alive and kicking
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iwfal,
The whole premise that sequencing the genome would be the key to understanding medicine or greatly improving heath care is absolute non-sense. I said it when the idea of genomic sequencing first came out, and it is non-sense now. You seem to be trying to diminish the importance of DNA when it comes to heredity with the comments about single mutation and their penetrance or lack thereof in diseases. There are layers of regulation to control pathways. Even when a mutation disturbs a pathway, positive and negative regulatory networks serve to buffer the system to help ensure a function that approximates desired output. They include alter RNA processing, RNA stability, translational regulation, post-translational modifications and so on. These are also encoded by primary DNA sequences, and the combinatorial effects are too astronomical to predict based on primary genomic sequences. There are trends that can be assessed for a number of allelic variants, but specific and reliable predictions from single gene mutations are rare. If it weren't for such redundancy and regulatory controls, none of us would be born.
Yes epigentics provides another regulatory mechanism to generate more plasticity without requiring primary DNA sequence changes. Yes there can be environmental inputs that alter pathways. Yes the are some unusual other regulatory controls, but I find in disturbing that you and that author keep diminishing "traditional" genetics in an attempt to appear profound.
iwfal,
I can't access the article but I will make some general comments. The article sounds like some self-promoter trying to over-emphasize some interesting observations by jumping to the most radical conclusions.
Something is wrong. I bought more MNTA this afternoon, yet the MNTA stock price rose afterwards. I guess TEVA's non-guidance on t-enox served as green kryptonite to my stock price delating powers. It is about freaking time somebody put me in my place.
jq1234,
We have waited a long time to get some good news from PGNX. Hopefully this will new deal will get PGNX back on track.
<FWIW a yahoo poster claimed HPG (HealthTrust Purchasing Group) will be switching from brand to m-enox at end of Feb. If true, would be interesting to see if more GPO contracts start switching over. >
I thought MNTA/NVS was already running near capacity in terms of their abilty to supply m-enox. Did I miss any news of an increase in production capabilities?
<Actually, it took 32 months (from Nov 2007 to Jul 2010).>
Dew, it would make me very happy to see TEVA get as "lucky" with their "minor" deficiency letter as MNTA did so MNTA can collect another 3 years of m-enox profits.
<Describe for me, please, where in the Constitution it says that a right of citizenship is basic healthcare?>
Where in the constitution does it say there must be public schools paid for by every taxpayer? It doesn't.
Where does it say in the constitution there should be something along the lines of social security and medicare?
It doesn't.
Where does it say there should be national highway system paid for by taxes?
I doesn't.
Where does it say in the constitution that the government can stop a woman from having an abortion, to block stem cell research, or for that matter prevent people form smoking pot?
It doesn't.
<Our Constitution is made up of negative rights, WHAT THE GOVERNMENT CANNOT DO TO YOU. You turn it on its head when we have a right to ENTITLEMEMTS from the government.
Your remedy: Amend the Constitution. >
I assume you mean the Bill of Rights, not the constitution per se. In total, the constitution and all the amendments do set limits to guarantee rights. However, they also give the federal government powers to promote the common good in a variety of ways not directly spelled out an subject to interpretation.
tinker,
<And in fact, it is much worse, you are taxed for living and breathing as no matter if you work or not, the only criteria for paying is that you are breathing.
How many here are in favor of a living and breathing body tax?
That argument is not going to make it anywhere. >
It is truly absurd to call it a living and breathing tax.
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.
tekcor,
<I guess this would be better than selling shares. Every insider that has sold has managed to sell at a higher price than the current price going all the way back to May 2010 (based on insider transactions page on Yahoo).>
Let's see. Insiders are granted a large amount of shares, their first product gets approved, and they sell some shares. You find this horrible and a sign that management knows a disaster is imminent.
Here are a few questions for you.
According to you, when can management EVER sell shares?
What percentage of these shares sold were options that were set to expire and become worthless if they weren't exercised?
Of the shares sold, how many were direct purchases by insiders, what price were they bought at, and what price were they sold?
< Quack.>
Yes, you are a quack.
If you have a job in the private sector, you have to pay social security taxes. Is that unconstitutional?
tekcor,
<Okay everyone, sorry I brought up opinions about MNTA management. I'll stop pointing out my observations -or- stating my opinions regarding the subject. >
Please stop whining about not posting your opinions simply because nobody agrees with your premise. You brought up an issue, and many people explained why they felt you were off base. It is fine if you don't agree, or still have reservations. What is a bit annoying is that you followed up with a comparison of the TEVA-MNTA situation to that of MSFT-Netscape. When the absurdity and complete irrelevance of your analogy was made clear by several posters, you whined and tried to play the victim.
Please feel free to raise additional issues in the future. If someone raises an issue and is challenged, then one needs to flesh out the rationale for that position, and then rebut if necessary to buttress your position, or change your position based on new information or viewpoints.
