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ie: LLY gamma secretase ph 3 trial recruitment
Master, I believe that the start date has been pushed back on this trial. My Contract site is being recruited and I was just asked to attend an investigator's meeting scheduled for late May. This is not to say that they may have launched a few sites already, but my understanding is that the official launch for this study will be June.
Of, course, if our site participates, I'll have to remain silent about this one (and am, in fact, holding my tongue on some other co.'s because of this).
regards,
aj
"I tried to help you out by posting the quiz while genisi was sleeping—there's only so much I can do :- )
It's my impression that DT doesn't ever sleep, it wastes too much time!
aj
Re: US healthcare costs
"Natasha Richardson probably would have lived if she'd had an accident here, because doctors would have done a cat scan, and there would have been a Medevac helicopter available. That's tens, maybe hundreds of thousands of dollars to save a single life."
$100,000 doesn't even scratch the surface!
For every Natasha Richardson that survives in the US, the resulting costs run into the millions of dollars. Closed head injured survivors, particularly those with moderate to severe closed head injuries, are a huge cost because they are young at injury, survive for many years after their injury, require specialized care and require multimodal care (ie. physical medicine, behavioral care, medication(s), {re}habilitation, etc., etc.)
aj
RT: Weight loss, pills, exercise and diet.
"Removing 1 can of regular soda a year and you lose about 12 lbs a year if everything else remained the same.
I have held my tongue through most of this thread; I mostly agree with PGS that behavioral change through diet and exercise is much more likely to generate successful weight loss than the ARNA drug (and be a SUSTAINABLE weight loss to boot.)
Dew's comment that bariatric surgery is the better of two choices for the over 300# pt is a false dichotomy in that behavioral change, as above is a third and ultimately much more powerful choice to be used. I'm not sure if Dew meant to communicate that there were only two choices, though.
The above quote, however, is meaningless, IMO. While the calorie calculation you make may be correct, Randy, the body works on "Body Set Point" which down regulates metabolism to preserve the homeostatic weight of a patient who diets (as well as upregulates metabolism for brief feasts). There is no such thing as "everything else remaining the same" and the body will fight to eep weight the same until some drastic changes occur. That's why both brief diets and brief gluttony never change weight for more than a day or two.
regards,
aj
OT: Struggling with a healthcare job in this recession
RPh- I appreciate your thoughts. To add, I just got a post from a pediatrician friend who mainly works as a clinical study ctr. physician. He ALSO reports difficulties within the pharma study business. Given that this had been the holy grail of deep pocketed funding, I am glad that I am just on the periphery of that business!
He sent me the following:
"The task must be made difficult, for only the difficult inspires the noble-hearted"-Kierkegaard
Have a great day
aj
PS: I too have an HSA. The account works well for me and my relatively healthy family, and it's nice to have dental and eye care (the entire family is near-sighted) taken care of even if it means cutting multiple hundreds of dollars in checks. I like xrymd's practice idea of stocking employees' HSA with deductable sums. Thanks for the idea as I will be looking to start a group practice soon.
Re: The economic impact of the recession of hospitals.
"I'm curious if these same issues are being seem throughout the US or is it just a regional thing."
I can assure you that this is occurring nationwide. I work in a very large not-for-profit healthcare system and our CEO has been clear that ALL of the hospitals within the system have been reporting increases in bad debt, more difficulites with collections and general financial constraints that are weighing down the system. Our facility had been cash flow positive and profitable for only the last few years and the word is that moving forward, losses will be considerable. Austerity programs have been initiated, with a public announcement of a 5% workforce reduction and a temporary call for nonclinical personnel to move to either a 36-hr workweek or to voluntarily take 3 days PTO each month until the workforce reductions can be realized.
I have lost my clerical staff, with the office manager telling me that the rest of the office staff will pitch in to cover her responsibilities, but that I should be ready to cover unmet needs if necessary. I started making my own patient confirmation calls this week and faxing my consulatation to my referring doc's myself.
aj
OT: Financial incentives
"Everyone needs to have ownership of the problems and the upside - hence stock options."
