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.
Dew,
The gist is, if the company is not a party to the lawsuit, then the law still applies to them. The paragraph cited insurance companies as an example, but that is not all inclusive. The Plaintiffs in the Florida lawsuit are the only parties to have relief from Obamacare.
The pharmaceutical companies can file their own complaint. I assume they are not because they like Obamacare, but I have not followed if any of the pharmas have filed either individually or as a group to find the law unconstitutional as to them.
Tinker
Dew, in regard to what happens to refunds, the Washington Post answered the question as follows:
However, Rivkin said, the ruling does not touch any provisions of the law that relate to insurance companies and employers, because they are not part of the lawsuit. This means, for instance, that the opinion does not jeopardize some aspects of the law that already have gone into effect, including the ability of young adults to remain longer on their parents' insurance policies.
vinmantoo,
This is not a place for a Constitutional debate.
I will quickly respond as none of the examples you cited are on point and then go on to something else.
Public education is a State mandate not Federal.
Abortion is a negative right. Roe vs. Wade put limits on what the government could do to you to prevent an abortion, it did not make an abortion a right.
Medicare and Social Security are tax funded programs with no debate over their Constitutionality.
Building roads and bridges is an integral role of government, as is collecting taxes.
I think you need to remove your support of Obamacare and passion for it, and separate it from the legal issues, and stick on point. I'm not debating the merits, but merely responding to some legal issues that are on point.
In the end, if the Supreme Court accepts certiorari on this issue, given the current make-up, and how the issues have been laid out and defined, there is at least, in my opinion, a 75% chance that a material portion of Obamacare is found unconstitutional. Which is very relevant for the managed healthcare industry, for example. For investment purposes that is relevant. As for the rest, your examples are not on point, and this is not a place to go into deeper discussion of them.
Tinker
Peter,
I am talking from a high level perspective. None of us has the time to dig through the nitty gritty litigation. Given the current make up of the U.S. Supreme Court, we know enough now that I can put down some pretty good odds that there is a better than 50% chance that the mandate is found unconstitutional, 25% chance that the entire bill is, and 25% chance that one justice may roll over to the other side. That is a 75% chance or so of the bill having some serious set backs, as it is written, and then having to go back to a Republican controlled House to address the issues.
One justice can make the difference, but as the Court is presently structured, that Florida decision put everything into play (not that the Court could not have unilaterally done it, itself, but it gives the Court cover).
Like with the recent tax compromise, Obama has to be weighing that most likely the Court is going to find this bill unconstitutional in some material manner. He may find it prudent to seek a compromise before it gets there (although his base would fry him if he did). Certainly Republicans are politically gearing up for that fight, even if they cannot currently get a vote in the Senate on it.
This is a truly historical issue, and we are living through it, and this issue is politically dangerous given how much venom there is on it from both sides.
Tinker
jbog,
I have my own opinions on the topic, which lean more towards HSAs and then perhaps group catastrophic insurance, and then focusing on Medicare, but I don't want to create a huge debate on that on these boards.
There certainly are Constitutionallly permissible ways to improve the system without trashing the Constitution in the process to get there.
Frankly this whole Obamacare bill, in my opinion, not only trashes the Consitutional and expands the scope of government to the point where there are practically no limits, but is going to make medicine both more expensive and of lower quality, not to mention what it is going to do to the deficit.
But from here to there we need to get through the legal issues, and then political issues, as clearly the bill is not going to be rescinded with the current make up of the White House and Senate, before we can get back to addressing these issues.
Single payor is one solution that many believe in. I do not believe in that system. The current Obamacare is designed to get us to single payor however, as its entire effect is to diminish competition until you are left with just the government plan, and a few very large private insurers who will be in essence quasi-government agencies. So in the long-run, without doing anything else, if Obamacare survives that is where it will go anyways for all practical purposes.
Tinker
jbog, whatever its nomenclature, insurance or otherwise, you pay it as part of your income that you earn. You can choose to not work, choose to live off of dividends, etc., but it is a tax on your income. Sixteenth Amendment makes that legal.
There is a lot of jurisprudence on the difference between a "tax" and a "penalty" in Constitutional jurisprudence. This is not a new issue, but what makes it different here is the scope of this issue.
The other issue, is simple democracy. The plan was sold as "not a tax" and then voted on under that pretense. Now after the fact they want to make it a "tax". How about this then, rescind the bill, and come back and vote on it, this time calling it a "tax".
That would still be problematic constitutionally, but at least it would further the democratic process rather than playing a shell game with a bill that could not otherwise have gotten out of Congress.
