgitated it back to the SHs. Give em what they want to hear! While in the process picking up a PASS.