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PinkSheetLauren

  1. Carson was the sole No vote in whether DMab needs a REMS; she cited lack of evidence that REMS is effective 1:53 PM Aug 13th from web
  2. Things are getting confusing/ugly in here, maybe we should just skip question 5... thanks 1:47 PM Aug 13th from web
  3. Carson then asked for confirmation as to whether Pazdur was the most senior FDAer in the room 1:44 PM Aug 13th from web
  4. Carson just told Pazdur that FDA doesn't like changing the words in questions after he proposed a change- he kindly reminded her he was FDA 1:42 PM Aug 13th from web
  5. Carson just tried to adjourn the meeting without voting on the last three questions; apparently she didn't see the last page of questions... 1:36 PM Aug 13th from web
  6. AC votes 3Y, 11N that Dmab can be used to prevent bone loss assoc. w/ hormone ablation therapy in men w/ prostate cancer 1:35 PM Aug 13th from web
  7. More robust data from a larger study in men with prostate cancer (compared to the study of women w/breast cancer) tipped the scale for cmte 1:20 PM Aug 13th from web
  8. Cmte. votes 9Y, 4N that DMab can be used to treat bone loss associated w/ hormone ablation therapy in men with prostate cancer 1:17 PM Aug 13th from web
  9. Cmte: DMab does't have favorable risk/benefit for treatment of bone loss associated with hormone ablation therapy in women w/breast cancer 12:46 PM Aug 13th from web
  10. Cmte: DMab does't have favorable risk/benefit for prevention of bone loss associated with hormone ablation therapy in women w/breast cancer 12:44 PM Aug 13th from web
  11. cmte members concerned about risks associated with long-term use 12:23 PM Aug 13th from web
  12. cmte: Dmab should NOT be used in postmenopausal women w/ low BMD who do not meet the criteria for treatment of osteoporosis. VOTE: 3Y, 12N 12:21 PM Aug 13th from web
  13. cmte. consensus: DMab should be limited to high-risk for fracture subgroup and patients who have failed or are intolerant of other medicines 12:05 PM Aug 13th from web
  14. Unanimous: 15 Y, 0N for denosumab's use in postmenopausal women 11:54 AM Aug 13th from web
  15. Rosen: This drug is as good as it gets... 11:49 AM Aug 13th from web
  16. Why is it that advisory committees NEVER know the protocol on voting!? C'mon people... 11:45 AM Aug 13th from web
  17. Amazing: Marilyn Brown, 83-year-old w/osteoporosis, retired NIH microbiologist, plays tennis 2x/week and tends to a full vegetable garden 10:23 AM Aug 13th from web
  18. Next, Roberta Biegal, National Osteoporosis Foundation 10:13 AM Aug 13th from web
  19. First up, Kathleen Cody, Executive Director, Foundation for Osteoporosis Research and Education 10:10 AM Aug 13th from web
  20. And we're back! Gearing up for the Open Public Hearing... 10:05 AM Aug 13th from web
  • Name Lauren Smith
  • Location Washington, DC
  • Web http://www.thepin...
  • Bio Reporter for Elsevier Business Intelligence
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