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Small.
But it doesnt matter if i am in or not. What matters is 113 and what Baker Brothers et al are doing.
this isnt diected to you, Andy, but, really, who gives a crap about what McMinn says... the only person who does is the one person on this board that keeps bringing her up because she probably laughs at that same person ( as i do). Constant criticism of her work from someone who cant properly analyze the back of a food label is laughable.
Either way, the fact that she assigns $14+ to Ponatinib and only $3 to 113 means only one thing: any positive news from 113 and there is major upside.
Really ugly H&S pattern here.
Those are nice looking curves in the highMET group.
Whats a good valuation for this stock at this point? 150 million shares out there, so, its pretty badly diluted. I would have to think, because the drug is wholly owned by EXEL, there is much more upside to the stock - but not crazy upside.
Yeah, thats what I mean. If there was a small-mid cap play in this drug-type, it would have speculation written all over it.
Thanks for the input on ARQL. i value the statistical perspective, a lot...and your opinions.
Yeah. MEDX. 2009... the time of the buyout. Those were awful times in the financial markets...I cant blame the Board for selling.
Too bad there wasnt a better way to play this drug without investing in BMY (or MRK, which I believe has a PD1).
MEDX former shareholders must be thrilled. :(
That blog is just a pile of rubbish. Some very interesting finds there, on occasion, but, its mainly "gold going to $8,000, and peak oil $400 articles.". The people who love that blog must, in general, be really miserable people happy with the loss of everyone elses capital.
Isnt this article about Martin Schkreli?
Again, if I were running a large multi-national company with FCF, I would be issuing billions and billions and billions of dollars of debt right now. As much as I could. And, at the ultra-long end.
FDA Draft Guidance for Accellerated Approval in Neoadjuvant Breast Cancer
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM305501.pdf
You should ask Sally. She seems to like the company, drug, and the trial design.
Exactly. I had a really hard time understanding what was going on in this abstract. Either, they wrote it incorrectly, or something isn't right.
(because its opposite the effects that Vis is having in a similar biomarker driven study at the U of Michigan).
Yeah, pretty similar to the INFI study, albeit, at least the GDC-arm wasn't worse, like the INFI trial.
I'm more interested in the Abraxane+Gem+GDC study that is going on at Hopkins right now (sponsored by Celegene, Roche, and Stand Up to Cancer). I'm almost positive the key "ingredient" here is Abraxane (from a lot of evidence I have seen to date).
IMO, Abraxane+Gem is SOC soon. So, obviously, going forward *IF* GDC-0449 happens to add value to ABX+GEM, they'll have to do a randomized trial.
"post hoc-ish"
How is it post hoc when they prespecified these groups from the beginning.
The Germans have just as much fault in this whole mess as Greece. I do think the Germans are way too rule bound and need to stop playing the tough mom in all of this.
Incredibly, the Fed saved our asses by printing like mad in 2008 when our banks were in serious trouble....the Germans and the EU could do the same thing but they are just so preoccupied with pre-WW2 inflation thoughts.
Just disgusting to me that they have all these royal meetings, time and time again, and no one can make up their mind.
When Germany can sell debt for a rate of 0.0%, you know there is absolute zero appetite for any risk at all.
I just can't believe we're dealing with this all over again....LOL, its quite pathetic. Whats next? S&P downgrade this August?
It is all nonsense. Think about how stupid it is: the leader of Italy says, "we want greece to stay in the EU"....
Algo driven market kicks in, .SPX moves 10-15 points.
It really is no wonder why no one wants to invest in equities, and bond yields are at records lows. People would rather avoid it altogether and lose 2% to inflation.
I am truly getting sick and tired of these doom and gloom idiot analysts and journalists all day long talking about major catastrophe when Greece leaves. Fact of the matter, no one knows whats going to happen - and fear mongers just sit at home stroking it to these times. If, after all this time, the Euros and the rest of the worlds banking system hasnt figured out how to see a Greek exit without killing economies of scale, and the banking system.....THEN SHAME ON ALL OF US. Banks, and countries have had YEARS to come up with a plan, to work out of their positions..... did they?
See it all day long on Twitter - people retweeting stuff they have no idea what it even means---but as long as they think its bad for the markets, they'll retweet it.
Heck, even CRIS/RHHBY got pushed through with a small 100 pt open-label Phase 2 in mBCC, aBCC.
Certainly not unheard of, if they target a specific unmet pt population.
They need a real partner for this though; if they do it alone, I can really see them screwing this up badly - heck, they couldnt even check the right box at ASCO.
CLDX
18:00 ET 5/23/12 [StreetAccount] CLDX Celldex confirms it will pursue accelerated approval for CDX-011 - conf call ($4.26)
On the call to discuss the preliminary results from the Phase 2B EMERGE study of CDX-011, the company said that it believes accelerated approval is a possibility for the drug, and it plans to discuss the issue and data with the FDA.
Of particular note was the presence - and exuberance - of investigator Linda Vahdat, MD on the call, whom expressed great enthusiasm for the results, and hope for patients with metastatic triple negative breast (TNB) cancer. At one point, she noted that there is "nothing on the horizon, no glimmer. This is the only thing, and I think highly promising." Analysts quickly took to addressing Dr Vahdat directly on the call. Additional responses from Dr Vahdat were similary glowing, such as calling the treatment a "no brainer" and that the drug is "as good as anything out there" in terms of a response.
Diagnostic assay: The company also discussed the diagnostic assay it has developed that identifies GPNMB expression patterns and levels in breast cancer. The company said it would likely not commercialize the assay itself, but would probably partner with a diagnostic manufacturer.
