NEO: NeoGenomics Revises Upward its Quarter 3 2013 Guidance

(This is very good news, demonstrating that the co. continues to execute on their plans to expand market share and provides the market with some assurance that they will continue to grow despite the prospect of medicare reimbursement cuts. Can they stay profitable in the face of cuts? Unknown at this point.)

http://finance.yahoo.com/news/neogenomics-revises-upward-quarter-3-110000994.html

FT. MYERS, Fla., Sept. 26, 2013 /PRNewswire/ -- NeoGenomics, Inc. (NEO) announced today that it was revising upward its previously issued guidance for Quarter 3, 2013. The Company now expects revenue of approximately $16.6 - $16.9 million and earnings per share of $0.01 - $0.02 in the third quarter. The Company had originally guided to revenue of $15.8 - $16.4 million and earnings per share of $0.00 - $0.01 on July 31, 2013.

Doug VanOort, the Company's Chairman and CEO, commented, "We experienced strong year-over-year revenue growth in July and August, and our rate of growth has continued to accelerate in September. This growth is broad-based, and is the result of a variety of growth initiatives we have made over the last eighteen months, including, but not limited to, increasing sales force productivity and various new product launches. We are scheduled to release our full third quarter financial results on October 23, 2013."

The Company reserves the right to adjust this guidance at any time based on the ongoing execution of its business plan. Current and prospective investors are encouraged to perform their own due diligence before buying or selling any of the Company's securities, and are reminded that the foregoing estimates should not be construed as a guarantee of future performance.


Best,,
aj

NxStage Reports Record Revenue For The Second Quarter Of Fiscal 2013

http://finance.yahoo.com/news/nxstage-reports-record-revenue-second-112400618.html
The numbers indicate that the co. beat analysts estimates by $1 million and (earnings) by 1 cent/share.

NxStage Medical, Inc. (NXTM), a leading manufacturer of innovative dialysis products, today reported second quarter financial results with total revenue at the top end of its guidance range.

(Logo: http://photos.prnewswire.com/prnh/20110503/MM94799LOGO )

Revenue for the second quarter of 2013 increased 11% to a record $65.5 million, compared with revenue of $59.0 million for the second quarter of 2012. The higher revenues were driven by increased adoption of the NxStage® System One™.

Home revenue increased to $32.7 million for the second quarter of 2013 compared with revenue of $30.7 million for the second quarter of 2012.

Critical Care revenue increased to $10.8 million for the second quarter of 2013 compared with revenue of $9.4 million for the second quarter of 2012. In-center revenue increased to $21.2 million for the second quarter of 2013 compared with revenue of $18.2 million for the second quarter of 2012.

NxStage reported a net loss of $3.4 million, or $(0.06) per share for the second quarter of 2013 compared with a net loss of $5.1 million, or $(0.09) per share for the second quarter of 2012. Net loss for the second quarter of 2013 includes a $1.2 million tax benefit related to the conclusion of a foreign tax audit.

"Our results reflect solid progress and early benefit from our strategic growth initiatives, including our new direct to patient marketing programs," stated Jeffrey H. Burbank, Founder and Chief Executive Officer of NxStage. "We believe our efforts to further penetrate both the US and international markets are on track to deliver 15 percent annual Home revenue growth in 2014 and beyond."

Burbank continued, "Based on our outlook and our continuing progress in key areas, we are reaffirming both our top line revenue and net loss guidance for 2013. Perhaps more importantly, we believe we're setting the Company up for an exciting new chapter of growth in 2014 and beyond."

Separately, the Company announced the opening of its first dialysis center in St. Louis, MO, through its wholly owned subsidiary, NxStage Kidney Care, Inc. The move is in line with the Company's strategic centers of excellence initiative to expand patient access to home therapies and the life-changing benefits possible with home and more frequent dialysis using the NxStage System One.

The Company also announced its expansion into Canada through a newly established entity, NxStage Medical Canada, Inc. Through this new entity, NxStage is marketing and selling the System One and related products and services directly in Canada. NxStage highlighted that its first Canadian customer has initiated patient treatment with the System One.

