Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I am a little confused here. I thought SCOTUS already ruled on this, and ACA mandate was not considered a tax, with Chief Justice Roberts casting the swing vote here. While i don't agree with that decision, I am curious how a lower court can revisit this prior SCOTUS decision?
Personally I think our current health care system is a debacle with a predatory pricing model and where patient decisions are out of the hands of patient and doctor. I prefer a transparent price/cost system, no limitations on access, and which is patient centric. Amazon has designed the most successful retail model ever implemented which keeps costs low and which is highly customer centric. Imagine if something like this was applied to all things healthcare. Prices would immediately drop and quality would improve and would put the patient back in control.
Thanks Dew. This makes sense. Merck would have to reduce much lower to have any impact to access.
May not have big impact on Merck at all, but will this increase access for patients who cannot afford the best in class treatment? In the end, a cure is a cure, and if lower price provides a cure for people who cannot afford the best in class treatment, then this is a win in my view.
Trump's approach is to increase competition in order to lower prices domestically which makes allot of sense. Still Not sure how his is proposing to raise prices in other countries since this would be up to individual companies to negotiate higher prices.
Don't understand why the generic companies just don't write themselves scripts to get the samples. They all have doctors on their staffs who could easily do this. May cost several thousand dollars but this is small cost to obtain a few samples.
Dew, I think this is really about the risk/benefit. This drug is known to accumulate in adipose tissue with a very long half life, so while primary efficacy endpoint was met, they will need to look closely at all other safety indicators which i am sure will take some time. Still a big surprise that efficacy against statins alone was statistically significant suggesting some other benefit wrt to HDL raising. Also, no obvious toxicity (they would have stopped the study) which is also surprising given the accumulation issue.
Only a matter of time now. This one could fetch a nice premium based on Linzess rapid growth.
Not likely there would be overwhelming efficacy considering they needed to power the study with 30K patients. The good news is that there were no significant tox signals. Given the the amount of LDL lowering I don't think efficacy will be an issue, however obviously the big question is if HDL raising is synergistic here and can lead to more favorable outcomes. Obviously we won't know until the end of the study.
The branded generic is very important in these markets because of reputation of the innovators and the poor reputation of the non-branded generics based on quality/counterfeits. The innovators spend allot of resources getting rid of counterfeits while the other generics do not. Just adding the innovators name gives a "seal of approval" if you will. There is little impact when the innovator product goes off of patent in these markets, so the period of apparent exclusivity can go on a very long time since these products still maintain a "premium' sale price. In markets like Korea the KFDA will actually let the companies maintain a premium price post patent if "product value extension" formulations are approved prior to the patent expiry, even when there are already several generics available. The Sun Pharma collaboration obviously looks like a way to maintain "reputation" while keeping costs low.
I think you are right, the MRK argument was weak, so from that perspective, the final compromise was pretty good for MRK. If this went to court, MRK may have ended up with zero. So not sure why J&J didn't push this further?
MNKD: The idea of changing to smaller DPI device before approval of the original device used in the pivotal studies is unheard of. If devices are signficantly different, FDA will require addtional clinical studies.
That may be true but corporations don't really care about the % of GDP. I am sure there is an optimum, but certainly 38% average tax rate is way too high. In principle, I agree with Dew and see this as double taxation. From practical point of view, the rate should be low enough so we don't provide dis-incentives for corporations to move their mfg jobs overseas. If you ever travelled through Singapore, you will know what i mean.
The reason we have off -shore tax havens is that the US has one of the highest corporate tax rates in the world. The US Pharma industry send s many manufacturing jobs overseas, including to Singapore, Ireland and even still to Puerto Rico on a case by case basis in order to get these tax benefits. US po licy should be to provide incentives to keep these excellent mfg jobs in the US. Instead of doing away with the tax havens which will be diffocult to enforce, why don't they give incentives for keeping the jobs in the US.
I have worked with Korean Pharm companies (never heard of Samyang) and if they eventually take control of the company, they will develop these compounds for regional market at very fast speed. I have found the Koreans very hard working, intelligent and diligent, something I have not seen from Cortex. In some aspects they are very smart, the Korean company will get a promising pipeline for peanuts, however bad for us shareholders as the stock gets diluted with Samyang's eventual control.
Wow, Cortex will eventually be owned by that biotech powerhouse Samyang from Korea. You know what they say, one born every minute.
MNKD: Agreed, plus I wouldn't expect any issues with the Organon plant.
Dew, just curious, what happens to the IP when these companies go BK?
I thought Mike Harvilla was a respectable reporter? Do you know otherwise?
