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Braves fan (Chipper) and your clue for almost helped to narrow the search, so I cheated a bit for that one :).
EDIT: I find your Biotech Quizzes harder even with hints
Manny
My point exactly, Webb is better then good so a big various in quality of starts can lead to that disparity. Did not mean to get in the middle of your argument about the Padres vs. the Diamondbacks (i'm not a fan of either).
BTW, I would take Valverde!!
Chipper Jones
I think Brandon Webb and José Valverde have a lot to do with their success. Webb is having another great year which can make up for some weakness at the back end of the rotation (and help in producing the disparity in runs) then you have a reliever that leads the league in saves and yeah I'd say they are pretty lucky to have those two :).
An interesting transaction, if one were to project the 25% price Drug Royalty paid [an interesting company now private] on the remaining 75% that Enzon still owns, the value would amount to about the entire market cap of Enzon. I haven't followed them closely lately and I know they have/had some debt but they also have some other commercial products the biggest being Abelcet [I always thought the name was too close too albatross perhaps appropriately so as thats what its been to Enzon since Mr. Higgins acquired it from Elan, if only he would have invested that money in an ownership stake in Elan at the time instead!]
http://biz.yahoo.com/bw/070820/20070820005492.html?.v=1
Enzon to Eliminate Its Remaining 2008 Convertible Debt
Monday August 20, 8:30 am ET
Company monetizes a portion of its PEG-INTRON royalty stream for $92.5MM
BRIDGEWATER, N.J.--(BUSINESS WIRE)--Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN - News) today announced the sale of a 25% interest in its royalty from PEG-INTRON®, marketed by Schering-Plough Corporation for $92.5 million to Drug Royalty Corporation, Inc. (DRC). Enzon is also entitled to receive an additional one-time milestone payment of $15 million in 2012 should certain royalty recognition levels be met for PEG-INTRON. A portion of the proceeds will be used for retirement in full of Enzon's outstanding 4.5% Convertible Notes due 2008. Enzon will retain a 75% interest in the PEG-INTRON royalty, as well as 100% of their other current royalties and any new royalties the company receives.
To date, Enzon has already reduced the outstanding amount of its 2008 convertible debt to $81.9 million through a series of successful open market repurchases at a discount to par.
"Today's announcement is a result of a thorough and comprehensive evaluation of our options to extinguish our debt due in 2008," said Jeffrey H. Buchalter, chairman and chief executive officer of Enzon. "This transaction now fully removes any risk associated with repayment of the 2008 convertible note, and allows Enzon to continue to focus on its goal of building an innovative oncology company."
Currently, Enzon earns royalties on three marketed products that are successfully utilizing Enzon's proprietary PEGylation platform, namely PEG-INTRON, Pegasys, and Macugen.
PEG-INTRON is a PEG-enhanced version of Schering-Plough's alpha interferon product, INTRON® A, which is used both as a monotherapy and in combination with REBETOL® (ribavirin) capsules for the treatment of chronic hepatitis C. Under our license agreement with Schering-Plough, Schering-Plough holds an exclusive worldwide license to PEG-INTRON, and Enzon receives royalties on worldwide sales of PEG-INTRON. Schering-Plough is responsible for all manufacturing, marketing, and development activities for PEG-INTRON. Enzon designed PEG-INTRON to allow for less frequent dosing and to yield greater efficacy, as compared to INTRON A. PEG-INTRON is marketed worldwide by Schering-Plough and its affiliates.
About Enzon
Enzon Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to the development, manufacturing, commercialization of important medicines for patients with cancer and other life-threatening conditions. Enzon has a portfolio of four marketed products, Oncaspar®, DepoCyt®, Abelcet® and Adagen®. The Company's drug development programs utilize several cutting-edge approaches, including its industry-leading PEGylation technology platform used to create product candidates with benefits such as reduced dosing frequency and less toxicity. Enzon's PEGylation technology was used to develop two of its products, Oncaspar and Adagen, and has created a royalty revenue stream from licensing partnerships for other products developed using the technology. Enzon also engages in contract manufacturing for several pharmaceutical companies to broaden the Company's revenue base. Further information about Enzon and this press release can be found on the Company's web site at www.enzon.com.
About Drug Royalty Corporation, Inc. (DRC)
Drug Royalty Corporation ("DRC") is a privately held investment management company, focused on the healthcare industry, with over $1 billion under management. DRC currently manages two funds: the Royalty Monetization Fund and the Structured Finance Fund.
Its Royalty Monetization Fund acquires existing royalty streams at competitive rates from companies, institutions and inventors. DRC is a leader in monetizing royalties, having acquired over $750 million in royalty-based cash flows on commercialized products. Its Structured Finance Fund will soon close with approximately $300 million in committed capital. This Fund provides predominantly non-dilutive financing for product acquisitions and launches, M & A, in-licensing, sales force expansion and general working capital purposes to companies within the healthcare industry. The Fund invests in cash flow monetization structures which can include debt and equity components, custom tailored to fit the needs of clients.
Forward Looking Statements
There are forward-looking statements contained herein, which can be identified by the use of forward-looking terminology such as the words "believes," "expects," "may," "will," "should", "potential," "anticipates," "plans" or "intends" and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from the future results, events or developments indicated in such forward-looking statements. Such factors include, but are not limited to the timing, success and cost of clinical studies; the ability to obtain regulatory approval of products, market acceptance of, and continuing demand for, Enzon's products and the impact of competitive products and pricing. A more detailed discussion of these and other factors that could affect results is contained in our filings with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K for the year ended December 31, 2006 and our quarterly reports on Form 10-Q. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. No assurance can be given that the future results covered by the forward-looking statements will be achieved. All information in this press release is as of the date of this press release and Enzon does not intend to update this information.
Contact:
Enzon Pharmaceuticals, Inc.
Craig Tooman, 908-541-8777
EVP, Finance and Chief Financial Officer
There was a similar article in Motley Fool but this is more substantive. There is a chart (on New Drug Approvals/New Molecular Entities since '98) with the article but I don't know how to post graphics so if you interested check out the link while Yahoo has the article available.
http://news.yahoo.com/s/ap/20070817/ap_on_he_me/fda_drug_rejections_9
FDA takes caution on approving new drugs
By LINDA A. JOHNSON, AP Business Writer
TRENTON, N.J. - Under growing scrutiny since the blockbuster painkiller Vioxx was pulled from the market, the Food and Drug Administration in recent months has rejected a slew of experimental drugs or delayed their approval and required more data.
Besides keeping drugs some patients might desperately need off the market, the rejections have battered drug company stock prices and are expected to increase the cost and time it takes to develop a new drug, not to mention the price of developing future ones.
