Thursday, July 30, 2015 11:18:51 PM
1) It meets the criteria of a terminal disease
2) No alternative treatment / unmet medical need (as it is designed to test outcome on those with no/low response to current treatments)
3) Predictable outcome based on theoretical cause of action + post treatment data to confirm cause of action. Remember the Perkin Elmer collaboration?
It becomes clear that if results are positive enough (and this is the key) then an application for accelerated approval could and is likely to be filed. Good companies do not wait for precedent, they set the precedent and pave the path to the future.
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