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I'm really surprised there hasn't been a financing after all the analyst meetings etc., which makes me think something is happening (business development-wise...although, like I said, I'm not 'feeling' an Asian partnership any time soon).
Maybe Berger just thinks they don't need the money right now.
the company and all the research reports I have read recently.
I keep hearing they will be filing an IND in Japan in 2012. And then what? Do another 2 years of trials in Japan to get the drug approved over there?
I'm just not "feeling" an Asian 534 partnership any time soon.
Brutal.
Haven't seen a "take-UNDER" in a while.
No, it's not normal.
I think the Value Investments Newsletter (or whatever you want to call it) that put out that report I referenced last night has a lot of followers.
Basically, the fact of the matter is this: anyone predicting to know the outcome of a blinded trial based on statistical "analysis" such as this, or saying the timeline is longer than anticipated so it must be working, etc., etc., is pure B.S.
This goes back to the entire discussion that this board had on EXEL last week.
This whole report on ONTY makes me more cautious, if anything. It reminds me of the crap I have seen on boards like NVLT, PARD, GNVC, KERX, et al.
But hey, ONTY's got a small float. If this crap makes it shine to $15-20, the guy who wrote it is a genius insofar as my portfolio is concerned.
Further, having said that, it doesn't take away from the fact that Stimuvax may be a raging success....it's just this report sounds more like a Garza report than anything else. Actually, it's better than a Garza pump.
lmao
I dont know dick about statistical analysis. i put that on BV so someone else smarter than me can sort it all out, lol.
i'm sure there was some kind of statistical rationale similar to this from some shareholder of GNVC and TNFerade.....either way, it cant be any worse than the investment bankers research.
thanks, PGS...always a good read from you.
ONTY STIMUVAX
http://university.asco.org/dgtfiles/ClinTrials/Symposium/3GlobalGaumond.pdf
you can read the whole thread here...
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_O/threadview?m=ts&bn=72373&tid=66811&mid=66811&tof=12&frt=2
from a yahoo poster...
I am a member of Value Investors Club. This extremely bullish article was posted a few hours ago. Whoever wrote this did an incredible amount of research and provides it all. Great work to whoever you are. This baby is going to be a homerun.
Description:
Statistical analysis of the inadvertently released enrollment curve for Oncothyreon's ("ONTY") lung cancer vaccine, Stimuvax, shows there is a
50%+ probability Stimuvax is working. At $8.84/sh, ONTY's EV is $350mm, but if Stimuvax works, the company is worth ~$1.8b, resulting
in a stock price of ~$39/sh, ~340% above today's close.
Stimuvax is currently in the Phase 3 Stimulating Targeted Antigenic Responses to NSCLC ("START") trial that we estimate shows a patient
survival benefit of 18 months. For Stage III, unresectable, nonsmall
cell lung cancer ("NSCLC") patients, the two major advances of the past
decade, concurrent chemoradiation
and Tarceva as maintenance therapy, have shown patient survival benefits of 2 months and 5 months,
respectively (note: the 5 month advantage of Tarceva has not been shown in a Phase 3 statistically significant trial). An 18 month survival
benefit would make Stimuvax the standard of care resulting in a few billion in annual sales.
The enrollment curve for the START trial was inadvertently disclosed by scientists working for EMD Serono, a division of Merck KGaA
("Merck"), at an American Society of Clinical Oncology ("ASCO") conference workshop. If you're not a healthcare investor, an enrollment curve
tells you when patients were admitted to a trial. Additional publically available data about the trial, such as the number of deaths that
occurred at the first interim look allows you to make a fairly accurate estimate of the median survival for the entire study. Knowing how long
patients with Stage III, unresectable, NSCLC generally live (i.e., the placebo group) allows you to estimate the median survival for patients
receiving Stimuvax.
Our work and the analysis of a biostatistics professor we employed indicate it is likely that Stimuvax will be shown to work at the second
interim look, which will occur in the next 6 months. As it is uncommon for efficacy to be shown at an interim look, there is an asymmetric
riskreward
as the typical biotech downside (i.e., the compound doesn't work) is statistically unlikely, but if the trial is stopped because
Stimuvax works, ONTY will skyrocket.
While I've spoken with oncologists who believe the scientific rationale behind Stimuvax is sound, our investment is reached not by studying
the drug, but through analysis of the enrollment curve for the START trial. This isn't about understanding the science behind a new biologic
vaccine it's
a math problem.
