alive and kicking
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I missed the point. I guess like everything else associated with GTCB, I needed to be smacked in the face by seeing the human actually falling off the cliff.
iwfal,
I don't think there is much more to be said as we probably agree more than disagree. Good then the thread is done. For your sake as a DNDN shareholder, I hope things work out for you. I don't have a stake in it one way or the other. For what it is worth, at this price, I would be more likely to short DNDN than own it, but I have never shorted any stock so I won't be going there.
<My $0.02: The only thing I can think of immediately is familiarity with concepts like signal-to-noise ratio and open loops (hardware) plus GIGO and perhaps fuzzy logic (software) ;^)>
imnot6,
Engineering is a fine profession and you make some good points. However, there is a fundamental difference between biology and engineering. One of the bigwigs at INTEL had prostate cancer and was talking about using the model of computer chip design and advance where a doubling of speed is about every 18 months, and applying it to cancer research. It is not possible. In ChIP design or engineering for construction, they know the precise physical properties of materials and forces the structure must deal with, so a systematic and logical approach is possible. They aren't going to find out that steel or concrete has some fundamental new properties they never dreamed of, which alter how the building or oil rig will respond to winds and pressure. Yes you can screw up the manufacturing of steel and concrete or neglect to factor in some forces, yes, but there isn't a fundamental uncertainty about basic properties of steel or concrete.
This happens all the time in biology and cancer research. Our knowledge is still relatively limited, incomplete and often wrong. This means the prevailing dogma is subjected to small revisions in our views, and yes, even to "paragdim shifts" that fundamentally alter our views. I think that two of the most recent paradigm shifts were the discovery of the RNAi (or siRNA) pathways, which include its relatives microRNAs. These not only provided tools for genetic examination of vertebrate cells, but also illustrated how complex the processes of transcription and chromatin remodeling were, and how they can be inter-related. The second was the ability to reprogram fully differentiated cells into stem cell-like states and the subsequent discovery that this can be accomplished by over-expressing only a few genes.
For cancer research , one uses tissue culture cells and animal models to identify promising candidates for clinical trials. However, both are crude approximations and candidates often fail in humans trials. You inhibit some growth pathway, but some other redundant pathway kicks in to alter the results, and generate resistance. Such pathways may not be stimulated in culture cells, or don't operate quite the same way in animal models as in humans. You get the picture.
<Again imputing something to me that is highly suspect - that I love the term 'paradigm shift'. And then hinting that only physician's are entitled to medical opinions? Or some other form of stereotyping? Really? On a board where >50% of the interesting analysis posts are written by non medical/researcher "professionals" (well, ok, that's kinda cheating since Dew posts more than anyone else on the board by a large amount -g-)>
iwfal,
Obviously you can post and invest in biotech without a science or medical background. I wasn't attacking or questioning the right of some not in science to post, I was just wondering why the term "paradigm shift" becomes an important defense of why one owns a company. I believe that you did use it so that was the source of my comments. I take it from your responses that you don't have a science background so my advice is to regard anyone who resorts to buzz words like "paradigm shift" as an excuse for problems a company is experiencing as a red flag. I will say I do have a science background and I was too blinded by my love of technological advances that I failed to see what a looming disaster GTCB was. Take my advice and admonitions as a warning based on my own failures. Obviously DNDN is different from GTCB, but if Provenge production facilities and Provenge sales continue to fall behind projections and cash reserves continue to rapidly dwindle, be more skeptical of the "paradigm shift" excuse.
You act as if I am the one raising the controversy. It was a very heated controversy in the NEJM. I will have to go back and re-read it.
If I am guilty of cherry picking, then join the club. I looked at a few taxotere studies, and you are correct there is variation, but the dosage and regimen was being varied as well. What is striking in the 2 taxotere studies I briefly looked at was that the 2 month and 2 1/2 month survival advantage came in studies when the placebo treated patients only lived about 16 months. When studies are trying to determine the best dosage and regimen, why do you think it is important to cite the regimen that doesn't work well? In contrast, the placebo treated group in the Provenge IMPACT trial lived more than 21 months (21.7). Unless I am mistaken, this wasn't when the placebo group received Provenge but a true placebo. This makes it difficult to compare absolute months survival increase in Taxotere and Provenge studies when the baseline survival is so different in the placebo groups. It is also difficult to compare different tumors, so let's stick to HRPC okay and not compare Provenge to Herceptin, Avastin or any other drugs in different cancers?
