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News Focus
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AlpineBV_Miller

03/25/11 12:46 PM

#116999 RE: jq1234 #116998

Unbelievable. No way Pazdur gifts that label based upon those data to a small biotech company. No way.
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jq1234

03/25/11 2:56 PM

#117014 RE: jq1234 #116998

Bristol-Myers To Charge $120,000 For Standard Yervoy Regimen

[Gosh, would be $360k for 1st line therapy! Is this possible?]

http://www.automatedtrader.net/real-time-dow-jones/54479/bristol_myers-to-charge-120-000-for-standard-yervoy-regimen
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DewDiligence

03/25/11 3:39 PM

#117029 RE: jq1234 #116998

The Yervoy monotherapy label on the FDA website has a qualifier not shown in your post: patients must have an annual income of at least $250,000 and net assets (excluding a primary residence) of at least $2M.
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DewDiligence

05/21/11 5:40 PM

#120368 RE: jq1234 #116998

CHMP approves BMY’s Yervoy for second-line melanoma:

http://www.reuters.com/article/2011/05/20/bristol-melanoma-europe-idUSLDE74J13T20110520

The European Medicines Agency said its expert committee on new drugs had backed the drug as a treatment for patients with advanced melanoma who had received prior therapy.

In other words, the EMA is giving BMY what they asked for rather than giving them more than they asked for, as the FDA did two months ago (#msg-61357010).