Why not go one step further. Require anyone with these types of incentives to put significant skin into the game. Make them put money on the table of their own that could be lost if they lose money, if their unit loses money, and/or if the co. loses money. This would certainly stand the current paradigm on its ear.
Until something like this happens, it can be said that professionals with big options packages and financial professionals who make the bulk of their money through such incentives have less moral integrity than even personal injury lawyers. At least when a personal injury lawyer puts on a case, they spend their own money (their risk) in developing their case. No win, No payoff and loss on the balance sheet. Where is the similar risk for someone working on Wall Street making such big bonuses for "performance" or even fund managers who make money regardless of whether or not they've made money for their customers.
aj
OT AIG: So, is this what the bailout is all about?
"Out of the $85B emergency bailout money, $12.9B (15%) flowed right to Goldman Sachs"
Why would you or anybody be surprised by this? AIG was in the business of insuring credit default swaps because they are in the insurance business. Since credit default swaps, in the rear view mirror at least, were crap balloons ready to explode, maybe AIG shouldn't have been touching them with their policies. Of course they couldn't, there was way too much money to be made on insuring them.
If Goldman Sachs was conservative enought to hedge their credit default swap position(s) with AIG insurance policies, then it was incumbant upon AIG to properly value what that insurance should cost Goldman Sachs.
The only thing to pity here is how inbred and overlapping the few big banks are in their responsibility for creating the whole damn runup. They all were in eachothers' pockets and all figuring out ways to value paper (read here CRAP not worth valuing) so they all could line their pockets.
aj
NGNM: xrymd, I'm interested in your pathologist's opinion(s) about NGNM. I find it interesting that "the big labs" (one would assume these are Quest and USLabs) are looking into providing tech only FISH services. This would suggest that they are taking note of NGNM's business model.
I am bullish on NGNM for reasons that go beyond tech only FISH. The genetics testing business is growing at 25% YOY in general, and NGNM has been able to grow at north of 70% YOY for the last three years. The industry is dominated by the two giants named above, and they tend to acquire the labs that are growing into their space rather than to compete directly with them. Given the healthy margins afforded in this space (NGNM is reporting 55% margins if memory serves) the big players are much better served in buying out their competitors rather than to compete by cutting into the margins. It is also true that these big co.'s can allow the smaller players to do the ground work of establishing a CLIA certified lab, get the lab cash flow positive and then profitable, rather than doing all of that themselves. The premise of NGNM has always been to build the co. big enough to become an attractive takover target.
aj
NGNM typo?
Dew, the co. states that they have industry leading turnaround times (the CEO built the US Labs genetics testing division before starting this co.), and seperately, they offer Flourescent In-Situ Hybridization (FISH) testing that provides the technical readout, without interpretation, allowing the pathologist to capture the interpretation professional fees for each dagnostic. This is attractive to the pathologists and a selling point when the reps go in and try to take business away from one of the bigger labs.
aj
GXDX: Here's my semi-annual pump for NGNM. Neogenomics is a similar genetics testing firm that is about two years behind GXDX in size and revenues. They claim to have excellent turnaround times and tech only FISH, allowing the pathologists to collect more revenue. FY 2008 was $20 million, 74% YOY growth from 2007.
A penny stock now, but has consistently put 15% QOQ growth for the last two years.
aj
OT: Lincoln's watch.
;)
Thanks for that story.
aj
Funny how this thread pops up now. I just returned from CA, settling my 99 year old late grandmother's estate. I was willed her Waltham lady's pocket watch. A beautiful piece from 1894.
aj
Re: Med Tech Co.s
Bridgeofsighs, don't tease us like this:
"I love the field of medical devices bordering on obsession. I would love to answer any questions (that I can) you might have on any of these instruments."
I have a similar interest in this sector, having made some nice profit (CASM and QGEN) as well as getting hammered (CAMH). Please share what you track and what you think of as a med tech value.
regards
aj
PS: I track
BABY, NXTM, ANGN, VSCP, HRT and many others
AP IMPACT: Drugmakers' push boosts 'murky' ailment
http://news.yahoo.com/s/ap/20090209/ap_on_bi_ge/fibromyalgia_drug_companies
WASHINGTON – Two drugmakers spent hundreds of millions of dollars last year to raise awareness of a murky illness, helping boost sales of pills recently approved as treatments and drowning out unresolved questions — including whether it's a real disease at all.
