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Thanks Nieves and Loop...I'm simply asking posters to include links in their copied and pasted articles or article excerpts. Revlis always does.
If there is a link to this, please post it. If not, please say why. Thanks
It was removed by the administrator for vulgarity. I requested it be restored because it was only mildly vulgar, in my view, and was not directed at any other poster here.
Actually, it's two Dems and one GOPer, not the other way around.
There's a lot of potential pitfalls here for the "conspirators." Scher is in by far the worst position, because he did not disclose his relationship with NOVC nor his relationship with Proquest. Then there is the potential that he was an oncologist source for the short hedge funds over the years regarding DNDN/Provenge. For example, if he had been paid by that Gerson Lehrman matchmaking firm to speak on conference calls with hedge funds prior to the Provenge AC meeting and did not disclose this to the FDA, then we are looking at possible conspiracy charges, even RICO charges, if Provenge was discussed. I imagine that if this were indeed the case, then he will be praying that 9902B misses statistical significance, because a participant in a criminal conspiracy that results in loss of life can be tried for manslaughter, even murder. This is all speculative, of course. We don't know how entangled he was with any hedge fund beyond Proquest.
If Scher is subpoenaed and not offered immunity, I think he will take the fifth. I really hope he is not offered immunity.
The only additional info that the company might know is the rate of progressions in 9902B, but the median difference between the two arms is only one or two weeks. Not easy to glean survival clues out of that. The company does know more about the 483 issue than we do, and their timeline for resolving it has moved from "end of 2007" to "when we unblind 9902B for the first time."
Thanks Saul, it's always nice to have additional confirmation of "douchebaggery a la Aschoff."
Sam, perhaps he doesn't know he is one, but merely fears he is.
Hilarious!! Thanks...James Watson, meet Ted Haggard.
If the funds are available, I would see any artificial drop on a negative Pumfrey decision as a buying opportunity. The headline could very well drop the stock price, and then enough info could come out about the negligible practical impact on royalty revenues that the price could go back toward where it was before the news of the decision.
Aschoff got three things right about DNDN: the general direction of the stock price movement in 12/04, the statement in 2/05 that 9902A would miss stat sig on survival (although DNDN had already said this would be the likely outcome), and the FDA decision in May 2007. He was wrong on:
-his accusation in 12/04 that DNDN mgmt was lying about the actual statistical significance in survival in the 9901 trial
-his accusation over this same period that the stat sig p value was driven by the imbalance of Gleason scores of 6 or less that favored the Provenge arm
-his accusation over the same period that the stat sig p value could also have been driven by the presence of more visceral metastases in the control arm
-his accusation from early 2005 through the present (after being proven wrong about the above three accusations) that the stat sig p value was definitely due to more and earlier chemo in the Provenge arm (he's still wrong)
-his belief that the FDA would not accept the Provenge BLA
-his belief that ODAC would review Provenge
-his repeated citation of incorrect FDA briefing document adverse event statistics that had already been corrected in the briefing doc errata section
-after being proven wrong on ODAC, his belief that CTGTAC would vote thumbs down
-his statement that CTGTAC changed the efficacy question (FDA execs changed it)
-his statement that the efficacy question was more lenient than FDA standards
-his belief that he is not a douchebag
Here's my guess from yesterday:
#msg-25071592
Bygones...eom
<<I don't think InterDigital had the foresight to try to give investors in my spot or the IHUB gang (as someone suggested earlier) a chance to react first...>>
That someone was me, but my post was clearly in jest.
#msg-25065220
I didn't view the panel, but in the past, if Pazdur wasn't supportive of the BLA, he would maneuver a way to let the biostatisticians dominate the discussion at the expense of the clinical discussion. Seeing as how there were two biostats people on the panel out of nine total members, I'm assuming that was the case this time as well (the DNDN panel had one biostat doc out of 17 members). I also think that sometimes consumer advocates pay more attention to toxicity than do oncologists, and Avastin's added toxicity may have been a major factor in the negative votes from the two consumer/patient advocates.
Perhaps the company is throwing a bone to the I-Hub board by delaying the PR, letting those of us in the know buy the stock outside of regular trading hours, at a lower price.
Just deleted the Maha thread. While her reasons for voting no on Avastin are wrong, in my opinion, there are better ways to direct putdowns towards her.
I believe that in the control arm, crossing over to Avastin after progression was not allowed.