As far as sub-groups are you talking about those who received taxotere after receiving Provenge? In any event, sub-group analysis on small patient populations are notoriously unreliable, so let's not go there to try and make a point, okay.
<4 months of improved survival with few side effects is quite an accomplishment and it will only get better with future vaccine therapys.>
Why do DNDN longs keep posting stiff like this, along with the paradigm shift comments? Yes, future anti-cancer vaccines could get a lot better, but that has nothing to do with Provenge. I never dismissed the anti-cancer vaccine approach, rather I just raised issues with DNDN as a stock because Provenge isn't an off the shelf treatment, and Provenge has issues that were raised in the NEJM among other places. I also questioned the high market cap of DNDN and raised issues regarding scale-up difficulties.
<You ask iwfal what is his background. I am a physician. I have a background in Engineering. May I ask what your background is?>
I asked iwfal because I didn't like the falling back on the "paradigm shift" comment that he made. Perhaps I was especially sensitized because the DNDN CEO did the same thing, so I wondered what the guy did for a living. What kind of physician are you? Why does a background in engineering have any relevance? Not that it matters since I can be wrong, but I am a research scientist doing basic research. I earned my Ph.D some time ago, did post-doctoral research then I used to run my lab at a cancer center before moving back to academia. I have also been burned by trusting what CEOs of biotechs tell you, so am now far more skeptical, hence my disdain for the use of the "paradigm shift" as an excuse for delays.
<Could you point me to one of the earlier cancer vaccines that has been anywhere near as thoroughly been proven to work? >
Since Provenge is the first anti-cancer vaccine approved, it obviously has the best data to date. It hasn't been proven to work. It has shown in small trials to provide a small survival advantage and fits statistical criteria that say the difference between it and placebo are below P=0.05. That is why I said based on the small improvement in survival and the failure to shrink tumors, that this will play out as more patients are treated.
I wrote <with regards to overall survival were not that dramatic when compared to taxotere ( ~ 4 months vs 3 months survival advantage).>
You respond with <Nowhere did I tout the survival benefit as ground breaking - because clearly it isn't. It is the side effect profile that is ground breaking.>
I object to the casual throwing around the term paradigm shift by DNDN management and investors. They use it as a bludgeon to attempt to silence critics. The small difference in survival between Provenge and placebo, and Provenge and Taxotere means Provenge is NOT a paradigm shift. It is a nice option for patients as they don't have to endure as many side-effects. One reason I don't find DNDN an attractive stock is because of the nature of Provenge. It is not off the shelf, but a personalized treatment so subjected to many potential steps for failure and delays. This many not concern you, which is fine with me. I did notice the CEO liked to use the term paradigm shift to explain away delays. That is completely irrelevant, but if it soothes you and satisfies you, that is fine with me.
I wrote the following, which has been raised by many highly qualified individuals. <it is still puzzling to many how it can show a small increase in survival when it doesn't shrink the tumors. This may be something unexpected for anti-cancer vaccines in general or Provenge specifically,>
You respond with <Neither did ipilimumab show a benefit in PFS (obviously ipilimumab is not a vaccine - but does use immune system). Yet it did show a survival benefit.>
That is great, but it doesn't mean that same is true for Provenge. If we have learned anything, it is not to generalize about different cancers. Why don't you provide me the details of the ipilimumab trial and the cancer it was being tested on so I can get a bit more up to speed?
You also wrote <As for how that might be - this is one of those things I was referring to when I said that one of the paradigm shifts is it will allow us to better understand how vaccines work:
a) Does it only block new mets and thus doesn't directly impact Progression?
b) Is it a delayed effect - and with more data we can find immune markers showing when the kick-in happens? >
That is more a what I would call better research that may help us to understand sooner if a vaccine has a chance for success, but that is hardly a paradigm shift. It sounds a bit like I cult to me when I keep hearing the term "paradigm shift" based on a small benefit. I am interested in your background as it may explain why you seem to love the term "paradigm shift" so much. Just what is it that is your field of business?
