Generally I agree with ptenn's and luv's comments. The discontinuation rate should not be a surprise given the disease state, the previously treated patients that one would logically believe should have shorter duration to treatment and additive toxicities, and ALSO that the original ASH presentation already demonstrated a 27% discontinuation rate in ARM A (Arm B was started later, having 4 months less median follow-up, so you would expect more fallout if the median duration of follow-up was as large as in ARM-B as ii was in ARM-A. The data is still preliminary and toxicities will continue to be monitored, but the results are NOT preliminary as it resulted in significant responses in this PHASE II trial.
I would add that with Spring Break, Passover and Easter week, that many people are away....making it difficult to research/communicate fully.
Agreed, especially going into next quarter....It is obvious shorts are recognizing that there was a plant closure for upgrade and this may impact the dividend/stock short term. Likewise, they are feeding off of the gulf refiners issues with differential which appears to NOT be affecting the upper Midwest the same...note Credit Suisse comments on Marathon " ....it appears as though Marathon only captured 30 percent of the product price spike in Chicago, it explains the lowered guidance." NTI is a very valuable asset in my opinion and has been running at increased capacity during the most recent spike
I normally will not reply to these tangential arguments, but Franz is right historically, and if you were going to change the definition of war, you need to include Clinton with the conflicts in Somalia (wasn't that a great decision!?), Kosovo, and Serbia (which although under the radar, still have significant issues). Let's not forget Carter's handling of the hostage affairs. Regardless, Republicans are not blameless either! The only way to circumvent some of these issues in the future is to rid yourself of party dynamics and frankly building a strong economic and socially responsible society, with a potent/mobile military, not necessarily using it thought, as economic demise is historically linked to poor policy with use of great military power such as recent history (since 1600) with Great Britain, Germany, Italy, Spain, etc. History has demonstrated this! In fact the United States was effectively formed from the anger many colonists had with England who attempted to tax the colonies so as to replenish its treasury after years of wars with France, Spain, et. al.
Presidents who initiated US involvement in large military conflicts since the Civil War:
Republican GW Bush - Iraq/Afghanistan
Republican GH Bush - Iraq (Persian Gulf War)
Democrat Kennedy - Vietnam
Democrat Truman - Korea
Democrat Roosevelt - WW II
Democrat Wilson - WW I
Republican McKinley - Spanish American
Republican Lincoln - Civil War
Absolutely....I have been scaling in and will do more. Calling a pullback after a big run-up is like telling someone they are going to get a ticket while driving 100mph on cruise control....tough call! Regardless of what Orelli or shorts say, this stock has legs and LOTS of support from the big investor community like the Baker Bros (look at their track record!) & Jeffries - target of $13 prior to presentation. But, let's not forget about the patients and families that this product would potentially help since that is what the FDA and others will be focusing on. Part of the risk/benefit scenario data that they will review are outcomes observed within the AAN presentation. Is there less risk or more? Answer: NO additional adverse event and side effect issues were brought forward (urinary tract infections and falls were hilighted). Couple this with current meetings of thought leaders and government officilas within the community to relax regulations so that these patients can get the help they need. As an investor, less risk is present than where we were just 1 or 3 months ago. What about the benefit scenario? Answer: The results were known prior to the presentation to some, however, what we did not know is the degree of acceptance of this data by the physician community....quoting Dr. Jeffrey Cummings, ..... pimavanserin "has the potential to transform the standard of care by providing an effective, safe and well tolerated treatment for patients suffering from this large unmet medical need." So who is Dr. Cummings??? Search his bio....he is a very well respected opinion leader in the field, award winner for his research, former Director of Neurotherapeutics at UCLA, and current Director of the Cleveland Clinic Lou Ruvo Center for Brain Health! Bottom-line, the basis behind the jump is not over-optimism, but rooted in the responses from those likely to prescribe and use it.
Somebody was not allowing this to sink long under $23 as it tested it a couple of times today...buy-back program? Regardless, if markets turn positive, this will likely revert quick....I stuck my toe in (again) and have not been disappointed with this stock so far. Don't forget that yield seekers will likely be cycling out of bonds and looking for places to transition to.
