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>>CEGE addendum: These are the worst results I’ve seen in a randomized, controlled cancer trial since TELK’s Telcyta.<<
Given that GVAX has shown a stellar safety profile in hundreds of patients over many years, my hypothesis is that the larger number of deaths in the GVAX + taxotere arm (67) compared to the taxotere monotherapy arm (47) is merely a statistical fluctuation, rather than an indication that GVAX + taxotere is bumping patients off.
A typical distribution function would give standard deviations of order sqrt(n), so the comparison is really something like
67 +/- 8 vs 47 +/- 7.
I think there is at least a 5% chance that the disagreement is simply statistical.
Anybody agree or disagree?
Implicit in my hypothesis is that GVAX provided no survival benefit in Vital-2.
micro
>>Dew, board, If anyone has bio buyout/takeover candidates to discuss, I created a new board specifically for buyout ideas (link below).<<
My feeling is that (i) buyouts are too rare to bet on and (ii) there is probably a lot of overlap between buying good companies and buying companies likely to be acquired.
I think simply buying good, undervalued companies is a more robust investment strategy than buying companies in the hope some of them will be acquired.
Oh yeah - I think Incyte is another good buyout candidate because of their JAK inhibitor.
;o)
micro
ACTC makes red blood cells from hESCs
>>I recognize this may be wrong board in theory for this
OTC.BB stock, but I would like to elicit comment, + or -,
from more experienced folks on this news<<
No big deal. Has probably been done before, and even if it hasn't, it is unlikely to ever be an economical way of making red blood cells - or a synthetic substitute.
Must be viewed in the lense of ACT's desperation. They are on the verge of bankruptcy.
micro
Life is an IQ test.
email: microcapfun@yahoo.com
Reply to private email on webcast subject:
Sure.
micro
>>I rarely have this problem because most webcasts remain available for a few months or longer. Which webcasts have you missed out on?<<
No need to name names, but about 1/3 of the companies I follow have webcasts available for 2 weeks or less. Sometimes one can find them hidden away somewhere after that (e.g. google finance), but sometimes not.
>>However, I just received an email from a message-board reader suggesting a utility called Total Recorder, which is described here<<
Thanks to you and icebrg! I'll try it.
micro
>>Does anyone know any company other than ZGEN thats pursuing a dual antagonist for VEGF and PDGF receptor??<<
Nexavar (sorafenib) inhibits the VEGF and PDGF receptors.
micro
ONXX
>>Second quarter Nexavar sales were 10% greater than first quarter.<<
Take away Japan (where Onyx only has single digit royalties), and sales were slightly DOWN in Euros.
However there was a large one-time clinical trial order in Q1. Take that out and ex-Japan sales in Euros were up ~3% from Q1 to Q2. Still sucks. But the present revenue run rate corresponds to only about a 4% worldwide market share in liver cancer (ignoring kidney and assuming $25K per patient taking Nexavar). Liver cancer is certainly ramping slower than I had expected, and no doubt the apparent effect is worsened due to their losing market share in kidney at the same time. But I've got to believe that 4% market share in liver cancer is not going to be the end of this story. There is only one approved systemic therapy, it has demonstrated clear improvement over SOC in 3 different randomized studies, and it is orally bioavailable.
A little more patience is in order ...
micro
>>A crude measure of the macroeconomic climate is the willingness of consumers to undergo self-pay elective procedures now rather than putting them off. Laser-vision correction fits this profile; procedure counts are down 25-30% versus a year ago.<<
On the other hand ...
>>Botox sales jumped 13% to $315.5 million. With Botox sales on the rise, one would wonder if we are really in an economic recession or has looking good become a necessity?