Guidance:

For the third quarter of 2013, the Company is forecasting revenues to be between $66.5 million and $68.0 million, and a net loss in the range of $4.5 million to $3.5 million, or $(0.07) to $(0.06) per share. The Company reaffirmed its top line revenue and net loss guidance for 2013.

NGNM: A YMB post states that the CMS lab reimbursement rates for 2014 were published today. I am having problems opening the Adobe document to review them, but there is likely bad news in the document regarding reimbursement decline, as NGNM is getting hammered today.

Can anyone open the reimbursement document and comment on the degree of reimbursement declines seen?

aj

DNDN: FWIW, I was in the doctor's lounge yesterday (scoring MMPI-s) and the TV was on some cable channel running "Walker, Texas Ranger" reruns in the middle of the day and up pops a direct to consumer ad for Provenge. I thought it was humorous that it happened.

NXTM: The behavior of this stock continues to impress me. When I posted last week, the share price was $12.50. It opens today at $13.50 with news that their vendor agreement with DaVita Healthcare has been extended and expanded:

http://finance.yahoo.com/news/nxstage-announces-agreements-davita-210900673.html

LAWRENCE, Mass., May 21, 2013 /PRNewswire/ -- NxStage Medical, Inc. (NXTM), a leading manufacturer of innovative dialysis products, today announced that it has entered into new agreements covering its supply of home, critical care and in-center products to DaVita, the kidney care division of DaVita Healthcare Partners Inc.

For the use of products for home hemodialysis in the United States, NxStage has executed a second amended and restated National Service Provider Agreement with DaVita (the "Home Agreement"). The Home Agreement continues, in all material respects, the terms of the first amended and restated National Service Provider Agreement between NxStage and DaVita dated July 22, 2010, with pricing for NxStage's products subject to System One™ home patient growth targets.

The term of the Home Agreement extends through December 31, 2015, and thereafter automatically extends on a monthly basis unless terminated by either party.

"We are delighted to continue working with DaVita to expand patient access to our life-changing therapy," stated Jeffrey H. Burbank, Founder and Chief Executive Officer of NxStage Medical, Inc. "These agreements underscore the value and strength of NxStage's innovative technology and our commitment to delivering high quality products to our customers and their patients."

NxStage and DaVita also entered into an agreement covering the purchase of NxStage's System One and other products for acute inpatient therapy within the critical care market through December 31, 2015.

Lastly, NxStage's subsidiary, Medisystems, and DaVita extended the term of their Needle Purchase Agreement dated January 6, 2008 through at least December 31, 2014, although DaVita may by October 31, 2013 elect to extend this to December 31, 2015.

AJ

NTXM and BAX: If Baxter intends to have a larger footprint in home dialysis then they may be a buyer for NXTM as NXTM's products are all hemodialysis products, which is a bigger and more lucrative market. Peritoneal dialysis is a simple process that doesn't actually require any branded products, just saline and a couple of peritoneal lines. Its been done for years with off the rack hospital products and is quite low tech.

BTW, NXTM is a buyer of supplies from Rockwell Med (RMTI) and I have opined elsewhere that NXTM should just go ahead and buy RMTI (market cap below $100 million), to broaden their list of products, reduce overhead (by erasing the RMTI product markup) and becoming a potential player in emerging hemodialysis products (RMTI has an Iron supplement that is in Ph3 trials.)

NXTM: Doesn't look like anyone follows this co. here (after my last post.) They are engaged in the manufacture of critical care and home-based dialysis products. Last quarter's report appears to be pleasing to the street and the share value has marched steadily up from $10/share to north of $12.50/share. I'm no technical analyst, but I like the behavior. The co. is worth a look. They have a new overnight dialysis product and a new rapid dialyzing product approved by the FDA. They also announced last quarter that they would stop selling product in the EU through vendors and start marketing them independently. Always an added expense, but better on the margins.