Denials and delays have hit everyone from pharmaceutical giants such as GlaxoSmithKline PLC, Merck & Co., Novartis AG, Sanofi-Aventis and Wyeth down to struggling startups trying to get their first drug on the market. The FDA also has recently stiffened warnings on several drugs, most prominently diabetes drugs Avandia and Actos, and five months ago made Novartis withdraw its constipation drug, Zelnorm.
"There have been no systematic changes in how we are approaching the approval standards for new applications," FDA spokesman Christopher Kelly said in an e-mail. "Whether the current public debate and criticism of FDA on drug safety has played any role in our actions is very hard to quantify."
But Chris Milne, associate director of the Tufts Center for the Study of Drug Development, said Friday the FDA has systematically implemented more controls for scrutinizing drugs, particularly for heart and liver side effects. While he thinks the trend on approvals is not yet clear, he said the FDA now is requiring experimental drugs similar to ones already on sale to be more effective and safer than their predecessors.
Some experts say they already see a trend toward increased rejections, although drugs for life-threatening diseases or conditions with no good current treatment are generally being approved.
"The FDA is being more cautious," analyst Steve Brozak of WBB Securities said, explaining that FDA staff now realize new drugs will be used by many patients beyond those intended — known as off-label use[comment: Is this really a new revelation?] because the drug is taken for another condition than the one it was approved to treat. That often boosts the chances that some patients will be harmed by side effects.
He sees the FDA mentality now as: "It's got to be so safe that we're not going to be criticized ever" for approving a drug.
The agency has approved 61 percent of drug applications through mid-August, down from 73 percent in the same period last year[comment: Is this figure statistically significant :)], according to BioMedTracker, a biotech and pharmaceutical research service.
James Kumpel at Friedman, Billings, Ramsey & Co. just published a report showing FDA approvals of "new molecular entities" — drugs made from new chemical compounds rather than just twists on existing drugs — so far this year are at their lowest level in at least a decade. Only seven were approved through the end of July, versus an average of 12 over the first seven months of each year since 1998.
"The FDA certainly has made it more difficult for pharmaceutical companies by pushing for more data and for more participants and for longer studies," said Kumpel, barriers he said will start limiting the number of new blockbusters.
Already, the average cost of shepherding a potential drug from discovery through approval is $980 million, up from $802 million in 2000, and the process takes 14.2 years on average, according to Tufts.
"It appears that FDA has been on defense since 2004," Kumpel said.
That's when Merck withdrew its blockbuster painkiller Vioxx from the market because of increased risk of heart attacks and strokes, making Vioxx an instant poster child for drug safety issues.
Last April, the FDA rejected Merck's Arcoxia, a long-planned successor to Vioxx on sale in many other countries.
Just Friday, Endo Pharmaceuticals Holdings Inc. said the FDA for the second time asked for more time to review its approved migraine drug Frova for a new use, preventing menstrual migraines.
In between, the FDA has cited safety or effectiveness questions in rejecting or delaying approval for experimental drugs including Novartis' diabetes drug Galvus, Sanofi-Aventis' weight-loss drug Zimulti, and even a higher dose of GlaxoSmithKline's Advair Diskus for bronchitis and emphysema symptoms. Also shot down: Wyeth's experimental schizophrenia drug bifeprunox and Wyeth's Pristiq, which would have been the first nonhormonal drug for menopause symptoms.
Likewise, small pharmaceutical companies have been hurt. One, Pozen Inc., this month got its second FDA request for more information about a migraine treatment called Trexima it is jointly developing with GlaxoSmithKline. That news sent Pozen shares down 46 percent.
Scott Gottlieb, an American Enterprise Institute fellow who was FDA deputy commissioner until January, said drug companies have long complained that FDA was too conservative. Now, there's even more uncertainty both at the agency and in the industry.
For drugs where benefits don't strongly outweigh risks, Gottlieb said, "The agency errs on the side of caution."
gilead not sure of what your referring too?
From the K - "Revenue Recognition. Sales and rental income for patient transactions is recognized when a product has been medically prescribed and dispensed to a patient and an invoice sent to the patient or a claim prepared by the Company has been filed with the patient's insurance provider. Revenue for a non-patient purchaser or rental, for example a hospital, is recognized when an invoice has been sent and the product shipped to the person or entity. Product and rental revenues are recognized net of a reserve for collectibility."
EDit:
I think receivables may tie into to orders in a quarter better then revenue. I agree not a problem, in fact I would be concerned if they were flat or worse!
I think it is harder to model a company like this for several reasons and that may frustrate some people. Keep in mind this is still a very small company with limited resources.
1-From the 10-k "A majority of our revenue is derived from private health insurance carriers and HMOs on behalf of their insureds. " and "Often more than 100 days is required to collect initial payment from insurance carriers and considerably longer from many attorney, personal injury and worker's compensation cases. Such delayed payment impacts the Company's cash flow and can slow its growth"
2-Someone posted about hiring someone for collections no doubt with the increasing in orders collections are requiring more resources. I wouldn't be shocked if the 100+ days is a bit longer.
I see some of the people who didn't get a chance to get in early are already out to bash the Q. I don't know what the stock will do next week but the numbers are all rising!
1-Anyone pay attention to the receivable growth? 1.19 9/06, 1.34 12/06 1.83 3/07 and 2.29 that is pretty good growth in my book! To those critics who complain about the receivables rising look at the next point.
2-If collections are 3+ months a good chunk of this quarters revenue is actual not from sales in April, May and June but perhaps December, January and February.
3-The number of reps are rising
I believe the company is positioning itself to continue its solid growth keep in mind this is a very young company! Sales in 02-04 were in the 1.1 - 1.3 range '05 was the first year of real growth 2.1, '06 was 2.55 and six months into '07 were are 2.84 that is pretty impressive growth!
I think Mr. Sandgaard had done a great job at growing within his means. By that I mean he hasn't issued 10's of millions of shares in an effort to jump start the company nor has he taken on huge amounts of debt. So we had very modest growth till late '06 while the financing seemed expensive it go us going!
Now the company is cash flow positive and as Mr. Sandgaard gets more resources he can focus on gaining more market share in additional ways (Studies, shows, EU/x-US in general, etc.). Keep in mind we don't even have EU Mark approval as yet which opens up another market (From the 10-k "We are focusing much effort and significant resources on preparation of the CE application, and it is targeted for completion, submission and approval in 2007.").
OT: A second life after Baseball
Lenny is the one (and thankfully) only. Derek Lowe I don't know about but I wondered the same thing when I saw Dew's post.
I read somewhere that when Lenny retired and wanted to get into investing he wrote Buffet and asked him to teach him about investing. He (Lenny) claims Warren wrote him back with a no but good luck. So I give him credit for seeking out the best.
I think Lenny does more technical analysis type of stuff (so I was surpised about the Buffet reference) not my cup of tea so I don't have any idea on how good or bad he is but my memory of him as a baseball player makes it hard think of him in another light.