Provenge is not the first cancer vaccine and it is not a paradigm shift. It is the first anti-cancer vaccine to be approved, and despite the pumping, its results with regards to overall survival were not that dramatic when compared to taxotere ( ~ 4 months vs 3 months survival advantage).
Provenge does seem to have less side-effects, but it is still puzzling to many how it can show a small increase in survival when it doesn't shrink the tumors. This may be something unexpected for anti-cancer vaccines in general or Provenge specifically, but it could also be a sign that the trial results showing the 4 moth increased survival compared to placebo were a statistical aberration. This will play out as more patients get treated with Provenge.
Actually, the goats will do just fine. The picture should be of GTCB investors falling off the cliff while the goats munch contentedly on some grass oblivious to the falling humans.
<This is precisely my point. The market is irrational undervaluing MNTA on the mere threat of a impending lawsuit. A lawsuit would guarantee MNTA 5-$6 EPS as the sole generic for at least 2-3 years, because the FDA will not get scared into approving TEVA's generic. The stock was trading at $16.5 a few weeks before approval, now under a sole generic (best case) scenario (with hundreds of millions pouring in) its trading at $15... huh... that smells fishy to me. >
I believe you are looking at the herd mentality and mistaking it for some grand plan.
Put me on the list along with you guys as someone ridiculing the conspiracy theorists. Market inefficiencies are driven by a combination of greed fueled by ignorance. The fact that there are a lot of people associated with Wall Street operating in this fashion doesn't make it a conspiracy.
I assume we will now get more some pro-TEVA analysts parroting the "lead to cancellation" non-sense and the MNTA stock price will drop a bit more. This will also allow some of the smarter (i.e. more well connected) shorts to get out without being too badly hurt.
John,
If you had over 200 stocks shown, then you must have posted when you sold them all in 2007, and then repost when you bought back into stocks in 2009 as you claimed here. Did you do so? If so, post the link to the site and I will go there and see the evidence to back your claims. Otherwise it is just another unsubstantiated message board claim by a message board stock picking genius. Yes you are correct, it doesn't matter what I believe, but when you make a claim about selling ALL your stocks near the top in 2007, then buying back near the bottom in 2009 but don't provide any evidence, you deserve to be dismissed, and perhaps even chided a bit. I am doing the latter, as did Dew.
I never owned a pain Biotech. I believe the company you are referring to is PGNX, which I do own, and their first drug on the market, Relistor, is to treat opiate induced constipation. It hasn't done well, primarily because they had to conduct a one year safety study after approval because one of their competitors drugs failed in trials because of side-effects, none of which have been seen with Relistor, but the FDA isn't taking any chances anymore after some recent safety debacles. The one year safety study is for the largest potential market for Relistor, constipation due to opiate usage for chronic pain, and the trial has just completed so won't have that long to wait. Management sucks as they reuse to hold conference calls. One very painful lesson I learned with GTCB is that crappy management will almost certainly drive a stock down and even out. One stock that has been mentioned here, ONCY, has a horrendous CEO, Brad Thompson, who predicted they would have their oncolytic REO virus on the market in 2002. The guy keeps making wild ass predictions that never even come close, but he never pays a price. I owned a small amount of the stock several years ago, but sold off after reading more about the CEO, and only lost a small amount in the process.
I do recall the issue at hand. PGNX just received cash from a Relistor deal, and stated they would use some of the money to periodically buy back some stock. It seemed like a reasonable move at the time, especially since there wasn't a rush or a firm commitment to do so and PGNX had plenty of cash on hand. You didn't know anything about PGNX, yet were sure it was a very bad move. I understood your view about cash, but disagreed. Don't post that I didn't understand your point.
