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"People don't run on a bank to make a deposit.."
No, but people do run up a stock's value when they perceive that there is money to be made. What's interesting (to me at least) is the assymetry of population that execute these two polar opposite runs.
aj
Egads!!!! $2/share for BSC.
BSC: 52wk Range: 26.85 - 159.36
This was a 21 billion dollar market cap co. when it traded around the 52 week high!!! Sold for $275 million......just like that.
Sorta assuages the hurt feelings of seeing CAMH drop from it's highs.
aj
Oldberkely, we are of like mind. As I was reading this thread, I was reminded that Jefferson insisted that democracy was premised on the need of an informed and educated populace. Some of his quotes include:
“Educate and inform the whole mass of the people... They are the only sure reliance for the preservation of our liberty.”
“If a nation expects to be ignorant and free, in a state of civilization, it expects what never was and never will be.”
“Information is the currency of democracy.”
Of course, he also said:
“Banking establishments are more dangerous than standing armies.” ;]
aj
"Yep, I had that same problem once, then I got married and had kids.
I never had cash flow problems until I got married and had kids. The cash was flowing fine before that. Now I've got too much cash flowing out of my pocket and into my children's hands.
"I am a river to my people" Anthony Quinn as Auda abu Tayi in Lawrence of Arabia
CAMH: This falls under the rubric of "unsubstantiated rumor", but word via the list of investors I created on RB has it that GE visited the CAMH corp. offices several months ago, before the CMS decision on MA MTWA and after the comment period for their application was closed.
GE could buy CAM with the change they find in their corp lounge couches. Spectral Analytic MTWA is IP at this point and GE could easily program it into many ofteir products.
Were all waiting.
aj
"CAMH:,,,did anyone notice Dr. Chow's letter,,,if it is a 180' turnaround statement to Medicare?
Saw the letter, saw the apparent 25% pop that the letter appears to have given the stock (for now).
IMO, the statement is NOT a 180' change in Chow's opinion. While we CAMH conspiracy theorists believe that MDT scripted Chow's comments about the MASTER results when they were released, his CMS comments confirm that he is indeed an advocate for Spectral Analytic MTWA only.
The GE MMA MTWA application is dead, the only question now is whether or not STJ will move forward with dictributing heartwave machines to EP's. It's still dead money until then (not a dead co. as NERF would like you to believe.)
aj
"The Baker Act will stay on his record as a mental
illness issue unless he gets that overturned and
expunged, and he will have to answer YES on applications
if ever being admitted for "psychiatric" reasons!
Something is radically wrong and overdone when hospital
workers can randomly "assume" that someone with no
history of mental illness is all of a sudden a threat
to themselves and or others, and Baker Acts them for
refusal to undergo a testing procedure that they do
not want to undergo...."
EXCEPT.....
The man was not likely ADMITTED for psychiatric reasons. He was admitted with a closed head injury. He won't have to report a psychiatric admission.
There is likely more to this case than what one reads in a news report. People with acute closed head injuries are often confused, poorly oriented and agitated. It is unfortunate, but either chemical and/or mechanical restraint is often necessary in order to obtain the medically necessary information via exam to ensure that serious developing brain and/or spinal cord injury complications are not occurring.
Think about this. What if this patient had a brainstem/spinal cord injury with the onset of edema that was exacerbating his symptoms and the ER staff had NOT performed a complete exam? The hospital would be liable for missing the diagnosis and allowing a potentially lifelong debilitating complication that could have been treated if found in time.
Just my 2 cents from a CHI professional.
aj
MYL: Been off fishing in the bayous of southern LA for a couple of days, thanks for your reply on MYL Dew.
aj
No revenue.
I guess they couldn't sell any dyloject in Dec.
http://www.nasdaq.com/aspxcontent/NewsStory.aspx?cpath=20080306\ACQRTT200803061602RTTRADERUSEQUITY_1281.htm&symbol=JAV`&selected=JAV&selecteddisplaysymbol=JAV&coname=Javelin%20Pharmaceuticals,%20Inc.&logopath=&market=Amex&pageName=Company%20News&mypage=companynews&title=Javelin%20Pharma%20%20Reports%202007%20Loss%20Of%20$0.68%20Per%20Share
Hope the CC has something good.
aj
MYL: Oldberkley, my question to the board was about specific opinions about MYL moving forward. This one appears to be getting oversold, with a string of financially questionable moves and conservative guidance, but with a profitable business and growing sales.
