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I'm in.
Hello surf and you other ISIS investors. Took a position today and hope o build on it over the next few months. Given my DD on Mipomersen and its efficacy, there will be a number of patients who will try it and do the liver enzyme work to stay on it. The MOA isn't limited to homohzygous FH patients (it works for ANY kind of hypercholestralemia) I will risk that there will be a considerable off label use of the drug after it hits the market.
The new news simply reaffirms my interest in this stock. It should be an easy $20 with any of the POC milestones (and there are potentially many triggers to push it up.)
I'll be watching; spend most of my time over on Biotech values.
regards to all
aj
Idenix Pharmaceuticals Appoints Tamar D. Howson to Its Board of Directors
http://finance.yahoo.com/news/Idenix-Pharmaceuticals-prnews-3739087483.html?x=0&.v=1
CAMBRIDGE, Mass., March 30 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX - News), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that it has appointed Tamar D. Howson to its Board of Directors. Ms. Howson is currently a Partner at JSB-Partners, a transaction advisory firm serving the life sciences industry. Ms. Howson has extensive experience in licensing, collaborations and M&A transactions in her 20-year career as a corporate and business development executive and advisor to pharmaceutical and biotechnology companies.
"Tamar is an internationally recognized pharmaceutical executive with broad industry expertise in global business development and venture capital investments. Over the course of her career, Ms. Howson has executed close to 100 transactions in life sciences," said Jean-Pierre Sommadossi, Ph.D., chairman and chief executive officer of Idenix. "Her background and strategic insight will be an important asset to the Idenix Board of Directors."
Prior to joining JSB-Partners, Ms. Howson was executive vice president of business development at Lexicon Pharmaceuticals where she led the company's partnering and licensing efforts. From 2001 to 2007, Tamar was senior vice president corporate and business development at Bristol Myers Squibb overseeing M&A, licensing and research collaborations across all businesses. In 2000 and 2001, Ms. Howson served as a business development and strategy consultant to biotechnology companies in the United States and in Europe. Ms. Howson worked at SmithKline Beecham from 1991 to 2000, where she was senior vice president and director of business development, responsible for worldwide in-licensing and business development. She also managed SR One, SmithKline Beecham's $100 million venture capital fund. Before joining SmithKline Beecham, Ms. Howson served as vice president, venture investments at Johnson Associates, a venture capital firm, and earlier as director, worldwide business development and licensing for Squibb Corporation. In 1999, Ms. Howson received the Healthcare Businesswomen's Association "Woman of the Year" Award.
Ms. Howson currently serves on the board of S*Bio Pte Ltd., a consultant to Pitnago Venture Fund and is a member of the advisory board to Triana Venture Partners. She previously served on the boards of Ariad Pharmaceuticals, SkyPharma, NPS Pharma, Targacept, and HBA. Ms. Howson holds an M.B.A from Columbia University, a M.S. from City College of New York and a B.S. in Chemical Engineering from the Technion in Israel.
Appears to have the bona fides, and a good fit for the co. Anyone know of her work?
aj
Word on the yahoo board from someone who attended the PDAC last week is that HOC will announce the SJ life of mine extension for another 5 years in their next quarterly numbers. This is likely to take us to $1.25.
If you don't read that board, the poster also talked to MAI folks about Los Azules and the co. confirmed that they have many inquiries about a JV, but MAI consistently says "no" and tell the suiters that they are drilling to find out "what we have" and won't talk partnership or sale until they have a better idea of the scope of their reserves there.
I've read that the "in the ground value" of LA ranges from $250-400 million, depending on the proven reserves (which is likely to go up).
aj
OT: Liquid He and superconducting.
Thanks for the reply, microcap. I posted that over a month ago, did you just get to it? If so, that's a helluva lot of posts to catch up with!
regards,
aj
MDVN and AD outcome studies:
I can categorically state that every AD trial that I ever participated in strictly required that patients be seen at the same time of day for each measurement visit, so this would limit the variance associated with diurnal rhythm and sundowning.
That said, there are points well made today about the subjective nature of AD outcome measures, as well as the reliance on caregivers' recall of patient behavior during the time in between the last visit. There are biases that we have yet to be able to control for that include misattribution biases, hindsight bias, and serial position effects, to name a few. I cannot recall any study that even starts to attempt to control these rater biases, which may wash out the significance of any dataset.
AD outcome trial aren't the only sphere that rely on "subjective" (wallstarb's term, not mine) measures for outcome. Pain studies, and virtually all psychiatric drug studies rely on similar outcome data.
