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Re: DewDiligence post# 3797

Thursday, 05/24/2007 5:01:22 PM

Thursday, May 24, 2007 5:01:22 PM

Post# of 12660
"Gold: We have had some preliminary discussions with the FDA since the CR letter. Let me just reiterate that we know that current ongoing study, the IMPACT study, is a binding agreement, looking at survival. There’s an interim analysis there and a final analysis. Based on some preliminary discussions that we’ve had with the FDA there may be some alternative pathways outside of the 9902b IMPACT SPA, and those are things that we’re going to discuss with the FDA. What we know is that we do have an SPA for 9902b looking at survival on both an interim and final analysis basis and we’ll get the interim basis next year. "

That sounds crystal clear to me. If another statement had some ambiguity, that doesn't counter a statement that removes it.

Unless Gold has outright lied, there is a specified interim.

I would wonder if they are trying to change the alpha allocation with the FDA, and that is why they are not telling us.
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