Just interested in opinions of others who might be following MYL.
regards
aj
MYL: The co. is trading at a 6 year low. It lost another 20% AFTER announcing concerns about forward outlook. Does anyone here have an opinion regarding value vs. dead money?
I've tracked this along with Teva and Barr for many years, but not bought any of these co.'s.
http://biz.yahoo.com/ap/080303/mylan_mover.html?.v=2
Mylan Shares Fall to a Near 6-Year Low on Continued Concerns Over Outlook, Dey Unit Sale
NEW YORK (AP) -- Shares of generic drug developer Mylan Inc. fell to their lowest point in nearly six years on lingering concerns over the company's plan to sell its Dey LP unit.
The stock fell 39 cents to close at $11.45 Monday after reaching a five-year low of $11.23 earlier in the day. Mylan shares felt a similar plunge Thursday after the company said it would sell Dey, likely slowing the launch of its respiratory drug Perforomist and cutting into profit over the next three years. Also, the company delayed providing 2008 guidance until it reports results for the first quarter.
ADVERTISEMENT
Though Mylan topped Wall Street expectations for the fourth quarter, Oppenheimer & Co. analyst Elliot Wilbur said the company generated surprisingly little cash. He reaffirmed a "Perform" rating.
"While one quarter does not a trend make and the fourth quarter will likely prove to be a trough, lack of robust cash flow metrics won't help growing angst over near-term fundamentals," he said, in a note to investors.
Also, cost savings from deals such as the buyout of Merck KGaA's generics unit and Indian drug developer Matrix, will likely carry little impact if the company cannot deliver financially.
Still, despite the delay it will cause with Perforomist, Wall Street viewed the Dey sale as mostly positive in the long-term, as the unit was losing money. Last week, Cowen and Co. analyst Ken Cacciatore reaffirmed a "Outperform" rating and said the Dey sale will allow the company to focus on its core business of developing generic drugs.
"The core franchise performances should not be overlooked," he said in a note to investors Thursday. "When the dust settles on Dey, which likely will sell for $750 million to $1.2 billion, we believe Mylan will be better focused."
AH trading is notoriously unstable, but at least there was some AH trading today in the right direction.
Moves like this come when deals are already made and the dealmaker(s) are leveraging positions that will enrich them. With a little luck, this has all been coordinated and we'll get a better picture of the underlying deal(s) on Thursday.
GLTA
aj
"It must a real drag for JAV longs to watch the stock getting pummelled like it has."
Worse than a drag, downright painful! Biopete's advise is good, and longs are looking forward to good news (any good news worth a damn) for JAV.
BTW, JAV did announce successful patient accrual for their PMI-150 trial. At this point, even the good news isn't helping.
Javelin Pharmaceuticals Completes Subject Accrual for all Pharmacokinetic Clinical Studies of PMI-150
Monday February 25, 9:00 am ET
http://biz.yahoo.com/bw/080225/20080225005546.html?.v=1
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Javelin Pharmaceuticals (AMEX: JAV - News) announced today that it recently completed accrual of subjects in the last of four planned Phase 1 human pharmacokinetic (PK) studies needed to support its intended filing of a New Drug Application (NDA) next year for its intranasal ketamine product candidate, PMI-150.
This group of four PK studies enrolled a total of 151 subjects, of whom 139 received PMI-150 intranasally, 32 received intravenous ketamine, and 12 received oral ketamine. Some subjects received ketamine by more than one route of administration. No serious adverse events occurred in any of the four trials. Detailed analysis of the PK data is ongoing not simply for the NDA filing, but also for planned presentations at scientific and professional meetings and in the peer-reviewed literature.