FWIW,

aj

ISIS: been following this, Dew. Clearly, I made the wrong call in switching my ISIS shares out for SPPI.

SUPPRESSING PROTEIN MAY STEM ALZHEIMER'S DISEASE PROCESS

http://www.sciencecodex.com/suppressing_protein_may_stem_alzheimers_disease_process-111106

Scientists funded by the National Institutes of Health have discovered a potential strategy for developing treatments to stem the disease process in Alzheimer's disease. It's based on unclogging removal of toxic debris that accumulates in patients' brains, by blocking activity of a little-known regulator protein called CD33.

"Too much CD33 activity appears to promote late-onset Alzheimer's by preventing support cells from clearing out toxic plaques, key risk factors for the disease," explained Rudolph Tanzi, Ph.D., of Massachusetts General Hospital and Harvard University, a grantee of the NIH's National Institute of Mental Health (NIMH) and National Institute on Aging (NIA). "Future medications that impede CD33 activity in the brain might help prevent or treat the disorder."

Tanzi and colleagues report on their findings April 25, 2013 in the journal Neuron.

"These results reveal a previously unknown, potentially powerful mechanism for protecting neurons from damaging toxicity and inflammation," said NIMH Director Thomas R. Insel, M.D. "Given increasing evidence of overlap between brain disorders at the molecular level, understanding such workings in Alzheimer's disease may also provide insights into other mental disorders."

Variation in the CD33 gene turned up as one of four prime suspects in the largest genome-wide dragnet of Alzheimer's-affected families, reported by Tanzi and colleagues in 2008. The gene was known to make a protein that regulates the immune system, but its function in the brain remained elusive. To discover how it might contribute to Alzheimer's, the researchers brought to bear human genetics, biochemistry and human brain tissue, mouse and cell-based experiments.

They found over-expression of CD33 in support cells, called microglia, in postmortem brains from patients who had late-onset Alzheimer's disease, the most common form of the illness. The more CD33 protein on the cell surface of microglia, the more beta-amyloid protein and plaques – damaging debris – had accumulated in their brains. Moreover, the researchers discovered that brains of people who inherited a version of the CD33 gene that protected them from Alzheimer's conspicuously showed reduced amounts of CD33 on the surface of microglia and less beta-amyloid.

Brain levels of beta-amyloid and plaques were also markedly reduced in mice engineered to under-express or lack CD33. Microglia cells in these animals were more efficient at clearing out the debris, which the researchers traced to levels of CD33 on the cell surface.

Evidence also suggested that CD33 works in league with another Alzheimer's risk gene in microglia to regulate inflammation in the brain.

The study results – and those of a recent rat study that replicated many features of the human illness – add support to the prevailing theory that accumulation of beta-amyloid plaques are hallmarks of Alzheimer's pathology. They come at a time of ferment in the field, spurred by other recent contradictory evidence suggesting that these presumed culprits might instead play a protective role.

Since increased CD33 activity in microglia impaired beta-amyloid clearance in late onset Alzheimer's, Tanzi and colleagues are now searching for agents that can cross the blood-brain barrier and block it.

NEO—As we’ve discussed on this board many times, getting paid promptly (or at all) is always an issue for diagnostics companies.
True, but this is a potentially onerous problem for NEO in the short-term. If the Barron's author is correct and the FL medicare contractor has completely quit paying, it will hit NEO's cash flow hard as they have their biggest footprint in that state. It is now more clear why they generated some cash with an offer earlier in the year.

aj

Related to NEO's upcoming earnings announcement:
Forbes Tells the World How Medicare Bollixed Molecular Diagnostic Test Payments, Leaving Nation’s Clinical Laboratories Unpaid for Months

http://www.darkdaily.com/forbes-tells-the-world-how-medicare-bollixed-molecular-diagnostic-test-payments-leaving-nations-clinical-laboratories-unpaid-for-months-421#axzz2RIVfDhrq

Since the beginning of the year, most Medicare contractors and private health insurers have not paid clinical laboratories and anatomic pathology practices for molecular diagnostic test claims coded to the 114 new molecular test CPT codes.

