"Second is that the compound is ineffectual..."
In the face of a trove of existing, peer-reviewed data...this is an abject lie.
Quick...somebody call the ToS police...
PFS was statsig in the Cabo group compared to the Prednisone group. MMM discussed this in the conference call, and again at the MSGHP. PFS was an investigator-initiated endpoint not considered to be predictive of OS in CRPC.
In OS, Cabo performed pretty much as anticipated. The prednisone arm performed better than predicted.
" I am probably quite a bit older than..."
Right You be sure to let us know when your IQ catches up to your age...
Somebody hand Ol' Quasimoto here a bedsheet so he can wipe himself...
Duckduffer, I've been looking for an opportunity to pass along an interesting piece of DD, and this is it:
Check out "The Changing Landscape in the Treatment of mCRPC" published in the journal Therapeutic Advances in Medical Oncology 2013 by El-Amm & Aragon-Ching. This treatise hypothesizes rationale for treatment sequencing relative to clinically recognizable stages of symptomatic/asymptomatic and aggressive vs dormant disease. Progressive hallmark staging and re-staging considerations may be futuristically best defined by improved understanding of the natural history of the disease, and sequenced interventions may be said to "plug & play" to best accommodate each shifting tide. The profiling the authors have leant to symptomatic disease with bony involvement does everything but stand up and shout "Cabo"... Solid read...
Watch out, the Yahoo ToS police are watching you...
Cyber-castration is not beyond their capability.
Mountain oysters, anyone...??
Thanks for putting this info on the board, Clem...
Datasphere type systems will become commonplace for cancer prognosis , and the IBM Watson holds a promising position in the coming techno-wave. The overall imperative of computer-driven prognostics will become most pronounced as the biomarker-guided treatment sciences mature to viability. Oncologists are already driven to the edge of performance by the glut of new data, and software-managed supplements to CME structure will prove an invaluable research tool. In addition, subscription fees may prove modest enough to enable patients, patient advocates - and perhaps even investors some form of reasonable, affordable access.
"Their best and only shot to do anything is a dud"
Better hang on tight, I think yer about to get one of those "instantaneous" visits from the Yahoo ToS police.
Keep spreading that horse manure, cowboy...
"If I were to spread lies, I would instantly get a warning from Yahoo that my account would be suspended for violation of the ToS. If I did it again, that would be it." You mean it never would occur to you to use another alias...???
Way to schmooze, Barely Manilow...
When you headed in for that gender reassignment?
In addition, I also take MMM's refusal to make any comment on Comet-2 recruitment numbers as a positive. If a decision had been made early on to recruit Comet-2 till Comet-1 read out - regardless of the actual patient numbers - it could only enhance the trial dynamics. Should this prove to be the case, there will be an additional OS (secondary endpoint) read out downstream that may prove viable. Exploring the regulatory pathway going forward in CRPC will not be an easy task without statsig OS data, but it's certainly not inconceivable.
The Comet-2 trial updated to "active, not recruiting" status on 9/4/14 with 82 trial centers participating. Although it's not likely that all centers have recruited to maximum, simple math indicates that only 3 patients per center would achieve planned enrollment of 246. The situation may not be quite so dire...JMO, but I suspect they've managed to recruit over 200 patients, and the statistical review can be mathematically compensated to accommodate new numbers. This is really no big deal, providing those numbers are still acceptable to the FDA regulatory review process. With the approval of so many new and effective therapeutics in recent years, CRPC will prove a difficult indication to recruit for many next generation drugs, and Cabo will not be the only victim of this "failure to enroll" phenomenon. At the very least, we can presume that data lock will take place no later than 12 weeks beyond 9/4/14, so it's reasonable to assume top line results by the first of the year as company guidance has suggested.
4) Short hedge fund cubicle lackey
5) ". ". ". ". ". : Employed by Roche to provide pre-take out control of market cap
6) Barry Manilow impersonator working to keep himself in sequins and fishnet attire
"Everyone is waiting to hear your opinion."
We'll wait no longer, here it is...
You are a knee-jerk nitwit. When the dust clears you'll be proven for the fool you are. Cabo will find placement in CRPC based upon a modest survival benefit, pain relief, improved patient function, and various improvements in biomarker analysis, bone metastasis free survival, and overall improvement in hrQOL in a population of late-stage mCRPC patients that are beyond the response capability of all other existing therapeutics. It's called unmet need. Grow a set, dummy...
Is that opinionated enough for you?
"...blah, blah, blah Chapter 11 filing...."
Thanks once again for your insightful contributions based upon nothing other than conjecture and innuendo. Worthless drivel, just like your life...
Print this page out and wipe yer pooper, you useless tool...
Pretty astute observation, truffles.
If the final data sort-out permits, I expect we could see a future Comet-1 presentation with some interpretive release pertinent to the potential for confounded OS data as a result of the dropout rate, subsequent interventions, and stack-on therapeutics, etc. EMUC at Lisbon is a Nov possibility...
I was actually thinking more along the lines of:
"Offsitehelp mans up, puts on his big boy pants, and grows a set of cajones"
Now there's a meaningful headline...
"...got any answers?"
Nope. Just like 98% of the other posters on this MB, I've got little else to offer you at this moment other than opinion, innuendo, and total disenchantment, distaste, and displeasure directed toward everything and everyone. The only discernible difference between my posts and theirs is that I try to bring a little verifiable DD and current information to the MB along with my rose-colored views.
Poor sots were probably too embarrassed to let on with a PR...
But I suspect they're gonna be there... Don't ask how I know.
Y'all can buy me a beer when you get the chance...
Thanks for the update, biopro...
JMO, but I suspect the main embodiment of comparison will be PFS, AE's, and possibly biomarker updates.
OS data is not yet likely mature for CoBRIM, though a preview might be in the works - after all, it is an oral presentation and I would expect potential changes right up until shared words. Good luck...
Beyond halting Comet-2 recruiting, here's MMM's commentary wrt Cabo future in CRPC. I took this to mean that there may yet be a path forward within the existing regulatory structure.
"We continue to expect topline results before the end of this year. Based on the outcome of COMET-2, we will discuss with the regulatory authorities the potential regulatory path if any for cabozantinib with metastatic CRPC."
The 2012 Laurie Burke FDA document may prove to be that regulatory pathway. JMO, but I suspect there may already exist enough data to constitute a successful application for NCCN compendium listing. Successful Comet-2 data would supplement the expansion cohort data from the P-2 RDT, the downside to this prospect being that without FDA approval there would be no commercial marketing opportunity within existing legislation. This would be unfortunate, but successful Comet-2 pain relief and patient function data may ensure the requisite minimum category 2b compendium listing, enabling payors a justification for insurance coverage. I think this story is far from over.