Replies to post #114692 on Biotech Values

[BTH]

Sounds like Morrisey is a chip off the old Scangos....

[jbog]

Dew,

The impression the street is getting is that the 1st place XL184 heads for would be in competition against Amgens Xgeva for bone mets in many indications.

Corporate said filing is by far longshot at this point, and I'd agree with them.

[urche]

EXEL-

Re: Cabo approval in 2011 ----"Based on what data?"

I think I misrepresented Feuerstein's report. The reference was to FILING, not APPROVAL in 2011.
Here is another blurb from his live blog today:

adam feuerstein:
EXEL looking at "longshot" approach to file cabo in prostate cancer in 2h 2011. sounds a bit aggressive to me but i understand the desire to push ahead as fast as possible. FDA very tough on accelerate approval these days.
Monday February 14, 2011 11:52 adam feuerstein
11:53


adam feuerstein:
more likely is ph 3 program in prostate cancer starting in 2012.. prevention of bone mets, symptomatic bone pain relief, extend overall survival..
Monday February 14, 2011 11:53 adam feuerstein
11:54


adam feuerstein:
EXEL is holding an investor event on thursday to fully update with the cabo data and future plans. sounds like that's the more impt investor meeting than the quick summary we're getting today.

This emphasis on prostate cancer and bone mets should not obscure the fact that cabo's lead indication is medullary thyroid cancer and top line phase 3 data is due in 2nd half 2011. It seems prudent to me to believe that approval would still be based on MTC data, an easier approval, though both MTC and metastatic prostate ca probably qualify as unmet medical needs.

Does anyone else smell a diluting financing coming soon?

Urche

[jq1234]

Based on what data?

Based on 150 post chemo CRPC patients. At least he said accelerated approval is long shot, but not zero probability.

I like XL184, but the timeline given by management is impossible. For example, they don't know the composite endpoint for phase III yet - depends on 150 patients trial result, but they want to seek SPA AND start the trial 2H2011. Did anyone in EXEL regulatory give CEO guidance like this?

One thing interesting from today, as obligation of collaboration for other compounds end 2011/2012, there will be further reduction of employees.