I hate to say it, but companies propose what they want to do to the regulators, and if the regulators don't see anything dangerous in what they're proposing, it gets presumptive approval after so many days. The regulators don't tell you how to spend your money unless they see something potentially harmful to patients. Once you've spent your money and provide your data while applying for approval, then they may ask questions that you can't answer because no one asked the question before.
In many ways it's like the IRS tax advisors telling you how to do something, then being audited and having the tax court say no, it doesn't matter that you did what they told you, that doesn't guarantee it's right.
Gary
Bullish
Market Data 
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