A survey conducted by the American Society for Dermatologic Surgery found that despite the economic concerns the use of fillers and Botox are on the rise. Twenty-eight percent of the survey physicians said that their current use of fillers increased up to 30 percent, compared to six months ago and more than 40 percent of survey respondents stated that the number of Botox procedures also increased compared to six months ago.<<
http://www.marketwatch.com/news/story/despite-bad-economy-botox-sales/story.aspx?guid=%7BF0607056-0DBF-4C3A-A004-FE027DD69E17%7D&dist=hppr
>>Despite the slowing economy, Allergan recorded the following sales of cosmetic-medicine products in the quarter that ended June 30:
Botox, $347.8 million, up 9.0 percent from the second quarter of 2007.
Breast implants, $88.5 million, up 7.1 percent.
Facial aesthetics such as the dermal filler Juvederm, $64.2 million, up 23.1 percent.<<
http://inyourface.freedomblogging.com/2008/07/30/botox-breast-implants-fillers-grow-in-popularity-despite-slow-economy/
micro
>>Speaking of iVillage… only on a cult board would a post like this garner 128 recommendations<<
>>Why did you put 100% of your money in one stock and borrow on margin to boot?<<
************************************************************
>>As a retired CPA., however, there are small companies out there who have no bias against age who do in fact look for seniors such as myself with a load of experience in the corporate world to serve as controllers, accounting managers, etc.
This is my second failure--I lost several million in the market crash of 02.<<
Life is an IQ test ...
micro
Archiving conference calls
Don't you just hate it when a dozen calls pile up, and then they begin to disappear from the web before you've caught up?
Is there an *easy* way to archive them on your hard disk???
micro
>>Taxpayers are now on the hook for the future losses on their 5 trillion dollar mortgage portfolio (trillion, guys - that's bigger than most of us can conceive of).<<
It's one Iraq war.
micro
>>gsk had their own orexin in development but never got anywhere with it, so maybe that's why they were interested.<<
rkrw:
That would be GSK649868. How did you know (prior to this deal) that GSK "never got anywhere" with GSK649868? Are you simply going by the lack of clinical progress as measued by clinicaltrials.gov?
micro
O/T ... an extreme view of unions.
Unions in private industry have been a victim of their own success. They are like a parasite which makes its hosts unable to compete and thereby both the hosts and the parasite lose 'market share' to companies which manage not to be unionized.
http://www.data360.org/temp/dsg1387_495_600.jpg
But there is still a dangerous reservoir of the infection - not in private industry, but in areas where there is no competition. This reservoir is found in the federal, state and local government, where unions are king and inefficiency is a way of life. No competition means the hosts and the parasite live on forever ... happily - like an overfed pig with ticks ....
>>Bankruptcy is not unthinkable for Detroit’s former king. The immediate cause of G.M.’s distress, of course, is the surging price of oil, which has put a chill on the sale of gas-guzzling sport utility vehicles and trucks. The company’s failure to invest early enough in hybrids is another culprit. Years of poor car design is another.
But none of G.M.’s management miscues was so damaging to its long-term fate as the rich pensions and health care that robbed General Motors of its financial flexibility and, ultimately, of its cash.
General Motors established its pension in the “treaty of Detroit,” the five-year contract that it signed with the United Automobile Workers in 1950 that also provided health insurance and other benefits for the company’s workers.<<
micro
>>it’s hard to believe it can take so many years to find out that a drug doesn’t work during phase-2<<
The most promising drugs are pushed forward as rapidly as resources allow?
micro
>>[OT] RE:Consciousness as an inherent property of the universe<<
A lot of successful physicists become unsuccessful philosophers after they get too old to do good physics anymore ...
micro
O/T Evolution, ID, weather
>>We're dealing with a genetic formula with billions and billions of variables. The stochastic equation that describes all of those variables and all of the variable interactions is well beyond the realm of science for any foreseebale future, in my opinion. We are just now scratching the surface with a full sequence for goodness sakes.<<
The weather is probably a lot more complicated. But scientists believe they understand the basic principles. They can make some decent predictions using those principles - even though a lot of the details (e.g. associated with turbulence/chaos) are beyond them at the present time.