Key components of the industry-funded buzz over the pain-and-fatigue ailment fibromyalgia are grants — more than $6 million donated by drugmakers Eli Lilly and Pfizer in the first three quarters of 2008 — to nonprofit groups for medical conferences and educational campaigns, an Associated Press analysis found.
That's more than they gave for more accepted ailments such as diabetes and Alzheimer's. Among grants tied to specific diseases, fibromyalgia ranked third for each company, behind only cancer and AIDS for Pfizer and cancer and depression for Lilly.
Fibromyalgia draws skepticism for several reasons. The cause is unknown. There are no tests to confirm a diagnosis. Many patients also fit the criteria for chronic fatigue syndrome and other pain ailments.
Experts don't doubt the patients are in pain. They differ on what to call it and how to treat it.
Many doctors and patients say the drugmakers are educating the medical establishment about a misunderstood illness, much as they did with depression in the 1980s. Those with fibromyalgia have often had to fight perceptions that they are hypochondriacs, or even faking their pain.
But critics say the companies are hyping fibromyalgia along with their treatments, and that the grantmaking is a textbook example of how drugmakers unduly influence doctors and patients.
"I think the purpose of most pharmaceutical company efforts is to do a little disease-mongering and to have people use their drugs," said Dr. Frederick Wolfe, who was lead author of the guidelines defining fibromyalgia in 1990 but has since become one of its leading skeptics.
Whatever the motive, the push has paid off. Between the first quarter of 2007 and the fourth quarter of 2008, sales rose from $395 million to $702 million for Pfizer's Lyrica, and $442 million to $721 million for Lilly's Cymbalta.
Cymbalta, an antidepressant, won Food and Drug Administration approval as a treatment for fibromyalgia in June. Lyrica, originally approved for epileptic seizures, was approved for fibromyalgia a year earlier.
Drugmakers respond to skepticism by pointing out that fibromyalgia is recognized by medical societies, including the American College of Rheumatology.
"I think what we're seeing here is just the evolution of greater awareness about a condition that has generally been neglected or poorly managed," said Steve Romano, a Pfizer vice president who oversees its neuroscience division. "And it's mainly being facilitated by the fact the FDA has now approved effective compounds."
The FDA approved the drugs because they've been shown to reduce pain in fibromyalgia patients, though it's not clear how. Some patients say the drugs can help, but the side effects include nausea, weight gain and drowsiness.
Helen Arellanes of Los Angeles was diagnosed with fibromyalgia in September 2007 and later left her job to go on disability. She takes five medications for pain, including Lyrica and Cymbalta.
"I call it my fibromyalgia fog, because I'm so medicated I go through the day feeling like I'm not really there," Arellanes said. "But if for some reason I miss a dose of medication, I'm in so much pain."
A single mother of three, Arellanes sometimes struggles to afford all her medications. She said she is grateful that a local Pfizer sales representative occasionally gives her free samples of Lyrica "to carry me through the month."
The drugmakers' grant-making is dwarfed by advertisement spending. Eli Lilly spent roughly $128.4 million in the first three quarters of 2008 on ads to promote Cymbalta, according to TNS Media Intelligence. Pfizer Inc. spent more than $125 million advertising Lyrica.
But some say the grants' influence goes much further than dollar figures suggest. Such efforts steer attention to diseases, influencing patients and doctors and making diagnosis more frequent, they say.
"The underlying purpose here is really marketing, and they do that by sponsoring symposia and hiring physicians to give lectures and prepare materials," said Wolfe, who directs the National Data Bank for Rheumatic Diseases in Wichita, Kan.
Similar criticisms have dogged drugmakers' marketing of medicines for overactive bladder and restless legs syndrome.
Many of the grants go to educational programs for doctors that feature seminars on the latest treatments and discoveries.
Pfizer says it has no control over which experts are invited to the conferences it sponsors. Skeptics such as Wolfe are occasionally asked to attend.