Rating :
(9 Ratings)
Rate it:
EXEL
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
(b) On July 18, 2011 Frances K. Heller, Executive Vice President, Business Development of Exelixis, Inc. (the “Company”), and the Company mutually agreed that Ms. Heller’s last day of employment with the Company would be July 18, 2011 (the “Separation Date”).
(e) On July 18, 2011, the Company and Ms. Heller entered into a Separation Agreement and Release (the “Separation Agreement”) pursuant to which, in exchange for Ms. Heller’s full general release of claims, the Company agreed (i) to make a cash severance payment to Ms. Heller in the amount of 6 months of Ms. Heller’s base salary, less required withholdings, (ii) to make a $146,000 cash payment, less required withholdings, to Ms. Heller as a transition payment, (iii) to pay the COBRA premiums necessary to continue Ms. Heller’s current health insurance coverage until the earlier of 12 months after the Separation Date or such time as Ms. Heller becomes eligible for similar health insurance through another employer and (iv) that Ms. Heller will be entitled to exercise vested stock options previously granted to Ms. Heller under the Company’s equity incentive plans until the earlier of January 31, 2012 and the original expiration date of each option, subject to extension to reflect certain trading restrictions that may be placed by the Company on Ms. Heller’s ability to sell the Company’s common stock. The Separation Agreement will become effective on the eighth day following Ms. Heller’s execution thereof, unless revoked by Ms. Heller prior thereto.
The foregoing summary of the Separation Agreement is not intended to be complete and is qualified in its entirety by reference to the full text of the Separation Agreement to be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ending September 30, 2011.
I know. It's a real bloated PIG.
INFI moving.
I don't own it, unfortunately.
Wonder if it's related to their Hh program in pancreatic cancer indications..?
$250 million market cap is not a lot IMO. I believe it was RKRW that was saying the valuations were more compelling for INFI vs. CRIS about $100 million market cap dollars ago....
I'd rather invest in a company that I can see a scan or pictures versus a company where a patient has a different "feeling".
Just my line of investing.
I won't invest in drug development companies where I think there may be a psychological effect on the patient getting "better". I just think these companies are seriously compromised by a placebo-effect.
Therefore, I play Russian Roulette with oncology companies where, at the very least, I can see scans, follow patients, and look at pictures and see, what I feel, is working, or isn't working. You can't have a placebo-effect on holes in people's bodies closing up ala GDC449 or Ipilumumab.
You just pegged the top.
Did anyone here call NABI's failure, yesterday?
I just pulled it up.. yikes.
I havent seen the report. They clearly are using a valuation model based on nearer term Ridaforolimus revenues and Ponatinib as a third line. I highly doubt they assigned any value to 113 or any other program.
NOTE: I generally don't read more than one or two of sellside investment bank research reports because IMO they're all rubbish. They all say the same thing essentially, and no one is willing to go out on a limb. I do pay attention to indie-research.
Merrill will probably upgrade to a buy once ponatinib is approved and the stock is trading 2 x as high as its current price.
BofA/Merrill Lynch initiates coverage on ARIAD Pharmaceuticals (NASDAQ: ARIA) with a Neutral.
$14.00 price target
Let me guess.
Today's one of those "healthy" pullback days?
LOL, Jenzyl.
I think you're thinking of the fake Viagra.
How about Contoriq? Was that name still around?
Yeah, in 3 to 5 years assuming all the drugs work out, it will probably be worth well more than 20.00. I dont really feel like watching and waiting for 3 to 5 years so I will take 20.00 per share in a buyout, no problem, tomorrow a.m.
I would gladly take 20.00 tomrrow a.m.
BRAF mutations in hairy cell leukemia
Posted: 18 Jul 2011 08:04 AM PDT
Last month an interesting article was published in The New England Journal of Medicine describing how BRAFV600E mutations may have a key role to play in hairy cell leukemia (HCL), which came out around the same time as the European Hematology Association (EHA) meeting that I attended in London. The news certainly caused a buzz at the conference!
Source: Wikipedia
Hair cell leukemia is a fairly rare type of leukemia that affects B cells (lymphocytes), which are distinguished by their hairy like appearance under the microscope because they have fine projections coming from their surface.
Over the past year, we have heard much about how the BRAFV600E mutation plays a critical role in melanoma and the progress with the testing of a specific inhibitor, vemurafenib (PLX4032), in the clinic, leading to some initial clinical success in this indication. What’s particularly interesting about the NEJM article is that it describes, for the first time, how the BRAFV600E mutation may be a key genetic alteration in HCL.