What Congress can do, is re-do the bill, and make funding it part of a payroll tax scheme like Medicare. But we both know, that would never get out of Congress.
Constitution works to keep Congress honest as well (at least in episodes like this anyways).
Tinker
Do you think that everyone should have to pay taxes for public schools even though they might not use them?
Do you think that everyone should pay for a fire department, even though they might not use them?
Do you have to pay social security taxes and medicare taxes as in FICA even though you might not ever use them?
Do employers have to pay unemployment insurance taxes even though you may not ever need it?
It will be a healthcare program and they should call it a tax and administer a program. I guess it boils down to whether you think citizens of a country should have basic healthcare as part of the benefits of their citizenship, or whether you think it is everyman, woman and child for themselves.
If you have a job in the private sector, you have to pay social security taxes. Is that unconstitutional?
What about the fiscal year of a given company that encompasses the date when ObamaCare is formally rescinded? Are you implying that the ObamaCare fees will be pro-rated to apply to only the portion of the FY prior to the change?
Biomaven,
That seaman analogy is off point. No one needed to be a seaman. They could avoid buying insurance if they decided tow work somewhere else. The healthcare mandate requires everyone to buy insurance, no opting out, the only requirement being is that you are breathing.
The fact that people are fat is encompassed by interstate commerce if the power to mandate purchase of health insurance is. This is because fat people raise the rates of insurance for everyone. The purpose of the mandate is to lower the rates of insurance for everyone. So interstate commerce can be used to justify mandatory laws to address the issue with fat people, as an example.
The real point is, there are real limitations on the power and scope of the Federal government. The ends don't justify the means, if it means stretching Federal power to the point that there are no meaningful limitations. That is what this is all about.
As for the merits of Obamacare, I don't even want to go there and I don't need to go there to get to the crux of the legal argument, which is far more important in the scheme of things than the merits of Obamacare itself. Obamacare can be repealed, modified, etc., if this stretch of Federal power is allowed, it will exist forever, and basically vitiating any real and meaningful restraint on Federal power. THAT IS A HUGE ISSUE that goes well beyond healthcare.
Tinker
Israel is a small smidgen of land, with no resources, surrounded by vast numbers of people who are their sworn mortal enemies, and yet Israel is still capable of producing top rate public companies that compete world wide. Somehow, I don't think I want to diss a group of people capable of doing this while living under such circumstances. The entrepreneur spirit is alive and well in Israel despite the obstacles, and we should learn something from that sort of perseverance.
Tinker
No, not an Israeli. Much more downtrodden, a Viking fan;(
Interestingly, there is little intellectual property protection on Copaxone
Is it the case that m-copaxone could be approved by the FDA, yet MNTA would not be able to sell it (market it?), unless a) the court rules in their favor in the current patent lawsuit, or b) they decide to do an "at-risk" launch?
characterizing the drug (in Amgen); Using a patented process
"Westerners reflect in a time of crisis. They learn a lot from that," said Hu Xingdou, an economist at the Beijing Institute of Technology. "And they sometimes exaggerate other people's success."
Moreover, he added, the very thing that Obama summoned Americans to do — revive the innovation spirit — is what's missing in the Chinese economy.
"Our system lacks creativity," Hu said. "The U.S. is a private sector. It will stimulate innovation. We may be temporarily ahead of America in the areas Obama mentioned, but to truly surpass the U.S., we have to reform our system."
Zipjet, courts understand the reality of how people communicate and that corporate statements are often fill of fluff, optimism, gamesmanship, or whatever terms you want to utilize. I've been in front of too many judges who bend over backwards to put these sort of statements in context. So I believe Dew's statement to be accurate.
This said, that letter TEVA received suddenly becomes very material in the context of TEVA's prior statements, and just the fact that the issues presented on it get to the gist of the issue.
I don't see how TEVA cannot turn over letter at this point, if the issue is how close or imminent FDA approval is. It will be interesting to see if we, the public, actually get to learn the substance of the letter.
Tinker
P.S. Just an observation. If the questions were minor, at this point in time, TEVA has every incentive to let the world know of their imminent approval from these minor issues. As I stated earlier, this defense goes away upon commercialization, so why continue to play this defense if commercial approval is expected. They will have to produce the discovery at that point in time anyways. I don't recall MNTA having any problem commenting on the immunogenicity issue. Makes you wonder why TEVA so fervently maintains this defense, and gives no indication at all as to what the deficiencies are other than citing the irrelevant "minnor" term in the letter. But more conjecture, I know.
Visit these companies today, see how many professionals working there are foreign born.
