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Dew, that is a literal and open tacit invitation for MNTA to submit their application so that the FDA can have one example to work with to demonstrate this two track path they are talking about.
Directly substitutable vs. branded similars? I don't see how branded similar compete vs. a directly substitutable bioidentical.
What is the process here, will there be direct substitutability or will MNTA and its partner need to market it like a branded?
This screams, "MNTA, we need some regulations and templates, show us how it is done so we can do our job."
Further reduces the risk and increases the reward for MNTA.
Tinker
The reason shares are down today is because shares were up 10% yesterday, on news that was amorphous. Such moves rarely stand without a large retrace the following day.
Teva and MNTA are not going to settle, really, because MNTA has no reason to settle with TEVA, and TEVA has every reason to settle with MNTA. It takes mutual interest to settle, and both MNTA and TEVA will play hardball and hold out for the best deal they can get related to the risk/reward of the ongoing litigation.
For TEVA, the litigation date has been set, but they can still use the litigation to delay; for MNTA, they have the science and reality on their side, and a dang good legal case (not certain, no). So why should either party move into the other parties self-interest spectrum so early on in the proceedings? Answer, no reason.
And MNTA is not going to settle for short-term shnare price movement. Management is embedded for years at a time, and want to create a great company that stands the ages if it can. If you annot wait another 6-18 months, then you cannot understand where management is coming from, for either company.
Tinker
Investorgold it looks like you know what you are doing. I have been 100% a stock before on 2 or 3 occasions, but have decided that one should at least have 2 positions becuase a 90% drop in one is only a 45% drop overall, 50% is a 25%, etc., it is at least not catastrophic.
But I don't want others to mimic me, because I have my own reasons as to what and how I do it, and most people cannot duplicate it. I like MNTA, hold a heck of a lot of it, but beyond that I'm not telling my portfolio weightings or holdings because it would be of no value to anyone. Often my largest position performs least well. But yes, I am much less diversified than most, but that may not be a smart thing at all. Depends on what time frame your discussing.
Holding 4 or 5 different companies I can live with when giving any sort of input to people. And it makes sense for many active investors, more so than holding 20 or more. But each person needs to fine their own balance between greed and risk, and just remember to catch yourself when your brain goes into "fantasy land". Sometimes it is difficult to ascertain the difference between what you "know" and your gut tells you, and what you just wish and pray will happen. Invest in what you know and your gut tells you, and stay away from what you wish and pray will happen. Tough to distinguish sometimes, but if you can do it, it pays off.
Tinker
Also, no matter how pretty the risk/reward may seem you need to understand and be able to live with the worst case scenario if it were to happen.
If you have to ask a third party how much to hold, then you should remain relatively diversified. How I invest is a personal decision and many would call it not the sanest manner to invest. I invest in my manner for my own personal purposes.
How you should invest, and what percentages is not something that anyone on a chat board should assist you with. That is something you need to work out for yourself, and if you are at this position as an investor, I would recommend holding at least 4 or 5 different investments, and probably most hold many more. I think with at least 4 or 5, then a 100% loss in one is a 20% loss over all, which most people (except those near retirement) can usually tolerate.
This said, maybe 10 stocks might be a better hold for you. I don't know.
One thing I do know, is that trading in and out of stocks usually materially hurts your portfolio performance. You need to buy at good buy in points, know what and why you are buying, have patience, hold and keep holding until it is time to hold no longer. And if what you are holding and in the portion you are holding makes you stressed out, then do something to destress like further diversification. I don't think you really need more than 5, but 10 is a manageable number as well when you run the math.
If your going to hold more than 10 then you might be better off with a well managed (low cost) mutual fund. Since you are here, I doubt you want the mutual fund. Others may tell you that 5 is way too little, and that even 10 is not enough. But as I run the math, each share with 5 is 20% and each share with 10 is 10%, a catastrophic failure is therefore tolerable holding these number of shares, and it is still few enough to beat the market if you make good long-term investments. If you make poor long-term choices however, at these numbers, then it is few enough shares for you to lose to the market.