Thanks rev...this is something I used to know off the top of my head. My mind has been too full of DNDN this year. I'm amazed at the recent stock price. A lot of it, I'm sure, is the macro market weakness plus tax-loss selling. The ~$10 million miss on recurring revenues was just an excuse to take the price down further. I'd sure like to see top mgmt buy some shares in the open market. I think the lack of insider buying is one reason WS support just isn't there, company buyback notwithstanding.
<<I think it's a lot more than that. First, it's 5% annually for the five years of 2002-2006. Second, it's 5% for the year 2007 post-award.>>
Someone (mschere?) mentioned that the $134 million amount plus interest, when awarded at the time, was only for 2002-2005. That would be great, as Sammy's sales for 2006 and 2007 have been big.
<<Back to Samsung III
The Tribunal will be hard pressed to take on an arbitration that involves issues disputes that have previously been resolved in an arbitration that has been confirmed by a US District Court. I suspect they will read the opinion and deny the application.>>
I would agree strongly. For the Tribunal to accept the application and let the Sammy III arb go forward, it would be tantamount to confirming the Tribunal's own irrelevance.
I think it's a lot more than that. First, it's 5% annually for the five years of 2002-2006. Second, it's 5% for the year 2007 post-award.
I must say, this was a real beatdown administered by the new SDNY judge. The previous judge was either clueless, shiftless, worthless, or some combination of the three. Sammy never had a chance in this appeal. We all should remember three things: (a) only one out of the past 10,000 ICC awards have been reversed by a judge, (b) 90% of these arb decisions are 2-1 votes, and (c) the Sammy II arb vote was 3-0 in favor of IDCC.
OT-GAB...to answer your question, IMO the stock you referred to in your PM is not yet a buy. I don't have a position, and I don't expect to see any positive catalysts for the next few months. For humanitarian reasons, I hope I'm wrong.
Because DNDN wanted to emphasize survival at the panel meeting, they spent very little time rebutting Hussain's falsehoods on the ttp issue. Probably a tactical mistake on the company's part, but they did get a thumbs up vote, so it's hard to say if it was more than a minor one.
LTV, you summed up my reasons for a current investment in IDCC better than I can. To expand on your Point #4, the General Dynamics and South Korea Telecom? consulting/expertise contracts may be even better examples of respect in the wireless industry than LG, Sharp, NEC, Kyocera, and even RIMM and Apple.
David, great interview with Kanzer. I'm surprised that no journalists or bloggers have made the effort to get his side of the story. Who would have thought that Maha had a conflict of interest there as well? LOL
The early deaths in the Provenge arm probably would have prevented 9902A from being stat sig, even if the trial enrollment was 125 pts and the patients had been followed for a longer period. That's my impression from the crossing of the two arms' survival curves for the first 12 months.
You can go to the OSTK board on I-Village if you want to hear everything on this subject. There actually has been progress made in the Overstock and Biovail suits against the brokerages and hedge funds, but there are smoking guns in those cases.
Speaking as an investor in biotechs for the past few years that have been heavily shorted (and some even lied about by analysts at the behest of hedge funds), there really isn't much that can be done if both Congress and the SEC refuse to act, and if the mainstream media remains as asleep as it has been for the past seven years. Even the FDA and highly regarded doctors at highly-rated medical centers such as Memorial Sloan Kettering have been compromised, but they're protected by the courts as federal employees or temporary federal employees. If the courts are not even going to allow discovery in cases brought by terminal cancer patients who sue the FDA and these corrupt doctors for access to safe and effective (but not FDA approved) medical treatment, there's not much we as citizens can do if we want to go after the hedge funds without a smoking gun. It's much better to have the hedge funds be a supporter of your stock.
All IDCC needs to do is sign a top tier licensee and most of this crap will go away. I fully expect Samsung to be ordered to pay up for 2G by the end of this year, and be on the ropes for 3G next year.
Hedge funds issuing marching orders to brokerage analysts is par for the course (and common knowledge), especially with the boutique analysts. Why? Because the boutique firms get a large portion of their revenue via their trading desks, through which said hedge fund routes its trades. If that hedge fund has a short position in a certain stock, and routes its trades through a certain brokerage's trading desk, it's damn well going to pressure that brokerage to pressure its analyst to fall in line with the hedge fund's position, be it long or short. This has been very common in the developmental biotech world, as companies such as UBS or Brean Murray regularly put out reports containing outright falsehoods about companies. Whether or not it's a pumping falsehood or a bashing falsehood depends on whichever position the hedge fund or funds has at the time.
There is just about nothing we can do about this, so it's not worth spending the time and effort on the subject. This board can become like a yahoo board or an Investor Village board with frequent posts bashing hedgie shorts or containing links to naked short articles...or it can remain a board with attorneys, wireless businesspeopole, and engineers contributing posts on what's going on with IDCC. I hope it's the latter.
