Replies to post #129611 on Biotech Values

[DewDiligence]

Hopefully, they are not going to get RTF like Complera original filing.

1 chance in 10,000 of that happening, IMHO.

[DewDiligence]

Viread got a 6-month pediatric extension from the FDA, which means GILD’s US patent protection on Viread, Truvada, and Atripla now expires on 1/25/18. The Orange Book is already updated accordingly:

http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=021356&Product_No=001&table1=OB_Rx

http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=021752&Product_No=001&table1=OB_Rx

http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=021937&Product_No=001&table1=OB_Rx

[DewDiligence]

GILD will cease US promotion of Atripla as soon as Quad is approved. (Source: today’s CC)

[DewDiligence]

GILD submits European MAA for Quad:

http://finance.yahoo.com/news/Gilead-Files-European-bw-3075624086.html?x=0

[DewDiligence]

FDA accepts GILD’s Quad NDA with a standard review:

http://finance.yahoo.com/news/U-S-FDA-Accepts-New-Drug-bw-1363457798.html?x=0

The PDUFA date is 8/27/12.

[DewDiligence]

GILD will discuss results from the Quad ‘102’ study tomorrow at 4:30pm ET:

http://finance.yahoo.com/news/gilead-sciences-quad-study-102-213500923.html