JM2C
aj
OT: Republic based upon a representative democracy is what I'm talking about. I'm sure you can see both the common ground between the two and the esoteric (read meaningless) distinction that you made in your post.
Are you represented by your congressional delegation in your district or our republic? The last time I went to visit my congressman, the waiting line included so many business interests that there was no room for me and my citizen colleague to sit. An attempt to set up a visit with my senator was fruitless.
aj
2 minute update: Exwannabe, beat me to the punch, enough said.
Connecting the Dots Between PhRMA and Congress
This story reads too ominously familiar to what Bush and Cheney were accused of doing in their first term with the energy lobby in crafting the Bush administration energy policy. Both are evidence of how disheartening it is to consider that our democracy is operational in anything but appearance, and lends credence for Evan Bayh's decision to "run away" from that morass as fast as he can. I'm afraid that this administration has already failed its mandate, the day of reckoning will soon be upon them and it won't be pretty for them or all Americans afterwards.
Bob Schieffer had a closing commentary that touched on this last Sunday on Face the Nation.
http://www.cbsnews.com/video/watch/?id=6228712n&tag=cbsnewsLeadStoriesArea
One might say that he was caught in a compromising position
aj
JAV:
Dew, does your comment apply to analyses that have not yet been submitted? I'm not certain that JAV has submitted the data on Ereska. Does this make a difference?
It would seem that if JAV found a data or computational error, this should be correctable.
I guess the only recourse, if not, would be for JAV to sue the vendor who made the mistake.
aj
JAV: Beat me to it acgood. If the data are good and were mismanaged, then the FDA should accept it, IMO. Certainly, I would expect the FDA reviewes to scrutinize both analyses to ensure that the second one was correct.
Recall that the Ereska trial data missed by several 1/1000's of a point for the .05 stat sig level, so one data entry mistake could have caused the error.
That said, the co. can certainly be seen as inept in handling the data, the potential sale, and the lawyers are going to have a field day with this kind of error.
I lost alot of money here. Not litigious (I take repsonibility for my own investments) but damn angry that our shareholder value got hammered because of this type of F*%# up.
aj
Thanks efar, I read right over that when I checked the ClinicalTrials site. I guess I need more coffee.
PFE's use of ADAS-Cog and CIBIC-plus are consistent with their previous trials. The CIBIC-plus does code for orientation questions as well. If memory serves, there is no real difference between it and the CDR, but my memory (and attention it seems) is not serving this morning (no amount of coffee could resolve the malaise of cabin fever today.)
regards,
aj
MDVN:
"The Dimebon results in HD are at best neutral, IMO, with respect to foretelling a successful phase-3 outcome in AD. What do you think?"
I haven't seen what PFE is using for outcome measures in their AD study, so there could be some upside to these data if they are using the CDR (which codes orientation scores into part of the outcome impairment rating) rather than the ADAS-Cog (which doesn't.)
The above would also assume some commonality in the development of orientation impairment in both populations, which is not too far a stretch.
regards,
aj
Herbal medicine:
Let's not forget that Digitalis (digoxin) is produced from the foxglove plant.
aj
Good day to all.
Dew, I finally established a position here with some of the measly leftovers of my failed JAV investment. Sure hope that I do better here.
regards,
aj
OT: Liquid He and superconducting.
Just curious whether anyone knows if Liquid N, touted at one point as costing as much to produce as beer and much more plentiful, could eventually replace the liquid He needs for superconducting. It's already used quite a bit, but there seems to be a cooling limit for N vs. He.
It would seem that our superconducting needs will continue to grow and the He squeeze has been on for some time. One might even foresee the end of retail He balloon businesses in the future if they become too pricey.
JM2C,
aj
GMO corn:
If the effect(s) are real, then the study should be replicated with both convergent and divergent methods (i.e. different animal populations, dose levels, dietary manipulations etc.)
As far as your concern about bias Dew, I have to wonder who ELSE would want to sponsor such a study?
I would hope that some young and enterprising food scientist will apply for some FDA research grand money and follow up on this one to better articulate the impact of these food sources.
aj
OT: Mass nouns
Does that also apply to "data"
e.g. "the data are consistent with....
vs.
"the data is consistent with...
I've always corrected folks by indicating "data" is the plural for "datum"
aj
Merry Christmas, happy holidays and have a safe and happy new year all.
JAV: the details are now being posted. Reuters is reporting that JAV will receive .282 shares of MYRX for each JAV share. Buyout pegged at $96 million.
