MAXM: Maxim Pharmaceuticals Message Board

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Biotech / Medical : MAXM: Maxim Pharmaceuticals

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To: keokalani'nui who wrote (29)	5/12/2004 11:45:22 AM
From: Icebrg	Read Replies (1) of 35

>>What does ceplene w/IL-2 vs nothing tell us about their drug?>> Not very much. The combination appears to bring some benefits. Although we don't know if this benefit comes from IL-2, Ceplene or the combination. Further, the company did not provide any survival data, so we don't know the size of the improvement in survival. Can be anything. I doubt very much that there is a SPA. If there was, Maxim would file a NDA immediately in order to have the drug approved. Even if AML is a very minor indication. Instead they are saying that they plan for a sNDA (or more probably off-label use) in case Ceplene is approved for melanoma. This seems to indicate that they are aware of the fact that this study has not been designed to lead to approval. Erik

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