<Disregard MNTA's $12.48 stock price, their management has absolutely nothing to do with it.>
I was glad to be able to buy more at a low price. I would like MNTA stock price to be higher next year and the year after that. I am not sure what else you want MNTA to do about the current low stock price or what TEVA is doing. MNTA filed a law suit over IP, and is challenging TEVA over Copaxone. Perhaps you would like Wheeler to say "TEVA, liar, liar pants on fire" and keep repeating this until the stock price rises.
<It's true that BRCA mutations represent a very small subset (and very resistant btw) of patients with breast cancer but various other cancers are linked to these mutation.>
Quite right, but if you are designing a therapeutic regimen it might be better to have a high percentage in a few defined cancer types, rather than a very low percentage occurence in a variety of cancers. Well, you could do genetic screening to parse out the BRCA mutations.
<I could cite Netscape which had the only web browser at one point. Microsoft entered the market and were relentless in trying to crush Netscape and increase market share. We all know what happened to Netscape.>
Of course the an analogy of Netscape with Microsoft in terms of their browsers is completely absurd. Anyone can develop a browser and market it. Microsoft used its almost monopoly position to drive Netscape out of business and they could do it because there was no regulatory agency that they had to submit to before releasing their browser. TEVA must go through the FDA and they can issue as many press releases as they want and pressure as many analysts as they like, but the FDA will make the final decision. How much TEVA can influence the street in the interval is irrelevant. If they don't follow up their nebulous "in the near future" comment with some specific timeline and ultimately, submission of data in the next few months, then it will become clear that their submission is in trouble. What the street believes now is irrelevant since they don't know anything specific. Even when TEVA finally does submit their response, they still have to wait until the FDA rules.
I am through with with this Tekcor as there is something wrong with him. I make a joke about ducks and decoys and the guy looks for a definition in wikipedia.
For all the press BRCA1/2 gets, it is prominent in familial breast cancer, not in sporadic breast cancer. Off hand, I recall that the BRCA1/2 breast cancers represent under 10% of the total and may be as low as 5%.
<"If it looks like a duck, swims like a duck, and quacks like a duck, then it probably is a duck.">
That is how hunters operate. They put out decoys that look like a duck and blow into a plastic/metal device to make sounds like a duck. Any gullible ducks who are fooled swoop down then get shot and served for dinner.
10nisman,
I see we are on the same page.
Tekcor,
<In my previous post I pointed out how (IMO) the street reacts positively to what TEVA says versus what MNTA says. This seems like a disturbing trend to me. And as we all know, stock prices are heavily based on trends (whether they are short term or long term). I am concerned that this trend might last long enough to where tEnox is actually approved. After all (IMO) the more time that passes the higher the likelihood of tEnox approval.>
Actually, stock prices based on trends are short term phenomena as the truth will eventually win out. That is why the FDA deficiency letter is a big deal, but not as a blow to MNTA as it seems the market has decided so far. TEVA can bluster all they want, but the letter is the crucible in which the truth shall begin to be distilled. Obviously no one except TEVA and the FDA can say for sure what is in the letter. What we do know is that the FDA didn't approve t-enox, but rather threw the ball back into TEVA's court. The longer it takes for TEVA to respond to the FDA, the harder is will be for them to portray it that the letter contains only minor issues easily deal with to secure approval.
tekcor,
Just because TEVA can distort and manipulate successfully for a short period of time doens't mean that MNTA should do the same. I much prefer sticking to conservative guidance and let the truth eventually win out.
<The fact of the matter is that MNTA has to show it has legitimate interests beyond generic Lovenox. In presentation after presentation, Craig Wheeler has proclaimed the generics business a sideline to allow Momenta to develop its new drug candidates.>
I really hate when people use the term "fact of the matter" in their comments. Can they really think using these extra words makes their point more valid. It reminds me of people using the term "at this point in time" instead of saying "now". Just say you think MNTA has to expand beyond Lovenox.
tekcor,
You have really asked only one question, why does the street consistently believe TEVA despite their having been wrong on their past two t-enox timeline predictions. It has nothing to do with MNTA and its credibility, and for you to suggest so makes me doubt your motives.
What makes you think that the street is a rationale and honest broker of news and probabilities for success? Jesus, the street was pumping the dot com stocks until they collapsed, pumping CDO and other toxic mortgage products until they collapsed. How much more evidence do you need?