There's some obvious analogies with evolution. But funny how nobody claims that our weather theories are all wrong. Funny that there isn't an ID theory of meteorology. Funny that nobody wants equal time to explain how a creator is required to make rain in New York, sun in California ...
And why stop at evolution and meteorology? Maybe there's no gravity, but instead God hangs onto the moon to keep it from flying away. Let's have equal time in physics classes for the ID theory of gravity.
WHY WAS BIOLOGY SO 'LUCKY'???
micro
>>Once a deal is in hand, the acquired company generally wants to talk down the competitive interest. This encourages shareholders to approve the deal in hand rather than holding out for something better, which would typically incur a breakup fee and might cost management a big payday.<<
Clearly not relevant to the MLNM deal. I'm sure 99.9% of shareholders were delighted to get $25 per share, double the stock price a few weeks before the deal was announced and well beyond what any sensible valuation would have suggested. Heck $8.8B for MLNM's share of Velcade, dwindling Integrilin royalties and some early stage molecules was not going to be turned down by shareholders in 100 years. Especially with MLNM's long history of pipeline failures. (They acquired Velcade, Integrilin and Campath.)
micro
>>I’m astonished that you and micro believe that these self-serving narratives in post-deal-signing SEC filings necessarily list all of the prospective buyers.<<
Color me gullible. But sometimes those narratives do list another prospective buyer, either by name or as e.g. "Company 2".
What would MLNM have to gain by censoring information about a Takeda competitor? Or are you suggesting that Takeda wouldn't want it to be known they were in a bidding war?
micro
O/T Belief in evolution: Fools Rule!
These numbers are truly astounding (below).
(In case anyone is unaware, "Intelligent Design" (ID) - is just another version of creationism.)
>>June 26, 2008
What a day for creation theory. John Lynch at Stranger Fruit blogs about the latest results of a Gallup poll on political leaning and belief in creation, intelligent design, or evolution. Republicans emerged with 60 percent believing in creationism, 32 percent believing in ID, and just 4 percent believing in no-strings-attached evolution. Democrats were an even split on creationism and ID (38 and 39 percent, respectively), with 17 percent opting for evolution. Independents had the highest rate of belief in evolution -- 19 percent -- but still had 40 percent opting for creationism and 36 percent for ID.<<
http://www.genome-technology.com/issues/blog/general/147785-1.html
micro
>>When does the FDA insist on confidential communications with an applicant? Almost never, IMO. If it happens at all, it’s probably with a product like Plan B.<<
O.K. Are embryonic stem cells like Plan B??
micro
Under what circumstances can a company make public a letter from the FDA?
>>MENLO PARK, Calif., May 14, 2008 – Geron Corporation (Nasdaq: GERN) announced today that the company received verbal notice today from the FDA that the company's Investigational New Drug (IND) submission for GRNOPC1, a cell therapy for spinal cord injury, has been placed on clinical hold. A clinical hold is an order that the FDA issues to a sponsor to delay a proposed trial or to suspend an ongoing investigation.
"We have not yet received a letter from the FDA explaining the decision to place the submission on hold, so we are unable to comment specifically," said Thomas Okarma, Ph.D., M.D., Geron’s president and chief executive officer. "Once we have the letter and have had a discussion with the agency, we will communicate our findings and our thinking to shareholders. <<
http://www.geron.com/media/pressview.aspx?id=840
That PR came out some 6 weeks ago. Geron received the letter, but has apparently not shared any of its contents with the public.
Does Geron have the right to release the letter to the public if they want to? Apparently Geron is now claiming the FDA wants to keep discussions relating to the IND private. Certainly possible, given the subject matter. But I am suspicious. Is it more likely that the letter is too embarrassing to the company to be released??
micro
>>p.s. You ought to be able to nail the Quadro quiz.
<<
I don't usually pay attention to the quizzes, which I find a distraction. No offense. But I guess Elvitegravir is probably in there.
micro
Incyte
>>I wish them the best in their CCR5 efforts—as long as they don’t get into the NNRTI arena<<
Incyte got some pretty good P2 results and then stopped development and said they would outlicense that one and concentrate on the rest of their pipeline - especially their JAK inhibitor program.