I assume we will see an even more aggressive attack on MNTA and the FDA by TEVA and its paid stooges. By the latter I include both talking heads in the media and "esteemed" member of the US congress. I mean how else can you refill the coffers for the next house elections in two years if not by taking cash from Teva lobbyists.
From a post by saw_bucks on the yahoo board.
<Onyx Pharma's Appeal Increases After Insights On Bayer DealFont size: A | A | A3:21 PM ET 11/4/10 | Dow Jones
By Jennifer Cummings
Of DOW JONES NEWSWIRES
NEW YORK (Dow Jones)--Biopharmaceutical company Onyx Pharmaceuticals Inc. (ONXX) may start looking a lot more attractive to potential suitors next month.
The new allure comes after Onyx late Wednesday eased fears that an acquisition of the company would trigger much lower payments from its partnership with Germany-based Bayer AG (BAYRY) on the liver and kidney cancer drug Nexavar.
Shares of Onyx were recently up 5.6% to $28.19 on three times the average daily volume. The gains came even after the company reported mixed third-quarter results and lowered its 2010 global net sales guidance for Nexavar.
The momentum was sparked by new insights Onyx provided in a regulatory filing Wednesday about a clause in its partnership with Bayer.
Under the terms of the pact, their 50-50 profit-sharing agreement on the drug would end if Onyx were taken over, and Bayer would instead pay royalties to the newly formed company.
This so-called "change of control" clause has been an overhang on Onyx's shares because it was expected to trigger much lower payments to the company, likely detracting potential suitors.
But on Wednesday Onxx revealed new details about this clause, saying that as of Dec. 20 -- the fifth anniversary of the approval of Nexavar in kidney cancer -- the structure of the agreement with Bayer adjusts, and after that date, the value of the royalty payments will be "substantially equivalent" to the current 50-50 profit sharing agreement.
Onyx declined to comment on its potential as a takeover candidate and said it isn't actively pursuing a sale.
"If we receive an offer, the Onyx board of directors will evaluate the opportunity and what is best for shareholders, but we remain focused on building a standalone leading biopharmaceutical company," spokeswoman Lori Melancon told Dow Jones Newswires.
However, analysts said the new insights increase the appeal of the company.
"In our view, this significantly opens the playing field next year to potential acquirers looking for rights to a marketed cancer drug," Canaccord Adams said in a note Thursday.
Stifel Nicolaus & Co. analyst Stephen Willey said that while he thinks this will make a "non-Bayer acquisition of Onyx a bit more friendly," he noted that ongoing litigation between Onyx and Bayer could still put off potential acquirers.
Nexavar is Onyx's only approved product, and the company is working with Bayer on expanding the drug into other treatment areas, including late-stage lung cancer. Onyx also has a multiple myeloma drug, carfilzomib, in clinical trials and plans to file for U.S. approval of the drug in 2011.
-By Jennifer Cummings, Dow Jones Newswires; 212-416-2474; jennifer.cummings@dowjones.com>
<Richard Adams, a former official in the FDA's generic-drug division who retired this year, agreed with the bias allegation. "Everyone closely involved saw that it was stacked and the whole direction was toward Momenta," he said. >
It depends on why Adams or anyone else felt the process was biased towards MNTA. If it was because MNTA was the only ones capable of definitively showing m-enox was equivalent to Lovenox, then it is obvious why the FDA would and should be "biased" towards them.
People don't want to face the facts they we don't have an unlimited amount of money and the idiots on Wall Street fuel the fire with even more unrealistic comments. I read where one analyst was talking about Provenge and saying DNDN wasn't charging enough because some drugs cost $200K to $400K per patient. Now those drugs are orphan drugs and the high price was set to enable companies to keep making drugs for a very small patient population. It is absurd and a mark of the delusional greed that fuels Wall Street to use that type of pricing for a large patient population.
Now if the US government decides that the benefits shown by DNDN isn't worth the $93K price tag, DNDN will have to lower the price and accept less profits to get Medicare approval. What a shame.
Dew,
Right on target. I will also add that in Canada, and in Europe they limit the price they will pay for drugs. Companies accept lower price abroad and jack up the prices in the US to cover the difference. In essence, US citizens subsidize health care costs in other countries.