The drug industry's grants also help fill out the budgets of nonprofit disease advocacy groups, which pay for educational programs and patient outreach and also fund some research.
"If we have a situation where we don't have that funding, medical education is going to come to a screeching halt, and it will impact the kind of care that patients will get," said Lynne Matallana, president of the National Fibromyalgia Association.
Matallana founded the group in 1997 after she was diagnosed with fibromyalgia. A former advertising executive, Matallana said she visited 37 doctors before learning there was a name for the crushing pain she felt all over her body.
A decade later, her patient advocacy group is a $1.5 million-a-year operation that has successfully lobbied Congress for more research funding for fibromyalgia. Forty percent of the group's budget comes from corporate donations, such as the funds distributed by Pfizer and Eli Lilly.
Pfizer gave $2.2 million and Lilly gave $3.9 million in grants and donations related to fibromyalgia in the first three quarters of last year, the AP found. Those funds represented 4 percent of Pfizer's giving and about 9 percent of Eli Lilly's.
Eli Lilly, Pfizer and a handful of other companies began disclosing their grants only in the past two years, after coming under scrutiny from federal lawmakers.
The message in company TV commercials is clear. "Fibromyalgia is real," proclaimed one Lyrica ad. Researchers who've studied the condition for decades say it's not that simple.
Since the 1970s, Wolfe and a small group of specialists have debated the condition in the pages of medical journals. Depending on whom you ask, it is a disease, a syndrome, a set of symptoms or a behavior disorder.
The American College of Rheumatology estimates that between 6 million and 12 million people in the U.S. have fibromyalgia, more than 80 percent of them women. It's not clear how many cases are actually diagnosed, but Dr. Daniel Clauw of the University of Michigan said pharmaceutical industry market research shows roughly half are undiagnosed. People with fibromyalgia experience widespread muscle pain and other symptoms including fatigue, headache and depression.
After 30 years of studying the ailment, rheumatologist Dr. Don Goldenberg says fibromyalgia is still a "murky area."
"Doctors need labels and patients need labels," said Goldenberg, a professor of medicine at Tufts University. "In general, it's just more satisfying to tell people, 'You have X,' rather than, 'You have pain.'"
While Goldenberg continues to diagnose patients with fibromyalgia, some of his colleagues have stopped, saying the condition is a catchall covering a range of symptoms.
Dr. Nortin Hadler says telling people they have fibromyalgia can actually doom them to a life of suffering by reinforcing the idea that they have an incurable disease.
"It's been shown that if you are diagnosed with fibromyalgia, your chances for returning to a level of well-being that satisfies you are pretty dismal," said Hadler, a professor at the University of North Carolina, who has occasionally advised health insurers on how to deal with fibromyalgia.
Hadler said people labeled with fibromyalgia are indeed suffering, not from a medical disease but from a psychological condition. Instead of drugs, patients should receive therapy to help them "unlearn" their predicament, he said.
Research by the University of Michigan's Clauw suggests people with fibromyalgia experience pain differently because of abnormalities in their nervous system. Brain scans show unusual activity when the patients experience even minor pain, though there is no abnormality common to all.
Clauw's work, however, illustrates the knotty issues of drug company funding. He has done paid consulting work for the drugmakers, and he's received research funding from the National Fibromyalgia Research Association, which receives money from the drugmakers.
While Clauw acknowledges that Lyrica and Cymbalta do not work for everyone, he has little patience for experts who spend more time parsing definitions than helping patients.
"At the end of the day I don't care how you categorize this — it's a legitimate condition and these people are suffering," Clauw said.
ARAY, Are they still using the same unorthodox definition of backlog?