I agree and will add two quick comments, pro & con to this. Currently 75% of the Canadian Sands Oil in the US comes through Enbridge and their "Mainline" pipeline which is operating at capacity even after a recent upgrade. The Enbridge BAKKEN pipeline connects with the Mainline near Clearbrook! Any disruption either way still allows downstream refiners access to one or the other through the Mainline, and NTI is the closest of these refiners which should garner them a price advantage. Keystone's max capacity is nearly 4 times Enbridge's (before their upgrade?) which should increase the competition for WCS since more refiners will not have easier access, yet this capacity will likely fall from rail shippers IMO (Canadian Pacific Railroad has been shipping a large amount of WCS to refiners). Thus, WCS should go up in price, but to what extent...who knows? With all the oil flowing from the Bakken and Texas/Oklahoma area, WCS still will need to be priced favorably for a long-time or be relegated to other non-US options. In short, NTI will be affected, but probably not impacted as much as other refiners when looking at just this issue. Disclosure...I am NOT an oil man either
The actual leaders in methylation with GBM are Henry Friedman of Duke University and Roger Stupp from Switzerland. Rul6t2 is right in his assessment of how methylation works. Temozolomide is an alkylating agent. In short, try to search for this article "Glioblastoma Multiforme: Current ,and Treatment Challenges : Current Approaches to the Treatment of Newly Diagnosed GBM" written in 2010 if you are looking for an article that gives some backdrop into results from past trials, and issues between results seen in treatment arms of protocols vs. those experienced in the clinical setting. Responses can be improved between trials with simple patient selection and that is why it is important to have balanced arms in any comparative protocol. The FDA will be looking at all known, and even assumed, prognostic variables when looking at the efficacy question with ICT-107. For me, there really is no way to tell what the interim results demonstrate without a thorough look at who responded in the trial. One thing you do know, is that the interim results took longer than expected..that could be pro or con pending assumptions (I am leaning pro). All I know is the trial is allowed to continue, which means it was not worse! Remember that although everyone short or long wants to make money in this stock, this drug brings much hope to patients and families...some may be reading these posts, so it is important to be detailed in assumptions.
Do you have CLL or have a family member suffering? Did you note the side effect profiles with others from fludarbine and CHOP regimens? Look at the prescribing information for Rituxan and you will note 57% grade 3/4 issues and it is believed to hold true through a variety of mechanisms. For ALL OUR SAKES...know what you are talking about!!
Yeah.... if it is the same one I read, the author screwed-up....they stated that the study demonstrated results in HER2 postive, advanced breast cancer in combination with Letrozole, where in fact it was for HER2 NEGATIVE, as you indicated in the header. Kadcyla is indicated for use in, and continues to be researched for, HER2 positive breast cancer, so it is NOT a competitor. The other thing is that the trial was phase II and demonstrated a large difference vs. Letrozole alone. However, advanced breast cancer progression free survival is very dependent on a variety of certain patient characteristics and thus, it becomes difficult to compare one trial vs. another, which the author did not comment on. Likewise, AstraZeneca's fulvestrant (Faslodex) has had similar results in trials, albeit not head on head with this drug. I feel the results were very strong and interesting, but the author really pumped its potential. Again, as I see the study results, this is NOT a competitor to Kadcyla
Regarding the CHK deal, I look at this differently. 1st, the agreement was a JOINT venture and not an outright sale. Other aspects within the joint venture have not been disclosed, so we need to be careful how we view this agreement, though I feel as others, that CHK has done a disservice to their shareholders (by not disclosing more), and to the other operators in this play. However, I cannot state that their acreage was of inferior quality given Sinopec's involvement and results from those wells in Wood County. I feel people are missing the point that others want to be in the play which aids all current lease holders! Second, the CHK properties in Wood County, where the great degree of CHK leases are held, are producing well, especially in comparison to Sand Ridge who was drilling in neighboring Alfalfa county, and frankly, has a greater number of properties in Kansas along with Apache. 3rd, I do believe as you, that the Nemaha Ridge plays are different, and should be viewed as such. Osage is very interesting, a small company, acreage in an oily part of the play, with lots of upside, driven with more successful wells and greater ownership of those properties. There is no doubt that location and driller expertise are proving out better results. Good Luck!!
Agreed about expectations. Roughly 90% growth in profit vs last year's quarter and revenues higher than expected earnings miss. Will have to wait to CC this morning, but expect refinery shutdown to have affected this. This stock provides you now a PE under 7 and an ongoing dividend above 2 with postive guidance already given. In fact, if you count special dividends this stock has brought you a dividend over 6% (even MUCH higher if you bought lower).
