Re: Beckers: 3 out of the first 5 patients have converted - others have displayed improvement. This same patient group, if left untreated,, only 16% convert in the first six months. Where's all this shoddy performance?
You on the right MB? Wouldn't you be best off trading REITs?
Seems like you noodleheads got nothing better to do - why not help out?
Take one for the team. You could start by practicing back flips into the shallow end of your swimming pool. Maybe practice your high dive into a bucket of water...maybe see who can do the best "dead German soldier" off the top step of an 8ft ladder. Encourage the wife, kids, & neighbors to participate.
It don't hurt so bad if yer makin' money off the results, does it?
Wishin' harm on others...y'all need a change o' scenery...
Dr Johanna Bendell reporting 6/29/16:
"In this phase 1b study, 23 previously-treated patients with metastatic colorectal cancer were treated with escalating doses of MEK inhibitor cobimetinib (20mg, 40mg, and 60mg daily, 21 days on, 7 days off), with an expansion of patients at the highest dose level, and a 800mg dose of intravenous PD-L1 inhibitor atezolizumab every two weeks.
Following treatment, researchers saw a decrease of at least 30% in tumor size in four patients (17%) and stable disease in five patients (22%). The duration of responses ranged from 4 months to over 15 months, and were still ongoing in two of four patients who were partial responders at the time of the data cut.
Three of the partial responders had microsatellite-stable or microsatellite instability-low disease and one had unknown microsatellite status. None of the patients in the study had known microsatellite high disease.
The baseline PD-L1 status did not appear to affect responses, and the combination was well tolerated with no serious treatment-related adverse events reported."
Still looking for a Celestial update - this would be an optimum early venue...
"...the number of times your camp has thrown around this sentence makes me LOL..."
Just basic IH accumulation strategy, nothing more... Nothin' says lovin' like risin' IH...
Basic, yer camped out in the flood plane. Got insurance?
"Wildly optimistic or gross negligence?"
...or perhaps a strategic withholding of information while institutional holders optimize their positions...???
Such back room deals are cut all the time. IH is upwardly mobile. You decide...
Don't let these cubicle monkeys sway yer opinion; don't give them your shares cheap...
These nitwits are the self-appointed consortium of doom - useless tools of "la combinazione"...
They want your cheap shares, and will say anything to that end...
"...why haven't we seen any new recommendations from the likes of ML,GS,JPM,MS,etc..."
Enabler, have you considered that all these "big players" are doing everything in their power to keep EXEL "under the radar" till they are "ready" ?? I'm betting these big boys are all in cahoots as to the timing of this upswing, and once everyone is optimally positioned - she'll run like a banshee. Not one moment sooner...
I actually thought I was me when I got here, but I suppose a YMB sophisticate like yerself will insist on exclusivity in correctness in everything you post. Someone get the hopeless dope some rope...
I think he wants to take the long step off the short interest...
"...patient 7 only has 1 month follow up"
Ya'll are acting like a bunch 'o namby-pamby schoolgirls caught smokin' yer first joint in the girl's room. Look at the investigative criteria attached to the INSPIRE pivotal study. None of the primary and none of the secondary outcome criteria is based upon anything other than a 6 month review of patient progress.
No wonder Ima dope-without-hope has ya'll a'quiverin' in doubt. Yer simply not pay in' attention...
The INSPIRE trial has a wonderfully optimistic chance of success, given it's early recruitment status, acceptable data to date, and clear indication of probable benefit. If this trial were mine to recruit, I wouldn't concern myself with any urgency of recruitment. I'd be high-grading patients for assured near-term success. JMO, but I think the actual strategy here is to complete the ASI trial with FDA blessing and move on to the Neural Trails analysis with a partner capable of cost-sharing. Be patient...
The most current CT orders I can find are pertinent to 10Q omissions dated to the 2006/2007 time frames, so my guess would be that they are not Japanese JV-oriented. Regarding Cabo being approved in Japan - I doubt that too, as no pivotal studies have been conducted and the existing data has only established baseline dosing. In an earlier post, I think Ernie commented that a Japanese partnering at this juncture would come with the liability of conducting a large pivotal trial in a Japanese-defined patient group. I tend to agree...
Investors always see the fastest track to approval as the best - but in the case of Cabometyx approval in Europe, I think a decision has clearly been made...a positive CHMP opinion has been put in place...and the wheels of the MAA approval process are in full swing...after having been delayed a bit, as OS data was not yet available at the time of initial MAA application. In view of the weekend OS update to EAU guidance in RCC, I'll be very surprised if we don't get a final EMA update in the coming weeks, and possibly an EC decision shortly thereafter. It should happen quickly now. The CHMP (and most of Europe) is on holiday during August, and no monthly meeting is planned. JMO, but I expect July's the month to get 'er done...