Biowatch,
RIP, GTCB. What a sad end to a once promising company.
Jq1234,
As far as the Tokyo real estate bubble, I vaguely recall a statement that at its height, the total price of all real estate in Tokyo was nearly as much as the entire commercial real estate value of the US. It seemed too bizarre to be true, and I never checked it out so it might have been hyperbole to illustrate how wild the Tokyo bubble became.
oldberkeley, zpjet and bladerunner,
What is wrong with you guys? Don't you realize what passes for good governmental policy is to repeatedly utter simple one liners with no depth or any thoughts of the costs of actually doing what one is proposing? I guess that is why an uninformed, superficial, inexperienced simpleton like Sarah Palin is considered a leading voice of the Republican party, God help us all. I sat that as a truly embarrassed Republican. Maybe Palin feels she is a monetary policy expert since see can see a bank from the front porch of her house.
It truly does astonish me that supposedly intelligent people were actually saying we needed to let things crash and burn and somehow that would make things better. I will bet the people offering that agenda are very wealthy so figured they would be fine, but they don't stop to think how much the value of their assets would erode if things actually did collapse.
john,
I do recall you wanting me to go to some site to check your record. Before that I asked you some very simple questions about what stocks you liked, what you owned, etc but you refused to answer and wanted me to go check some site. I had no desire to go there or participate exactly because you refuse to give a direct answer.
I have been very straight forward and clear, in contrast to you reluctance. The stock I have been buying over the last year or more has been ONXX. You can check it out because I posted when I bought on the ONXX board.
Now you are claiming you sold all your stocks in 2007 and bought back in 2009. Good for you, assuming you are telling the truth. I for open don't believe you. Now if you want me or anyone to actually believe you, then show us the posts where you stated at the time you sold in 2007, and where you posted at the time you bought in 2009. It is quite easy.
Dew,
<I sold out of all stocks in 2007 and went to cash, bought back in 2009 pretty near the bottom…>
{{{You and 95% of the people who post on investment message boards.}}}
Now that was funny, but don't you see that it makes perfect sense. These message board geniuses all sold near the top in 2007, and that caused the big market decline. Then they all bought back in at the bottom in 2009, so of course all that buying drove the stock market higher. It really is so simple. Of course it depends what stocks they bought back into in 2009, and how they performed since buying them, but why bother them with details.
oldberkeley,
Well, there is a difference between feeling good about some wealth accumulation as opposed to the dread at watching ones entire portfolio shrinking week after week and month after month. It is fine to feel better as I do myself about the current rise. Maybe that is what the not so wise Greenspan is pontificating about. Irrational exuberance would be buying lots of new big ticket items and increasing your spending but "financing" it by going deeper in margin to "maximize returns". I don't think we need the market to go much higher very quickly. It will be pretty good if we just drift sideways or perhaps a slow increase.
I will mix some metaphors in an effort to sound as profound as Chauncey Gardiner. It is okay to dip your toes in the water at the ocean, but the water goes in and out so don't wade in over your head and get stuck without a chair when the music stops. :)
I haven't even started drinking yet today!!!
Dew,
DNDN with their $40 price was priced to perfection so I am surprised that it hasn't dropped more. One of main my criticisms of DNDN was how difficult it was going to be to scale up. The sales numbers that were being thrown around were absurd with analysts talking about $1 billion is sales in 2011 as if it were nothing and easily reached. Making Provenge is a much more labor intensive process than most therapies as it must be personalized, and as such, will be far more prone to disruption, delays and increased expenses.
It liked this excuse by the CEO with hyperbole thrown into it.
<<CEO Mitchell Gold asked investors to be patient as the company builds out its infrastructure to make Provenge.
“It’s one thing to launch a new drug,” Gold says. “It’s entirely different to launch a new class of therapies that dramatically changes the paradigm of cancer care.”>>
The broad class of treatments called immunotherapy does have the promise to dramatically change the paradigm of cancer care, but that isn't relevant to DNDN right now and Provenge isn't that therapy. What matters is that yes, it will be difficult to expand production of Provenge, which is stock is still over-priced since many questions remain as to how quickly or how reliably they can expand production.