In closing, the company said it is pleased to have defined a patient population, and looks forward to finalizing data from this study in Q4 2012 and to determining the next steps for CDX-011.
StreetAccount notes that the stock is trading down (~8%) to $3.92 in after-hours. A blog post (see reference link) from Forbes' Matthew Herper getting circulation is far more cautious on the results than Dr Vahdat. Herper discusses the relatively small numbers of patients enrolled in the trial (n=122 total) with triple negative breast cancer who also highly express GPNMB (n=11; 4 of 11, or 36% responded).
23-May-12 16:05
CLDX Follow-up: Celldex announces preliminary results from ph.2B EMERGE study of CDX-011 (glembatumumab vedotin) antibody drug conjugate in patients with glycoprotein NMB ($4.26)
CLDX announced preliminary results from the company’s randomized Phase 2B EMERGE study of CDX-011 (glembatumumab vedotin) antibody drug conjugate in patients with glycoprotein NMB (GPNMB) expressing, advanced, heavily pretreated breast cancer.
Preliminary results suggest that CDX-011 induces impressive response rates compared to current, available therapies in patients with advanced, refractory breast cancers with high GPNMB expression (expression in =25% of tumor cells).
In this high expressing patient population, treatment with CDX-011 resulted in a 32% overall response rate (ORR; includes confirmed and unconfirmed responses), whereas treatment with Investigator’s Choice (IC) single-agent chemotherapy resulted in a 13% ORR.
CDX-011 also demonstrated strong response rates in patients with triple negative breast cancer across all levels of GPNMB expression (CDX-011 ORR of 21%; IC ORR of 0%), where treatment options are extremely limited.
In addition, in patients with triple negative breast cancer who also highly express GPNMB, greater activity was observed (CDX-011 ORR of 36%; IC ORR of 0%).
The ORR across all levels of GPNMB expression was 19% for the CDX-011 arm and 14% for the IC arm, and a direct, positive correlation was observed between increasing levels of GPNMB expression and increased CDX-011 response rates.
Based on these data, the company believes CDX-011 has significant promise as a targeted therapy for patients with breast cancer and high expression of GPNMB, and especially for those with triple negative disease.
Well, the lead investigator for this trial on the call seemed to think these data were a big deal for this pt population. Granted, shes the lead in the trial....but, she is a big deal in breast cancer, not some schmuck halfway out of Grey's Anatomy.
Full data set not coming out until SABC in San Antonio, December.
I agree. I think it is BS that journalists have access, well in advance, of reporting to public.
You dnt think there is ever a coffee shop, wink and a nod, with a hedge fund buddie prior to public release? Gimme a break.
FWIW, the full presentation is here on CLDX for anyone who hasnt seen it
http://phx.corporate-ir.net/External.File?t=1&item=VHlwZT0yfFBhcmVudElEPTQ3NzAyNDl8Q2hpbGRJRD00NjgyMTk=
I read the article when it came out.
Herper is one notch above a Motley Fool writer and consistently misunderstands things.
I would be surprised if CLDX did an offering, here, considering where they did one only a couple of months ago.
They would look like idiots to have two financings, one right after the other, with $100 million in cash right now.
But, then again...this is small cap bio...where most CEOs are idiots.
Is the P3 metmab trial one with a diagnostic for high-low met pts?
The P3 Arq trial is non-squ NSCLC but without a diagnostic?
Either way, I think the MARQUEE study will be a success....but, generally, when a stock declines from 8.50 to 5.40 with a constant drip of 3% daily, and 18 out of 20 days "red", I am missing something, or someone leaked something.
I am beginning to wonder if ARQL sucks so incredibly badly because of this selected trial with MetMab. Isnt the Roche trial more highly selected than that of the ARQ trial? Granted, ARQ has a little head start on Roche but a targeted, more defined trial is going to have a chance of a higher degree of success, and better comp results.
http://www.roche.com/media/media_releases/med-cor-2011-05-19.htm
I honestly dont know. I have no idea if management has even said. pcrutch might know.
LOL. Based on the fact that 95% of Phase 3 trials don't get halted for efficacy at the interim.
I would have to say that there is probably less than 5% chance of this trial being halted for efficacy.
Why is this interesting?
Isn't it just a go, no-go, run of the mill interim?
Darn.
What am I going to do with all the physical-gold I have been hoarding in my closets?
Yes, thats what three straight years of huge sell in May declines, and the prior two years being some of the worst trading conditions around, will do.
That and that fact that no matter how good your ideas are, when the market is correlated 90% to the Euro, your longterm longs are still going to go down 5% daily, it seems, for the past 14 trading sessions.
In these market conditions, if a company misses a hurdle, or just so so results, its going to get punished...hard.
Just sick of it.
I am long quite a bit of this stock, and, really think their management team are clowns, so, I am not trusting. Further, the rest of my biotech holdings are just pure garbage at this point, so, to see this trial fail would just be one more feather in my cap of sh-t.
Which is why I am just asking the stupid and truly anecdotal question of whether or not lead clinicians spin data at conference calls, or are there to say, "yes, the trial failed... but...blah blah blah.". Granted, this is a little different in that this is THEIR ASCO presentation bc some imbecile screwed up a filing....so, the lead clinician would have been at ASCO either way, good or bad, I presume.
I am honestly asking anyone on this board if lead investigators participate in conference calls where the trial either sucked or imploded. I am sure there are examples, or not.
Just curious.
Or spin the data...
How many cases have there been where the lead investigator does a conference call with managment when the trial FAILS? This is a serious question.