REGN-I sold out my position during a previous spike.
Flip a coin...but don't count on BP collaborating on Provenge or buying the company whole. Not going to happen before the interim.
Regeneron Initiates Major Global Collaboration with Sanofi-aventis to Develop and Commercialize Fully-Human Therapeutic Antibodies
Thursday November 29, 2:00 am ET
Sanofi-aventis plans to increase its stake in Regeneron to approximately 19%
http://biz.yahoo.com/bw/071129/20071128006177.html?.v=1
TARRYTOWN, N.Y.--(BUSINESS WIRE)--Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN - News) and sanofi-aventis (Euronext: SAN and NYSE: SNY) announced today that they have entered into a global, strategic collaboration agreement to discover, develop, and commercialize fully-human therapeutic antibodies utilizing Regeneron’s proprietary VelociSuite of technologies (including VelocImmune®).
Sanofi-aventis will also increase its ownership of Regeneron’s outstanding common stock from approximately 4 percent to approximately 19 percent by purchasing 12 million newly issued shares of Regeneron common stock at a price of $26.00 per share, subject to customary closing conditions including antitrust clearance.
As part of the research agreement, sanofi-aventis will make an $85 million upfront payment to Regeneron and will fund up to $475 million of research over the next five years. Sanofi-aventis will have an option to extend the research agreement for up to an additional three years.
Sanofi-aventis will have the exclusive option to co-develop with Regeneron each drug candidate in the collaboration portfolio. Development costs will be shared between the two companies, with sanofi-aventis funding drug candidate development costs up front and Regeneron reimbursing half of the development costs from its share of future profits to the extent they are sufficient for this purpose.
The first therapeutic antibody to enter clinical development under the collaboration is an antibody to the Interleukin-6 receptor (IL-6R), which has started clinical trials in rheumatoid arthritis. The second is expected to be an antibody to Delta-like ligand-4 (Dll4), which is currently slated to start its clinical development in 2008.
For any new product successfully developed as part of the collaboration, sanofi-aventis will take the lead in commercialization activities and will consolidate the sales. Regeneron will have the right to co-promote any and all collaboration products worldwide. In the United States, profits will be shared equally. Outside the United States, profits will be split on a pre-determined sliding scale with sanofi-aventis’ share ranging from 65 percent to 55 percent. In addition, Regeneron will be entitled to receive up to a total of $250 million of sales milestone payments when the collaboration achieves certain aggregate annual ex-U.S. sales levels, starting at $1 billion.
Conference call
Sanofi-aventis will host a conference call to discuss the new collaboration today, November 29, 2007, at 12:00 Paris time. It will also be available in a hear-only mode on the sanofi-aventis website: http://www.sanofi-aventis.com.
Participant access number:
France: +33 (0)1 70 99 42 99
UK: +44 (0)20 7806 1967
US: +1 718 354 1391
Regeneron will host a conference call to discuss the new collaboration today, November 29, 2007, at 8:30 a.m., Eastern Time. The dial-in information is:
Domestic Dial-in Number (866) 700-0161
International Dial-in Number: (617) 213-8832
Participant Passcode: 82276731
The slides and management discussion will be available on the Regeneron website: http://www.regeneron.com on the presentation page of the Investor Relations section at the time of the presentation.
The replay of the Regeneron presentation will be available beginning at approximately 10:30 a.m. Eastern Time on November 29, 2007 and will end on December 13, 2007. The presentation may be accessed through the Regeneron website: http://www.regeneron.com on the presentation page of the Investor Relations section or using the following information:
Domestic Dial-in Number: (888) 286-8010
International Dial-in Number: (617) 801-6888
Passcode: 53180945
About the Regeneron VelociSuite of Technologies
Regeneron has developed and validated a group of novel technology platforms, known as the VelociSuite of technologies, to improve its ability to develop new product candidates. VelociGene® and VelociMouse™ are designed to aid in the identification of specific genes of therapeutic interest for a particular disease or cell type and validate targets through high-throughput production of mammalian models. VelocImmune® increases the speed and efficiency of fully-human therapeutic monoclonal antibody development and is currently being used to generate antibodies to address clinically relevant targets of therapeutic interest.
If IDCC actually were in play, wouldn't there have be a sustained rally for at least a few trading sessions?
Great, that clears things up...thanks iwfal and ocyan.
