"It must be another lunatic"
Funny how you become so accustomed to lunacy that you don't really notice the addition of yet one more.
Leastways I didn't notice.The MB's become an asylum these days, eh? Regular loony bin with a TA "expert" on board as the head loony. Notice how much off-color sounds like Nomad these days?
At this juncture, I think it's fortunate that COBRIM has fully recruited, and the trial has so far progressed. In the wake of Nivolumab breakthrough designation, I expect future trial enrollments to slow significantly in mela - same with RCC. Reaching a saturation point of treatment options is an unnerving prospect, but in some indications I think it's inevitable...at least until the algorithm assimilates newer treatments, and appropriate sequencing is brought to bear on subsequent unmet need.
Posted 6/27/14 at EPvantagedotcom...
"The results of a phase Ib trial called Brim7 were presented at the European association of dermato-oncology congress in May. In the trial cobimetinib was again given in combination with Zelboraf. Of the 129 patients, 66 had previously progressed while receiving Zelboraf and 63 were BRAF-inhibitor naïve.
In the naïve group there was an 87% overall response rate (ORR) with a median PFS of 13.7 months, with 83% one-year survival. In the Zelboraf progressor group the ORR was 15%, with a median PFS of 2.8 months and 32% one-year survival.
The most common adverse events were rash, diarrhoea, fatigue, photosensitivity, liver abnormalities and nausea, and permanent discontinuation owing to adverse events was infrequent. Based on the results of this early trial Leerink Swann analysts assign the latest study a 90% probability of success."
No FUD, just fact...
Post it. Someone might wanna send that splooshbag a Christmas card, a dead fish, or a decapitated horse head or something perhaps even more meaningful...
Like a lifetime pass to the Jerry Springer Show...
In earlier posts, you (and Ernie, I think) had discussed cabazitaxel approval based upon an HR =0.7, and in looking at the Sanofi website, I see this is also expressed as a range of 0.59 - 0.83. I take this to mean that some of the P3 treatment group outliers were likely not statsig, yet the median was acceptably significant. Looks like a close call can actually work favorably, and given hrQOL consideration potentials wrt cabozantinib (specifically, pain relief) I just wonder if - ultimately - final approval considerations for Cabo in mCRPC may require additional ADCOM guidance with Comet-2 trial results in hand. I can't think of a precedent for such an approval scenario, can you?
"FWIW median OS on Cabo arm was 26 months and Placebo at 20 months at 162 events of the total 217 needed for final analysis."
If this ratio holds to the required event, will the trial have displayed statsig OS?
A 6 month comparative mOS survival advantage seems adequate to me...
Am I looking at this correctly?
I can't answer your question specifically, but my understanding of alpha spending requires some prior specification of the numbers and times of intended interim analyses. Do the Lan & DeMets rules somehow apply also to unplanned, unscheduled IA's? As I see it, the interim you refer to was an unplanned unblinding of events by the FDA at a previously unintended event cycle. Is there another set of rules that applies?
I went looking for updated information on MTC, and found this reference to OS on the patient education site of the American Association of Endocrine Surgeons website:
"Overall, people who have MTC only in the thyroid gland have a 10-year survival rate of greater than 95%. If the cancer has spread to the lymph nodes in the neck, the survival rate decreases to 75%. For those whose cancer has spread outside of the neck to other parts of the body including the liver, lungs, and bones (i.e. metastatic disease), the 10-year survival rate is 20-40%."
Though I realize EXAM has enlisted an advanced patient group, the fact remains that MTC is a slow killer and I suspect many afflicted patients that receive advanced therapy beyond surgery and RT actually manage to outlive the disease. Patience is a requirement here...
"Why would anyone attempt to delay the inevitable & eventual cure...??
Greed. Regardless of what they may say to the contrary, the shorts on this MB are cubicle monkeys insidiously representing short hedges that are likely also stockholders and convertible holders. The longer they get to control this stock, the more money they make playing it for whatever percentages they elect to range-trade. To them, the actual SP isn't even a consideration....and there really aren't many of them. I figure there are perhaps three that post regularly under a number of pseudonyms.
I've mentioned it before, but this is a good spot to reiterate. I figure Roche is likely a large short, as well. If they decide they've just got to add Cobi to their pipeline, it makes sense that they've played toward a minor controlling interest that plays right into a success story in melanoma, particularly at the valuation we are seeing today. There are folks on this MB that have shared stories of the Medarex buyout. I personally witnessed the manipulations prior to the buyouts of both Human Genome Sciences and Inhibitex - in both cases the fudsters were every bit as thick as here.
