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Re: DewDiligence post# 1731

Saturday, 11/04/2006 6:37:07 PM

Saturday, November 04, 2006 6:37:07 PM

Post# of 19309
Thanks, Dew -

I certainly didn't intend to imply that the approval of Kineret was based on less robust clinical data. I was only trying to reconcile Amgen's statement in Q2 '99 that they would submit the application after phase II based on FDA guidance, and my memory that approval didn't happen until late 2001. I dug a little deeper - it turns out they did submit the application after phase II, but were rejected. They went on to complete the additional studies you described and resubmitted.

Anyway, this is all a big boondoggle motivated by my interest in understanding Merrimack's delay in reporting results. I am not assuming the worst like some.

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