JP Morgan's analyst dumped Carizzo just before it rocketed 50% over the next month in a call earlier this year...they hold little weight to me in regards to their oil analysis. On another note, there has been an oil pipeline issue with Enbridge in northern Alberta that is shutting down some of the oil sands flow. Again, this is overblown IMO, as the pipeline in Alberta is a short 11 mile track and affects other producers/refiners, yet the Enbridge Mainline is intact and Bakken crude is flowing. Note that Bakken and US sections of the Mainline are running at capacity last report.
I believe the $85m you are speaking of is actually $62-64m net to Zaza from my memory of a recent presentation. Half of this was to be used to be pay down a note, leaving ~$32m for drilling, lease-holds, operations, etc. Also a divesture of certain properties have been a part of the plan since last year. Shorts will likely try to exploit this, but again, it is part of the plan. For me this was a speculative play that has a lot of upside given their acreage. Hess's fire sale proved that their interest lies in the large holding elsewhere in the world....in short their position in the Eagleford was less substantial than elsewhere, and it had nothing to do with viability. So for me, it really comes down to Zaza's execution at the well. As stated earlier, others are hitting huge volumes all around their acreage in the Woodbine/Eaglebine, and Eagleford areas. Currently, holding.
Seems you should be thanking them for allowing you to exit your short prior to the reporting AND potential for more positive news. This news could have happened all at once! Assets = money and it appears they just lowered their debt and risk levels, while finding a way to increase production. Congrats ZaZa! This will be interesting to watch/participate in.
I have roughly 12,700 bopd of oil which would make roughly 25K boepd NEW oil based on initial production numbers from wells drilled by MPO for Oklahoma alone. This for a company that averaged 16.2K boepd last quarter. I am expecting at least a 25% increase in total boepd quarter over quarter regardless of Louisiana results. Anything from the Wilcox will be additive.
The Motley Fool article is written by the same people that originally could not understand the difference between HER2 expression levels, depicting Neuvax as being researched for use in HER2-positive patients (which it is not) and what this product does....It is meant for treating HER2-low expressors, thus it would not currently compete with HER2 positive products like Herceptin as others may have you believe. It is hard for me to respect an article from a person or group that cannot distinguish this fact in the first place. In fact, it must be looked as a hack-job and is disgraceful when you think about the patients this would potentially benefit, if all holds true. I expect better from Motley Fool in particular, and think everyone should be careful on any opinions from this group as being nothing more than self-serving. The company has a market cap way under the potential for just this one drug, especially in comparison to many other biotechs, and has the potential for multiple catalysts going forward that can take place over the short-term. HER2-postive patients make up roughly 20-30 percent of the breast cancer population in the US alone, HER2-low expression thus, represents roughly 70-80% of the breast cancer population. If you are in it only for the money, would you have invested in Genentech and Herceptin in the pre-release years? How much could you be worth now? Obviously biotechs are risky....but do your OWN research.
I took money some off at $12.55, thinking we would revisit 9 or 10 and never got there. Anybody that would long-term bet against the Bakers will find it difficult. Once they get their teeth into a biotech, they will defend it, as they are not in it for 10% gains but, serious upside while bringing innovation to reality for patients.
The failed trial is real, but has been talked about and researched in length for some time now, so it is old news, but still important (Not only for the reasons you present though!). Do you not believe this was considered prior to the ruling from the FDA and/or the company? At the time of approval, the failed trial will be re-appraised, but this likely will benefit Acadia for two reasons. First, patients in this trial can be included in their safety and adverse event submission, thus increasing the pool for analysis and allowing one to investigate any long term adverse events (a huge hurdle for most new drugs)...,.this may be one of the reason's for no required confirmatory trial. Second, the failed trial served to "tweek" the successful trial reported on at the international meeting. This is valuable for many different reasons, but aids in understanding the parameters by which the FDA will make their decision in an area of unmet medical need. (In otherwords, in the FDA world, how does this aid them in a deeper understanding of the disease state and enable or improve selection of proper patients for treatment and assessment of efficacy?). Furthermore, please read the new FDA designations and "goalposts" for unmet medical needs. If you pose to be for the patient, you would not condem something you, nor I, have in depth data on...for this truly is ALL about the patient.
Yeah....thanks for allowing me to explain. In a small trial of 21 patient, 38% of the patients on Oncosec's IL-12 treatment demonstrated a partial response at 6 months of treatment. Impressive results for an immunotherapy compared to 10-20% in older regimens such as IL-2 and interferon which were done often in untreated patient populations. What is noted, but not expanded upon is the tolerability of their IL-12 treatment. Older regimens are known for the severity of side effects making them prohibitive with many physicians. The reported outcomes can only be looked at as favorable for this trial by Oncosec in my opinion.