Published 4/8/14 in the Asian Journal of Andrology
"Anti-angiogenesis in prostate cancer: knocked down but not out
Marijo Bilusic, Yu-Ning Wong
Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA"
Small wonder the short interest is so large. Considered as a class, anti-angiogenics have established a history of inadequacy in improving survival. Hopefully, Cabo's MKI synergy makes all the difference. Worthwhile read... GLTA
This answer will not serve to define all officer holdings, but the lion's share of MMM's stake is held in a legal device referred to as the " Morrissey Family Trust". I strongly suggest you look it up.
I expect to see abstract presentations in whatever appropriate venues are on the horizon, but - EXEL's in crunch mode wrt the P3 Comets & Cobi trials - and that news will present as it is processed to deliverable completion...most likely in a PR. Presentations will come later. Another Cabo trial P2 halted for obvious efficacy might move the needle somewhat, but we need approvable pivotal data to gain any real traction, and that'll constitute material news warranting a PR and an SEC filing. It's crunch time...
Should make for some interesting debate...
Placing a valuation on human life is difficult, but legislating toward limitations on social responsibility to extend that life is a true quandary that will test the humanity of government. Should affordability of treatment be addressed during the approval process, as well? That'd place all the workload on the FDA, and that agency would sink in the morass of added responsibility. Is a first-line treatment worth more than treatment in a later stage of disease - after that initial treatment is no longer effective? Who decides? Does India have it right..?? Will the US ultimately over-regulate the pharmaceutical industry, possibly even conscripting BP to provide drugs at cost? How do we get from here to there?
There is a much larger debate looming on the horizon, and I suspect that the cost of oncology drugs is simply another egg in a very large basket that'll need to be processed into the omelet of ObamaCare.
Health-related quality of life improvements improve survival in European lung cancer study, BJC today. As patient-reported outcome data mature in Cabo trials, I expect to see strong interaction of these subjective prognostic factors with clinically quantifiable biometrics...resulting in improved OS.
"results: After controlling for covariates, every 10-point increase in baseline pain and dysphagia was associated with 11% and 12% increased risk of death with hazard ratios (HRs) of 1.11 and 1.12, respectively. Every 10-point improvement of physical function at baseline (HR=0.93) was associated with 7% lower risk of death. Every 10-point increase in pain (HR=1.08) was associated with 8% increased risk of death at cycle 1. Every 10-point increase in social function (HR=0.91) at cycle 2 was associated with 9% lower risk of death."
Nice try, Snowflake...here's the conclusion from the study you've posted:
"Published drug trials that are financed by pharmaceutical companies may present a distorted picture. This cannot be explained by any difference in methodological quality between such trials and trials financed in other ways."
In addition to Exelixis funding, cabozantinib research is being funded by the NIH, the DOD, a host of CTEP & CRADA grants, and the following premier cancer research institutions: Mass General Hospital, MDACC, MSKCC, Cedars-Sinai, Fred Hutchinson Cancer Center - U of Wa, Loyola Med School, the Univ of Chicago, and many others. The academics that have researched and peer-reviewed the data submissions to date reads like a virtual "Who's Who" of cancer research, and thought leader participation from a variety of cancer-related disciplines is notable. If there has been some conspiracy to fraudulently enrich the data pool...that conspiracy must include the CIA, the US military, and the Oval Office. If that piece of ancient history pub is all you've got...you've got nothing.
Your assumption is preposterous.
Re: the Goldkorn article and the accompanying editorial:
Lots of research is being conducted wrt endpoint surrogates for OS. CTC redux is one of many, and the work to keep an eye on is taking place at MGH's Dan Haber lab, Scripps Institute, and the Ed Posadas lab at Cedars-Sinai. They are all trying to skin the cat in different ways, and I expect to see some 510K filings in the near future. At present, these CTC platforms are "reference use only (RUO)", and the only approved device is the Veridex Cellsearch.
Here's the CTC data as reported by the P2 RDT:
" Robust reductions in circulating tumor cells (CTCs) were observed regardless of prior therapy in 62 patients with baseline CTC counts greater-than or equal to 5/7.5 mL of blood and a week 6 and/or week 12 assessment. Fifty-seven patients (92%) had greater-than or equal to 30% decrease in their CTC count. Thirty-nine percent of evaluable patients converted to
Over on the Yahoo "market pulse" board, you just posted this same comment as "uxncombr"... So this is how you spend your days...spouting silliness.
Your mother must be very proud...
Classen's lost his way. Here're the P2 results and the investigators' conclusions. Nothing controversial, inconclusive, or ambiguous here...