Webcast Calendar
[Please see updating procedure at the end of this post. Events listed here are regular quarterly conference calls unless indicated otherwise. All times are U.S. ET. unless indicated otherwise.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Deleted old entry, Preliminary information for UBS, CIBC and Bear Stearns (Links will need to be updated)
Bear Stearns Healthcare Conference
September 10-11
Grand Hyatt New York
New York, NY
http://www.bearstearns.com/sitewide/institutions/conferences/2007/healthcare/index.htm
UBS Global Life Sciences Conference
September 24-27
Grand Hyatt New York
New York, NY
http://www.ibb.ubs.com/Conferences/co_highlights.shtml
CIBC Healthcare Conference
November 5-7
The Waldorf-Astoria
301 Park Avenue
New York, NY 10022
http://conferences.cibcwm.com/health07/
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Thanks for the source. Didn't mean to imply that you were making it up just wanted to know where you heard it. Obviously I don't agree [based on my comments on other treatment options]. I'd be cautious with that figure!
NTII -
When a company does a shelf for more then their market cap it certainly makes one stop and think. I thought it was a nice small company and liked that they had a small (but for them meaningful) royalty on Memantine and a potential decent royalty on Xerecept. The problem was the main focus of the company is Viprinex for ischemic stroke which seemed a bit too risky for my taste. The CEO is very direct and open (at least in calls) but also quite the risk taker apparently he could not find anyone to share the risk for Viprinex.
http://biz.yahoo.com/prnews/070813/aqm150.html?.v=12
Neurobiological Technologies Files Registration Statement for a Common Stock Offering
Monday August 13, 6:36 pm ET
EMERYVILLE, Calif., Aug. 13 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NTI®) (Nasdaq: NTII - News), a specialty biopharmaceutical company, announced today that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission for a proposed public offering of up to $65 million of its common stock. Proceeds from the offering will be used primarily to fund the ongoing clinical development of Viprinex(TM) (ancrod). All of the shares in the proposed offering are being sold by the Company.
Merriman Curhan Ford & Co. will act as underwriter and book-running manager for the proposed offering. This offering will be made only by means of a prospectus. When available, copies of the prospectus relating to these securities may be obtained from: Merriman Curhan Ford & Co., 600 California Street, 9th Floor, San Francisco, CA 94108, Telephone 415-248-5600, Fax 415-248-5690.
A registration statement relating to these securities has been filed with the Securities and Exchange Commission but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.
About Neurobiological Technologies, Inc.
NTI is a specialty biopharmaceutical company with expertise in identifying and acquiring promising drug candidates and in designing and managing late- stage clinical trials for central nervous system conditions. The Company is currently developing Viprinex (ancrod), a novel reperfusion agent that is in pivotal Phase 3 trials for the treatment of acute ischemic stroke.
How do you figure 200k? Was that mentioned on the CC (I only heard part of it). TIA
FYI, there are other copper removing products already on the market (Galzin, Cuprimine and Syprine) and the cost is in the 100's of dollars not 100's of thousands. It seems like Coprexa may have some advantage over these but 200k I would be very very suprised if they could get anywhere near that.
PP -
I'd be cautious here as well. I didn't feel comfortable with managements characterization of their Pulmonary Fibrosis program to consider investing especially when its only been tested on about a dozen patients. From what I gather it certainly seems like it could be a good drug for Wilsons disease though I am not sure it will be a profitable one (judging by pricing of other drugs in indication, number of patients and improvement it may have upon them). Now Alzheimer's that sounds like a good potential market opportunity for Coprexa... what next?
Aside from the science, the options and warrants (at much lower prices) raised another flag.
This from the 10-k (Need to adjust for the reverse split I believe was 3-1 still quite a number of low priced warrants):
http://www.sec.gov/Archives/edgar/data/894158/000089016307000211/s11-7240_10ksb.htm
(G) Stock Warrants
In October and November 2006, the Company issued warrants to purchase 10,351,979 shares of common stock as part of the private placement offering. The warrants have an exercise price of $0.74 and each warrant has a life of 5 years.
In addition, as part of the private placements, the Company issued warrants to purchase 2,874,831 shares of common stock to the placement agent, which is a company that is controlled by the Company’s Chairman and CEO. The warrants have an exercise price of $0.74. The fair value of the warrants totals $4,555,457 and was determined by using the Black-Scholes model with the following assumptions: expected dividend yield of 0%; expected volatility of 79.4%; risk-free interest rate of 4.54% and an expected life of ten years. Since these warrants were granted as compensation in connection with an equity raise, the Company has treated these warrants as a direct offering cost. The result of the transaction has a $0 net effect to equity. The warrants are fully vested and non-forfeitable.
On October 31, 2006, the loans payable to the Company’s founder, President and CEO were converted into 4,995,633 shares of common stock and 2,497,817 warrants to purchase common stock. The warrants have an exercise price of $0.74 and a life of 5 years. (See Note 4)
12,849,796 of the warrants are callable by Pipex in the event that Pipex’s common stock trades at $1.85 per share for 20 of 30 consecutive days. Accordingly, net proceeds of approximately $9,500,000 may be realized by Pipex in the event that all of the warrants are exercised.
A summary of warrant activity for the years ended December 31, 2006 and 2005 is as follows:
Number of
Shares
Balance as December 31, 2005 —
Granted 15,724,627
Exercised —
Forfeited —
Balance as December 31, 2006 15,724,627
OT: General Market
I agree I wish I had more funds to buy some of these biotechs that have taken a beating! I don't have a good sense for timing a peak or a bottom but I agree too that if everyone thinks the world is coming to an end its probably a good time to buy and if your barber starts giving you stock tips its a good time to sell.
A writer (economist, lawyer, actor, former speech writer for Reagon, etc.) I like Ben Stein has had a few good columns on this and how the whole subprime issue has much less impact then people make it out to be. Anyway here is the link to his columns
http://finance.yahoo.com/expert/archive/yourlife/ben-stein/1
Webcast Calendar
[Please see updating procedure at the end of this post. Events listed here are regular quarterly conference calls unless indicated otherwise. All times are U.S. ET. unless indicated otherwise.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Deleted old entries, Canaccord Adams Link
Canaccord Adams 27th Annual Global Growth Conference
08/07/07 - 08/09/07
Boston, MA
http://phx.corporate-ir.net/phoenix.zhtml?c=128696&p=conferenceAgenda&id=1469135&day=1
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Gene Therapy:
This is the Washington Post article from the other day didn't see this posted may be worthwhile for archival purposes. Also a recent article in the Journal of Science on a potential link between liver cancer and using the AAV vector may be of interest to those who follow the field http://mednews.wustl.edu/news/page/normal/9733.html
http://www.washingtonpost.com/wp-dyn/content/article/2007/08/05/AR2007080501636_pf.html
or
http://www.washingtonpost.com/wp-dyn/content/article/2007/08/05/AR2007080501636.html?hpid=topnews
Death Points to Risks in Research
One Woman's Experience in Gene Therapy Trial Highlights Weaknesses in the Patient Safety Net
By Rick Weiss
Washington Post Staff Writer
Monday, August 6, 2007; A01
Robb Mohr sat by his wife's hospital bed two weeks ago, trying to take it all in. His wife, Jolee Mohr, was breathing with the help of a ventilator in a Chicago intensive care unit -- her body bloated from internal bleeding, her liver failing -- and no one could figure out what was wrong with her.