This unprecedented situation of labs going unpaid for more than three months has created financial turmoil and uncertainty across the medical laboratory profession. In fact, the question must be asked: Did Forbes columnist Scott Gottlieb, M.D., wake up the nation’s Medicare contractors with his column published on March 27?

In his essay, Gottlieb wrote “This is a story of bureaucratic mismanagement at the Centers for Medicare & Medicaid Services [CMS], and the harm it’s visiting on the diagnostic testing industry.” Within days of his reporting on the molecular diagnostic test payment stoppage at Medicare, individual Medicare contractors began publishing prices for some or all of these 114 molecular test codes.

Once Medicare contractors issue prices for these molecular CPT codes, clinical laboratory billing and coding experts said checks could be mailed. These checks could go out by the end of this month. But, according to Gottlieb, there is uncertainty about even that scenario.

“Some contractors have not priced anything, such as the Medicare contractor for the market covering Florida,” observed Gottlieb. “That means diagnostic labs located in markets like Florida aren’t getting paid at all… There’s no clear deadline on when this will all get resolved. There’s some speculation that when the Medicare contractors submit their 2013 pricing on April 30, they’ll have to declare their prices for these various molecular tests. Once they do, the labs should get paid retroactively. But the April 30 deadline seems soft. This could linger much longer.”

At this time most clinical laboratories are not being paid for molecular tests. This is probably the most under-reported story in the medical laboratory industry. For that reason, our sister publication, The Dark Report, devoted its latest issue (dated April 15, 2013) entirely to this important topic.

Gottlieb is knowledgeable about the Medicare program. He has served as Senior Adviser to the Administrator of Medicare and Medicaid Services, where, according to Politico, “he supported the agency’s policy work on quality improvement and coverage and payment decision-making, particularly related to new medical technologies.”

This is not good news for any genetics testing labs and means that cash flow, at the very least, will be impaired for Q1. I have lightened my position in NEO based upon this and will await the CC to hear what they have to say and may look for a lower re-entry price.

aj

SPPI: Not all of us :(

I'd tell you how it tastes to eat crow, but I'm on a diet, eating my words has fewer calories.

aj

I am forthwith adding a rule to never invest in a co. where the majority of posts on the YMB comes from a combination of cheerleaders and bashers!

SPPI:TOPO

Belinostat BELIEF trial exceeds primary endpoint with encouraging response rate

https://newsclient.omxgroup.com/cdsPublic/viewDisclosure.action?disclosureId=544760&messageId=671384

Final top-line data confirm that the primary endpoint was met for the belinostat pivotal trial for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) with an encouraging objective response rate.

Top-line data show an objective response rate (ORR) in the efficacy analysis set which is above the protocol criterion for a positive outcome of the trial. Belinostat thus has an ORR that is on par with the accelerated approved drugs Folotyn™ and Istodax®. A Special Protocol Assessment agreement with the US Food and Drug Administration (FDA) required the CLN-19 BELIEF trial to reach an ORR of at least 20%. The FDA has granted belinostat Orphan Drug and Fast Track designation for the treatment of PTCL. All patients who received at least one dose of belinostat and had a confirmed PTCL diagnosis by the central pathology review were included in the efficacy analysis set. The responses have been confirmed by central independent radiology review. Final data have been submitted for presentation to the 2013 ASCO annual meeting.

“Our belief in belinostat has never wavered and the encouraging objective response rate together with the earlier announced favorable safety profile further supports the potential of our product. We strive to improve the lives of cancer patients and this is a large step in the right direction" said Anders Vadsholt, CEO of Topotarget.

Favorable safety profile
On January 24, 2013, Topotarget announced that preliminary safety data from the BELIEF trial in PTCL, presented at the T-Cell Lymphoma Forum 2013 in San Francisco, USA, showed that belinostat has a favorable safety profile and that the compound has the potential to become a well-tolerated alternative for the treatment of PTCL. The favorable safety outcome from this trial, as well as experience from earlier belinostat trials, shows that full doses of belinostat can be combined with other cytotoxic regimens making combination therapy for cancer patients feasible. The low incidence of myelosuppression is of special notice as this offers the opportunity to combine belinostat with other cytostatic agents for the treatment of patients with PTCL.