"One hundred seventy-one men with CRPC were enrolled. Random assignment was halted early based on the observed activity of cabozantinib. Seventy-two percent of patients had regression in soft tissue lesions, whereas 68% of evaluable patients had improvement on bone scan, including complete resolution in 12%. The objective response rate at 12 weeks was 5%, with stable disease in 75% of patients. Thirty-one patients with stable disease at week 12 were randomly assigned. Median PFS was 23.9 weeks (95% CI, 10.7 to 62.4 weeks) with cabozantinib and 5.9 weeks (95% CI, 5.4 to 6.6 weeks) with placebo (hazard ratio, 0.12; P
Check it out: this guy double talks just like ol' please_insert_foot_in_butt:
"In a report Wednesday, analyst Bart Classen said, "In late March we hosted a conference call to discuss Exelixis’ (EXEL) cabozantinib, which is in the phase III COMET-1 trial for metastatic prostate cancer. EXEL recently announced that the trial would continue, and topline data is expected in 2014. COMET-1 enrolled 960 prostate cancer patients with bone metastases who have failed prior chemotherapy; the trial uses survival as the primary endpoint. There is little evidence that the drug will cause a meaningful improvement in survival. A phase II study demonstrating an improvement in bone scans has been highly criticized for lacking a correlation with clinical outcomes. We believe the product will be expensive, poorly tolerated, and show little benefit. Its benefit over taxanes is dubious. However, we cannot exclude COMET-1 showing a small statistically significant improvement in survival."
We really don't think it'll work, but can't rule out that it might....
Lemme get my foot outta my mouth and say that again....
I agree..but feel this a good time to air this stuff, particularly as the e-pub is a fresh one, and there have been recent unfounded claims of side effects and toxicity. It's preposterous to make such claims unless you are willing to divulge sources. I simply wanted to clarify that point. Thanks for responding.
"1 what are odds that cabo get fda approval"
Cabozantinib already has FDA approval, and I feel future label expansions are inevitable.
"2 don't you feel mm is atotally incompetent ceo and should have said something in past few weeks to appease stock holders"
No. Whether MMM is a maniac or a visionary remains to be seen. I see Mike as a brilliant medicinal chemist in his first position as a CEO. It is no small task to take an un-partnered onco-pharmaceutical into global approval. As unrefined as MMMs leadership skills may appear and regardless of how well he performs in the short term, what counts is that he makes the best decisions for the future of the company. This is a huge part of the speculative play here... should you choose to remain invested in EXEL. Again, I don't feel MMM has ever acted without the advisement of the BOD.
You'd be best suited to channel your animosity toward them...
I'm not a pumper, and I think most of you know that...
I think it important that we -as investors - keep informed of the issues that surround the research in which we choose to invest. Of course, if you are prudent, you will do your own DD and find your own best answers. Longs should be aware of this publication, and I encourage you to seek it out. I doubt this retrospective study has any immediate implications wrt the recent sell-off, though it undoubtedly provides fuel for the short thesis. See it for yourself:
E-published ahead of print in the ATA journal Thyroid 4/11/14...Yavuz S et al...
JMO - but this study is not telling us much of which we weren't already aware.
Further to which, if thyrotoxicity were a compellingly unmanageable issue with Cabo treatment, the pediatric trial - the protocol of which allows Cabo dosing of children down to age 2 - would be the first to shut down for data monitoring, metabolic, and AE concerns.
I feel discussions of this nature are best undertaken at SP bottoming than after we've spiked on company spin or analystt hype. If anyone has further toxicity concerns wrt Cabo, please include your source prior to initiating your commentary.Too many posters here are stating opinion without reference, and I will no longer respond on the basis of unfounded opinion. Life is simply too busy, and I've no time for bashing for the sake of bashing...or cheerleading for the sake of cheerleading. Other than that, I invite all commentary on this topic.
What is that word used to describe people that insistently subject others to advice...
..that they - themselves - will not heed?
There are only two bets to be made here..and both are based upon the premise that the IP (Cabo) will either perform to a quantifiable, industry compliant, FDA-approvable standard...
...or it will not. It's strictly a hit-or-miss asset play. Most recently, cobimetinib has been thrown into that asset mix, and might actually serve to enact some salvage, should Cabo underperform expectations. And...the answers are very, very close at hand...no further presentations are necessary. Cabo either delivers OS and a convincingly FDA-approvable clinical benefit package...or it doesn#$%$ very simple, and it's no longer about management, presentations, or timely commentary to soothe the shareholders. It's only about the science. It's crunch time...it's either go or no...It's not an investment, it's an asset play. The IP asset either fits the required profile, or it does not.
FYI - EXEL is not a REIT, and Cabo is not a condominium of timeshare beachfront condos whose intrinsic value relies upon the valuation of the peso.
Simple enough for you?
Omigosh...you've got it right...!!!! Congrats!!
EXEL's greatest asset is a beachfront resort off Mexico...
Brilliant is what you are...Gimme a fishin' pole...
I'm headed to Cabo??? They gotta lemme fish...
I'm a shareholder..!! Baby gone fishin' all de time..
I'm a goin' fishin' too...
Who wipes yer bum-bum after you make boom-boom?
I think you've lost yer way...turn on yer GPS.
You wanna invest in Dydees and the tidy bowl man...
You haven't made one researched comment since you arrived.