I liked this comment.
<A day after Momenta announced earnings of $0.70 a share, which beat estimates of $0.52 a share, Teva decided to rain on Momenta's parade. Teva management said it would be "deeply disappointed if we didn't get the approval this year" only a day after Momenta's management touted its solid position as the only generic version of Lovenox.>
I will be deeply disappointed if I don't have relations with a hot starlet. The important thing is what are the probabilities of such an event happening.
TEVA will continue to spout as much BS as they like until the FDA issues a ruling that they can't BS about. Analysts will publically say and interpret what they want to benefit their biggest clients. The reality is that until the FDA officially rejects TEVA there is a possibility of T-enox, no matter how slim it seem or how much the evidence seems to point against approval. We MNTA shareholders will just have to bide our time until more time passes and it becomes more and more apparent that no approval will be forth coming. That is why I said it might take 2 or 3 quarters. Since MNTA has paid up its developmental costs, the next earnings report will show a nice boost in MNTA cash on hand.
I finally learned how Wall Street works and did expect this to happen. I do appreciate getting the opportunity to buy more at lower prices.
I was thinking it would take at least 2 or 3 quarters before the TEVA overhang is lifted, excluding of course an FDA rejection. I wouldn't expect TEVA to volunteer any information unless they are legally obligated.
Did you see how much the cash burn has been reduced? It would have meant something if they did it 2 years ago.
oldberekely,
Thanks for a big laugh in the late afternoon.
I bet the company had some hot women in skimpy outfits handing out the trinkets, and that raised their profile, among other things. :)
biopearl,
The truth is I don't recall much of our exchanges, rather the what sticks to me is my failure to sell at a higher price than the $2 I did for 60% of my shares. I think that we were both frustrated by what we saw as the squandering of a potentially great company by truly clueless management. Rather than beating a dead horse and now blaming GTCB management, we both take full responsibility for our decisions, and ultimately, our losses. That way we learned valuable lesson to be really skeptical by management who can't seem to ever deliver but always has a good excuse. Best of luck to you as well.
Vinny
<How did the scientists know whether the mice were depressed? >
Simple, you just read their investment portfolio and see they invested in GTCB.
The board should hold out for $0.31 a share.
biopearl,
Yes I did. It just serves as a lesson on how absolute shit management can destroy just about anything. A painful lesson that won't be forgotten.
Flo,
No, the GTCB board is just waiting for the partners that Cox kept telling us were coming to appear as a white knight. What a freaking disaster.
Does the fact that SGEN has 3.5x the market cap of IMGN and the fact IMGN has using an"armed" antibody (Herceptin) that is already approved for a very large market factor into your comparisons?
<<Termeer also would get a cash change-in-control payment of $11 million. So he would pocket $29 million if Genzyme accepts the $69-a-share offer. However, he would lose $38 million in the present value of three year’s future pay and so would end up $9 million in the hole.>>
I would love to fall into that kind of hole!!
Dew,
I just took a brief look, but the guy is really stretching the point to the absurd. I guess it depends on what you mean by false and what kind of experiments are being looked at. You have stated co-relation is not causation so I know you the issues at hand. It gets worse now with people doing large scale genomic studies looking at how different drugs or treatments such as shRNA knockdowns affect transcriptional profiles of all genes, cell growth, death etc. You will always find some interesting correlation, but one needs to confirm independently in several ways, which isn't possible to do for all the or even many genes in large scale genomic studies. I look at such studies as possibly proving some hints with which to examine later in more detail if I see something that catches my eye, but one knows you have to sift through a lot of garbage to find a gem.
I am sure the author wasn't talking about all science.
Wallstarb,
If you can contact the guy you know, tell him I am just one of many rooting for him. I think the card counting analogy is pretty good, except the casino doesn't have the ability to use hidden rules to alter the payout and take a bigger cut if it looks like you made a good bet.
I think they should get a reward, and a job at the SEC. They can use their knowledge to identify and lead prosecutions against companies that do use trading algorithms to manipulate markets.