Biotech Values

[DewDiligence]

Xgeva sBLA for prevention of CRPC bone mets has a PDUFA date of 4/26/12: (i.e. this is a standard FDA review):

http://finance.yahoo.com/news/Amgen-Announces-PDUFA-Date-prnews-2216452933.html?x=0&.v=1

The sBLA was submitted on 6/27/11, so this is a standard 10-month review.

Xgeva is already approved for preventing skeletal-related events in patients who already have bone mets (#msg-56882220).

The newly sought indication corresponds to the fourth row in the table in #msg-57938233.

An sBLA for preventing bone mets in metastatic breast cancer will be submitted much later, pending data from the phase-3 trial (see fifth row in #msg-57938233).