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Replies to #81954 on Biotech Values
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DewDiligence

12/15/09 8:10 PM

#87570 RE: genisi #81954

NVO has evidently gone into radio silence regarding the NDA for Victoza (liraglutide). NVO’s most recent public comment came in late October:

http://sec.gov/Archives/edgar/data/353278/000120864609000291/c101679.htm

Novo Nordisk continues the constructive dialogue with the United States Food and Drug Administration regarding the regulatory process for liraglutide. Formal feedback from the FDA regarding liraglutide, a once-daily human GLP-1 analogue, is still expected in the fourth quarter of 2009.

NVO submitted the Victoza NDA in May 2008; the original PDUFA date was in Mar 2009.
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DewDiligence

12/30/09 10:30 AM

#88336 RE: genisi #81954

FDA decision on Victoza (liraglutide) delayed again, but only for “a few weeks”:

http://www.reuters.com/article/idCNLDE5BT09520091230

I wonder if NVO knows that this is what HEB said about Ampligen :- )