It seems increasingly probable that a CHMP opinion has been delayed - and possibly withheld at the sponsor's request - to ensure that an overall survival benefit be included in the MAA labeling. Glad to see this update. Thx for posting...
"Beta 1-integrin–c-Met cooperation reveals an inside-in survival signalling on autophagy-related endomembranes" Rachel Barrow-McGee, et al... Open access Nature Communications 6/23/16
Given what is currently known of Cabo activity to date, these findings could set the stage for future combination workups.
I dunno what all the fuss is about...
I really like slow-smoked brexit with lots of those little-bitty honey-glazed baby red potatoes...
Salad inclusive, it's one of my favorite feeds.
At least for purposes of correspondence, the EMA central office is located in London. As Brexit shakes out (I haven't yet found a timeline), I wonder what impact we'll see in processing drug approvals, GMP, etc. it seems potentially very disruptive, particularly with Cabo approval waiting in the wings, so to speak. I'm glad the approval process has gotten so far along - chances seem good that the RCC approval may be minimally impacted. I am assuming, of course, that an exit from the EU also means an exit from the EC and the EMA...
"...so far there is no evidence of efficacy."
How is it you suppose that the FDA signed off on the program to date - enabling human trial without evidence of safety, efficacy, or hypothetical benefit? Are you suggesting that Perrin has bribed the FDA into permitting human experimentation?
Are you an insane misanthrope? I gotta ask....
Are you the MB short here - say anything to anybody at any time to discourage investment? I gotta warn...yer quickly headed for the ignore button unless you've got something of value to contribute. Unsubstantiated horse-puckey won't cut it...
You've gotta be somebody's cubicle monkey to spout endless reams of nonsense..
Do you at least have a view of the water cooler?
"The fact that none of the relevant preclinical work from NVIV has ever been subject to peer review or released in any journal..."
Given the current circumstance of a pivotal human trial in progress, this argument doesn't carry weight. Looking forward, the FDA has enabled the potential for an HDE and subsequent approval based upon existing pertinent human data return. Primate trials are in the past, and of little purpose nor consequence to current events. It's important to focus on the prize, not to dwell on the past...
"...gossip = $19/share. peer-reviewed publication = $5.9/share..."
LOL. I can't argue the obvious disparity. There's no justice in the stock market.
However, I will add...
If you are looking to establish the.biologic significance of a potentially landmark surgical procedure, you won't find that reinforcement on gofundme, Facebook, or any gossip site. You are simply looking for love in all the wrong places... Peer-reviewed publication is a much more reliable starting point. I belong to the school that believes the NSS story is just beginning.
I think a lot here are missing the entire point of peer-reviewed publication vs presentation at an appropriate industry venue. Updates to procedural concept, proprietary data, and financial disclosures that might constitute potential conflict of interest have all been reviewed by an editorial staff far more accomplished than most MB participants, and that data previously presented passed muster. This is never-before published data that had been previously presented in peer venue, has since been been reviewed by the governing infrastructure, and determined worthy of dissemination to the neurosurgical community.
Never underestimate the importance of peer review. It is a vital step, regardless of whatever it is you think has been established by trial, by presentation, or by gossip on a gofundme website.
In academia, it is the renowned measure of statistical acceptance. All else is gossip...
"Don't become a cancer statistic."
Great points, Ernie.
Many are discomfited by these somewhat invasive procedures. Not me. I take every opportunity I can get to explore a little levity now and then. Colonoscopies and DREs are my faves, and I find myself pushed to my creative best in these scenarios. Here's a few lines I've used in the past to defuse the uncomfortableness of these necessary medical procedures:
"If I catch you smiling, I'm gonna kick yer $@#%..."
"Most of my dates at least offer to buy me a drink first..."
"I normally enjoy these types of parties..."
Invariably, someone asks "Why is that..??" (Docs and PAs make great straight men...)
"Same reasons everyone likes 'em. Liquor in the front, poker in the rear..."
"Now that we got that done, tell me: is it true familiarity breeds contempt?"
"Have your secretary call my secretary. Now that we've gotten acquainted, you owe me lunch."
"Don't be shy just because you think I'm pretty..."
Be creative...a little humor goes a long way.
"Didn't Wilder point out a couple weeks ago...??? "
During May of 2016, cabozantinib was listed on the PRAC agenda for adoption of its RMP, and on the CHMP agenda for discussion of the 120 LoOQ. I can't explain why it is not current to the agenda, though it remains on the current listing of drugs scheduled for pending EC decision.
JMO - I suspect an opinion has already been issued, and an application for transfer of marketing authorization to Ipsen is being processed concurrent to an EC announcement. According to the EMA website, the transfer must be applied for...can take up to 45 days to process, and is sensitive to the indication being considered. I can see this issue getting bogged in beaurocratic process while it's sorted out.