"Timely completion of these trials keeps us on track for submission of the NDA for PMI-150," said Dr. Daniel Carr, CEO/CMO. "These studies did not involve patients in pain but instead were conducted in pain-free volunteers with the purpose of extending prior PK results. Their encouraging safety data adds to our already substantial safety database for this product candidate. Most importantly, these four PK studies comprise an integral part of our planned NDA submission because they provide essential dosing information for PMI-150," he added.
Dr. Curtis Wright, Javelin’s Executive Vice President for Risk Management and Regulatory Affairs, commented, "This group of four PK studies addressed the multiple dose kinetics, the effects of common nasal decongestants and allergy medications, and the relative contributions of nasal and oral absorption to the bioavailability of PMI-150. As additional intranasal medications for systemic applications are developed, studies to evaluate how widely-used nasal medications affect (or not) the pharmacokinetics of a product are becoming more common. Completing these studies leaves us free to concentrate on our efficacy trial and start preparing modules for the NDA”
About Ketamine
Ketamine, a non-opioid, is an N-methyl-D-aspartate (NMDA) receptor antagonist that has been in clinical use for over 30 years. Since its approval by the FDA, ketamine has been safely used as an anesthetic in tens of thousands of patients. NMDA receptors are located in the central nervous system and play a role in the perception of acute and chronic pain. Ketamine, at lower doses than those approved for anesthetic use, has been reported in the medical literature to be an effective analgesic for post operative settings, nerve injury pain, and pain during medical procedures, such as burn dressing changes.
About PMI-150 (Intranasal Ketamine)
The Company is developing PMI-150, a proprietary nasal formulation of ketamine, for several intended indications. Javelin believes that PMI-150 is optimized for use as a pain medication and may offer a safe, non-opioid alternative for the treatment of acute moderate-to-severe pain. Prior randomized, double-blinded, placebo-controlled phase II clinical studies of PMI-150 have demonstrated rapid, statistically significant relief of moderate to severe postoperative and breakthrough pain. The Company is now planning a Pivotal Phase 3 postoperative acute pain study for this product candidate.
Yes, please educate me as well. I'd like to learn what/how your read these things for the underlying message(s).
aj
"We don't see things as they are, we see things as we are. -Anais Nin.
If that were true in the extreme, then all we know is a function of the individual. Tested at the extreme, I judge it false."
Both of you are correct, in that perception is a phenomenon of the individual, but with the reality of consensual validation.
As an aside, this larger thread provides much entertainment for this neuropsychologist. There are many varied personalities at play here and I enjoy speculating about all of them (and it's all about speculation and entertainment, participating in this forum.)
aj
Stength of Euro:
I am curious whether anyone has an opinion about how the strong Euro/weak dollar will impact dollar revenues in the next couple of quarters for JAV's dyloject. I have tracked some other investments in the past and the strength of the Euro has meant bigger revenues recognized for US co.'s when the money was brought back.
Not expecting too much this or next quarter, but this could be meaningful by the end of the year. Any thoughts?
aj
ADAS-Cog: It's about time that the industry pushed for an alternative to the ADAS-Cog. The instrument relies too much on memory and practic components of cognitive functions and there needs to be more measurement of executive function and processing speed (both are more sensitive to subtle/early decline.)
I have not reviewed the components of the NTB yet, but look forward to seeing what the battery contains and the psychometric structure.
My recollection of the development of the ADAS-Cog was that there was quite a pitched battle over who would control what was included in the battery and neuropsychology as a discipline was largely left out of the decision process and it was left to psychiatry.
regards
aj
Thanks for the DD pastemp. Clearly, having an insider buying big chunks is a positive sign.
The price pressure is wearisome for even the most bullish on our future. The psychology of compromise can lead to lowered expectations, but I refuse to fall into that trap. When we go north, it will be for good and a robust move.
I remain patient.
aj
"NTII is all or nothing on viprinex anyway"
I'd like to think that Xerecept has a market as the only practical alternative for brain edema is either dexamethasone and/or intervention via shunting.