So my rec (and I don't necessarily follow it, but for most people it is very aggressive, but still not insane) is hold 5 - 10 shares that you know very well, bought at excellent times, have patience with it, and this provides enough diversification to avoid losing the ship, while still allowing market beating returns without having to become a full-time investment researcher.
Caveat: Free opinion, and I don't necessarily follow it, as I don't necessarily consider myself to be "most people" although in the end I probably am "most people" just like most people are.
Tinker
It is just back of the napkin, but taking out $16 million per quarter as expenses MNTA is gaining about $55 million a quarter at this rate. That is over $200 million in net cash for 2011, meaning that MNTA should exit 2011 with over $400 million in cash and equivalents (including a/r).
Market cap is $879 million, giving enterprise value of $479 million at end of 2011 which is about 2x fcf. If lovenox market becomes less "speculative" vis a vie Teva the share price has to soar. If copaxone is approved the share price has to zoom, and by zoom, talking multiples higher, not just 25, 50%, or even 100%, but by multiples with this sort of cash flow, particularly given that the copaxone market should be very solid with the expected FUD to be the upcoming orals and how they may eat into the market (which will reduce the copaxone multiple from what it might otherwise be, but certainly nothing like the discounting given to the lovenox money which is discounted to the point that TEVA entry is almost guaranteed to happen in the nearer term).
Share price will fluctuate wildly, and a t-lovenox would hit the stock, but down to what? And a copaxone approval would rocket the shares back far beyond where it is now.
Risk/reward: I guess a positive risk/reward, if one wants a textbook definition, is with MNTA at present. Hate to utter that phrase at risk of it jinxing the whole deal, but it is what it is. Limited downside, likely multiples higher upon expected outcome if one believes that MNTA has produced m-copaxone to the same degree of sameness that they produced m-lovenox, and no one else seems likely to be able to do so.
And this ignores the FOB assets (I am ignoring M-118 and the new cancer agent in their entirety. M-118 is looking less and less viable as time drags on and the new cancer drug is too early to pay much heed to at present, other than its development costs).
Tinker
Is there anything in the public domain to suggest superiority of copax over newer oral agents? Regards, bp
I am a lawyer from a good law school who graduated with honors and also do not practice ip law and I refuse to invest in an ip lawsuit. It is a disservice to his audience to comment like this and probably derives from people he networks with with teva connections. I have seen cramer fall for this sort of personality old boy grape vine before with much conviction. I suggest reading the read me on the issue for thebest analysis of the issue. I do not know the outcome of the suit but I do know on the merits TEVA has some real vulnerabilities but all Teva needs is to preserve one patent and drag this out.
Tinker
I would suggest that, in due course, a high proportion of Tysabri patients who test positive for JC virus will indeed cease treatment with Tysabri, either temporarily or permanently. The only reason this hasn’t happened yet is that the JC test is relatively new and the sample size of patients for the issue discussed in this thread is small.
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Funny, how with the TEVA recommedation you cited, that they gave thought to the hypothetical of lovenox being approved mid-2011 but no concern at all to copaxone generic being approved at all, which would be a calamity for TEVA share price.
Nothing like a calculated bias.
Tinker
CRA is the top example along with some B2B companies and heck even QCOM that valuation to vision does matter. CRA was a multi-bagger on the genome hype with a valuation that ate into any visionary forward looking revenues. You just had to sell it no matter what you thought of its business prospects because the best case was already priced in and in the risk/reward analysis there just was not much reward left. QCOM is still a great and succesful company but you even had to sell QCOM when its valuation ate up the forward looking rewards, even on a visionary basis. Still, I had hoped CRA would fare better but the government genome project, when faced with competition, stepped up to the plate. A tesimony to the merits of school competition there I think but not going there.