"BioMedReports.com is a news portal covering the biomedical news and financial sector. BioMedReports is not paid, or compensated to report the news and developments of publicly traded companies."
Thanks. I am up over 4x so far but still contemplating holding some through the PhIII results. I have taken some profits already in any event. Like DNDN, there will be allot of trading opportunities up until the binary event.
Yes I think we have been miscommunicating. HCV represents a potential long term upside based on my vison for it's potential application, but certainly I would not invest in Novelos now based only on the value of this compound for HCV which is based on a very incomplete data package from Russia.
Additionally, based on iwfal's recent analysis, I would now proceed with caution in the oncology area as well. Whether this is a failure or a true chemopotentiator and chemoprotectant we should know early next year. As a previous poster suggested, the stock will be either $10 or zero after the binary event.
Thanks Iwfal for the insightful analysis. You made several points where I haven't seen previous discussions of, including the improved survival due to 2nd and 3rd line treatment, effects of drop out rates, and the Eastern Euro patient enrollment uncertainty. Do you have the capability to do Monti Carlo simulation of the variations of the key inputs to get the most likely MOS based on varying timing endpoint of 725 deaths?
Dew, you're kidding me right? Companies quite frequently decide NOT to develop drug candidates all the time based on available resources, timing and relative commercial potential in the portfolio. I work with internal candidates as well as external licensing candidates and these discussions happen on a daily basis. This is far more critical for a small company compared to larger companies given their limited resources. This is especially true for Novelos who has out about 162MM shares already to develop the oncology indication and thus,very little leverage to focus on HCV as well. While the HCV candidate may have some potential, it wouldn't be worth licensing based on the current data package out of Russia, and would require additional internal development to make it worth something for licensing. I don't see how you can characterize my previous comments as drivel and take offense to this.
Thanks Iwfal for your comments. I look forward to your more detailed analysis.
Can we agree we wouldn't license a drug based only on Russian results? I think Novelos understands this.
I am not suprised at all. As you know, the cost of HCV trials is extremely expensive and the co can only focus on oncology indications at this time, and would need a partner to develop for HCV, which would be extremely unlikely with only Russian based results. The ceo already indicated they would need a partner for HCV and should be given credit for completing a pivotal Phase III trial in NSCLC.
The design of this study is completely appropriate for this patient population (platinum resistant tumors with patients having received their last Pt treatment).
Some modelling here suggests MOS at about 15 months based on study termination in January which would make it superior to Avastin. I can send you the link for your review if interested.
I was also highly skeptical of this company, especially with results coming out of Russia. However, allot has happened since the 2005-2006 when your referenced posts were written, First it is pretty hard to fake PhII results, especially when run by highly respected clinical investigators in the US. Additionally, highly respected researchers in the US now have a greater understanding of the mechanism of action, so now the "hocus pocus" factor is all but eliminated, at least in the cancer arena. Additionally, the DoD awarded a grant to Novelos to evaluate as a protectant from radiation. No additional studies have been done in HCV, so that remains to be seen but not too hard to believe that this drug could be used with SOC in individuals showing hepato toxicicty from the currently toxic drug treatment. The pivotal PhIII results are due out in 1Q10, so if these results are positive, will you still claim this is a scam? BTW, I would think that Purdue Pharma disagrees with your assessment, given that they now have the EU rights.
I posted the PhII results for Novelos (NVLT) several months ago. Did anybody get into this at that time? What do you think of the recent run-up?
Does anyone know, that if co. goes Chapter 7, how will IP be distributed?
GFP, I am really surprised by you. There will never, ever be any clinical data of any value from this mgt group. How many times can you be punched in the gut? At this point they are strictly haggling between each other for the last remaining pennies to split between themselves before Chapt. 7.
No, just keeping it real. One has to allow for the reasonable probability of the worse case scenario. Could be the IP just isn't worth anything substantial and based on the current market cap, that is probably more closer to the truth than people here realize.
No same outcome and not inconsistent. Mgt is running out the door NOW with as much as they can take!
Personally I think this one could surprise. Mann has put hid money where his mouth is so I wouldn't underestimate thsi guy who has been steadfast in both his conviction and his plans. i could recommend taking a small position as a speculative play with high upside with risk this could go to pennies.
I have opposite. 1>2>3>4. The mgt will drain the coffers for everything they can get in ultimate Chapter 7. At this point, who would give them money?
Delisting really doesn't matter. This is a penny stock company with small thinking management anyway. Being on the AMEX doesn't change that.