The short answer is no, but I'd be hard pressed to tell you what changes they've made in the accounting process. I've been almost completely disinterested in this investment with the exception of their quarterly numbers for almost a year now. Their new CFO is suppposed to be cleaning the books up.
aj
ARAY: 2nd quarter earnings and guidance
( I have comparatively more skin in this game now that the rest of my portfolio has wilted. Today's news and guidance just might finally call the bottom for ARAY. Let's hope mgmt seizes the opportunity to grow share value)
http://finance.yahoo.com/news/Accuray-Announces-Results-for-prnews-14200570.html
SUNNYVALE, Calif., Jan. 29 /PRNewswire-FirstCall/ -- Accuray Incorporated (Nasdaq: ARAY - News), a global leader in the field of radiosurgery, announced today financial results for the second quarter of fiscal 2009, ended December 27, 2008.
For the second quarter of fiscal 2009, Accuray reported total revenue of $57.6 million, a 10.8 percent increase over second quarter of fiscal 2008 total revenue of $52.0 million and a 3.2 percent sequential increase over the first quarter of fiscal 2009.
In the second quarter of fiscal 2009, Accuray recorded a market fair value charge of $860,000, or $0.02 per share, in connection with a settlement agreement entered into with the distributor of the auction rate securities that guarantees repayment of the securities at par value beginning in June 2010. As a result net income for the second quarter of fiscal 2009 was $1.4 million, or $0.02 per diluted share, compared to net income of $2.3 million, or $0.04 per diluted share, during the same period last year. Non-cash, stock based compensation charges for the second quarter of fiscal 2009 were $3.6 million.
For the six months ended December 27, 2008, total revenue was $113.5 million, a 12.7 percent increase over total revenue of $100.7 million for the same period last year. Net loss for the first half of fiscal 2009 was $1.8 million, or a loss of $0.03 per diluted share, compared to net income of $4.6 million, or $0.08 per diluted share, for the first half of fiscal 2008. The net loss in the first six months of fiscal 2009 was primarily driven by non- recurring costs associated with employee separation expenses and inventory write downs incurred during the fiscal first quarter of 2009.
"We are encouraged by the year-over-year revenue growth plus strong installation and shipment numbers for the quarter, reflecting an expanding demand for our CyberKnife® Robotic Radiosurgery System," said Euan S. Thomson Ph.D., Accuray's president and chief executive officer.
In an effort to contain costs, Accuray has eliminated approximately 60 positions or approximately 13 percent of its U.S. workforce. The Company is focused on improving processes and cross-company collaboration with the goal of raising efficiency, and has taken these actions to enhance the Company's success in the long term and position itself to weather the potential impact of the current global downturn. The Company estimates that the future savings in employment related expenses will be approximately $8.7 million per year. Due to severance pay and the timing of employment terminations, limited savings will begin in the fourth fiscal quarter of 2009 with the full benefit starting in the first quarter of fiscal 2010. Most of the affected jobs are located at Accuray's Sunnyvale, Calif. headquarters.
At December 27, 2008, non-contingent contracts, for which all contractual obligations have been satisfied, accounted for approximately $452 million or 76 percent of total backlog. Accuray's backlog is composed of signed contracts that the company believes have a substantially high probability of being recognized as revenue in future periods. Total backlog at the end of the second fiscal quarter of 2009 was $598 million, with approximately $311 million associated with CyberKnife Robotic Radiosurgery System contracts and approximately $287 million associated with services and other recurring revenue. Contingent contracts made up $146 million of backlog.
Accuray's cash and investment balances at the end of the second quarter of 2009 totaled $154.7 million, which includes cash and cash equivalents of $29.4 million, restricted cash of $0.6 million, short-term investments of $80.2 million and long-term investments of $44.5 million. At the end of the second quarter of 2009 the Company continued to have zero debt.
Outlook
The following statement is forward-looking and actual results may differ materially. Accuray expects total revenues for fiscal 2009 to be in the range of $230 million to $250 million.
Re: ABT - Vicodin CR FDA rejection
curious, I had not been following this drug development. One has to wonder if ABT's formulation interferes with efficacy.
regards
aj
Re: Savella and FRX reps
It will be interesting to see if the FRX reps provide any ancillary depression stats in their presentations for Savella. As an SNRI, Savella might be one of the drugs that doc's look to switch to when the patients have the vague and amorphous presentations that include both pain and depression syndrome symptoms.
aj
Re: Suggestions for improving this board
4. Vacuous stock-pumping posts and posts about technical chart patterns should be BANNED.
Microcap, I agree with the latter part of this but not the former. Allow the vacuous posts occur so they can be debunked as the fraud that they are. I monitor many boards and when I see the co. being mentioned elsewhere, I'm always interested in whether an opinion has been offered here.
regards
aj
"But have one thing in common with Preciouslife1, a rock solid faith."