Sad face again :(
aj
"I think you'll see MYRX trade down to $3.30 - $3.80 over the next few weeks/months"
From you lips to the market's bid buttons! If I can get my JAV shares up to that level, I will be happy indeed. The principles in JAV have several million shares at about $4.30, so I'm fairly certain that they see this as a bigger win than your projections.
Time will tell.
aj
MYRX and JAV
As a shareholder of a boatload of JAV, I'm tickled that they finally got a deal done, ANY deal. MYRX gets a drug ready for the market and some cash flow, JAV gets a partner with deep enough pockets to get Dyloject out in the market.
Anyone with an opinion about the efficiacy potential for azixa?
aj
Re: Niacin treatment and artery plaque size
Thanks DT. It looks like my bet on the previous reason for the early study discontunation is likely due to robust positive effects of Niacin treatment.
aj
A new imaging study supports niacin's positive effect on change in carotid artery wall area:
http://content.onlinejacc.org/cgi/content/abstract/54/19/1787?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=Justin+MS+Lee&searchid=1&FIRSTINDEX=0&sortspec=date&resourcetype=HWCIT
"Results: NA increased HDL-C by 23% and decreased low-density lipoprotein cholesterol by 19%. At 12 months, NA significantly reduced carotid wall area compared with placebo (adjusted treatment difference: –1.64 mm2 [95% confidence interval: –3.12 to –0.16]; p = 0.03). Mean change in carotid wall area was –1.1 ± 2.6 mm2 for NA versus +1.2 ± 3.0 mm2 for placebo. In both the treatment and placebo groups, larger plaques were more prone to changes in size (r = 0.4, p = 0.04 for placebo, and r = –0.5, p = 0.02 for NA)."
TDLP: Hey righty, can you say "pump and dump?"
Can you see it?
http://finance.yahoo.com/echarts?s=TDLP.OB#chart3:symbol=tdlp.ob;range=5d;indicator=volume;charttype=line;crosshair=on;ohlcvalues=0;logscale=on;source=undefined
I wouldn't touch that with your "you know what" and if I had some I'd get rid of it faster than a bad case of the clap.
aj
Re: War on specialists
Jbog, you highlighted the following:
"The chunks Team Obama took out of cardiology RVUs are especially drastic. The basic tools of heart specialists—echocardiograms (stress tests) and catheterizations—are slashed by 42% and 24%, respectively. Jack Lewin, who heads the American College of Cardiology, said in an interview that the crackdown will cause "a horrible disruption" that will force many community and independent practices to close their doors, lay off staff or make senior patients wait days or weeks for tests and services."
suggesting that you find this particularly onerous.
Given how organized cardiology has killed MTWA as a useful way to reduce the grossly wasteful use of ICD's (uneccesary for 1/3 of all patients who get them at $30K a pop + all the professional/surgical/hospital fees vs. a $300 test), I think it's high time government stepped in and stopped wasting my money so that cardiology and their overpriced device industry can make their billions.
aj
On PCT patent applications:
Just for background, US co.'s are counseled that US patents are first and foremost the most important patents to establish. Once they have been granted, the application to "Patent Cooperation Treaty (PCT)" countries in europe and the rest of the world is what is recommended. Often, patent lawyers suggest that limited PCT applications be made as to not waste money on getting patents in countries where the product will never be used or will be hijacked with no chance of legal recourse.
Given the patent portfolio that MNTA has, my guess is that they are following the above protocol and have chosen selected PCT countries in which to pursue patent protection.
aj
Quick question floblu (or Dew) are these PCT patent appliations of patents already granted in the US?
aj
Re: Relative risk for using aspirin for heart health prophylaxis.
Clark, your quote of Dr. Elwood is spot on. I sit at age 47 years, knowing that both of my grandfathers had cardiovascular disease, knowing my untreated LDL level and my body type. I've never had the hint of disease and, in fact am healthy and conditioned (getting ready to ride a 150 mile two-day MS150 in two weeks), I've used aspirin for almost 7 years and will continue to do so.
aj
New Controversy on daily aspirin use for prophylaxis
http://www.timesonline.co.uk/tol/news/uk/scotland/article6816402.ece
Millions of middle-aged people who take a daily does of aspirin in the belief that it may help protect them from a legion of future illnesses now face confusion as new evidence has emerged suggesting that, for some, popping a daily pill could harbour more risks than advantages.
Yesterday doctors from across a wide spectrum acknowleged that the situation was “difficult and confusing” for people due to conflicting medical research, and suggested that the decision about whether or not to continue taking aspirin should ultimately come down to personal responsibility.