Robb Mohr had his suspicions. Jolee, 36, had been feeling fine just a few weeks earlier, save for occasional stiffness from her arthritis. Her decline had begun the day after her right knee was injected with an experimental drug made of genetically engineered viruses. Doctors at the hospital shared his concern.
Jolee Mohr died from massive bleeding and organ failure July 24, leaving behind a 5-year-old daughter and a host of questions about why she was recruited into a gene therapy experiment whose chief goal was to test the safety of a novel arthritis treatment that had virtually no chance of helping her.
No one knows yet whether the treatment was to blame. Of the dozens of other volunteers who got the injections, only Mohr suffered anything more than short-lived side effects, said officials at Targeted Genetics Corp., the Seattle company that makes the product. The Food and Drug Administration and the company are investigating.
But a close look at the events leading to Mohr's death reveals failures in the safety net that is supposed to protect people from the risks of medical experimentation -- and in particular, the risks of gene therapy, which for 17 years has struggled in vain to live up to its optimistic name.
Breaches of clinical research standards and a federal oversight system that allowed key decisions to be made behind closed doors may have helped draw Mohr into an experiment that was not, her husband says, what she thought it was.
"It was presented to her like this is going to make her knee better," said Robb Mohr, an agronomist who lived with his wife of nine years in a modest vinyl-sided ranch home near Springfield, Ill. "It was supposed to be just a simple thing."
Company officials vigorously defend the study, saying they were upfront about risks, adhered to all regulations and were terribly saddened by the loss. "We're human," said H. Stewart Parker, Targeted Genetics' chief executive. "This is not just a patient. This is a person, and this is a horrible tragedy."
A two-sentence paragraph halfway through a 15-page consent document that Jolee Mohr signed warns of the possibility of "unknown side effects," including, "in rare circumstances, death."
Further in, after long descriptions of how the product may help, a single sentence states: "We do not expect you to receive any direct medical benefits from participation in this study."
Mohr was in an early-phase study, the prime goal of which was to see whether the treatment was safe, not to provide a therapeutic benefit. If the drug passed muster, other studies would determine whether it was an effective treatment.
Her rheumatologist, Robert Trapp, whose Springfield clinic got payments from Targeted Genetics for each subject he recruited, also defended the study. "The theory behind it seemed good, and the science seemed good," he said. "There's nothing I knew of that could have predicted this."
Arthritis is a disease in which the immune system attacks the joints, causing painful inflammation and degradation. Even when treated with powerful medicines, up to 40 percent of patients have ongoing pain in at least a few joints.
That medical reality is an economic opportunity worth as much as $3 billion a year, Parker has said. The company hopes to tap that market with tgAAC94, a virus engineered to have an extra gene. Injected into a joint, the virus infects cells and continuously produces proteins that sop up inflammatory molecules, according to the company.
Like other gene therapies -- hundreds of which have been tested since 1990 and all of which are still experimental -- the approach has the potential advantage of having the body crank out its own medicine for months or years after treatment, right where it is needed.
That sounded good to Mohr when Trapp, one of 20 U.S. doctors testing tgAAC94, invited her to join the study on Feb. 12.
There would be two injections, months apart, he explained. The first might be real, or it might be a placebo, but the second would definitely be the test product. She signed up immediately, and Trapp drew several tubes of blood to get the study going.
Two fundamental rules of clinical research were violated that day, experts said. First, consent forms are to be taken home and considered, not signed on first sight. Second, when a patient's own doctor is a principal investigator in a study, someone else is supposed to make the proposal.
"Because of the relationship . . . you have to worry that they won't listen carefully enough to the risks," said Hank Greely, director of the Center for Law and the Biosciences at Stanford University. Patients, he said, may think, " 'After all, if my doctor is doing this, it must be good for me.' That can be difficult to overcome with words in a consent form."
Trapp said he thoroughly explained the risks to Mohr.
Jonathan Moreno, an expert in the ethics of medical experiments at the University of Pennsylvania, said the consent form used by Targeted Genetics to outline the drug's potential dangers was thick with technical descriptions and thin on explaining "what's really going to happen."
"Even a smart person would have a very hard time figuring out what they're talking about," said Moreno, who examined the form at the request of The Washington Post.
The form was approved by one of the growing number of for-hire review boards that contract with biotechnology companies to ensure studies meet patient-protection standards. Targeted Genetics noted that the review firm it used is accredited and accepted by the FDA. But the use of private boards, as opposed to those run by universities or government agencies, has raised alarms among some medical ethicists since a for-profit review board risks losing repeat business if it is too tough on its clients.
Mohr's first shot, administered on Feb. 26, had no noticeable effect, and she wondered whether she got the placebo. But she was excited that the next one would be the real thing, Robb Mohr said.
That happened on July 2, a Monday. She was tired and out of sorts after a weekend of boating with her husband and daughter, but she had gone to her data-entry job at the secretary of state's office in Springfield and later to Trapp's office.
He recorded her temperature at 99.6, then gave her the shot.
"The next day she woke up and didn't feel good at all. By afternoon she started vomiting," Robb Mohr recalled. "By evening her temperature had shot up to 101."
She spent July Fourth feverish and vomiting. Her family physician told her it was probably just a virus.
When her symptoms worsened and her temperature hit 104.1 on Saturday, she went to the emergency room. Tests indicated a possible infection and signs of liver damage, but she was sent home for more care from her family doctor, according to Robb Mohr and medical records.
Aware of the experiment, Mohr's family doctor called Trapp, who reassured him that the virus was safe -- something Trapp said he had learned at a training session sponsored by Targeted Genetics. But Mohr only got worse, and on Thursday she was admitted to the hospital.
Things went downhill fast, with Mohr's body showing signs of being ravaged by an infection. But tests for standard bacteria and viruses came up negative. With breathing problems and the possibility she might need a liver transplant, she was transferred to the University of Chicago hospital.
Suspecting a possible link to the experimental drug, the doctors in Chicago contacted the FDA.
