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Re: DewDiligence post# 1038

Monday, 07/06/2015 12:25:57 PM

Monday, July 06, 2015 12:25:57 PM

Post# of 3202
If I have the info right, Gilead submitted Sept 24, 2014 (oct, nov, dec, jan, feb, mar, apr may, june = 9 months to get approved?).

http://www.natap.org/2014/HCV/120314_03.htm
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Gonzales said Abbv HCV program approval could come as early as Sept 2015 in Japan (perhaps this was more of a hypothetical than a possibility; an example to talk about potential 4th quarter earnings), but at minimum expected by end of 2015.

I am somewhat expecting that he is including that 3 million run rate to include Japan. I would almost guess it is predicated on it. Abbvie appears to have submitted Feb 11, 2015.

http://abbvie.mediaroom.com/2015-02-11-AbbVie-Submits-New-Drug-Application-in-Japan-for-its-Investigational-All-Oral-Treatment-for-Chronic-Hepatitis-C

This would/could bring the approval date to November if approval took the same amount of time. A slightly earlier approval would mean more competition in the Japan market place, and some time to get the drug priced, placed and prescribed before the year end holidays slow prescriptions.

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