Funny, the U.S. has been trailing the world in math and science since at least the 70s, if not the 60s, by all these studies, and yet the U.S. is still the place most of the world's math and science achievements are made. China may be starting to change this now, but quite the juxtaposition. Which does put these studies into perspective as being largely not representative of real world practical outcomes.
Math and science are great, but what is more value are people who can imagine up ideas that math and science people can work on, and people who can manage the math and science people who are working ont he ideas by people who dreamed them up.
Also funny how Google, Yahoo!, Facebook!, CSCO, MSFT, INTC, go on and on, were made in this mathematical and scientific deficient nation, that still leads the world, by far, in biotechnology and pharmaceutical developments.
Tinker
http://www.in-thought.com/resources/GilenyaSurvey.WK.16Nov.pdf
Here is a detailed piece put out a few months ago as to anticipated mareket for Gilenya. Survey indicated that only 14% of patients are right for first line Gilenya use. These are patients that would probably go straight to tysabri or other aggressive treatment up-front anyways.
From this analysis, until more safety data is gathered (probably 3-5 years at least I would think). Report predicts $1.5 billion in sales in 2017. I don't know the cost, but using $25K per year, per patient (which is on the cheap end compared to tysabri for example) equals 60,000 patients on the drug in 2017, which would equate to about 9000 copaxone patients lost to Gilenya in that year.
It should be noted, that these patients may have been lost to tysabri or other medication anyways if they were not responding well to copaxone.
I was a bit more concerned about this myself, and the analysis can still be totally wrong and Gilenya just take over the entire market, but the drug had some serious safety issues in its clinical trials that were concerning, particularly at its more effective dosage. It does not seem to be associated with PML though, last I looked.
But that is the best information that I have on the issue. I've brought up the issue, if Teva successfully defends its patents, and MNTA can only launch copaxone in 2014-2015, what might be left for it? I like having time on my side, and since I am very confident MNTA will get copaxone approval at some point, time we do have on our side (unless copaxone fades materially away over time). It seems the chances are very high that copaxone will still be a front line drug, and in fact may grow stronger with a generic on the market, at least through the next 5-7 years.
If Teva successfully defends it patents, then that would give Teva the chance to put its new version of copaxone on the market as an alaternative, but since that is nothing more than a different dosage methodology, a generic copaxone should eat its lunch as insurance is going to be wary of paying a premium for something you can get in a cheaper generic. So time has consequences, and leave Teva with an opportunity still if they can delay things long enough.
Nevertheless, a good sized copaxone market should exist at least until MNTA can get its generic on the market, and the copaxone market will continue to grow in both users and price increases until that time. Lets give Teva credit for that!
Tinker
Assume that the use of a patented process/technique is reasonably believed to be necessary to achieve a certain end and there is no exception allowing the use. Further, that the company could use it behind closed doors and conceal that they have used the protected process.
Their [Teva's] statements over time are perfectly consistent with the FDA having at one point told them...
In the United States, this exemption is also technically called § 271(e)(1) exemption or Hatch-Waxman exemption. The U.S. Supreme Court recently considered the scope of the Hatch-Waxman exemption in Merck v. Integra. The Supreme Court held that the statute exempts from infringement all uses of compounds that are reasonably related to submission of information to the government under any law regulating the manufacture, use or distribution of drugs.
Bolar Exception: An exception to patent rights allowing a third party to undertake, without the authorisation of the patentee, acts in respect of a patented product necessary for the purpose of obtaining regulatory approval for a product.
There were several cases where the court ruled that the Bolar exception provision applied as long as the act of using a patented invention was reasonably related to gaining data for the FDA's regulatory approval.
The gist of my comments was not that Teva does not have other defenses, but instead went to the point that Teva has dramatically changed their language in support of this one particular defense.
If Teva actually has a product on the verge of approval, that defense goes out the window anyways, so why change one's behavior so dramatically to support that defense? It has no real benefit to a firm that is on the verge of a commercial launch. It would seem that there would be no need to change one's behavior then to support that defense.
But instead, Teva has gone all out to do just that, to support a specific legal defense that has no merit, unless Teva has no commercial product that is imminently destined for commericial use, for the sole purpose of delaying any discovery that MNTA can conduct.
Once Teva gets approval, there is no question that MNTA can get all the discovery they want from Teva.