The latest research, from the University of Edinburgh shows that aspirin had no benefits for people who appeared to be suffering from some furring of the arteries in their legs.
Other studies have found aspirin may benefit the over-40s, helping to prevent bowel cancer, breast cancer, asthma, deep vein thrombosis — and may both increase and decrease the risk of strokes.
Related Links
'Worried well' should not take aspirin for heart
The Aspirin Foundation, which pointed out that the life-saving properties of the drug continue to be firmly supported by the medical profession, yesterday estimated that 30 per cent of the over-50s take the drug as a preventive measure.
Peter Elwood, who as a researcher back in 1974 was first to show the now widely accepted benefits of aspirin upon those suffering from cardiovascular disease, told The Times that it was reasonable for the “worried well” to continue to take aspirin as long as they were aware there was a very small risk of an intestinal bleed.
Professor Elwood, 79, argued that it was a question of choice and that preservation of health was the responsibility of the individual: “If someone is at risk of a heart attack — and they may not be aware they are — then heart attacks carry a 40 per cent mortality rate. A stomach bleed carried a 4 per cent mortality rate.
“The new research may show that the risk of a stomach bleed is nearly doubled, but that figure is very low — 2 per cent compared with 1.2 per cent among those who didn’t take aspirin — and this can be balanced against the severity of the possible outcome.
“People should be aware that there is a very small risk of bleeding, which will probably mean them being taken into hospital, given a transfusion, and told not to take aspirin again.”Andrew Buist, a GP in Blairgowrie who is the deputy chairman of the Scottish GP Committee of the British Medical Association, said that he believed research papers should ask of resesarchers: “What would you do?”
Dr Buist, 45, said: “You have to take into account the latest evidence, but then you have to interpret that in the light of the individual.”
He added that he planned to start taking aspirin in a few years’ time.
Jackie Price, a researcher on the Aspirin for Asymptomatic Atherosclerosis University of Edinburgh study, emphasised that the message for people who had had a heart attack or angina was clear: the benefits of aspirin outweighed the risk of internal bleeding. For others, this was not the case. She said: “The clear message is that there is no evidence that aspirin is helping, and there is evidence that it may be doing a small amount of harm”
CASM: FDA approves expanded label for CAS Medical device
(This tiny med device co. once made me much money when it transitioned from the BB to the NASDAQ. The story has always been about their cerebral oximeter and the new wide label gives this one room to run.-aj)
http://finance.yahoo.com/news/FDA-approves-expanded-label-apf-3880137991.html?x=0&.v=1
BRANFORD, Conn. (AP) -- Medical device maker CAS Medical Systems Inc. said Tuesday regulators approved a labeling expansion for its FORE-SIGHT Cerebral Oximeter so it can be used on all patients, including infants that weigh less than 2.5 kilograms.
The device detects oxygen-saturation changes in brain tissue, "allowing clinicians to quickly react to reverse potentially harmful events before they become critical," the company said in a statement.
The new labeling, approved by the Food and Drug Administration, will allow for monitoring of smaller newborns at risk for intra-ventricular hemorrhage, central apnea and seizures.
Company shares soared 97 cents, or 68 percent, to $2.40 in afternoon trading.
MELA-Indeed, derm's might use this to push MORE biopsies, rather than fewer, which would end up being a good thing for NGNM's melanoma genetics test coming on line early next year.
aj
"Great post, tinker, but I suspect it will not be well received by some of the PhD regulars in these parts"
Not from this one. Medicine, Law, Science, all have some who have been attracted to these as a calling, some who have been drawn to the business, and some because it is a "racket".
I am a clinical Ph.D. I spent the endless hours of clinical training, not unlike that spent by MD's, got paid a pittance, and became a patient oriented clinician. I have colleagues who run efficient businesses with their practice, and know some god awful mental health practitioners who run a racket (ever heard of a medicaid mill?).
Biowatch, I pay liability ins. but thank goodness that it pales in comparison the the fees that some physicians have to pay. as long as we mental health practitioners keep our hands to ourselves, our risk of harm is pretty low. That said, our reimbursement rates are also pretty low.
aj
ABT and NGNM:
Ahhhhhhhhh....I'm back from a week-long beach vacation that included a self-imposed blackout from internet information, office related cell phone interruptions (and I personally thank my new secretary for managing to manage things and leave me alone) and even newspapers and watches (left that damn thing in the nightstand). All eschewed for the beach, sun, sand and snorkling!
