Replies to post #166950 on Biotech Values

[jq1234]

Thanks for link to the old article. Bioinvestor X is wrong in this part at least:

With Zytiga approved and MDV3100 and Alpharadin going to be filed for approval soon (and both available already under compassionate-use programs), Exelixis will have a tough time enrolling patients in Study 307. If we assume the trial starts now, I don't expect the company to have data until the first half of 2015 at the earliest, and that assumes a lightning-fast enrollment pace and an early halt for efficacy. How likely is it that the cabo trial can be halted early for efficacy? Not so much because cabo has yet to show any survival benefit to date.

Study 307 (COMET-1) finished enrollment this week:

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Sep. 26, 2013-- Exelixis, Inc. (NASDAQ:EXEL) today announced that the enrollment target of 960 patients has been reached for COMET-1, the company’s phase 3 pivotal trial of cabozantinib in patients with metastatic castration-resistant prostate cancer (mCRPC). The primary endpoint of COMET-1 is overall survival, and Exelixis continues to expect top-line data from COMET-1 and a second pivotal trial in mCRPC, COMET-2, in 2014.

http://www.exelixis.com/investors-media/press-releases?cpurl=http%3A%2F%2Fir.exelixis.com/phoenix.zhtml?c=120923%26p=irol-newsArticle%26ID=1858952%26highlight=

We'll have to wait and see if BioinvestorX was correct that COMET-1 placebo arm would mimick Zytiga/Xtandi post-chemo trial post progression survival - my guess right now is COMET-1 placebo arm mOS will be less than what he suggested:

Let's turn to an explanation of how Study 307 is mis-modeled. Exelixis designed the study with the assumption that the control arm (patients treated with prednisone) will live an average of 7 months. But look at the post-progression survival for MDV3100 (10.1 months) and for Zytiga (9.2 months). Is it realistic to expect dosing beyond progression? I say no, it isn't. A blend of 10.1 months and 9.2 months is unlikely to give you 7 months survival. The patients in the control arm of Study 307 will live longer than Exelixis modeled.