Seems to be too many CCR5 antagonists out there. Not sure they will be successful finding a buyer. It's been a few months already ...
micro
Sale of drug companies is efficient?
>>From what I have seen, it is typically not the case that you get potential bidders competing. A seller is usually lucky to get one interested buyer and the final price is a function of which of the two parties is more interested in making the deal.<<
That was my impression too. The Teva acquistion of MLNM comes to mind. MLNM hadn't changed much as a company in the previous year or two. Yet suddenly Teva swoops down and makes an apparently outrageously generous offer MLNM couldn't refuse. Was there any other suitor in that price range? I don't think so. (There was a detailed description of the sale published as an SEC filing, and no other bidder was mentioned.) My impression is that MLNM couldn't have done nearly as well on the auction block if Teva hadn't been around.
I think Teva overpaid; if so, by definition the sale was inefficient.
micro
>>Melanoma Stopped in Patient With 5 Billion Copies of Own Cell<<
Not as new as it sounds from the articles. Steven Rosenberg of the NIH has used this adoptive immunotherapy for years and has obtained spectacular results. He seems to be getting a serious following.
I think the main problem is that this method is about as far from off-the-shelf as is possible. Still ... if he ever hooks up with a public company - please let me know!
micro
>>Take the aspirin before going to bed. Think it was a huge Swedish study that demonstrated that the CV benefits of aspirin depended on taking the aspirin at bed time.<<
Interesting. My doctor told me to take my aspirin in the morning - and my statin at bed time.
Have a reference? My doctor doesn't read any journal articles unless I shove them in his face ...
micro
>>I think the reason nothing has yet superseded Sustiva is that it’s a tall order to develop a drug which is qD and is effective at a low enough dose to enable safe and tolerable co-administration (ideally co-formulation) with Truvada. Not that many companies have the expertise to do it.<<
Much of the team which designed Sustiva is still intact - but at Incyte, rather than Dupont Pharma. At Incyte they have put together an impressive pipeline in a relatively short time. They seem to have some of the best medicinal chemists anywhere.
micro
How many unique ways are there to acquire at least 270 electoral votes without any excess?
micro
>>Avastin is seen by oncologists as a very well tolerated drug actually. If vegf-trap is less well tolerated, unless they show trap is more effective, why would it be used?<<
Another way of putting it is one can always dial down the AEs by dialing down the dose. So when someone says a drug is less well tolerated than another drug, what they are really saying is that it has a smaller therapeutic window.
Another observation is that in monotherapy, efficacy tends to trump side effects in life-threatening indications. But in such indications, lesser side effects become a more significant advantage when drugs are used in combination.
I always found it interesting that despite multiple approvals with more on the way, Avastin isn't approved as a monotherapy in ANY indication. (I think that's right.) Is there any other cancer drug which can make that claim?
I guess that could be considered a quiz question to which I don't know the answer ...
micro
>>The SIRT premium was “only” 85% and the MLNM premium was an utterly pedestrian 50%<<
It's true the MLNM premium was only 53%, but the stock price inexplicably jumped close to 30% in the month before the acquisition was announced, so I suspect the 'effective premium' was fairly close to 100%.
micro
Cancer vaccine success claimed in P3 randomized blinded trial ...
Only one problem. The trial is still blinded ...
Anybody ever seen a PR like this before? Do companies usually have access to this sort of data before unblinding? What do you make of the claim?
http://biz.yahoo.com/bw/080611/20080611005573.html?.v=1
micro
>>I would think the only people able to pull similar numbers would be -
1. Steve Jobs
2. Bill Gates
3. Dhirubai Ambani (the ex-Reliance patriarch)
<<
I never even heard of #3, but wikipedia said he died in 2002, so yeah ... I agree if he gave a talk in 2008, that would certainly generate a crowd.