New Drug Application
Belinostat is currently being developed jointly by Topotarget and Spectrum Pharmaceuticals. Spectrum possesses the commercial rights to market belinostat in North America and India. A New Drug Application (NDA) for belinostat in PTCL is expected to be filed with the FDA by Spectrum in mid-2013.


TOPO is up nearly 100% since the initial results were posted and 50%+ in the last two days. Now all SPPI has to do is get belinostat to market and SPPI will lose the cloud of Fusilev revenue problems.

aj

"Patients get monitored overnight while the dialysis is performed during their sleep."

That's just bloody brilliant! ;0

aj

NXTM: Anyone here follow Nxstage Medical, a device co. that provides equipment for in-home hemodialysis? I've watched it for several years. They have robust sales growth but continue to lose money (although they appear to be approaching break even.)

Any opinions?

aj

NEO: Another idea I had was that I haven't heard much from management about Cap ex for some time. As the genetics testing business is evolving quickly, they may be interested in the faster and more highly automated analysis machines that are coming onto the market. Gotta assume that faster is expensive, but may laos be less labor intensive.

JM2C,

aj

NEO: To increase capacity generally, or to broaden the spectrum of tests performed?

They've not said, but they do have a history of culling their less complex and profitable lines of lab services in the past.

NEO: I like the market response to the news. The co. is almost debt free and has some cash reserves, so the additional $7+ million will be helpful in expansion efforts. The co. has long stated that they were in the market to purchase a small private lab and this might be the signal that they have something brewing.

aj

NEO: "What is the TC grandfather sunset?"

There was a billing clause that allowed genetics labs to independently bill medicare for the technical component of the testing and allow hospitals to bill for the professional services. NEO now has to bill the hospital for the technical component, which delays reimbursement. I believe that during the CC, mgmt provided details of the average days for accounts receivable, longer now in the past because of this change. There was no specific comment on any deals that NEO had to cut with the hospitals regarding changes in reimbursement, but I suspect that some discount was likely to keep these customers.

Peter's comment and link to the changes in CPT for genetics testing is clearly a concern, but I'm not certain to what degree this will impact reimbursement. The key issue appears to be "stacked" billing where the lab can charge for each individual procedure when multiple levels of genetics procedures are run on a single sample. Here is an excerpt from the article:

"For over a decade, the bane of coding for molecular tests has been the infamous issue of stacked codes. Unlike traditional assays, molecular tests do not have single, analyte-specific codes that labs can use to bill Medicare or private payers. Rather, a list of codes that signify each procedure involved in performing the assay are listed together. Each code describes a separate step or methodology performed to complete the test, such as gene amplification, nucleic acid extraction, or nucleic acid probes. For some tests, these codes must also be multiplied if the lab uses a step more than once to perform the test, especially in those tests that look at multiple markers.With payers closely watching what they pay for, providers and payers can now work together more closely to make sure patients receive appropriate care, Synovec emphasized. “Under the current system, when a set of stacked codes is submitted, the payer doesn’t know if it’s something medically appropriate or not, and some payers, out of frustration, globally don’t cover molecular stacking codes,” he said. “On the other side, patients are having experimental tests done that are not part of the patient’s insurance plan, but cannot be teased out of the current coding stack submitted for payment. The greater granularity will allow for a better understanding of the analytes being tested, test ordering patterns, and it will allow payers to determine how and which tests should be incorporated into the insurance plans for their beneficiaries.”"

NEO: Quick note
NEO reported Q4 numbers last week, mostly in line and with continued positive numbers on test volume growth and margin increases. They reported that most of the TC grandfather sunset is now behind them, they have added 4 new sales reps and continue to guide up. Share price has responded positively and today is trading at an all-time high (currently $3.38/share).