What great news for my portfolio and NGNM. This gives NGNM the bona fides, from a business standpoint, to be able to garner the attention of both potential partners and competitors that they are a growing force to be reckoned with. The co., already growing at a healthy clip of 40-60% YOY, will likely be able to push revenues to above $100 million by 2011 rather than 2012 as they have previously hinted was their goal, with this new partnership.
More importantly, from my point of view, is that the co is now capable of sitting down with smaller private labs to talk consolidation and merger activity. This co. was built, from the beginning, to grow and become a consolidation target themselves. I suggest that there is value here at least below $4 a share, which will undoubtedly be the next technical threshold for the co. to overcome (along with full listing).
aj
Niaspan v Zetia: "Yes, an interim analysis in an imaging trial CIMT, strikes me as uncommon, guess it was meant to save money. If Niaspan didn't show a meaningful effect on IMT, it makes sense to stop the trial and forget about it, if it was more effective, I assume we would have heard about it."
Although I have no skin in this game (except the bragging rights if my prediction is correct) I would generally agree that we ought to have heard something if the interim analysis was good news, with this exception. This was a VA study and those VA people, 1. could care less about saving money (in fact are incetivized to spend ALL the money that they are budgeted), and 2. the VA has no business incentive to get the news out. The PI might want to squeeze as much PR out of his findings by waiting for an "official announcement" at some scientific meeting.
JM2C
aj
Citalopram and seizures:
Looking at the PDR, the rate of seizures during clinical trials for Citalopram was 0.3% of patients treated, vs. 0.5% of patients treated with placebo.
If the TRGT data included one seizure event, I would not be too concerned so long as their sample size was sufficiently large. I haven't looked at the study, so if this was a relatively small PII with less than 200 enrolled, caution would be advised.
regards,
aj
Niaspan and Intima Media thickness: DT, don't you think that this tough outcome measure would NOT be included in an interim analysis (or at least allowed to trigger a halt to the study.) If artery wall thickness is the ultimate goal of treatment and the treatment was indeed lowering LDL and raising HDL, I would imagine that the study would wait until the prescribed endpoint before an analysis of thickness.
Of course, the interim analysis might have included an artery wall thickness measure that demonstrated an INCREASE in thickness, but I would think that unlikely.
aj
MRK ABT: Niaspan vs Zetia:
Dew, I'm violating scientific principles here because of my personal observations and niacin results (ie. my niacin regimen has lowered my LDL and raised my HDL much better than using simvaststin), so I'll lay 4 to 1 odds that the Niaspan was superior.
What I'd like to get opinions on is just how much of an increase in Niaspan prescriptions a positive outcome from the study will provide. Do we have any models for comparing a prescription form of an OTC health aid readily available to the public?
aj
Niaspan vs. Zetia: I'm betting on Niaspan. the outcome measure for the study was artery wall thickness and all subjects were already on a statin medication. Zetia's mechanism should not, at least in theory, have a significant impact on LDL plaques already accumulated within artery walls while Niaspan should.
aj
DBS for OCD: Fortunately, most OCD patients do not have delusions that electrodes have been implanted in their brains; that is generally the purview of schizophrenics.
aj
BEAT: just to clarify, I put BEAT on the top of my track list to focus on DD, not to say it would be my first buy. This is at near it's 52-week low, having lost 85% of its value. I see the CMS reimbursement change as exposing the weakness of the co.'s business model, likely once trumpeted as its strength (ie. no capital costs for users of the technology as BEAT apparently owns their devices, bills medicare and provides clinical reports to the Dr.'s).
Growth rate has been robust and they are profitable and stand a good chance that they will remain so despite the cut in reimbursement. I don't know if they deserve the haircut they've received in the last year and the next 2 quarters will tell much about continued growth and profitability.
The nix of the merger is much less of a problem. BTEL is a microminicap and not likely to be much of a hinderence going forward, IMO.
regards,
aj
BEAT: "CardioNet, Inc. Announces Highmark Medicare Services Reimbursement Reduction Regarding Code 93229"
Be prepared to hear this type of announcement from all corners of medicare reimbursement. It happened to our procedure codes last year and this looks to be CMS's approach to cost containment.
That said, BEAT is starting to look attractive from a price valuation. It now heads to the top of my list of device makers that is topped by BABY.
aj
Semi OT: Niaspan
I just purchased a bottle of 200 500mg flush free niacin capsules at Sam's club for $6, making my 1500mg daily dose about 10 cents/dose.
aj