I hold a small piece of NTII with this in mind.
aj
These results are, IMO, another example of how our interventions, even at the research level, are too late in the disease progression to amount to an effective therapy. Lower cortical loads of amyloid begs the question of whether having a cortical load of amyloid produces a degenerative disease process that is irreversable.
If the ELN immunization agent were to be given to patients in their 40's rather than in their 60's or 70's, we might be able to see the intended effect (after of course tracking the patients for 30 years.)
aj
Peter Kiernan-A solid money man with an outstanding pedigree and ALOT of JAV stock in his pockets. Does anyone think that this ISN'T a very positive move with regard to share valuation in the long run?
aj
"I really don't see it used except for acute pain indications due to its short duration. It only works for 15 - 30 minutes until you have to take another hit."
But the fast acting onset of intranasal delivery might be attractive to patients with these conditions, particularly when a strategic intervention might abort an otherwise serious pain event (ie eg coughing that exacerbates headache or sore throat pain, or prodromal migraine headache.)
What I know from my clinical practice is that pain meds that are approved and on the market are tried in a variety of off-label ways for a variety of pain conditions. Particularly notable are the chronic migraine patients who usually play the "pain management" game and settle on the med. or med. regimen that they've accepted as best for their personal response.
JM2C
aj
Potential app's for PMI-150.
I'm not a pain expert, but spent some time last night thinking about app's for intranasal ketamine (after a long day of reflection about our investment). I'd like to hear from others here about some other possible app's for this drug. Let's not worry too much about indications vs. off-label at this point as that would amount to splitting hairs for this relatively safe and effective drug. Here are a couple of apps to consider:
Chronic headache pain
Sinusitis caused by severe environmental allergic reaction (when I get these, the HA rivals a migraine!)
Migraine HA
Sore throat, no matter what the etiology (I wonder if this would not be better served with an inhalable form ather than intransal)
food for thought
aj
"As far as I know, Niaspan is not available as a generic and it won’t be until 2013."
That amounts to some hair splitting, IMO. Flush free niacin is widely available (as you well know) and any physician can recommend it as part of a cholesterol lowering regimen, along with any other medication.
aj
Bio Pete, thanks for the "attaboy". Still too cheap to have an account, but inching closer, especially after following Dew Diligence over to the ihub Men's Room (LOL). The Man's Code was worth 10 minutes of laughter.
aj
Bull Case for JAV:
Bladrunner, there are others here that would do this better, but here's my bull case:
The co. has market approval for injectable diflocenac in Great Britain, with the expectation that it will receive an approval letter for Germany within 6 months from 10/31/07. This product will become the best alternative to Toradol as a post-op pain med. It has a superior side effect profile and no other competitors, so use should be robust. Injectable diclofenac is in P3 trials in the US. Estimated market for this drug is in the neighborhood of $250 million.
The co. has 2 other med's in P3 trials; intranasal Ketamine and intranasal morphine, both to be applied to breakthrough pain problems. Intranasal ketamine has the support of DOD. P3 trials are co-occurring in both the US and Europe for these two. Breakthrough pain is a significant problem, with IM/IV opiates having problems with slower than acceptable onset of relief and respiratory depression. Ketamine has been approved in other forms and used safely for years. JAV has been smart in developing a proprietary formulation of their intranasal product (same is true of diclofenac for that matter.)
http://javelinpharmaceuticals.com/pipeline.html
The current theory of the share price crater is that mgmt isn't repsonsive to IR needs/shorts are having a field day/unproven biotech startups are being sold out/ etc.etc. The co. recently announced a $60 million shelf registration, indicating to most of the longs that they are willing to go it alone with marketing rather than partner up and dilute via revenue/profit sharing. Short interest has steadily moved up in the last several months.
I don't see anything of note happening news wise for the co. with the exception of announcing acceptance in Germany and the first Q report with an actual revenue stream (this will be very modest, imo as the GB approval came late in the Q). I believe that most who have held this aren't expecting any sig revenue until the end of Q2 of this year.
So, there's much to like here. The co. is on the path to 3 approved Meds. They will own the revenue stream and they are an attractive takeover target with stronger atraction as each new drug gets approved. There is potential for a short squeeze here if ANY unexpected news occurs.
regards
aj
JAV: My impression of the longs who follow this board are a patient bunch, no panic here.