For those watching, we continue to be on track with long-term growth and establishment as a legitimate stock, now fully listed. If the share value can reach and sustain $4/share, the co. will be available for more institutional investment and will likely shoot past the $4 threshold, given the reasonable no. of outstanding shares (45 million) and float (16.5 million).

The only drawback I see in the short-term would be the sequester, which would cut medicare reimbursement 2% across the board.

Sexual side effects and antidepressants.

Thanks for the edits Biowatch, I wrote it on the fly and didn't catch them. Seems I'm doing everything on the fly lately. D'ya think I could give work up for lent?

Antidepressants with low sexual side effects:

Bladerunner is generally correct about lexapro (and Celexa, the enantiomer), but the truly lowest rate is for Remeron. That said, there's uch to be said about getting the RIGHT antidepressant for your kind of depression as antidepressants aren't close to being fungible. Wellbutrin and Effexor (and Cymbalta to a slightly lesser degree) anchor the most adrenergic antidepressants (SNRI's) and are the most activating/stimulating: best for vegetative symptoms including inertia, hypersomnolence, and amotivation/fatigue. On the other end, Remeron, Lexapro and Celexa are the most anxiolytic of the antidepressants and best for worrisome, ruminative anorexic and hyposomnolent patients. Most of the SSRI's (prozac, paxil, zoloft) and in the middle and useful for that crying, sad affect, poor self worth kind of depression.

The other thing to keep in mind is that most of the sexual side effects wear off after 3-4 weeks even for the worst offenders.
Sex is important, but if you're depressed enough to need treatment, maybe sex can wait a little, N'cest pas?

JM2C,

aj

Good Morning NEOphytes!

Surf, how the hell are you? Haven't seen you post on biotech values for a while.

I am a long-timer here, in since '08 (I think). The co. is moving right along. Next step is to sustain a share price over $4 so the funds can start buying in. When this happens, I'd expect a share price to go to about $6.

I also expect the co. to start beating their estimates. New sales staff, new HDVY-based Fish analysis that is more cost effective and better, no more reimbursement issues (for now). If the sequester doesn't screw us, we should hit $20 million/qtr by Q4, and $100 million/yr in the combination of Q3 and 4 2014, + Q1 and 2 2015.

Here we go!

aj

PS: Post to Yahoo to getb them to turn their damn message board on!

ISIS: Funny how the market values this co. Even with an exhorbitant price on Kynamro, the revenue stream will be tiny. ISIS's pipeline may be wide, but not so deep, at least in my opinion.

GXK: monophosphoryl lipid A vaccination potential for Alzheimer's Disease

(Haven't seen this posted yet and this looks quite promising so would like to hear from some of the board members who are much more expert than myself. I've also attached a comment from noted neuroscientist Paul Patterson at CalTech)

Major Step Toward an Alzheimer's Vaccine

http://www.sciencedaily.com/releases/2013/01/130115143852.htm

"One of the main characteristics of Alzheimer's disease is the production in the brain of a toxic molecule known as amyloid beta. Microglial cells, the nervous system's defenders, are unable to eliminate this substance, which forms deposits called senile plaques.

The team led by Dr. Serge Rivest, professor at Université Laval's Faculty of Medicine and researcher at the CHU de Québec research center, identified a molecule that stimulates the activity of the brain's immune cells. The molecule, known as MPL (monophosphoryl lipid A), has been used extensively as a vaccine adjuvant by GSK for many years, and its safety is well established.

In mice with Alzheimer's symptoms, weekly injections of MPL over a twelve-week period eliminated up to 80% of senile plaques. In addition, tests measuring the mice's ability to learn new tasks showed significant improvement in cognitive function over the same period.

