I agree with all you're saying Biosect, but I must admit delays caused by the FDA in the past have certainly taught me not to bet on what they'll do. In time I have no doubts, the only question is, how long will it take.
In IMGN's case, on both Kadcyla and Elahere they had results they could have deemed worthy of approval, but they didn't. More trials were demanded and that adds years and many millions to the costs. I do believe they've changed a little since then, today I'm inclined to believe they'd do a conditional approval but insist on a confirming trial. It's a far better solution than no approval at all, but I still believe it would be completely unnecessary if after approval all applications of the drug were reported in a Phase 4, something easy to input if the expected outcome is seen, but in greater detail if something unexpected occurs. We all have to realize we're treating people who're fighting deadly diseases, so deaths will occur. The big thing I see a Phase 4 doing is allowing others to see that it's been used off label in certain diseases, and evaluate the results reported to date. I believe Insurance would have problems denying use if say 20 patients with a given type of cancer had off label treatment and the majority had positive outcomes, and no unexpected problems.
Gary
Bullish
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