Flo just stated it very well. TEVA is a $49 billion company and they have a lot of influence. Many of the analysts and the brokerages have vested interests in promoting TEVA, and to foster their goodwill. Why in God's name would they put themselves on the line by publically criticizing TEVA until they have to do so? The street will continue to buy whatever TEVA is selling until they are forced to retreat. TEVA is playing it very well by continually keeping the specter of T-enox alive.
jb,
Correct, TEVA got a letter and none of us knows what is in it. TEVA could have said, we will respond in 2-3 weeks, like the other company cited here, or in this quarter, or by mid 2011. The point is they we were willing to place specific timelines when they knew nothing and subsequently missed those timelines. Now that they get information form the FDA, they can't place an estimate, say 6 months and then beat it. Sounds like purposeful obfuscation after receiving less than stellar news to me.
jb,
<I don't recall ever having a company announce a date when they will respond to the FDA upon making the announcement that they have received an FDA letter. >
So how many deficiency letters have you read, and more importantly, how many company responses have you read? We do know TEVA had no problem talking about specific dates when they expected approval as they mentioned August 2010 or that they would be disappointed if it didn't occur by the end of 2010. These precise timing expectations were given WITHOUT specific input from the FDA. Now TEVA gets a deficiency letter from the FDA and all they can say is they will respond in the near future. That is a change in tone.
<Okay, TEVA might be spewing a lot of BS, we get it. But one has to wonder why MNTA's credibility is lacking/disregarded.>
tekcor, I have no idea what credibility issues you think MNTA has. It can't be anything related to t-enox since MNTA cannot possibly say what news TEVA received in their deficiency letter. We do know TEVA had no problem talking about specific dates when they expected approval as they mentioned August 2010 or that they would be disappointed if it didn't occur by the end of 2010. These precise timing expectations were given WITHOUT specific input from the FDA. Now TEVA gets a deficiency letter from the FDA and all they can say is they will respond in the near future.
cactus,
NIce characterization of change in TEV's language from specific dates to the more nebulous "in the near future", as that is something that stuck me as well.
I bought more today at $13.13, just for luck!
I always jump in too soon after a big drop and almost bought in the low $13s today. I am holding off buying more until tomorrow at the earliest to see if second drop is coming.
<Secretary of Defense, Gates said today that North Korean missiles could reach the US mainland in five years. Isn’t that kind of slow for a missile?>
LOL
<Squeezin' the family jewels - thanks,>
Well, sometimes it is nice to have someone new do the squeezing.
I am always amused by projections about sales or earnings several years in the future. I read one analyst talking about his projections for Provenge sales in 2020!!
Dew,
Thanks again for the reference to previous posts. You are a great resource. I think I have said enough about DCTH now.
exwannabe,
Thanks. I vaguely recalled that the OS numbers for PHP were worse than the control arm. To be honest, I haven't spent a lot of time looking over DCTH, just drips and drabs from DCTH longs making wild claims on other boards. Was there some correlation with declining liver function from the PHP treatment, and the lower survial in the PHP group?
jq1234,
My dad had RFA done for his HCC, and it was very effective since he had only one or two lesions at any time. He made it about 2 1/2 years and had three RFAs, but was done in by a stroke. Apparently, Hep C infected patients are at a high risk for stroke. Still, it wasn't a bad way to go, as he was shopping, had a massive stroke, never regained consciousness and was gone in 2 days.
ron,
A secondary endpoint is indeed overall survival, so the question is, why isn't the overall survival data being mentioned? I was also amused by the following description in the 10K
"" The primary endpoint of the study is to determine hepatic progression free survival, which is the length of time a patient is both alive and free from any significant increase in the size of the tumor within the liver. ""
If the patient is dead, measuring tumor progression isn't a good metric.
One thing that has bugged me about DCTH investors is that they keep going from board to board making wild projections. One guy kept talking about the DCTH system being used in hepatitis B and C patients, as if it was inconsequential that those patients had compromised liver function, and the DCTH system subjects livers to massive doses of chemotherapy.
Can you provide a link showing the SPA agreement for the DCTH trial where is states OS isn't the primary metric?
It is hard to say there is extreme bullishness now. There was extreme bearishness for a long time, and now that appear to have lifted so people seem more inclined to invest some money. Perhaps by comparison it looks very bullish to where we were but I don't see any frenzy of people saying a major bull market is here or coming. I guess one indication of extreme bullishness would be high levels of margin. Anyone know where such figures can be found?
Dew,
Thanks. I thought you had posted your skepticism about DCTH before. When management pushes a spin heavy view, it is cause for major caution.
If the DCTH trial wasn't powered to show OS, then they will have to conduct another trial that is powered to do so, right?
Regarding DCTH, why isn't there any data for overall survival?
As far as the BMY-EXEL decision, internal politics can play a role as well. For example, some big-wig could put pressure to make their baby the number 1 priority to maximize their profile in the company.
imclonian,
Please keep going as I can use a good laugh each morning. Yes, inflation is sure surging in our economy now, NOT. Will there be some inflation? Yes, there will but please stop with the chicken little act.
Right,some guys are yelling about deflation and others inflation. Oh who to believe.
zipjet,
I knew it was a joke, but I couldn't come up with anything funny, so I tried for a profound comment. I did like the visual analogy of the turtle neck and foreskin.