Replies to post #142083 on Biotech Values

[biomaven0]

The only data for patients "Refractory to all approved tx" come from a 44 patients group with ORR=20.5 so very few responders.

But note the ORR was very consistent across all these groups, as was the duration of response. The issue here is whether the drug is appropriate for accelerated approval, and I think this data is supportive of the fact that the drug is meeting an unmet need.

Peter

[DewDiligence]

FDA briefing docs on ONXX’s Kyprolis (carfilzomib):

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM308563.pdf

http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/ucm308560.htm

The panel meeting on Wednesday will be webcast.