Holding this one for 2-4 years minimum. I'll evaluate my investment then.
regards
aj
GE's application for Modified Moving Average Microvolt T-Wave Alternans testing denied. For those following the CAMH story, they will remain the only game in town for the time being.
http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=213
aj
MDRX:
Folks this one is more a medtech than traditional biotech stock reviewed here, but it may be entering in to the "value" sphere (depending on your opinion of value.)
Allscripts is an electronic health records co. that I've held in the past and luckily sold out of when it lost momentum last year (see chart):
http://finance.yahoo.com/q/bc?s=MDRX&t=2y
It had been a high flyer, commanding a PE north of 100 for some time on the prospects of widespread adoption of EHR's touted to be occurring in hospitals nation wide. Suffice it to say that the growth has not been nearly as robust as those bulls once thought, but the co. is profitable, it has been on GE's radar screen for a long time, and, IMO looks to be good value at its present share price.
Getting hammered today on less than expected growth. I'm putting it higher on my watch list.
regards
aj
So, there's never a perfect co. for comparison's sake, but just to provide a reasonable comparison, take a look at BioMarin (BRMN). They are in a very different specialty pharma space, but with sales metrics that I think will be similar to JAV in the next 3 years (if not better). The co. has almost 100 million shares issued and in it's fourth year of marketable drug sales, is at 84 million in sales. They are not profitable (in fact have lost/burned huge amounts of money in their development process) and yet command an almost 4 billion market cap.
FWIW, I can see JAV developing value faster in the next four years than BMRN. Dyloject in and of itself should be worth $100 million in sales in 3 years.
aj
'Nothing significant in the near term unless we get a partnership. We could also get positive data on Dyloject sales in the UK. German approval for Dyloject will be good for a 10 cent pop."
I sure hope you meant 10% LOL
aj
OT: On my way back from Tucson. I found a pair of opal cabs perfect for some earrings, a small sample of pure opal crystal grown in a test tube, and a beautiful opalized ammonite fossil piece.
Lots of other goodies!
aj
OT: IMYN
http://investorshub.advfn.com/boards/read_msg.asp?message_id=26641729
Tina Marie, please read my original post on this again. I said the co. looked like a pump and dump, I never said you were doing pump and dump. Aggressive investors find interesting ideas every day and share the news. I like hearing what you're looking at, just called that one as I saw it.
good luck and congrats for your continued success here. I will have to wait on some other investments before doubling down on ARAY, but fully intend to build a position closer to 10K rather than 1.5K
BTW, I'm in Tucson for two days the mineral mecca of the world. Anybody need some moldovite? Opal? Crystal wands? This place is the biggest rock shop in the world.
aj
Tina, your missing the basic DD here! The co. has just received their first commercial drug approval, and have announced that it is being supplied in the UK. No one here believes that revenies will be all that great this Q (the release of the drug was late in the Q), but we'll have revenues and the drug is a solid hit. 2008 will also have drug sales in the greater EU.
Don't play that way, sour grapes are unbecoming.
aj
IMYN: C'mon Tina Marie, stick with it if you see something here. Tell me how they are going to make money and be specific.
I saw 107 million shares issued in 2006, 272 million shares by 2007. Revenues????
http://secfilings.nasdaq.com/filingFrameset.asp?FileName=0000950120%2D07%2D000729%2Etxt&FilePath=%5C2007%5C11%5C13%5C&CoName=IMMUNOSYN+CORP&FormType=10QSB&RcvdDate=11%2F13%2F2007&pdf=
BTW, I still hold every share of ARAY originaly purchased. Like I said in an earlier post, I don't have enough dog in that fight to worry about where the price on my 1500 shares is today vs. in 2 years from now when I would expect to look at selling.
I applaud your aggressive trading tactics, but this looks like a big ugly dog.
regards
aj
IMYN: Tina Marie, what do you see here. From what I can dig up (and there's not a whole lot out there) this looks like a pump and dump scam to me.