I predict they will essentially give the company away, but will work out the best deal for themselves, not shareholders.
Both studies are required if the company wants to launch both a monotherapy and a fixed-dose-combination with atorva at the same time. Hence, these studies are essentially independent of each other, because different products will come out of each. So from this perpsective, the study design is efficient and makes business sense.
CETP: Not yet anyway.
I am sure a long term outcomes study is being planned.
CETP MAKING A COME BACK
Merck's Investigational Anacetrapib Phase IIb Study Results Presented at American Heart Association Annual Scientific Sessions
Persistent Lipid Effects Remained in the Higher Dose Arms After Cessation Of Therapy in Patients with Dyslipidemia
Press Release
Source: Merck
On 9:00 am EST, Tuesday November 17, 2009
ORLANDO, Fla.--(BUSINESS WIRE)--In a phase IIb study in 589 patients with primary hypercholesterolemia or mixed hyperlipidemia treated with anacetrapib as monotherapy or co-administered with atorvastatin, there were persistent lipid effects in the higher dose arms in both the monotherapy and co-administration treatment groups eight weeks after stopping active therapy with anacetrapib. These findings were announced today at the American Heart Association (AHA) Annual Scientific Sessions in Orlando, Florida.
Anacetrapib is an investigational oral compound currently in Phase III trials that works by inhibiting the activity of CETP in the blood. CETP inhibition with anacetrapib decreases LDL-cholesterol (LDL-C) levels and increases HDL-cholesterol (HDL-C) levels. The effect of CETP inhibition on cardiovascular risk has yet to be established.
“The study findings add to the data from the initial Phase IIb efficacy and safety results published in the American Heart Journal in February 2009,” said Yale Mitchel, M.D., vice president, Cardiovascular Disease Clinical Research, Merck Research Laboratories. “A phase III trial, titled DEFINE, is ongoing to further evaluate the safety and efficacy of anacetrapib in patients with coronary heart disease and will provide important information on this compound.”
About the Study
The results presented today represent the second part of a randomized, double-blind, placebo-controlled, parallel-group dose-ranging study. In part 1 of the study, 539 patients aged 18–75 years and with moderate elevations in LDL-C were randomized to either anacetrapib (at 10, 40, 150, or 300 mg doses) plus placebo, or anacetrapib (at 10, 40, 150, or 300 mg doses) plus atorvastatin 20 mg for eight-week period.
In part 2 of the study, treatment with anacetrapib was stopped and patients continued to receive either placebo or atorvastatin 20 mg for an additional eight weeks. The effect of withdrawal of the drug on lipid efficacy (LDL-C, HDL-C, total cholesterol, non-HDL-C, apo B, apo A-1), CETP levels and safety were assessed. Safety was assessed through physical examination, vital signs, laboratory evaluations, electrocardiograms, blood pressure measurements and adverse event (AE) assessments.
In the reversal phase of the study, eight weeks after cessation of therapy persistent lipid effects remained in the higher dose arms (150 mg and 300 mg) for both the anacetrapib monotherapy and co-administration treatment groups. These effects may be due to persistent drug levels which are likely related to the high lipid solubility of the drug. Also in the study, there were no patterns of clinically important blood pressure elevations or adverse experiences in the treatment groups.
Percent changes from baseline eight weeks after cessation of therapy were:
Anacetrapib monotherapy (relative to placebo):
10 mg 40 mg 150 mg 300 mg
LDL-C reduction 0% -1.2% -9.3% -15.3%
HDL-C increase 3.7% 18.6% 40.5% 43.4%
Total cholesterol reduction -0.3% 3.8% 1.9% -1.2%
Anacetrapib + atorvastatin (20mg):
10 mg 40 mg 150 mg 300 mg
LDL-C reduction 1.7% -3.9% -11.2% -11.9%
HDL-C increase 2.6% 13.1% 40.7% 41.8%
Total cholesterol reduction 1.0% -0.8% 0.1% -0.6%
About CETP Inhibition
Cholesterol ester transfer protein (CETP) is a plasma protein which plays a critical role in the cholesterol transport pathway. CETP transfers cholesteryl esters from anti-atherogenic high-density lipoprotein cholesterol (HDL-C) to pro-atherogenic low-density lipoprotein cholesterol (LDL-C) in exchange for triglycerides. Low levels of HDL-C are associated with an increased risk of atherosclerosis (the formation of plaques in arteries) and coronary heart disease (CHD). Research has shown that inhibition of CETP is associated with decreased LDL-C levels and increased HDL-C levels. The benefit of CETP inhibition on CHD risk has not been demonstrated.