I am hoping that MNTA might give us the same "problem" someday on FOB hype and craze with MNTA being the only pure play and only company to dump the label "similar" out the window for identical. Toasting to having this sort of valuation risk/reward conversation on the visionary scale with MNTA in a few years.
(it deserved a few smilies that pleasant thought).
Tinker - from the motor XOOM which I Cannot say enough good things about
Were investors placing no value on the Symlin program in obesity?
that's general stuff..
Do you have specifics of the strengths in MNTA's case or weaknesses in TEVA's case as far as composition patent goes, from a legal perspective case ?
tinkershaw - what do you think on copaxone patents? can MNTA win the trial
maybe TEVA says we will not launch LOVENOX until 2014 and you don't launch COPAXONE until 2014....
Sorry - did not know you were posting ancient history.
Teva President and CEO Shlomo Yanai said last week after presenting second-quarter results that he had good reason to believe his company was close to getting approval for its generic version of Lovenox, but he gave no timeline.
Zip,
Seriously, that is the sole basis for your Teva gets lovenox approved in July? That is it?
As stated previously, Teva would not have gotten the minor deficiency letter if that were the case. Clearly there is some "minor" deficiency in their application, and on top of this, even if Teva corrected it, the FDA would not approve it until such time as Teva addresses this other issue.
However, this issue otherwise has absolutely and utterly nothing to do with tLovenox development.
Tinker
I have never seen a management team so confident, without hyperbole, as to the quality of their product. I don't think there is any question that MNTA's management team does not believe, but knows, that their version of copaxone is as identical to the innovator drug as enoxaparin is to its innovator drug. Unfortunately, they have to wade through the regulatory thicket despite this fact.
I do agree that if MNTA is conducting a month or two long bioequivalence study, that they are near the end of the process. It is not something that they would do early on in the process.
I put the odds heavily into 2012, only because of FDA backlog. Were this a less overburdened and efficient agency, I would think the drug is ripe for a 2011 decision. I give it 6-12 months after the period of time that management believes the decision could be imminent. Similar to what happened with enoxaparin.
Yes, it does appear unlikely that tenoxaparin will be approved any time soon, but here is a scenario no one else has broached, what if the FDA approves both mcopaxone and tlovenox on the same day! I think MNTA share price skyrockets once the market actually takes into account what just happened with copaxone, and Teva crashes. Then again, that scenario does seem somewaht ridiculous givne Teva's current enoxaparin posture. It just seems incongruent for the FDA to approve something that is clearly not the same, as MNTA has proven the "same" within the biological variability is indeed possible. A generic is suppose to be medicinally equivalent after all, and not just good enough. Which is s standard that the FDA appears to be holding firm on, at least with enoxaparin.
Tinker
AP made the same mistake as Adam Feuerstein
1.3-1.7 average A1C reduction is consistent across the board with the extended release version of the drug. What bydureon is stuck with at present is that we are probably about the same as Victoza, but only one stick a week, vs. We are better and only one stick a week (that was the monster blockbuster).
Still, if you own MNTA, bydureon is the same drug as byetta. Just a different dosing and release process. Hmmmm, is that not what Teva just tried with low volume copaxone that Teva insists is so material to MNTA's copaxone application and the need for clinical trials?
Just an example at out finger tips demonstrating that same formulation, different delivery methodology does not equal the same drug to the FDA.
Tinker
Update: I take back the "we are probably abou the same" as this quote from the AP story:
The companies said earlier this month that Bydureon proved inferior to Novo Nordisk's Victoza, according to initial results from a late-stage study comparing the drugs. The companies said Bydureon reduced average blood sugar levels in type 2 diabetes patients
Unless Teva wants to launch at risk (which presumes they don't have much respect for this lawsuit) it is hard to see an interpration of this that is negative for MNTA vis a vie the near-term prospects of t-enoxaparin approval.
Tinker
By “horse needle,” I mean a product/needle combination that causes injection pain.
