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BTH

10/29/10 9:49 AM

#3020 RE: DonShimoda #3018

Don, just for the record.

What odds (%) are you placing on a successful Phase 3 SUCCEED trial which meets the pre-defined endpoints as determined in the SPA?

Unless you are saying it will meet with 100% odds, what would you attribute as the reason for not meeting its pre-defined endpoints.

Also, assuming it meets its pre-defined endpoints, what are the odds that the FDA, because of the recent scrutiny they have placed on "progression-free survival", goes back on its 'word' in the SPA, and makes ARIAD continue the trial until 2013 to see what the "overall survival" rates are in the patients?

One more thing. Is there any chance at all that there are AEs which would make the FDA scrutinize the drug and not approve it because it is only "maintainence therapy" and not a true first, second or third line therapy?

Thank you.