Yup, EXEL sure has become the Rodney Dangerfield of biotech....
It remains to be seen whether simple solid trial results will suffice to get the stock price appreciated, or if the CEO must be keel-hauled....the competition smothered with the proverbial pillow.
Fun times ahead...
Scott Garland is perhaps one of the most successful oncological pharma sales reps in the history of pharmaceuticals. The BOD reads like a "Who's Who of oncology research. Upper management is well-versed, capable, and academically top-notch. Being as this is Kennedy week...
"Ask not what DanSmily can do for you...
Ask what you...can do...for DanSmily..."
To which I say, "Buy... DanSmily....Buy..."
Just doing my part to enlighten the hopelessly dim...
Kurzrock has got to be one of the most prolific and creditworthy researchers of her generation. I completely enjoy finding her research crossing paths with my own, though we are obviously of different agendae. I 've managed to log into NCCN functions in the past as a patient advocate, and -given a bit of license in interpretation of that term - perhaps I am...
Hopefully the future holds a reliable marker for response to Cabo that will resolve the persistent dosing issues. The dramatic early response to Cabo is of course very encouraging, but perhaps it is simply too much too quickly...overwhelming the physiologic pace. I am hopeful that the biologic verification trials in process by PI's D.Smith, Tia Higano, Ed Posadas, and Russ Schmueliwitz will knock the mystery out of this investment, and maybe give Mr Market something he can sink his teeth into...GLTA
Two articles published in the Oxford Journals: Annals of Oncology...similarly titled.
One in the editorial section, published by S. Postel- Vinay, et al.
Another published in the Head & Neck Cancers section by Razelle Kurzrock, et al.
Both are in the Sept 2013 issue, Volume 24 Issue 19...
Ernie, have you seen these? Any commentary greatly appreciated...
FWIW-Cabo is also listed on the agenda for the recent COMP (orphan drugs committee) meeting that took place 11/5-6. This can verified by seeking out page 4 of those minutes (the segment wrt ongoing evaluation). The current CHMP meeting began today, and will post highlights shortly after adjournment on 11/21. It is entirely possible we could see news out of Europe as early as Friday.
Dimples, the quote below is from the EXEL Q3 PR. If you have another source, please produce it.
Otherwise, keep your hands down Jonesy's pants and off your keyboard.
"Cash and cash equivalents, short- and long-term investments and short- and long-term restricted cash and investments totaled $464.7 million at September 30, 2013, compared to $634.0 million at December 31, 2012."
Glad to c you are still hear...
If I here of any jobs requiring zero ability...zero peeple skills...zero communication skills...
... zero talent...and a host of zeros all of which add up to you...
I'll be shore to lett u no...
in the meen ways check out "Uselessbuttmonkeysdotcom"...
The pay ain't great...but you'll get some time outside yore cubicle.
GL, you hapless, insufferable butt-clown
"I'm laughing so hard I have urine running down my leg..."
Unfortunately for you, that's my urine...
BTW - I'm laughing too...
I believe we are getting close to an EMA consideration. Cabozantinib was listed for consideration and "evaluation of an RMP in the context of an initial marketing authorization application procedure" when the PRAC met on 11/7/13. The PRAC ( Pharmacovigilance Risk Assesment Committee) is somewhat to the EMA as ODAC Ito the FDA. No results nor commentary are displayed, but this necessary step has been completed.
For confirmation, see EMA PRAC minutes 14.1.2 page 55 dated 11/7/13. I like this a lot...
We are about to get some news from across the Atlantic,
Glad you'll be hear...illiterate twirp...
You gotta be dumber than a box o' rocks...
Daft as a fence post??
Yer Mama nickname you "Bag o' Hammers" ???
Little Jonesy Bag O' Hammers??
GL (you need it)
Posted at Newscientistdotcom 11/14/13...cancer info megadatabase...and it's free!!
"The online resource, called CanSAR, was developed by a team at the Institute of Cancer Research in London, and contains 1.7 billion experimental results relating to genes, clinical trials and pharmacological data.