And you have the supportive thoughts of dozens on this board. Fight the good fight and live each minute!
regards
aj
OT: Dementia and aggression. This is an unsolicited opinion and may be worth just what you paid for it, but you might want to suggest a titration of topomax to the cocktail. The doc has to do this slowly, but if the patient tolerates it, you may be able to back off the antipsychotics. If the aggression has an impulse control component (disinhibition can be particularly problematic for patients with dementia) I've seen topomax turn the trick.
aj
Re: cervical dystonia
LOL, thought for a minute that this was some type of sexual disorder!!!
aj
MNTA and seeking alpha:
"There’s a reason Mike Havrilla’s article from SeekingAlpha sounds a lot like the ReadMeFirst primer on this board: he copied the information directly from the ReadMeFirst, using the verbatim language in some cases. I don’t mind because it increases the exposure.
Plagiarism is pliagarism, nonetheless. Seeking Alpha makes money by writing opinions. They made money taking credit for your opinion(s) and that's fundamentally wrong in the eyes of journalism. That said, a nice compliment, dontcha think?
aj
Ereska/JAV
Genisi and anyone else who might be interested:
I suspect that Ereska for analgesia will be a big hit for breakthrough pain mostly because of the subjective experience reported by so many street users of ketamine. The type of dissociative euphoria that ketamine can provide will be a big relief for the target populations of pain patients who have a miserable life because of the pain they are experiencing. These same patients will have been on opioids, have developed a tolerance to the opioids, and most will tell their doctors (and anyone else who will listen) that the opioids dull the pain, but don't eliminate it. When one lives with this kind of pain, the ability to enter into a controlled dissociative state will be a great relief, even for a short amount of time.
(Biowatch, thanks for the PM's; I could fill your ears with the struggle to get DoD to fund brain injury rehab outside of the VA system)
aj
Re: Zolpidem oral spray vs. other inhalable drugs (particularly Ereska)
Maxx, I held off responding to your original post about the potential for inhalable zolpidem, and would have asked the exact same question that Dew rasied. To put it another way, just how fast does one need zolpidem to work? An inhalable formulation would, it would seem, be faster acting. Personal and professional experience, however, indicate that the tablet form of zolpidem is quite satisfactory for the patients who respond to it.
Intranasal ketamine (Ereska by JAV) is another story altogether. Ketamine is available in liquid (injectible) form, but is being developed for breakthrough pain, so having it available as an inhalable makes all the sense in the world. I anticipate that Ereska will eventually become part of an "A-B" treatment for pain, alternating with opioid medications to limit patient exposure to opioids.
Of course, I'm biased here as I have considerable skin in the JAV game ;0
BTW: zolpidem is showing some modest paradoxical effects with severe traumatic brain injured patients. Use of the drug during the day increases arousal and responsivity in some patients with severe TBI who approach the chronic vegetative state end of the injury continuum. I have seen this with several of the patients in my care.
aj
OT: Evolutionary propensity for deceit.
One of this board's raison d'etre is to provide information that allows us to uncover the many and varied ways in which biotech co.'s try to lure us into giving our money away. The following article lends evolutionary evidence that such deceit is a common practice and provides perspective on why Bernie Madoff's scam shouldn't surprise anyone.
http://www.nytimes.com/2008/12/23/science/23angi.html?_r=1&ei=5070&emc=eta1
aj
Thanks for the info look1
aj
I'm just happy that we've steadily moved up to challenge the $1 level. Each day we gain some strength and each new high gives more breathing room and potential for the shot up if/when the partnership announcement is reported.
