METEOR is expressly designed for RCC-diagnosed patients that have already failed VEGFR inhibitor therapy and not yet moved on to SOC 2nd line mTOR inhibitor therapy. Your argument would have us believe these patients are "dead men walking". With this patient group, the diagnosis has already been made...the treatment path already chosen - METEOR comparing Cabo to existing 2nd line therapy (Afinitor). What part of this trial's inclusion criteria has convinced you this patient group is at death's door?
Sorry, your argument makes but little sense to me...you are dwelling on the Comet-1 patient group definition of unmet need based on limited treatment options. That's not the case here...
Not at all...
"As far as Seman goes, he may be right he may be wrong..."
Doc...ultimately, the choice is his...
Personally, I think he's a great candidate for gender reassignment.
Snip, snip...nip...nip...tuck...tuck - Seymourina!!
Continued hormonal maintenance with that Amgen VooDoo med "Nads-be-gone"...
Tame that feller right up...minus his gizmo, of course...
This MB would be a changed enterprise...might even be fun again.
"Dude, that story was about Exelis, a defense contractor not Exelixis..."
Precisely my point. Next thing you know, we'll be reading about Seymour's gender reassignment on Yahoo's EXEL summary page as well. Is there no end to the madness?
Abby, please put this where it belongs...
If you don't know, I'll gladly show you...
...or do all you big players spew your glue just like semanresu??
Shoot it everywhere and see what sticks..??
"A person WON'T carry on conversations with themselves..."
Seymour has posted the same thread on multiple occasions with multiple aliases...
Abso-positively useless waste of good air...
"...attacking each other won't help..."
Scroto and Seymour live for the stock drift doldrums, when FUD is most effective...
Let 'em be...neither one has the good sense God gave a goose.
Might be different if they had half a brain - in which case might be dangerous - but they don't...
Nary a whole brain betwixt 'em. No worries...
In other words - sweetheart deals, golden parachutes, and endless joy for all if you just keep botching up the works with clinically inept scientific drivel till Tarceva patent expiration. What else explains the lack of MMM's stock disclosures? Virtually all his holdings are in blind family trust - no one knows what he really has... How rare is that scenario? I've researched a lot of bios...this is the onliest one in that regard...
Whassup with that? Duck...you have any thoughts on this...???
"Amen to that..."
I'm just getting started...
Positive results have been reported in EGFR+ NSCLC for going on 5 years...dating back to Zheng Cao - SFO's premier mezzo soprano. Yet, EXEL has not sponsored a registration trial...nor applied for a compendium listing...despite further successful reporting and ongoing analysis. It smells a bit as though they've cut a deal to hide the asset in this indication, despite ongoing positivity. Sorry, but this smacks of neglect...
If some combination of Roche and Genentech turns out to be the dominant short influence in this stock - and a play evolves to sell out to this short influence - I foresee an endless parade of shareholder-instituted lawsuits. Those never bode well for anyone...and can only serve to further tie up the asset play that we appear to have here...
"What am I missing?"
The exorbitant fees attached to maintaining MMM's hair-do...
Just kidding... Perceptions of irretrievable debt, poor management, poorly handled science, and badly sequenced Cabo trials will continue to haunt EXEL. In the event that METEOR is a miss, I can't even begin to fathom an argument to keep MMM as CEO...or Gisela as CSO. At that juncture, I think the entire BOD should be suspect of the intentional undoing of Exelixis, and be held in criminal contempt for malfeasance, disregard of fiduciary responsibility, and utter stupidity. I think most would agree - enough is enough.
"None of these developments are negative."
As Bif has pointed out, the developments in PD-L1i are also far from negative, and it's an easy assumption that market share will be compromised. Though - in fact - PD--L1 does not work for every patient, and is also susceptible to induced resistance - leaving room in the space for treatments that DO work in the wake of prior therapy. I feel confident that Cabo will find space in RCC, although actually defining that space in a changing treatment landscape may prove troublesome in the short term. METEOR success in itself may not be a guarantee of commercial success as the treatment algorithm evolves. I think it is this uncertainty has fueled the short thesis. JMO
"Is Choueiri's P3 different from EXEL's P3?"
One and the same... If there can be said to exist a leading authority on Cabo in mRCC, that would be Doc Choueiri. He is the Kidney Cancer Center chief at Dana-Farber Cancer Center - an affiliate of Massachusetts General a Hospital. His expertise is likely the largest trial design input in METEOR.
"...theoretically there are no leaks...?
Ya really gotta have a sense of humor to persist on a YMB. The insanity that this MB has become serves to make every new participant appear as short "bait"... And each new player is continually being accused of alter egos, aliases, and a seemingly endless range of agendas. My advice to you - enabler - is unchanged. Be skeptical of everyone you encounter on a YMB, particularly if they robustly and endlessly encourage you to deny your own DD. Most of these idiots are simply that - morons. Period. Others are sometimes pretty good at misleading and dispensing FUD - and likely have some sort of a paid agenda - even if it's simply "nickel per post" nonsense.
Here's from the company PR. Separate criteria for both primary and secondary endpoints. No mention of an interim: Scroto - get it right or go home. Do you do all your DD on YMBs?
"The primary endpoint is progression-free survival (PFS) and the secondary endpoint is overall survival (OS). Exploratory endpoints include patient-reported outcomes, biomarkers, safety, and pharmacokinetics. PFS is an established acceptable endpoint for RCC clinical trials and has been used to support approval of sorafenib, sunitinib, everolimus, axitinib, and pazopanib in this indication.
Based on available clinical trial data, the primary endpoint assumes a median PFS of 5 months for the everolimus arm and 7.5 months for cabozantinib arm. This provides for a hazard ratio (HR) of 0.67 and 90% power and requires 259 PFS events among the first 375 patients randomized. The secondary endpoint assumes a median OS of 15 months for the everolimus arm and 20 months for the cabozantinib arm. This provides for a HR of 0.75 and 80% power and requires 413 events."
To the best of my knowledge, there are only 3 mRCC Cabo trials. The successful P1b reported by Choueiri et al was a by-product of the DTC PK endpoint trial conducted by Cabanillas...the NCI-sponsored Alliance trial comparing sunitinib to Cabo in a frontline setting...and the P3 METEOR trial. Though there were 9 diseases studied in the large scale P2 RDT, RCC was not amongst those. I admit - it begs the question - does a 25 patient trial lend credibility to the design of a large scale registration trial? Fact is...we'll know soon enough...
"Will the insurance system support (or be able to support) a patient taking two $100K a year drugs simultaneously?"
I often wonder how this scenario can play out - especially if you add yet another to the mix...for a triplet. Good example might be the proposed combo of Zelboraf, Cobi, and XL-888. The limitations of research creativity may prove boundless, but payors will eventually need to draw a line in the sand or ????
It's been awhile since a new optimistic viewpoint has opted in here, boonie. Welcome aboard... I share your confidence in Cabo wrt a PFS endpoint, and have followed the published opinion of Dana-Farber's Doc Choueiri in working with Cabo in mRCC for quite some time. GL
...that Seymour is a relictual sub-intellect, doomed to extinction...citing lack of cerebral mass.
No kidding. I saw it on TV...
I stand corrected. This was completely unexpected (at least to me) - and really great news. Good intuitive call... I really didn't expect to see expert corroboration this quickly. In my experience, this is truly unique, and bears tribute to the potential of NSS. GLTA