The idea is to provide a free computerised system that can analyse the huge amounts of data accumulated over the past decade on cancer, in order to provide leads for genes or drug targets to pursue for future treatments.
For example, CanSAR summarises what is known about any gene of interest, including which drugs react with it and whether it is active in healthy tissue. A prototype evaluated 479 cancer-associated genes, and picked out 46 leads, many not previously considered as targets for therapy."
For God's sake, Jonesie...it's Friday night.
Get a life, get a girlfriend, get a job...
Find a mission that'll feed you.
Your job here is done. It's over...
Starting now... Adios, Mijo...
Hasta la bye-bye, drizzlebritches...
Been fun...but you are done.
I found the recently listed Cobi/ MetMAb trial while actually looking for some recent P2 MetMAb/ erlotinib results in NSCLC - keeping informed on the competition. Just wanted to post some interesting findings from that trial, as the notable difference between OS in high-MET patient pops may limit the commercial opportunity for MetMAb...and tip the scales favorably for Cabo, at least in NSCLC. I know it can be futile to cross-compare trial data, but thought this was worth a heads-up... The quote below comes from an interview with PI Dr Spigel.
"A similar pattern occurred with overall survival. In the intention-to-treat analysis, overall survival was not significantly different between patients given erlotinib plus onartuzumab (8.9 months) and those given erlotinib plus placebo (7.4 months).
But overall survival was nearly three times longer in patients with MET-positive tumors given erlotinib plus onartuzumab (12.6 months) than in those given erlotinib plus placebo (3.8 months). In contrast, among patients with MET-negative tumors overall survival was markedly better for those given erlotinib plus placebo (15.3 months) than for those given erlotinib plus onartuzumab (8.1 months)."
NCT01974258...updated at Clinicaltrialsdotgov on 11/4, not yet recruiting.
A simple P1 trial in solid malignancies...and also in combination with Vemurafenib...
Could be a real value driver for Cobi in the long run...and also for EXEL.
Pretty sly game being played by Roche here...totally unannounced.
I believe Exelixis has assumed a median OS of 7-months for the control, and this has proven the contention of some web-based argument over the validity of this assumption.
FWIW- "Tinker" has a pretty good post on this topic over on the MF board. Ernie has made some past commentary on the powering of Comet-1, and I would encourage you to search it out. JMHO, but I've satisfied myself that the trial is adequately powered.
"COMET-1 is a randomized, double-blind, placebo-controlled trial designed to enroll 960 patients with mCRPC who have previously been treated with docetaxel, abiraterone acetate and/or enzalutamide. All patients in the trial have bone metastases and there is no limit to the number or type of prior treatments. Patients are randomized 2:1 to receive cabozantinib (60 mg daily) or prednisone (5 mg twice daily). The trial is event-driven and has 90% power to detect a 25% reduction in the risk of death (HR = 0.75) at the time of final analysis, which requires 578 events. A single interim analysis after 387 events is also planned and will assess if the trial achieved its primary endpoint; it will not include a futility analysis. The secondary endpoint of the trial is bone scan response as assessed by an independent radiology facility."
"I have to disagree..."
Perhaps the stock will trade in a slightly higher range, but the size of the MTC indication is the limiting factor. At best, MTC revenues could double...
I really don't expect any significant stock action till we see some OS data that also incorporates some credible info wrt the apparent relationship between bone scan resolution, pain relief, and Cabo's effect on the bone micro-environment. There are still many unanswered questions of Cabo's MOA, and the "smoke & mirrors" of relic artifact and errant uptake will eventually devastate the short thesis.JMHO.
That said, I see us breaking thru $6...and perhaps visiting the $7's by early spring, 2014 just on the strength of pending Comet 2 success...
Lots of wild cards that could play at any time...
Including the elusive buyout, tho I can't begin to put a price on Cabo...
The CHMP will meet twice more this year....11/18/13 thru 11/21/13 & 12/16/13 thru 12/21/13.
They don't publish their meeting agenda, but will post highlights in the wake of each meeting.
I wouldn't expect a significant impact on SP, as the NPU has been in place since the deal was first announced with SOBI. I think European approval in MTC will be largely a non-event.