The researchers used Sanger sequencing to undertake an extensive analysis of the genome in normal and HCL peripheral blood samples. The findings were also validated in additional patients with HCL (n=47). The results were a little surprising:
“Whole-exome sequencing identified five missense somatic clonal mutations that were confirmed on Sanger sequencing, including a heterozygous mutation in BRAF that results in the BRAF V600E variant protein.”
The mutation was only found in patient samples who had HCL, not other types of leukemia or lymphomas:
“None of the 195 patients with other peripheral B-cell lymphomas or leukemias who were evaluated carried the BRAF V600E variant, including 38 patients with splenic marginal-zone lymphomas or unclassifiable splenic lymphomas or leukemias.”
Some immunohistologic and Western blot studies, were performed. They found that:
“HCL cells expressed phosphorylated MEK and ERK (the downstream targets of the BRAF kinase), indicating a constitutive activation of the RAF–MEK–ERK mitogen-activated protein kinase pathway in HCL.
In vitro incubation of BRAF-mutated primary leukemic hairy cells from 5 patients with PLX-4720, a specific inhibitor of active BRAF, led to a marked decrease in phosphorylated ERK and MEK.”
PLX-4720 is another BRAF inhibitor that Plexxikon have in development in addition to the original one, PLX-4032 that became vemurafenib.
Now, while is promising evidence that needs to be researched further, we must exercise caution. Remember that just because a mutation exists, does not mean that it is a key driver. We saw this with colon cancer and BRAFV600E mutations – where vemurafenib had little of no effect in patients, despite promising preclinical data – a stark contrast to the results in metastatic melanoma! Why does the same target produce entirely different results when inhibited by an effective agent? One reason could be that that BRAF is a passenger not a driver in colon cancer.
In the meantime, I will be keenly following any progress with testing of specific BRAF inhibitors for patients with hairy cell leukemia to see whether it will be a useful clinical approach in managing the disease or not.
(source: pharmastrategy)
FWIW. Hopefully Polycom is also contributing to the sales of this product. Could be a biggie.
From today's Polycom press release
http://finance.yahoo.com/news/PolycomR-RealPresenceTM-Ready-iw-2098377705.html?x=0&.v=1
"Cloud Solutions from the Polycom Ecosystem
Launching this week, a new cloud-based "Virtual Room" service from 8x8, Inc., enabled by the Polycom UC Intelligent Core software platform, will include Polycom HDX video solutions and Polycom VVX business media phones. 8x8's "Virtual Room" service allows users to join meetings via video and audio devices as well as web telephony and smart mobile phone clients."
The problem is, most critical posts of absurd/laughable messages on the Ariad board get removed immediately.
I think what "poorgradstudent" et al are complaining about is the zealot-like posts that are inline with Yahoo posts.
Like, the fool who insists he/she knows everything and will argue to no end about him/her being entirely/foolishly right, when proven laughably wrong over and over and over and over again.
There are many posters over there that are very good. On balance, I think BV has a much more "market-neutral" balance of posters....instead of "Ariad can only go up" posters. Unbiased postings are much better to learn from....IMO.
I suggest you do a closer assessment of your own posting catalog.
(that was a joke re: the stent deals)
How come the JEFF analyst didn't include any numbers on the stent deals?
Wait 'til the analysts start talking about those numbers!
LMFAO
You gotta admit...there was a LOT of BRUTALLLLL stuff over the weekend on the ARIA Board re: that FoxNews interview.
I was seriously embarrassed for some of those posts.
.."why would "X" spend millions on the trial if they thought it would fail?"
.."Why would "X" partner and spend millions to develop the drug if they thought it would fail"
ergo, it must work because they are spending money on it.
Yes. Lots on unintelligent life out there.
There's a few posters over there that I get seriously embarrassed for (over at ARIAD).
could easily be taken out at $17.
Oh terrific! It's correction time for ARIAD.
FYI-
It's from May 2010, but worth a read for anyone who missed it.
I'm sure Berger will add colour on this program in a couple weeks.
http://www.lcfamerica.org/blog/wp-content/uploads/ALK-Lung-Cancer-and-Personalized-Therapy-JNCI-2010.pdf
LMFAO!!!!!!!!! AGREED ENTIRELY.
Yes, in the sewerage of Yahoo, that was a well thought out post. Worth a quick read.
Are they all from the same IP address... :o)