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Bxofscidad

01/16/11 8:12 AM

#4910 RE: biotech_researcher #4909

Help Scientists


Would some of you scientists please shed some light on the changing of the dates in the succeed trial.


It appears that Merck has extended the time in which to report the final results of the trial. Is this statement correct?

What may be some of the reasons for this action?

Does this action reveal. or give us any hints, as to the success or failure in meeting the primary endpoint of PFS?

Could it be that the primary endpont of PFS is very close to being met and that an additional period of time might be needed to meet that goal?

Could it be that the primary endpoint has been met in certain forms of sarcoma and addtional time may be needed for other forms to also meet the objective?

Please help me, and the other non-scientists, understand the significance of this action. That's, of course, if there is any significance at all.


Thanks, Barry

DonShimoda

01/16/11 9:03 AM

#4911 RE: biotech_researcher #4909

Does Ariad get paid at submission or, acceptance of the NDA?

Both - $25mm upon acceptance of the new drug application by the FDA, $25mm for U.S. marketing approval, plus another $15mm for approval in EU and Japan