The researchers see two potential uses for MPL. It could be administered by intramuscular injection to people with Alzheimer's disease to slow the progression of the illness. It could also be incorporated into a vaccine designed to stimulate the production of antibodies against amyloid beta. "The vaccine could be given to people who already have the disease to stimulate their natural immunity," said Serge Rivest. "It could also be administered as a preventive measure to people with risk factors for Alzheimer's disease."
"

Dr. Patterson's comment:

"There are many indications of a subclinical, inflammatory state in AD. Whether this is a cause or effect of Aß accumulation is a topic of considerable interest. A number of epidemiological studies found that a history of use of anti-inflammatory medications can significantly postpone the onset of AD. Clinical trials of such drugs have provided some evidence of very modest, positive effects on AD progression. In mouse models, induction of proinflammatory cytokines can reduce Aß levels, while reducing cytokine efficacy can increase Aß. Moreover, stimulation of Toll-like receptors (TLRs) on microglia accelerates Aß removal in culture and in vivo, while knocking out TLR4 exacerbates Aß accumulation. A worry is that sustained activation of microglia, as with repeated injection of lipopolysaccharide (LPS) in mouse models, appears to result in excessive inflammation and increased Aß levels. Thus, it would be useful to have a molecule that hits the sweet spot of decreasing Aß while being safe. This new paper from Serge Rivest’s group at Laval University in Quebec describes results with a molecule that may indeed fulfill these criteria. Monophosphoryl lipid A (MPL) is a modified version of LPS that is a TLR4 agonist with immunomodulatory properties, but is much less toxic than LPS. Moreover, MPL has been used as an adjuvant in a number of vaccines without apparent side effects, and is deemed safe in humans, at least for acute applications.
Michaud et al. provide convincing evidence that MPL stimulates microglial phagocytosis of Aß in vitro and monocyte phagocytosis of Aß in mice. The MPL stimulation of the immune system is considerably milder than that seen with LPS. Most importantly, weekly i.p. injections of MPL over a period of three months in APPswe/PS1 AD mice results in significant (P <.01) decreases in plaque number and area in the cortex. Levels of extracellular Aß monomers are also down in the brain, and the number of Aß-containing microglia is strongly increased. The final key piece of evidence in such experiments is an analysis of learning and memory in the mouse model. Michaud et al. evaluated reversal learning in the T water maze and report that MPL treatment improves scores at a significance level of P <.05, although the scores of half of the controls overlap completely with those of the MPL mice. It will be informative to see the results of further behavioral analysis of these mice. Overall, then, peripheral injection of MPL lowers Aß and plaque levels in AD mice, and may positively affect learning. The mechanism of its action could be via the peripheral sink action of lowering blood levels of Aß and/or its stimulation of Aß uptake by brain microglia. Since this molecule is approved for human use in vaccines, MPL is a good candidate for clinical testing in AD."

http://www.alzforum.org/pap/annotation.asp?powID=142104

Comments and opinions?

AJ

MDCO: I wonder if the MDCO news resulted in the pop in MDCI with people unaware of that they are riding the wrong co.

http://finance.yahoo.com/q?s=MDCI

aj

CAMH: Agreed. Sad state of affairs, IMO. An example of how a "David" tech co. got squashed by a goliath (MDT).

Esophageal Ca: Appropo to this thread, this is from NGNM this am:

http://finance.yahoo.com/news/neogenomics-validates-launches-neosite-barretts-120000517.html

From the PR:

Approximately 3 million Americans suffer from Barrett's Esophagus in the United States, a condition which can be a precursor to esophageal cancer. Although less than 1% of these patients develop cancer each year, esophageal carcinoma is frequently not detected until later stages, at which point therapy options are limited, extremely invasive, and often ineffective. Therefore, early detection is important and regular surveillance is recommended. Endoscopic examinations with multiple tissue biopsies to look for dysplasia and cancer have long been considered the standard surveillance procedure for BE patients. However, current data suggests that an esophageal "brushing" may be more effective than a traditional tissue biopsy, because it allows for the collection of cells from a larger area of the esophagus for testing, which results in less sampling error. Esophageal brushings are also generally easier and less costly to obtain than tissue biopsies.