So it appears to me to be a very large change in behavior on the part of what was otherwise a very, best descriptive terms, cocky, and boastful management team, all of a sudden, to support this one legal defense that goes away anyways if they really have a product. Teva has no reason to change its behavior in regard to any of their other substantive defenses, and it could not have been easy to reign in managements comments. In fact, it probably took some very serious potential consequences to get this management team to reign in its comments to comport with this legal defense, and it did not take very long to get them to cooperate. I mean, how easy do you think it was to get Marth to chill on the comments and play along with the attorneys?
A lot of work, and a lot of lawyers having a face to face with management, for such little practical benefit, unless, well, there was really some important stuff that this legal defense could protect. As it cannot protect Teva once ANDA approval is given.
Tinker
Here is the gist part of a post on MNTA that I did on the Motley Fool New Paradigm site that I was requested to post here, for which I am happy to oblige:
And yes, the change of language {talking about Teva's change of language in its public statments} may all be due to the litigation posture. Which brings up a conjecture: if Teva has the real goods, and they acquired the real goods without trampling over MNTA IP, then why would Teva be so concerned about such protocols in relation to the litigation? TEVA should have nothing to fear in litigation, if they plan on selling the product in the U.S. anyways, if they have not trampled on MNTA IP. The only reason Teva would be acting this way in regard to the litigation (that I can think of at present) is if either (1) they don't have the goods, or (2) they only have the goods after violating MNTA IP and they know it.
I mean, really. Can anyone think of any other reason for this? And in particular with how carefully Teva drafted their P.R. in early December in regard to the litigation and how they very carefully specified the following: "Teva's version of generic Lovenox, which is manufactured and tested outside of the U.S." That defense disappears as soon as Teva attempts to market in the U.S. (which is the entire basis for the ANDA to begin with). So that is not much of a defense, as it shortly becomes irrelevant upon FDA approval, that is, unless, Teva either does not expect approval, or Teva has indeed trampled MNTA IP.
Tinker
I'll need to take a lot more time to look at the MNKD CR details, as the puffery obviously cannot be trusted. But one positive is that the FDA is requiring a comparison with the old device as to performance. If the old device did not produce something approaching data that might be approval, then there would be no possible reason to compare the new device to the old device in terms of the efficacy. At least none that I can think of.
That may be very positive indicator, and perhaps why shares have only fallen 35% and not further.
But to be determined.
AMLN, who is better situated with bydureon at this point in time IMO, than MNKD is with Afrezza, shares have performed relatively well since the initial price collapse, because of similar circumstances I think, that the market thinks the drug works and is relatively safe and it is more of a timing issue. But I'll have to think it out in more detail when I get the chance.
But that was a thought that occurred to me, the requirement to compare the devices as this is part of the press release:
"with at least one trial including a treatment group using the MedTone inhaler in order to obtain a head-to-head comparison of the data for the two devices."
could MNKD have received FDA approval if it had limited the NDA dossier to the old inhalation device?
Mr. Mann has lost all credence at credibility, and for nothing! Unless his intent was to allow a window of opportunity for insiders to get out. He is the biggest insider and did not get out. So other than it being a congenital character defect, it is hard to understand any other motivation, as the FDA decision was going to determine the share price, not some fluff from Mr. Mann. Why even participate in such trite?
He held the dang CR letter for an entire day! And then he did not release it until after close of the market, while it traded all day, until a short attack which was obviously caused by a leak.
Worldcoms CEO lied to the world, straight-faced, just weeks before the company fell. I saw that on CNBC. Clearly a congenital character defect there to enable anyone to be able to do that as he did, Mr. Mann (not in WCOM's league - no intent to say he is) but clearly he has some of that promoter aspect to him that makes the words he say much more acune to a Teva statement on tLovenox or mcopaxone.
I however very much doubt that Teva would withold a CR letter of this significance in this manner.
The more you think of it, the more this MNKD action really sucks, and the more that I should have bought some puts (and a lot of puts on this binary decision). I had not followed MNKD very close before, and things came up quickly, but that should have been my first use of going short (via naked puts), as there was just no way that attempting to prove bioequivalence with a new device so late in the process was ever going to get past the FDA.
Operational and PR issues to say the least.
Tinker
Lovenox is Sanofi’s biggest product. The Paris-based drugmaker has urged the FDA to reject generics of that medicine, because the Lovenox molecule isn’t “fully characterized” and can’t be duplicated. Teva says the same thing about Copaxone, which generated $2.26 billion in 2008.‹
This process could take years, if not decades. It’s hard to say what the pharmaceutical manufacturers will do. The only biosimilar we have seen come to market was generic enoxaparin and we have not seen a great uptake of that because the brand name company decided to be financially competitive with a generic biosimilar.
