Jbog,
Poorgradstudent gave really good response. I have to add, your thought is typical industry outsider who think all companies' goal was to get the drugs approved. Unfortunately, from someone who has worked in the industry for a long time, I can tell you it is not true at all. Those who do have that goal in mind all the time, if the drug works, they get approved. Many companies make decisions based on other reasons. Unfortunately I can't give you examples here. That's why people like you get this idea it's all FDA's fault because people work in the industry can't really talk about confidential deliberations even after they leave a company. We all have these big confidentiality agreement carried everywhere.
Let me give you one general example. FDA had given the statistics for years that NDAs submitted at end of qtr/half/year have more deficiencies than NDA submitted at other times. Thus it showed companies rushing NDA submission. And they do. Many companies still do rush because that's the matrix they used to measure against. They'd rather submit deficient NDA than missing self imposed timeline.
Read some real industry insider comments on Pharmlot, you'll get better idea of the whole picture, rather than general crap like FDA works against industry. FDA has many issues, but not what you said.
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