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mcbio

06/18/12 8:54 PM

#144059 RE: jq1234 #144058

I don't think these new found issues are going to affect Carfilzomib in the long run. As I mentioned in previous posting, these issues are found in the context of single arm trial, and inadequate mitigation strategy for cardiac and hepatic risks. Velcade has similar and more than these risks, the difference - read Velcade label - is to identify patients at risk with clearly pre-defined dose reduction strategy.

Fair points. You have any comments on Genmab's daratumumab? Per their Jefferies CC, they claim to be in advanced partnering discussions.
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pcrutch

06/18/12 11:03 PM

#144065 RE: jq1234 #144058

Quote " Velcade has similar and more than these risks, the difference - read Velcade label - is to identify patients at risk with clearly pre-defined dose reduction strategy"

This is something Onyx presumably has not done, which is another reason why the FDA likely punts the NDA.