$1.50??? Who knows.
aj
NTII: (here's the reason this one died yesterday)
Neurobiological Technologies Announces Viprinex(TM) Does Not Pass Interim Futility Analysis
Wednesday December 17, 7:00 am ET
Further Enrollment in Viprinex Clinical Studies to be Terminated
http://biz.yahoo.com/prnews/081217/aqw024.html?.v=82
EMERYVILLE, Calif., Dec. 17 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NTI®) (Nasdaq: NTII - News) today announced that an independent Data Safety Monitoring Board (DSMB) has determined that the current clinical trials of Viprinex(TM) for the treatment of acute ischemic stroke are unlikely to show benefit. As a result, the company has terminated further enrollment in the trials. NTI will obtain and analyze the data before evaluating the potential for any future development of Viprinex. The interim analysis conducted by the DSMB evaluated stroke patients' outcome 90 days following an acute ischemic stroke, comparing treatment with Viprinex to treatment with placebo. The DSMB determined that there was no clinically meaningful difference in outcome between the two treatment groups as measured on the modified Rankin scale of disability, the primary endpoint of the study.
ADVERTISEMENT
"We are deeply disappointed that Viprinex did not improve overall patient outcomes in our clinical study," said Paul E. Freiman, president and chief executive officer. "This news is a significant set-back for our clinical program. Once we obtain the data and we have analyzed the results from this study, which we expect to occur in early 2009, we will determine whether we will pursue any further development of Viprinex. In the meantime, we are implementing plans we have developed to reduce our expenses, which will likely result in a significant reduction in our overall headcount if we determine that future development of Viprinex is not warranted."
NTII: Update on Xerecept
(Xerecept was more interesting to me than Viprinex and the rationale for my taking a small position in NTI. The need for an improved cerebral edema treatment is much larger than the target of the P3 study mentioned below. More specifically, there are close to 100,000 traumatic brain injury cases each year that require the use of dexamethasone and/or ICP bolt placement each year as part of the acute critical care. If xerecept gets any traction, it could be a well used drug.)
Neurobiological Technologies' Partner, Celtic Pharma, Provides Update on XERECEPT(R) Clinical Program and Planned Sale in 2009
http://biz.yahoo.com/prnews/081216/aqtu041.html?.v=78
"Celtic Pharma Announces Update on Status of XERECEPT® Program
Sale Planned in 2009"
"New York, London and Bermuda, December 16, 2008 - Celtic Pharmaceutical Holdings L.P. ("Celtic Pharma")announced today that the databases have been locked and preliminary analyses completed on the two double-blinded studies of XERECEPT® (corticorelin acetate), as a treatment for peritumoral brain edema, as well as an initial database lock on the open-label study of XERECEPT's long-term safety and efficacy.
"The results of these studies are the subject of several abstract submissions for the American Society of Clinical Oncology (ASCO) annual meeting in May 2009, as well as the American Association of Cancer Research annual meeting (AACR) in April 2009. In conformance with the requirements of both ASCO and AACR, XERECEPT® data will be published only after presentation at these meetings.
"Celtic Pharma has also retained a top-tier investment bank to serve as its financial advisor in the planned sale in 2009 of Neutron Holdings Limited and its geographical subsidiaries who are the owners of the worldwide commercial rights to XERECEPT®.
"We believe that the trial data we now have in hand indicate the efficacy and long term safety of Xerecept as a treatment for cerebral edema associated with primary and metastatic brain tumors, permitting substantial reductions or elimination of cortico-steroid dosing in this patient population, and that Xerecept has the potential to become part of the generally accepted standard of care for these patients." said Stephen Evans-Freke, Managing General Partner of Celtic Pharma. "We believe we have built substantial value in Xerecept® and we look forward to achieving superior returns for our investors through the sale of this important program in 2009." said John Mayo, co-Managing General Partner of Celtic Pharma.
"About Celtic Pharmaceutical Holdings L.P. Celtic Pharmaceutical Holdings L.P. (Celtic Pharma) is a global private
equity investment firm focused on the biotechnology and pharmaceutical industries. Celtic Pharma was founded by Stephen Evans-Freke and John Mayo, CBE and is based in Bermuda, with offices in New York and London. Celtic Pharma acquires and invests in late stage pharmaceutical programs and manages these programs through their development to regulatory approval. Celtic Pharma's aim is to bridge the gap between the established pharmaceutical companies' new product pipeline crisis and the biotech industry's capital drought. For further information, please visit Celtic Pharma's website at www.celticpharma.com.