Federal regulations require a company to report any serious complications that are even "possibly" related to an experimental treatment "as soon as possible" and no later than seven days after learning of it. But Targeted Genetics and Trapp had at first classified the problems as not serious, and later classified them as serious but unrelated to the treatment. So no FDA report was made, and the study went on, with other volunteers unaware of the problems.
That reflects a widespread problem in clinical trials, said Adil Shamoo, a professor at the University of Maryland School of Medicine and editor in chief of the journal Accountability in Research.
"There are no uniform standards for 'adverse events' reporting," Shamoo said. "And there is no motivation to report them. . . . No one wants to show their dirty linen."
Dirty linen can drag down a company's bottom line, and Targeted Genetics, like all companies, puts a lot of work into keeping that line afloat. An interim report on tgAAC94, for example, spoke in June of "very encouraging results" and evidence of "clinical benefit," although, by one measure the company considered key, patients who got high, medium or low doses of the drug did the same as those who got placebos.
"The company was talking about lucrative markets and a promising product much too soon," said Marcy Darnovsky, associate executive director of the Center for Genetics and Society, an Oakland, Calif.-based public interest group that focuses on genetic technologies.
Company officials said the drug does show promise by some measures. "We don't know what the best indication of efficacy is yet," said Barrie Carter, the company's chief scientific officer.
Finally, on July 20, a day after Mohr's emergency transport to Chicago and four days before she died, the company sent a "serious adverse event" report to the FDA and suspended the study, conceding that her life-threatening symptoms were "possibly" due to the treatment.
Three weeks after Mohr got the injection that she had hoped would cure her, she was unconscious and beyond hope of recovery. With family and friends gathered around, her life support was removed.
"Basically, I told my daughter that her mommy has died and gone to live with Jesus," Robb Mohr said. "She prays every night that Jesus will make her better so she can come back home."
Tests on Jolee's Mohr's tissues may tell the story of what happened, but for now scientists say they are scratching their heads.
One reassuring aspect of tgAAC94's engineering is that genes required for replication have been removed, so the viruses cannot make more of themselves. But animal studies conducted by the company have shown that the product can escape from the joint space and travel about the body, perhaps catching the attention of the immune system. In general, the immune system mounts much more robust -- sometimes dangerously robust -- responses after a second exposure. In fact, both shots Mohr got were the real thing, the company said.
Further complicating matters, Mohr was on three conventional but potent arthritis drugs, each of which can cause serious side effects.
Years ago, when Targeted Genetics first sought permission to test tgAAC94 in people, federal reviewers approved a single dose in patients who were not taking other drugs but said they would think twice about approving multiple shots or testing in people taking other arthritis medications. Some questioned whether the risk of even a single shot was worth it for a non-life-threatening disease such as arthritis, according to the minutes of meetings at the National Institutes of Health, which used to review, in public, every proposed human gene therapy experiment.
After completing its initial study of single shots, Targeted Genetics sought permission to start giving two -- and to patients taking other drugs. Whatever discussion led up to that approval is hidden from the public because of a federal rule change in 2000 that placed most such follow-on studies under confidential FDA review rather than a public NIH process.
In testimony before a congressional subcommittee in 2000, a chief executive representing the Biotechnology Industry Organization spoke out for the rule change, to streamline oversight and harmonize NIH and FDA regulations. Among other things, the change gave companies up to a year to report serious adverse events as long as the doctor overseeing the study does not think the problem is caused by the test product.
The chief executive was H. Stewart Parker of Targeted Genetics.
Staff researcher Madonna Lebling contributed to this report.
I got them where you did too, so unless someone shows me different I'll take what I came up with in the PR's and filings. Good to see that someone else is on the same page.
I think its a good story and with good growth potential for some time. Just some unrealistic expectations maybe?
So people don't get too unrealistic in expectations. Going from PRs/Filings and the additional info Hank provided from his conversation with Mr. Sandgaard:
6/1/06 10 sales reps
8/1/06 20 sales reps
8/14/06 26 sales reps
6/1/07 32 sales reps (date estimate)
Also from the 2006-5-25 8K: 10-15 sales reps goal to be about 100 within 3 years (of a financing)
If I recall correctly I believe a couple of follow-ons for the CD-20 MAB are in the works. I vaguely recall Inex (small canadian company) working on one before their RNA split (don't know where it stands now) I recall seeing at least one other company working on one but that eludes me. I don't think BIIB will let their Rituxan franchise slip anytime soon.
I am relatively new to GTC after seeing many of the posters are the same as on Biotech Values. I had thought GTC's Transgenic business was more a play on generic biologicals but after seeing this: "...and to have relatively higher antibody dependent cell-mediated cytotoxicity, or ADCC" I was wondering if GTC's follow-ons may provide some sort of benefit in efficacy/dosing/toxicity/etc.? Sorry if this has been addressed here before.
rfj,
Your prediction is looking pretty good, unfortunately I had purchased some before your post. I've added more. Judging by the timing of their call and when the IND was filed for 237 (hyperoxaluria / kidney stones) and the fact that we have not had a negative PR they should announce it being accepted and hopefully dosing patients soon!
I haven't been too thrilled with their lack of progress with 238 (growth hormone) and their business development (what good is it to tout crystallization of 70+ proteins and not have the ability to form strategic collaborations). I'd think Biomarin would love to get their hands on 236 (PKU). I keep hoping Sidney wants to retire (he sure is selling his shares as quick as he gets them) and they can convince Michael Astrue to give up the government job (Bush's term is ending soon anyway) and become CEO. Its interesting that David Pendergast is on the board.
ZIOP - Did a trade really execute at 99,999.99 today? Curious if the buyer can get it canceled or are they out some big bucks?
General Counsel is the new fast track to CEO in Big Pharma,
I did pretty well with the General Counsel taking over one of the biotechs I owned. I don't have any hard stats but given the choice between a finance background, a law background or a medical background I think the latter seem to do worse as CEO, particularly if they were founders.
What happens to the early access program if approval is delayed or worse? I would think GPC has some leverage and hopefully is as well prepared as they seemed to indicate on their calls!
I would think if people take into consideration this is still a chemo drug so its not without its toxicities and limitations a better perspective can be had that even without final survival data it still has several benefits today:
1-It is oral
2-No other (approved) treatment options in this indication [OK this is a weak point for bureaucrats, I remember Marquibo with Enzon]
3-Pain Reduction even if the measurement is under some dispute is still significant in this patient population [On one Pharmion's calls the pain was described as an extreme pain that is not easily responsive to other meds]
4-I find the fact that the Bristol-Myers trial that was stopped is part of the submission an interesting tid-bit. I know it would not be an apples to apples (one front-line other 2nd line) comparison but I wonder if the results of the interim analysis are pulled with the limited Bristol results if a meta-analysis would show a statistically significant survival advantage?