For Byetta/Bydureon specifically, I’ve long thought that reduced dosing frequency was offset or even outweighed by the kind of needle that has to be used to administer Bydureon.
Gulp! I've been in that position of suffering fools (okay I've been the fool before as well). But it is clear Shea is getting tired of answering questions like this to those who are sticking to rule of thumb and surface level analysis, in particular from Teva talking points.
Quite impressive. You don't talk like this if your just spinning and don't have real conviction and knowledge behind the statements.
Tinker
His sideways comment was a 10 year period, so from that perspective he's correct.
It’s touting a metric—“bone-scan resolution”—that isn’t precisely defined and hasn’t been cited in previous peer-reviewed studies.
FWIW for the next 42 patients the bone response rate dropped from 95% to 81%. Still appears good - but given the lack of published historical data... .
when I see that 46% of the patient population stopped taking narcotics for their bone pain tells me something is happening.
I listened to both presentations, and clearly both speakers were put out there to emphasize the point that M118 was not dead. Does not make it so, but the company is pushing that message. I have not known MNTA to participate in hyperbole in the manner that TEVA does, so I'll take it at face value. M118 is not dead yet. Does not make it very healthy right now either, but I'll bite, it may still have some economic value.
Tinker
Did we listen to the same conference call? I keep hearing this refrain that there is "new found optimism" in M118. What I heard was no partner has yet been found, the environment for finding a partner for M118 has been difficult, that maybe things will be loosening up in that market, we have no specific leads but we are still out there talking about it, and in the end the drug has been sitting for so long that any interest in it cannot be real strong.
Well, my reading of it. I'm not ruling something out, but come one, a drug just cannot sit this long without interest. If someone does offer to partner, don't expect much upfront, and don't expect a rapid push through clinical trials. There obviously is not much enthusiasm for M118.
Does not mean that something might not come along, but that is my reading of the issue. It was not quite as bad as Teva's "internal" discussion on low volume copaxone (code for the drug is dead) but it was approaching it, without quite pulling the plug quite yet, as there is always hope, but not looking real good.
Tinker
However, from what I have seen of the civil court system in general is that: they are very attuned to determining economic damages and that they are sensitive to the matter of standing. If Mnta/Sandoz was to clear the FDA approval hurdle, I think the court would view this as a change in standing and would be sensitive to the motions from NVS/Mnta for the need for immediacy of a determination.
Listen to the actual call. I have seldom (maybe never) heard a more confident and precise presentation, that appeared to be spin free.
It sounded like I do in court, and there is no B.S. in court. I was impressed. You can sense frustration in regard to the share price as management honestly believes there is a real disconnect and they articulated it very well. Didn't move the Street any, but it was the most confident and straight forward presentation I have heard in a long time.
Tinker
A total of 31 samples were removed due to insufficient quantity, breakage or failing pre-specified quality control criteria.
Surely a lower priced generic Copaxone, of which NVS would only derive 50% of the revenue, would have some negative effect on the uptake of Gilenya.
Tysabri may be an interesting drug, but more people went BK in ELN stock than most others I know
AGEN,DSCO,SNSS, MRNA, CTIC, OXGN, CYCC, HLCS, DDSS, STEM, APPA, PARD, ANPI, ALXA, ENMD, APRI, BCRX, ACUR,
These are on my somewhat doubt list, but it's possible they might be "biotech values". Affy, vvus, xoma, bcrx, Sva
EXEL: Is there anything unique to EXEL's tyrosine kinase inhibitor that distinguishes them from other TKI's? There seems to be handfuls of companies studying TKI's with limited success.
Good point. Clearly Sandoz is not going to want to give away those copaxone revenues, just because it might be worth billions of dollars in marketcap for MNTA.
Which, of course, it should also be worth to MNTA if/when they do get copaxone approved and on the market. Clearly a significant chink in any merger discussion. Probably a fatal one.
Tinker
The antitrust cops would not allow a company with a big-selling branded drug to acquire the only company capable of developing a generic version of that drug.