Dropping the SPA is actually very negative news, and amounts to "giving up." The SPA is an agreement between the FDA and the company on the approvable endpoints of the trial. If they kept the SPA then the endpoints would in effect be guaranteed - but this is no longer the case.
It will now be much easier for the FDA to reject or delay the drug with an "approvable" or "non-approvable" letter.
And don't be too sure of exclusivity in the resectable market - Nexavar will soon gain approval in resectable liver cancer.
Much of the hope now rests with the melanoma trial. If that fails they are right royally screwed.
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