Maybe a (cautious) FDA is just looking for a scapegoat/out should something negative turn up such as not showing a survival advantage? Perhaps a comprise (Phase IV trial of some sort, maybe that is what the points raised about Docetaxel in only 51% and/or the pain measurement?) OK I'll admit I am a SPPI long so I don't mind seeing GPC flip the bill for another trial and appease the FDA :)
Tuesday ODAC/satraplatin:
Sorry I am missing the fun. Does anyone know if a webcast of the meeting is available? I believe the DNDN one was and someone posted a link appreciate if anyone has a link for this. TIA.
Been wondering about 2 things:
1. If FDA rejects/delays satraplatin will the significance of an SPA be even more diminished? Without being privy to all the details its hard to know if there are major breaches or the FDA is looking for an out but with ENCY recently if I were a CEO I'd think twice about lengthy discussions and focus more on getting pristine data.
2. If ODAC recommends one way and the FDA does something different are panel meetings less meaningful?
I've had Urilogix on a watch list too and hear the calls every now and then. I'd been interested if someone gives me the bull case. I can think of a few negatives that have prevented me from looking at it more closely:
1-Poor management (missed estimates, generally don't seem to be on top of things - but this is just an impression from calls)
2-Revenues have been declining.
3-I believe the insider buying isn't really insider buying it is a fund whose in pretty deep if memory serves. The fact that they've bought at higher prices doesn't exactly instill confidence that its a good fund.
4-They have a much bigger competitor
The above said with the cash, the fact that they have a product on the market that is producing revenue they could be a value if there is a turnaround in sight. Appreciate anyone's bull case for them. TIA
The only thing that scares me is why hasn't
Henri Termeer jumped back into GTCB full
throttle ahead?
I won't comment on Genzyme's interest here there are far more informed posters on this board who can do that.
I'll point out something into Mr. Termeer's thinking though from a little quote in a book I read recently ("The Cure") in it there are negotiations between Genzyme and Novazyme who was working on a Pompe treatment at the same time Genzyme was and it was believed they (Novazyme) may have a better product but they were short of cash and nearing desperate straights. Anyway John Crowley was trying to negotiate a sale of the company and commented "... At the point where you have to have us we'll be too expensive for you." then the quote I love from Mr. Termeer (it is a direct quote in the book) "We'll always be able to afford you."
I don't know if there is enough interest but I'd be curious on sentiment on the satraplatin arbitration between GPC and Spectrum. I can think of a range of possiblities
1-Strongly advantageous to GPC (leans toward Spectrum loses on all claims and GPC wins most important award, paid-in-full royalty free obligation to satraplatin)
2-Strongly advantageous to Spectrum (GPC loses all claims and Spectrum wins most important award, namely return of rights to Satraplatin without significant restitution to GPC)
3-Slightly in favor of Spectrum (Modest Cash ~ 11.8 million and entitled to 20% of all cash payments, specifics on copromotion)
4-Slightly in favor of GPC (no financial compensation to Spectrum, no additional financial benefit to Spectrum if they opt to coprome)
5-Neutral
6-Settlement
a. In favor of Spectrum
b. In favor of GPC
c. Neutral Each party drops their claims and pays own legal
My guess would be along the lines of 6a
Thanks for the info from IR. 5-6 sounds like a conservative type of response by IR. I don't have experience in this but in baseball it is a whole lot shorter, hopefully we hit a homerun but I'd settle for a single :)
Its in the Q.
http://sec.edgar-online.com/2007/05/02/0000892569-07-000570/Section9.asp
I think Russell may have said so on the 5/31 Friedman Billings Ramsey Conference (I'm not positive though but it is the best discussion on the arbitration I've seen the company do)
OT:
Beijing steamed buns include cardboard [Don't forget to brush afterwards :)]
I don't seem to be hearing quite a lot about drug imports from x-US to cut costs these days.
http://news.yahoo.com/s/ap/20070712/ap_on_re_as/china_cardboard_buns_3
BEIJING - Chopped cardboard, softened with an industrial chemical and flavored with fatty pork and powdered seasoning, is a main ingredient in batches of steamed buns sold in one Beijing neighborhood, state television said.
The report, aired late Wednesday on China Central Television, highlights the country's problems with food safety despite government efforts to improve the situation.
Countless small, often illegally run operations exist across China and make money cutting corners by using inexpensive ingredients or unsavory substitutes. They are almost impossible to regulate.
State TV's undercover investigation features the shirtless, shorts-clad maker of the buns, called baozi, explaining the contents of the product sold in Beijing's sprawling Chaoyang district.
Baozi are a common snack in China, with an outer skin made from wheat or rice flour and and a filling of sliced pork. Cooked by steaming in immense bamboo baskets, they are similar to but usually much bigger than the dumplings found on dim sum menus familiar to many Americans.
The hidden camera follows the man, whose face is not shown, into a ramshackle building where steamers are filled with the fluffy white buns, traditionally stuffed with minced pork.
The surroundings are filthy, with water puddles and piles of old furniture and cardboard on the ground.
"What's in the recipe?" the reporter asks. "Six to four," the man says.
"You mean 60 percent cardboard? What is the other 40 percent?" asks the reporter. "Fatty meat," the man replies.
The bun maker and his assistants then give a demonstration on how the product is made.
Squares of cardboard picked from the ground are first soaked to a pulp in a plastic basin of caustic soda — a chemical base commonly used in manufacturing paper and soap — then chopped into tiny morsels with a cleaver. Fatty pork and powdered seasoning are stirred in.
Soon, steaming servings of the buns appear on the screen. The reporter takes a bite.
"This baozi filling is kind of tough. Not much taste," he says. "Can other people taste the difference?"
"Most people can't. It fools the average person," the maker says. "I don't eat them myself."
The police eventually showed up and shut down the operation.
SPPI/GPCB:
With the arbitration scheduled to end tomorrow and no news if one were to speculate based on the stock prices of the two companies, I would think this is the action I would expect if the arbitrators rejected both parties claims or if the two parties came together and concluded to settle with neither party prevailing on their claims.
That being said I think Spectrum has a better then even (> 51%) chance to get at least something. I still think a settlement between the parties, perhaps after each side has finished presenting and before the arbitrators have ruled each side can get a better sense for where they stand and make an amicable agreement before the ODAC meeting this would seem to be the most constructive approach.
Does a rod think someone else will pay him $27 million per year for the next three years? He's delusional if he does.
Figuring what Clemens makes on a pro-rated basis he is getting more than that and I think Rodriguez is worth more then him at this stage. OK so maybe Clemens isn't worth that either :).
Mike, I also appreciated your going through the PR's/filings and putting it all together. I really admire someone who takes the added effort to look at the numbers!