OK, in this same vein, let's say that there are 340 patients in the Provenge arm and 170 pts in the control arm. Assume the interim unblinding point occurs at the 170th death. Assume further that all 170 pts who died are in the control arm, and thus no events in the Provenge arm. Is the p value better than 0.01?
<<The point I am making here is that the p value is NOT a function of the between the curves. It is a function of the ratio normalized events in each arm. No events, no improvement in p value.>>
A question was raised by henry on the other board about this specific issue. To measure the p value, are we only comparing the events in each arm, or do the surviving patients in each arm attain p value "credit" for that arm? I was under the impression that when the 180th event is reached, any surviving patients will be counted for however many days post-randomization they are alive. Is this in fact the case, or do all surviving patients get thrown out of the p value equation when the 180th death occurs?
Anytime the phrase "event-driven" is used (as opposed to time-driven), it means that the data is collected when a prespecified number of "events" takes place. These events can mean number of progressions or number of deaths, depending on which metric is used as the primary endpoint.
I think some of the foresighted analysts realize this, as more and more are forecasting big eventual Asian revenues for Nexavar. One other factor to consider is the large transfer of wealth from the US to Asia.
OT-At some point, most people recognize the point when enough is enough, when it comes to piling on. Most of us who follow this board realize that he is who he is, and on a day like this, repeated kicks to the groin are unnecessary overkill.
ONXX--moronic article on Seeking Alpha attributes Nexavar's huge recent increase in revenues to the kidney cancer indication, and says that it will soon face competition from Sutent.
http://tinyurl.com/2lfe4d
Onyx's Cancer Drug: Potential Blockbuster - But With Competition
posted on: November 26, 2007
Onyx Pharmaceutical (ONXX) is enjoying the rewards of its potential blockbuster, Nexavar. On Monday, November 19th, FDA approved Nexavar, already approved for kidney cancer, for treatment of liver cancer. The product did so well in clinical trials that the company and its partner Bayer (BAY) had to halt the trials for ethical reasons to give Nexavar to the control group as well.
Onyx's stock has been doing tremendously well. In 2007, it rose more than 500% from about $10 to its current price of $53, but is off its 52 week high of $61.
But is this a good time to buy the stock?
Let's first look at the revenues and stock valuations.In the third quarter, Nexavar achieved global net sales of $104.6 million (half to Onyx). This included approximately $41 million generated in the United States and approximately $64 million outside the US. This growth reflects a 26% increase over the previous quarter's US sales numbers and a 30% quarterly increase in sales throughout the rest of the world. The majority of this sales and growth have come from kidney cancer and this growth is expected to moderate due to competition from Pfizer's (PFE) kinase inhibitor, Sutent.
The company and investors believe China could be a great source of growth with its growing middle class population. They expect the Chinese to be able to afford a $4,000/month treatment. I am not sure I agree that there will be significant sales from China in the near term as I believe $4,000/month payment is hard for people who are the cheapest labor force in the world!
On the other hand, Onyx has the advantage of having a pipeline-in-a product. Nexava, a multi-kinase inhibitor of cell growth and proliferation, has been shown to be safe and effective inkidney and liver cancers. The company is currently performing clinical trials to assess its performance in small cell lung cancer, melanoma and breast cancer. Theoretically, a multi-kinase inhibitor can slow down disease progression in all these diseases if they rely on the same kinases for their growth as the ones inhibited by Nexavar.
Given its specific mechanism of action with flexibility to treat many types of cancer, Nexavar can become a huge blockbuster. However, besides clinical challenges, the company may face increased competition from other companies. Almost every big pharma and many small biotechnology companies have been working on kinase inhibitors to treat cancer and immune diseases.
Nexavar's success may have paved the way for the competition. Statins and HIV protease inhibitors come to mind as fields with many copycat drugs. In the short term, Onyx will be spending a lot of cash on all of these clinical trials to expand usage of Nexavar, which will eat into its profits. Onyx has about $450 million in cash reserves and can afford to spend some money on these critical trials. I am guessing Bayer will pick up some costs as well. Onyx also has to share 50% of its revenues with Bayer which makes it more difficult to increase earnings per share.
However, I believe the company has a great head start and will have market exclusivity for the next 3-5 years. I think the early surprise profits have attracted some hasty investors which has made ONXX overvalued in the short term with a market cap of $3 billion. In other words, the easy money has been made. The company will most likely post some losses in the coming quarters and we may see the stock drift lower. In addition to sales growth, the success of Nexavar in trials for treating other types of cancer will be a key to the stock movement in 2008. I would recommend waiting for a better buying opportunity in ONXX.
Disclosure: The author does not currently have a position in ONXX.