FUD - fear, uncertainty, and doubt. That's the game we are seeing here. They want your cheap shares, and this next few months will be endurance run w/ an endless parade of FUD.
Enjoy your weekend...
Even EXEL has turned over 300.000 shares in the AH...
Pay no attention to that man behind the curtain.
He desperately wants to latch onto your shares as we enter 2nd half 2014. Catalysts abound.
I see no change in the spirit of the literature, clinical adoption is growing, and trial results are nearly upon us...
The only real change is in the desperation of the short element. I think they'd like to cover. I think they are screaming out loud to cover. But, I also think the MM is going to play this game to the very gnat's bottom, and with a downturn in the macro-market, they may be given the opportunity to cover somewhere in the high twos$$...I'm keeping some dry powder on hand. New, smarmy MB ID's are showing up daily, and the bothersome boys in the Bozo suits are increasingly rude. Downright pesky little twits, ain't they? Screw 'em...
Have a great weekend...!!!
Frontline Medical News June 20, 2014 P Wendling. Available free at Practiceupdatedotcom...
Some interesting insights into palliative care and improved cancer survival based on timely pain management interventions and symptomatic hrQOL considerations. Generic, but viable...based on a recent study published in the NEJM. The post-randomization statistics in NSCLC are compelling, as well as statically significant.
It's apparent that the mission to capture relief from AR escape is a large one. I went looking...
In addition to the two XL-184 combo trials, Abiraterone is being investigated in combination trials with at least 25 other agents - chemo therapeutics, radio therapies -including RA-223, testosterone resensitizers, LHRH agonists, Provenge, and a trove of targeted agents...including a handful of TKI's. Lots of rationale to explore...
Cabo is one of the few to date to make the transition from post-chemo to pre-chemo investigation...
Nemes A, et al published Apr-June issue of J BUON. PMID 24965392
Discussions of AR escape and rationale for drug combinations with AR axis therapy.
I can't access the Balkan Journal, but the abstract is available at PMC. Implicating pathways of disease escape and progression in AR therapy is an immediate need, as AR manipulation has limited DOR with treatment-induced resistance presenting as early as 3-4 months. Cabo gets a mention in the abstract...
Ernie logged a comment a few days back in response to oncodoc.
Sounded like he was still in and waiting for OS data like the rest of us.
"...very uninspiring information that was so abstract and so irrelevant...that not one analyst commented on the presentation..."
So uninspiring, so abstract, and so irrelevant that Hofmann La Roche (ever heard of them, knucklehead?) decided to skip a phase 2 efficacy study and move the combination of Zelboraf and cobimetinib straight into pivotal analysis in a large population Phase 3 registration trial.
Or are you gonna argue that one of the largest, most successful commercial pharmas on the planet knows less than you, too..?? Another great argument, genius...
Give it up, drizzlebritches...
Actually I found the feller to be much like you.
Another halfwit talking junk about about that which he has no clue. Blah, blah, blah...zero shareholder equity...
Blah, blah, blah...not economically viable...
Jack and Zack, handing out crack candles at a buttbuddy party.
You and the dairy king..buttbuddies forever.
Blah, blah, blah...IP drug compounds without value...
Stand wide and spread'um, drizzle britches...
This big black candle's for you...
"...it was at the end of the discussion..."
The AUA clearly picked the wrong technician to give this presentation. Despite the integrity of the information he was presenting, he mispronounced and fumbled over cabozantinib...and several times referred to it as a monoclonal antibody. He did OK with the bone scan data, but in ending his talk mangled any understanding of the "inhibiting seed, disrupting soil" analysis. His mention of cancer cells remaining to be found at biopsy isn't surprising, as he has continued on to suggest that the activity of Cabo prevents bone response to these remaining tumor cells.
I think I could have drawn a clearer picture of Cabo activity in the side column of a phone book with a lump of coal. Unfortunately, we don't always get to pick and choose our representatives, do we?
"If it doesn't register on wall street it ain't worth squat!"
It's scuzzy buttsuckers like you that have made that system.
You should be ashamed for the lies you perpetuate. If there was any law in this country, you'd be cut down for the useless sht you are...
"This information you reference is so profound, so important, so overwhelming..."
Blind, crippled, and abjectly stupid is what you are...The significance of this post lies in that the AUA is instructing urologists in cabozantinib application in the advanced prostate space. IE - they anticipate approval - and they'll get approval. You are impossibly stupid if you don't see the writing on the wall...or your boss' agenda won't let you face any reality except to endlessly bash the facts. Who is it you work for? Get a freakin life..Get a real job. Stand wide and spread'um for another candle... Stop posing. Quit pretending.
Get a clue, dummy.