Even if a biosimilar is approved by the FDA, we’re not going to see a dramatic cost savings overnight. It will happen over time.
That's why I asked what their intentions are at this moment, go alone - they need to dilute via equity or debt quite massively, or partner, or selling. If they go alone, I can't ignore the massive dilution potential.
I know EXEL very well. I don't have number with me right now. Yes, they have debt raised last year due in a few years, partly to pay back GSK loan. They also have obligation to conduct early clinical trials for the partnered compounds.
I think you came to know EXEL late. EXEL laid off 40% in the 1st qtr 2010 already before they knew XL184 result. Once BMY dropped XL184, there was no question in my they would have to do the same because they don't have the resources.
is that EXEL pruned the rest of its pipeline because it was objectively unpromising.
If XL184 turns out to be something less than the greatest cancer drug of all time, EXEL will carry on just fine. Perhaps they will in-license one or two new compounds.
so 'resolution of lesions' would just mean stable disease. And I spent a little while looking for comparative data for Docetaxel but didn't find any - so it is hard to compare.
EXEL: forgive my ignorance- but why did that big pharma turn down partnering XL184 a while back? Were they not aware of the last batch of data?
Thanks
Zipjet,
I just went through the presentation, and I can see how it is possible for EXEL to possibly get an NDA filed that quickly, given the methodology they are using on their trial.
The other thing I noticed is that this CEO (although no one can really know for sure) has no doubt that Cabozantinib works and is a valuable agent, and has no hesitation, regrets, or any such reservations about making EXEL the Cabozantinib company, none at all. You get to understand why in the presentation, going all the way back to resolution of bone scans in pre-clinical animal studies through present data.
As I specified in my last post on the topic, February is going to be a huge month, and then June is going to be a blockbuster month. I don't think there is going to be much doubt after the June presentation in Chicago as to whether or not this drug has unprecedented medicinal properties. Clearly, yes, it could still flop, and just be another run of the mill drug, but that is not my sense here.
I know the usual rule of thumbs, and frankly I don't have the science understanding to analyze the nuances. What I do is peer through the veil of uncertainty and doubt through inferences from many things that are mostly human related (not strictly data and science) to figure out when something is up, something is real, and when something does not fit the rule of thumb that pretty much describes 90% of most everything in the circumstances that the particular rule of thumb applies to.
I am not sensing that EXEL themselves (in any manner, and it is not just putting on aires, or confidence, or anything not legitimate or on the level) thinks that Cabozantinib is anything but an unprecedented agent.
With VRTX and telaprevir we got to figure that out early. So I bought early. Turns out, there were still risks that I amy not have fully understood at the time, as for example, when you look at ITMN's supposed superior drug that fizzled out due to side effects. But it is sometimes best not to be that much of an expert.
Here, with EXEL, I think we are really going to be able to figure out this drug, early, a lot like telaprevir, within the next 3-6 months, and perhaps as early as next month. The share price is going to react to it quickly, one way or another once we do.
Which is why I'm not so concerned about the technicalities as to whether or not EXEL can get an NDA out in 2012 or 2013, or the exact end points, because we are going to know one way or another if this drug really works as they say it does well before then (which is not something you know with most cancer drugs until much later in their progress) and like with VRTX, the share price is going to reflect this early.
But those were my thoughts (some I've expressed here before) after listening to the EXEL presentation at J.P. There was nothing really new data wise (although the pre-clinical animal slide was nice), but it did put into perspective, much better, the why EXEL is taking this drastic step. I really don't recall any company that has laid off 65% of its work force to focus on just one drug (absent necessity, after a drug fails, or a CR letter is received or some such thing like that).
This is not the normal circumstances, and although the rule of thumb on cancer agents like this may come back to describe what inevitably happens, this is not the normal circumstance (and yes, I don't expect 49/50 bone resolutions, but I do still expect the 50 patients to come back with unprecedented bone resolutions results (and that is not difficult, given how infrequently such situations resolve themselves).
Tinker
HCC and Ovarian data are very good compared to other drugs at this stage. If EXEL had enough resources, I am sure they would move forward on those two indications along with mHRPC.
While everyone is focused on HRPC right now, I like XL184 broad spectrum of activity on wide variety of cancers. I always thought dual inhibiting VEGF and MET had merit. I wouldn't mind pick up some EXEL when it tanks because HRPC data are not up to other people's expectation.
I haven't figured it out what EXEL really intends to do after HRPC data, partner XL184, sell the company, go alone at least until XL184 in last line mHRPC phase III result? If the later, they certainly will need money. I don't know whether they will finance via debt or equity.