I've been meaning to look deeper and perhaps contact Mr. Sandgaard. It was a small position for me but the price jump has made it more meaningful. I think if the price moves higher I will be more motivated to do that :)
A couple things about your modelling that may/may not help:
1-The neuromove is 5K-6k (depending on if purchase with discount).
http://www.neuromove.com/prescriptionforms.html
2-If patients lease it for the amount of time that equals the purchase price they are given ownership of the unit [It may be a quite a stretch through to speculate that as the typical length of use]
3-The (low and I'd suspect most common) rental price is $99 / month (after $198 down-payment).
4-I would think there is a significant lag to reimbursement from insurance companies. The website info on how much insurance is billed seems quite substantial too so knowing the breakdown of how payments are received would be important in modelling.
5-There has been a direct relationship between sales growth and sales reps hired (after some rampup/familiarity lag of course). What we (or at least I, perhaps someone has more insight? don't know is since last August has the company further hired sales employees? This to me is the key as the timing and number of new reps could perhaps be a good indicator for future monthly sales.
Hope this info is of some help. Thanks again for going through with the data-gathering and analysis!
I don't follow the company but saw this and thought this was a very creative way to say normal or low milestones/royalties
Gene Logic Enters Into Agreement with Lundbeck to Discover New Development Paths for Clinical Drug Candidates
Thursday June 28, 6:00 am ET
Agreement Includes Potential for Significant Success-Based Milestones and Royalties [notice the wording hear in the sub-title]
http://biz.yahoo.com/bw/070628/20070628005221.html?.v=1
GAITHERSBURG, Md.--(BUSINESS WIRE)--Gene Logic Inc. (NASDAQ:GLGC - News) announced today that it has entered into a drug repositioning and development agreement with H. Lundbeck A/S to seek alternative development paths for certain Lundbeck drug candidates. These drug candidates were discontinued or de-prioritized in clinical trials for reasons other than safety.
The drug repositioning agreement provides for milestones and royalties similar to those paid for development-stage in-licensing deals, discounted to account for Lundbeck's contribution as the originator of the compound. [Notice the creative downward wording of the payments/milestones here. My guess if they release figures in an 8-k the figures will be more typical and thus the wording here.] The agreement also provides Gene Logic the option to receive an exclusive license to any of these drug candidates for which Gene Logic identifies a potential new use and that Lundbeck chooses not to pursue, in which case Lundbeck would receive success-based milestone and royalty payments.
Gene Logic's Drug Repositioning Program seeks to find alternative development paths for drug candidates with good safety records that have been de-prioritized or discontinued in clinical trials. The program offers pharmaceutical partners a novel approach to bolster their pipelines with high-quality drug candidates that originated from their own R&D efforts. Applying a diverse set of drug discovery technologies in parallel, Gene Logic's Drug Repositioning Program evaluates drug candidates for potential utility across a wide spectrum of disease indications.
Charles L. Dimmler, III, Gene Logic CEO commented, "Lundbeck has an outstanding reputation as a developer of therapeutics for central nervous system disorders. We are pleased to be partnering with an innovative organization such as Lundbeck. With six current pharmaceutical company drug repositioning partnerships, our approach is establishing Gene Logic as the industry's drug repositioning leader."
In a separate agreement unrelated to its drug repositioning partnerships, Gene Logic announced that it expects to realize approximately $2.5 million in fees from Lundbeck for a license to certain technology rights controlled by Gene Logic. The revenue will be recognized over the coming year.
Gene Logic Overview
Gene Logic is transforming into a biopharmaceutical development company through partnerships with pharmaceutical companies. Our partners provide Gene Logic with access to their drug candidates that have been assessed as safe in human clinical trials but discontinued for other reasons. Gene Logic applies its drug indication platform to find new therapeutic uses for the drug candidates. Gene Logic expects to receive milestone payments and royalties on drug candidates that our partners choose to develop based on the indications we find or, if the partner elects not to pursue such new indications, Gene Logic may receive ownership and development rights.
Gene Logic has also developed proprietary genomics databases and services to enable customers worldwide to discover and prioritize drug targets, identify biomarkers, predict toxicity and understand mechanisms of toxicity, and obtain insights into the efficacy of specific compounds.
Founded in 1994, Gene Logic is headquartered in Gaithersburg, Maryland, with additional research and development facilities in Cambridge, Massachusetts. The Company currently has about 150 employees worldwide. For more information, visit www.genelogic.com or call toll-free - 1/800/GENELOGIC.
Safe Harbor Statement
This press release contains "forward-looking statements," as such term is used in the Securities Exchange Act of 1934, as amended. Such forward-looking statements include the Company's ability to identify strategies for making its businesses successful and the impact of such strategies on our business and financial performance and on shareholder value. Forward-looking statements typically include the words "expect," "anticipate," "believe," "estimate," "intend," "may," "will," and similar expressions as they relate to Gene Logic or its management. Forward-looking statements are based on our current expectations and assumptions, which are subject to risks and uncertainties. They are not guarantees of our future performance or results. Our actual performance and results could differ materially from what we project in forward-looking statements for a variety of reasons and circumstances, including particularly such risks and uncertainties that may affect the Company's operations, financial condition and financial results and that are discussed in detail in the Company's Annual Report on Form 10-K and our other subsequent filings with the Securities and Exchange Commission. They include, but are not limited to: whether we will be able to identify and successfully implement strategies, on favorable terms or at all, for improving the performance and value of our businesses and improving the value of our Genomics business and whether repositioned compounds are successfully returned to our customers' pipelines and generate sales, and resulting milestones and royalties for the Company or whether we acquire repositioned compounds on acceptable terms and are able to derive revenue from these compounds through licensing or otherwise, whether we can enter into agreements to develop sufficient compounds to fulfill our plans for the Drug Repositioning Division, and improving the value of our businesses to shareholders; whether there will be remaining price adjustments or liabilities associated with the sale of the Pre-Clinical Division, whether we will be able successfully to manage our existing cash adequately and whether we will have access to financing on sufficiently favorable terms to maintain our businesses and effect our strategies, including development of repositioned compounds; whether we will be able to recruit and retain qualified personnel, particularly in light of our restructuring efforts; potential negative effects on our operations and financial results from workforce reductions, other restructuring activities, and the evaluation of strategic options; the potential loss of significant customers; the possibility of further write-down of the value of certain intangible assets of the Company, including goodwill associated with the Genomics Division; and the possibility of delisting from NASDAQ Global Markets, which could have an adverse effect on the value of our stock. Gene Logic undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact:
Gene Logic Inc., Gaithersburg
Investors:
Philip L. Rohrer, Jr., Chief Financial Officer
301-987-1700
prohrer@genelogic.com
or
Investors and Media:
Christopher Culotta, Director, Strategic Communications
301-987-1752
cculotta@genelogic.com
Its not a sales job but could be more sales need more help seeking reimbursement :)
http://denver.jobing.com/Job_Details2.asp?JobID=971537&SearchID=89323660&Position=0&Came...
