Replies to post #99166 on Biotech Values

[p3analyze]

For the paclitaxel indication to stay, IMO, Roche has to run another E2100 trial.

Pazdur essentially shut the door when he commented that the only ongoing phase III studies were in the HER2+ or ER+ setting, making it hard to ascertain the HER2- metastatic chemo indication.

[genisi]

It was the last question on the draft:

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM219429.pdf

QUESTION # 5 (discussion)
If the Committee's answer to Question 4 is No:
Please discuss what additional trials should be performed to verify the clinical benefit of Avastin in the treatment of HER2-negative, metastatic breast cancer.

but I have no idea if there was a discussion.