Huge float
Nothing at clinicaltrials.org
Homepage is full of innuendo, fluff and "beliefs"
No income
aj
Market response to the shelf is rather muted so far. Mgmt knows how to play this game and IMO the next ER and CC should be upbeat with some guidance. Should move the share price and generate better value if/when they exercise any part of the shelf.
Looking forward to the next 4-6 quarters here, it should be exciting.
regards
aj
CAMH: For those who had followed our posts on this (Lumpy is the trailblazer here), Cambridge heart has had a considerable recovery from a short-term bottom of 79 cents per share. On Monday, the co. announced that Premera Blue Cross Blue Shield has decided to allow MTWA coverage (adding another 1.2 million insured to the eligible pool), the co. filed SEC forms that indicated an insider buy of 600K shares in the last quarter, and there has been chatter in the back channels that STJ has confirmed via pilot studies that use of MTWA results in increased ICD referrals.
The co. is up to $1.23 today on better than average volume; a trend that has been solid for the last week. We faithful longs are convinced that GE's MTWA application will get the thumbs down in 2 weeks and that will bring us back to at least the $2 range.
regards
aj
The following is not new, rather it reinforces what has been considered to be a schizophrenia risk for at least the last 4 decades. Of note, the increased risk for schizophrenia was only found for those exposed who ALSO had the genetic risk as well.
Severe Stressful Events Early In Pregnancy May Be Associated With Schizophrenia Among Offspring
http://www.sciencedaily.com/releases/2008/02/080204161433.htm
Children of women who undergo an extremely stressful event--such as the death of a close relative--during the first trimester of pregnancy appear more likely to develop schizophrenia, according to a new report.
"The common conception that a mother's psychological state can influence her unborn baby is to some extent substantiated by the literature," the authors write as background information in the article. "Severe life events during pregnancy are consistently associated with an elevated risk of low birth weight and prematurity." Schizophrenia, a disabling condition associated with abnormal brain structure and function, is increasingly believed to begin in early brain development. Environmental factors, including those occurring during pregnancy, and susceptibility genes may interact to influence risk.
Ali S. Khashan, M.Sc., of the University of Manchester, England, and colleagues used data from 1.38 million Danish births occurring between 1973 and 1995. Women were linked to close family members using a national registry, and the same registry was used to determine if any of these relatives died or received a diagnosis of cancer, heart attack or stroke during each mother's pregnancy. Their children were followed from the 10th birthday through June 30, 2005 or until they died, moved out of the country, or developed schizophrenia.
During the study period, mothers of 21,987 children were exposed to the death of a relative during pregnancy, 14,206 were exposed to a relatives' serious illness during pregnancy and 7,331 of the offspring developed schizophrenia.
The risk of schizophrenia and related disorders was approximately 67 percent greater among the offspring of women who were exposed to the death of a relative during the first trimester. However, death of a relative up to six months before or any other time during pregnancy was not related to risk for schizophrenia in the child, nor was exposure to serious illness in a relative. The association between a family death and risk of schizophrenia appeared to be significant only for individuals without a family history (parents, grandparents or siblings) of mental illness.
"Risk associated with exposure to a well-defined, objective stressful event confined to the first trimester of pregnancy suggests a number of possible mechanisms," the authors write. Chemicals released by the mother's brain in response to stress may have an effect on the fetus' developing brain. These effects may be strongest in early pregnancy, when protective barriers between the mother and fetus are not fully constructed.
Journal reference: Arch Gen Psychiatry. 2008;65[2]:146-152.
This study was funded by Tommy's the Baby Charity and the Stanley Medical Research Institute.
regards
aj
"How big of a market could there possibly be for a IV Iron replacement therapeutic for chronic kidney disease patients."
That market is quite big, but there are competitors in this space and the following co. is a much bigger value if there Iron replacement therapy gains approval.
http://finance.yahoo.com/q?s=RMTI
They are in the dialysis supply business in general, where, I'm told, margins are razor thin. See the recent PR's in the yahoo page for they're updates on Fe replacement.
regards
aj