One other point on the 31,000 at Berkshire's annual meeting, though. It didn't take place in New York or even San Francisco. It was in fricken Omaha, Nebraska!! Probably 30,000 of those people flew in special!
I'd like to see Steve Jobs or Bill Gates attract 31,000 people to an annual shareholders meeting in Omaha, Nebraska.
micro
>Look at the photo!<
Holy moly!
Seems to be something wrong with the link now.
Try this:
http://s.wsj.net/public/resources/images/MI-AQ222_BERKSH_20080504181136.jpg
micro
Geron
>>I presume that MRK and Dr. Stephen Friend would have the inside track (#msg-7088215).<< (Dew - 2008)
From (#msg-7088215):
>>Getting back to the main point… if Dr. Friend thinks Geron’s telomerase science is as worthy an endeavor as he makes it sound in the bold-faced quotation above, perhaps GERN is a company with some bona fide investment appeal.<< (Dew - 2005)
Perhaps. But are you aware that Merck decided not to exercise its exclusive option to inlicense Geron's telomerase vaccine GRNVAC1? Essentially they paid $1M for a right of first refusal in 2005 and Geron pathetically extended it for free, but in the end Merck let it expire.
Merck is still working on using telomerase as an antigen along with their liposomal and adenoviral vaccine platforms, but it is interesting that they took a pass on Geron's vaccine.
Geron really looks pretty ugly these days. The dendritic cell-based telomerase vaccine was in some kind of haitus for 5 years and then clinical trials started over - in a different indication. (The CEO has talked about dumping it in favor of an off-the-shelf version using dendritic cells derived from ESCs - talk about combining untested technologies - telomerase, cancer vaccines AND dendritic cells derived from ESCs!) Their telomerase inhibition 'drug' GRN163L has generated a lot of AEs in clinical trial - but no evidence of efficacy or even telomerase inhibition. Their telomerase activator product for certain degenerative diseases didn't work out in preclinical and they are back to square one with that. And of course you know the recent news on their hoped-for first embryonic cell derived product, i.e. the clinical hold ...
All the more reason they should just sell out their great IP in telomerase, cloning and ESCs to the highest bidder.
Isn't 18 years and more than half a billion dollars burned enough?
They have revenues of ~$4M/year and are still only in Phase 1/2a trials! Their share count has gone up about a factor of 8 in the 12 years since their IPO and their stock price has gone down by 50%.
What a bunch of losers! But they could probably get a billion dollars if they sell their IP. What are they waiting for???
micro
Berkshire Hathaway annual meeting
I go to a lot of annual meetings. The relevant companies have market caps ranging from ~$150M to a few billion dollars.
Typically I see low single digit other investors there who are not company insiders or the auditor.
When a company has a lot of hype associated with it - like a certain ethanol company a year ago or Geron anytime the earth is in orbit around the sun - there are typically a dozen or more. I think the most non-insiders I've ever seen at an annual meeting is ~30.
But I've seen pictures of annual meetings of the rock star companies - the Pfizers, the Microsofts, etc. I think a couple hundred is typical at these.
But this is news to me ... I knew Buffet was a cult figure and had investing gems of interest to many. But Jesus H. Christ! More investors attending a Berkshire Hathaway annual meeting that attend most baseball games??? Amazing!
>>This year at Mr. Buffett's annual gathering for shareholders -- often called "Woodstock for Capitalists" -- 31,000 Buffett enthusiasts were serenaded by Fruit of the Loom minstrels, enjoyed samples of Berkshire portfolio companies such as Dilly Bars and watched artist Michael Israel speed-paint a Buffett portrait with Benjamin Moore paints.<<
http://online.wsj.com/article/SB120990596389565539.html?mod=googlenews_wsj
Look at the photo!
Probably everybody knew how big the Berkeshire annual meetings were except me. In that case, sorry for a silly post.
micro
>>FDA Places Clincial Hold on Geron's GRNOPC1
[Comments?]<<
Apparently Geron has been getting *informal* input from the FDA for years about what will be required for an acceptable IND. Then a month or so ago the FDA started the process to decide on what their 'formal' expectations should be, beginning by holding a panel meeting where Geron and two other ESC companies presented and questions were raised.