Been lurking, and now have a question or two. When this board started, I compiled a list of high yield funds to watch and have watched most of the share value crumble (along with the rest of the market). The yileds on some now seem so high that they are "too good to be true" which usually means that they are.
I'm sure that the share value has dropped because there have been problems with valuing the underlying securities that comprise the fund. However, enough time has passed to allow for someone, SOMEWHERE, to do some valuing of these securities/funds. So, I would be grateful if anyone knows who is touting funds that are considered safe and worth investing in.
Examples of some of the funds (and yields) being tracked:
BKCC 19%
ADVDX 28%
BEP 19%
ERH 13%
HTE 32%
regards
aj
"'The November Intel Corp. (Nasdaq: INTC) survey of 2,119 adults found that 46 percent of women and 30 percent of men would rather give up sex than go without the Internet for two weeks.
Well, given the baserate of sexual encounter frequency for most americans 35 years or older (more than 50% of this group has sex less than twice per week, with 20% or so have sex less than once per month) they would not be giving up much by choosing abstinence.
If we were to ask if adults would give up either coffee or chocolate rather than the internet for the same duration, I think you'd see much lower numbers.
Re: CAMH
"I know it’s bad form to say, “I told you so,” but I told you so"
A slow learning curve on this one, but a learning curve just the same. I definitely rode the short bus on this one. Just hoping that some of the better lessons here sink in so I don't get held back another grade!
aj
CEO(S) with worst track record:
I'd like to nominate the CEO of Cambridge Heart, but you'd need a scorecard just to keep up with the number of CEO's that have shuffled through in the last year.
Rob Khederian was the idiot who signed the deal with St. Jude Medical that allowed CAMH to wither.
aj
Alexza's AZ-004 (Staccato® Loxapine)
I'd be cautious about taking a position based on this P3 trial result. I don't know too much about this co. but it fits our "unpartnered" category. More importantly, the drug being touted here doesn't have much of a market. The problem of mania-related bipolar agitation is a minor one, and it is a complication that is handled with relative ease using well established drugs already on the market. I have doubts that psychiatrists and/or ER physicians would use this largely unkown drug with no clinical track record.
aj
JAV: "i would imagine with the ketorolac data showing bleeding with repeat dosing this is not only prudent to have in the NDA for approval, but to get a better label which would be huge commercially. I remember when toradol first came out - i was a resident managing a lot of post-ops and using toradol like crazy and then the black box restriction (i think it was no more than 4-5 doses allowed) and we cut back drastically"
This is a direct marketing point for Dyloject, per mgmt in the past. Their formulation of diflocenac has a much lower platelet response profile; one of the main reason that I invested originally (another being that Dyloject was easier to stock and cheaper).
Price action is encouraging today, at least we are moving away from that candy bar share price level. Sure would be nice to see us break a buck by the end of the week.
aj
JAV: Completely expected results here, no downside (unless readers were expecting a stat sig superior effect when compared to ketorolac or more vigorous wording on lower side effect issues).
The co. revealed that they would not be ready for the NDA until at least June, which will leave the co. dangling for money. The recent layoffs will help the cash burn and the winding down of the PMI-150 trial will also help (if rapid enrollment continues), but we will not get any respect until a partner has been announced.
Any other upside? It would be nice to hear continued acceleration of use in the UK.
aj
"BFRM CFO quits to take CFO job at ARAY"
Probably saw just how well the insiders deal the money to themselves. You all thought UTHR mgmt did itself some harm with the internal payoffs, ARAY insiders have those moves down!
aj
McBio, Neutropenia could be a game stopper if it is severe enough and/or chronic enough. Many RA patients are old and weak, with already weakened immune systems, so I'm sure that there would be a concern about exposing these patients to a long-term therapy that has a 10% neutropenia side effect profile.
What will be an absolute game stopper is the number of agranulocytosis patients found in P3 trials, at least IMO.
aj