OT: So according to the AMA you can't accuse someone of being addicted to video games :)
http://news.yahoo.com/s/ap/20070627/ap_on_hi_te/ama_video_game_addiction_2
Too much video gaming not addiction, yet
By LINDSEY TANNER, AP Medical Writer 2 hours, 11 minutes ago
CHICAGO - The American Medical Association on Wednesday backed off calling excessive video-game playing a formal psychiatric addiction, saying instead that more research is needed.
ADVERTISEMENT
A report prepared for the AMA's annual policy meeting had sought to strongly encourage that video-game addiction be included in a widely used diagnostic manual of psychiatric illnesses.
AMA delegates instead adopted a watered-down measure declaring that while overuse of video games and online games can be a problem for children and adults, calling it a formal addiction would be premature.
"There's no science to support it," said Dr. Stuart Gitlow, an addiction medicine specialist.
Despite a lack of scientific proof, Jacob Schulist, 14, of Hales Corners, Wis., says he's certain he was addicted to video games — and that the AMA's vote was misguided.
Until about two months ago, when he discovered a support group called On-Line Gamers Anonymous, Jacob said he played online fantasy video games for 10 hours straight some days.
He said his habit got so severe that he quit spending time with family and friends.
"My grades were horrible, I failed the entire first semester" this past school year because of excessive video-game playing, he said, adding, "It's like they're your life."
But delegates voted to have the AMA encourage more research on the issue, including seeking studies on what amount of video-game playing and other "screen time" is appropriate for children.
Under the new policy, the AMA also will send the revised video-game measure to the American Psychiatric Association, asking it to consider the full report in its diagnostic manual; the next edition is to be completed in 2012.
Dr. Louis Kraus, a psychiatric association spokesman, said the report will be a helpful resource.
The AMA's report says up to 90 percent of American youngsters play video games and that up to 15 percent of them — more than 5 million kids — might be addicted.
The report, prepared by the AMA's Council on Science and Public Health, also says "dependence-like behaviors are more likely in children who start playing video games at younger ages."
Internet role-playing games involving multiple players, which can suck kids into an online fantasy world, are the most problematic, the report says. That's the kind of game Jacob Schulist says hooked him.
Kraus, chief of child and adolescent psychiatry at Chicago's Rush Medical Center, said behavior that looks like addiction in video-game players may be a symptom of social anxiety, depression or another psychiatric problem.
He praised the AMA report for recommending more research.
"They're trying very hard not to make a premature diagnosis," Kraus said.
Just my opinion but I think a lot of people are still skeptical of the sales ramp. If we get June and July PR's for sales and deliver a strong Q2 I think we will get a whole lot more interest.
Its hard to do a lot of speculation on what sales will be but a couple of observations:
1-The company has not 8-k'd any financing's since late last year (technically January 5 of 2007).
http://www.sec.gov/Archives/edgar/data/846475/000107997407000050/zynex8k_1302007.htm
To me this could be for a couple reasons. I'd like to think it is because they are generating enough revenue that they don't have any short-term liquidity issues and they are continuing with the slow ramp in sales force.
2-Last year (sorry no link but you can find it in an 8-k) the company had a call with institutions to try to raise cash in it (the filing I have no idea on the call contents) they seemed to indicate a much large sales force. If the think has not changed and I am right in my thinking they may be incrementally adding sales people which may mean incremental sales increases (giving time for reps to get more productive).
3-Along the lines of the above, one would think reps get more productive over time.
On the downside. I am not certain on avg length of use for the neuromove, so perhaps the revenues may not be extending for many months (I don't know just an observation).
Another thing I am curious about is the potential to partner overseas.
I didn't have a huge position but the price increase is making it significant enough that I may try to talk with Mr. Sandgaard. Had anyone here ever contacted him or for that matter anyone else at the company (though I'd think the CFO being relatively new couldn't give as much useful info as Mr. Sandgaard)? TIA
OT - Cell Phone Do Not Call
I think this is an urban legend. FYI you can also register on the do not call list on-line (at least a while back you could, didn't try it recently)
http://www.ftc.gov/opa/2007/02/dnccellphones.shtm
Despite Re-Circulating E-mail, It is Still Not Necessary to Register Cell Phone Numbers
As the number of phone numbers on the National Do Not Call (DNC) Registry surpassed 139 million, the Federal Trade Commission today reiterated that despite the claims made in e-mails circulating on the Internet, consumers should not be concerned that their cell phone numbers will be released to telemarketers at any time in the near future. In addition, according to the agency, it is not necessary to register cell phone numbers on the DNC Registry to be protected from most telemarketing calls to cell phones.
The truth about cell phones and the DNC Registry is:
* Contrary to the e-mail, cell phone numbers are NOT being released to telemarketers, and you will NOT soon be getting telemarketing calls on your cell phone.
* There is NO deadline by which you must register your cell phone number on the Registry.
* Federal Communications Commission (FCC) regulations prohibit telemarketers from using automated dialers to call cell phone numbers. Automated dialers are standard in the industry, so most telemarketers are barred from calling consumers on their cell phones without their consent.
* The national associations representing telemarketers have stated that their clients do not intend to start calling consumers’ cell phones.
* There is only ONE DNC Registry. There is no separate registry for cell phones.
* The DNC Registry accepts registrations from both cell phones and land lines. You must call from the phone number that you want to register. If you register online, you must respond to a confirmation e-mail.
* While the telecommunications industry has been discussing the possibility of creating a wireless 411 directory, according to the FCC, even if a wireless 411 directory is established, most telemarketing calls to cell phones would still be illegal, regardless of whether the number is listed on the federal government’s National Do Not Call Registry.
For More Information
To learn more about the National DNC Registry and the rules that enforce it, visit the FTC at www.ftc.gov or the FCC at www.fcc.gov. For more information about a planned “wireless 411” directory, visit http://www.qsent.com/wireless411.
The FTC works for the consumer to prevent fraudulent, deceptive, and unfair business practices in the marketplace and to provide information to help consumers spot, stop, and avoid them. To file a complaint in English or Spanish (bilingual counselors are available to take complaints), or to get free information on any of 150 consumer topics, call toll-free, 1-877-FTC-HELP (1-877-382-4357), or use the complaint form at http://www.ftc.gov. The FTC enters Internet, telemarketing, identity theft, and other fraud-related complaints into Consumer Sentinel, a secure, online database available to hundreds of civil and criminal law enforcement agencies in the U.S. and abroad.
Media Contact:
Mitchell J. Katz
Office of Public Affairs
202-326-2161
Staff Contact:
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202-326-3747