I think the FDA just isn't ready, and the clinical hold is their way of punting for more time. They are probably thinking - shit ... another new technology like gene therapy that we have to regulate. If we screw up and a patient dies in the first trial, this field will be set back half a decade. We need to move slowly and be very, very careful.
That said, Geron is probably far from blameless. They've always been good at early-stage (read: laboratory) R and weak at D. They've had rat model data for the spinal cord injury for several years, but they decided not to do a pig or primate study. Why??
All the more reason it would make sense for a Big Pharma to gobble them up and sit down with the right people in the FDA to figure out how to move forward.
Could politics have played a role? Sure. But I haven't seen any clear and direct indications of that.
Find me a couple creationists on the panel and I'll quickly change my mind ...
;o)
micro
>>Nexavar - Not a fair fight to compare its 9th quarter of sales to those of Avastin (estimated 148k new cases of CRC in the US vs 54k and 19k of RCC and HCC, and it was approved for HCC only on 4Q07).
I suspect that one possible cause for your displeasure from those figures is that a lot of patients (more than expected) on Nexavar have to receive a reduced dose (400mg only once a day), due to side effects.
I think we'll see increasing adoption in conjunction with liver-directed therapies (like TACE). Also, currently many patients on Nexavar got it at a very late stage of their disease (it wasn't available before), but in the future, patients will get Nexavar earlier in their treatment, and so will stay on it longer.
Last, it was mentioned before by Roy and/or yourself that liver cancer can be caused by HBV and HCV infection and thus we should expect an increase in its incidence in the coming years. <<
No offense, but I feel one can always find excuses for the performance of a company or a drug, but data doesn't lie. Nexavar for liver cancer apparently was marketed to all U.S. oncologists in Q1, yet the bump up in quarter over quarter sales in the U.S. was rather pathetic. Part of the modest growth in overall sales is due to the liver cancer growth apparently being offset to a significant degree by kidney cancer erosion. But that's in the way of an explanation rather than an excuse.
I have noticed that oncology drug sales tend to grow quite close to linearly over time. It's really rather amazing how well that rule of thumb works with few exceptions to my knowledge. I think the growth rate of Nexavar has already been set at ~$20M per quarter which is $320M/year. But I think it will continue to grow at this rate for many years as it continues to make inroads in liver cancer, stabilizes in kidney cancer and nails another couple indications, with lung, breast, melanoma and pulmonary hypertension among the most likely at present.
I still believe peak revenues will be in the billions, but with a less steep slope than I had expected.
micro
>>HGSI – Agree with your post on all counts. Moreover, HGSI’s “preference share” market research supposedly showed that most of the sampled docs who thought q4w dosing was a big deal also thought q2w dosing was a big deal; hence, these docs will be on board in any case if q2w works out on safety, efficacy, and tolerability.<<
I agree that q2w is likely to be sufficient for Albuferon to become the market leading IF alpha *if* it works out as you say, and if none of the other q2w IF alpha candidates do any better. (Albuferon is the 'first-mover' q2w IF alpha at this point.)
micro
>>Doubling the mass<<
It only doubles the mass of the hydrogen atoms, and of course they have much less mass than the other atoms in the drug (e.g. 1/12 of Carbon). So it would not seem to be that big an effect even for enzymatic reactions.
But it must be big enough if people are putting up tens of millions of dollars to try it out ...
micro
>>If this is true, why are there often sharp moves in the share price of biotech companies just before an abstract is posted on the web?<<
I hadn't much noticed this effect other than with ASCO, but let me assume you are correct. Conference organizers, session organizers and referees see the abstracts before the general public. As do those people who collect the abstracts and organize the web pages where they are posted.
The latter group probably can't make sense of them, but they might be able to sell them to those who can.
micro