"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.
Just in case y'all were wonderin'...
Genentech R & D also makes a little extra on the side...
...turning back odometers in the parking lot...
"Genentech And OSI To Pay $67 Million To Resolve Charges" published 6/19/16.
Small wonder some folks hate drug companies...
Going around saying my datas better'n your data...
Makes about as much sense as saying my Johnson's bigger'n your Johnson...
Meanwhile, all the girls are gigglin' in the background...
Anybody got a tape measure?
Hbomb, yours is a good example of how outlandish these arb claims can get. Soon after the article you mention, this story published:
"Bayer to Onyx: You Don't Even Know the Name of the Drug We Didn't Steal From You"
This storyline forces me to consider the negotiability of a me-too asset like EXEL's other MET/VEGFR2/RET/Axl/Tie2/ROS1 inhibitor...
"Hey wilder, what's ur take..."
I think the EMA/ CHMP agenda for the week will be published before market open tomorrow...
I'm reasonably confident Cabo final opinion will be amongst the items up for consideration. I expect to see a positive opinion passed to the EC this week - next Monday at latest. The window for accelerated assessment is upon us... I expect heavy pre-market volume as well. We're due...
Not to nitpick, but I think the Ipsen to EXEL MP is $60M upon european approval...
What's a mere $10M amongst pals?
"Obvious that this board has watching eyes."
All the more reason to toss out an occasional "off-the-wall" thread...
Catch the cubicle monkeys off-guard, maybe they'll slip up...
...and let something valuable keep till it's totally absorbed by the MB minions.
"According to Jean Baker... “[t]he case numbers are small ... the size of the claims tend to be very large” - we can hope...eh?
Interesting that the first case covered in the article is Genentech vs Sanofi. Looking beyond that article, Genentech appears to be a veteran of multiple arbs...it'll be instructive to see how EXEL fares, given their relative inexperience swimming with the sharks.
"It seems to dispute every facet of the agreement including the pricing of Cotellic, the amount of the expense side that Genentech is attributing to Cotellic and the revenue split."
Ernie, as you mentioned in an earlier post - both parties have already agreed to be bound to arbitration. A lengthy disagreement would seem contrary to the nature of such a binding agreement. My sense of this is that EXEL has the most to gain, as they have been dealt such an obviously short stick in cobi's first approved indication. As combination therapies become more commonplace, will we see an increase in these arbitrations throughout biotech as revenue-split imbalances get resolved? Seems a likely catalyst for increased M&A activity across the sector, as value-perceived assets are sure to be disputed - as in the case of Cobi...Any experience with this?
Selecta - (SELB) - next week...more Langer IP...
Any of you ASCI freaks into nanoparticle gene therapy?
Early stage stuff...lots of promise...keep it on your radar...
I've placed a request into IR for clarity. A review of the 2006 collaboration agreement is nearly valueless, as dates, terms, percentages, and profit/loss considerations were all withheld to support confidentiality, making it difficult to determine exactly that which is subject to dispute. Obviously, it's about money...
Any thoughts on a possible outcome? Is this an issue that might warrant a PR when resolved?
Or will we perhaps hear of it again at the next ER?
"...what does this mean?"
With so many treatment options available, oncologists can look to this type of KOL review to determine peer usage and prescription. This type of info is really only valuable till it's pre-emptied - which may be quite soon... That said, oncodocs like to see what their peers are prescribing...how they are sequencing treatments...and the responses they are seeing. Real-world data - without the inclusion/ exclusion and design- limiting criteria of the clinical trial reporting process. Keep in mind, for Cabo to become commercially successful, it must necessarily enjoin clinical adoption under "real-world" circumstances of individual patient need, circumstance, and interpretation of disease biology. This is the type of data that will assist Oncodocs in determining "best" applicability of newer therapies, like Nivo & Cabo.