NeoGenomics' NeoSITE™ Barrett's Esophagus FISH test was designed specifically to be performed on brushing samples and can be used as an objective and easier means to aid in routine surveillance of BE patients. The Company performed an extensive trial to validate this new test in which the test showed initial sensitivity of 86% and specificity of 67% when the Company's proprietary algorithms were used to assist with interpreting the FISH results. Reported sensitivity and specificity levels were even higher when brushing samples were obtained from nodules rather than pan-brushing.

The Sensitivity/Specificity reported does not particularly impress me, but the addition of a more comprehensive surveillence technique for this type of aggressive and often fatal Ca. would seem to be a good idea.

Best,

AJ

NGNM: 7:09AM NeoGenomics (NGNM.OB) common stock has been approved for listing on the NASDAQ Capital Market; will change ticker to NEO (NGNM) 2.71 : The co expects to commence trading on the NASDAQ Capital Market on Monday, December 10, 2012 under the ticker symbol "NEO". Prior to the listing change to NASDAQ, the company's common stock will continue to trade on the OTC Bulletin Board under the current ticker symbol "NGNM".

http://finance.yahoo.com/marketupdate/inplay

Been waiting for this for a long time, glad that the day has been announced.

aj

Currently used anti-psychotic medications used in ADP (Alzheimer's Disease Psychosis) actually increase the mortality in ADP patients.

http://jama.jamanetwork.com/article.aspx?articleid=201714

Risk of Death With Atypical Antipsychotic Drug Treatment for DementiaMeta-analysis of Randomized Placebo-Controlled Trials

(From the conclusions section)


Considering the consistency of the risks among the trials, it is likely that there is increased risk from any of the drugs and not from a particular atypical drug. This is supported by the observation that the risk for haloperidol, which was randomly and double-blindedly assigned in 2 of the trials, was similar in magnitude to that of the atypical drugs, although not statistically significant. A fair speculation is that in frail, often medically ill, elderly patients with dementia a wide range of classes of drugs (antidepressants, sedatives, hypnotics, anxiolytics, mood stabilizers, anticonvulsants, and cardiovascular or antihypertensive drugs) similarly could be associated with this level of risk. This review also demonstrates that there is a substantially larger body of placebo-controlled trials of atypical drugs vs other central nervous system–acting drugs in very elderly patients (>81 years), mainly in an institutionalized population with dementia, and this collection of trials is larger than has previously been identified in the published literature.9,52
.


An absence of evidence for either efficacy or safety with nonatypical antipsychotic drugs was observed and the existing trials are not of adequate statistical power or quality to detect any increased risk at the level reported herein with atypical drugs. It is plausible that increased mortality is associated with the use of many or all classes of drugs used to treat these symptoms and syndromes. In elderly patients, it is likely that any given medication will both help and harm, and the safety of a drug must be considered in the context of known efficacy. Ironically, analyses such as these expose the risks of performing clinical trials in elderly patients as well and are likely to discourage pharmaceutical companies, governments, and institutions from undertaking future trials in this area.

There may be a little "bending of the truth" in stating that there is an increased risk of mortality in using antipsychotics as some would argue that this is a generalized phenomenon, not even specific to antipsychotics (per paragraph 1, above)

One last thought, as provided by a clinical superivor to me years ago, "Absence of Evidence is not Evidence of Absence."

JM2C,
AJ

NiacinMy personal experience was that Niacin 2000mg/qday dropped my total cholesteral from 300+ to 176, but for an unknown duration. After assuming that it was continuously working (for more than a year), a routine check found that I was back to my baseline. Suffice it to say, I dropped the regimen, started on Simvastatin, 40mg, and am back down to 190.

AF (and other opinions): Appeal to Authority is a logical fallacy of argumentation that is often used by novice posters here (I don't know how many times PPHM posters appealed to the authority of the PPHM CEO in making their arguments for the vaidity of their drug).

There are more Ph.D's and M.D's on this board than you can shake a stick at, but few use "appeal to authority" to forward their arguments. Likewise, Roy has no official "authority" in the biotech arena (you can correct me if I'm wrong Dew, but I've read your background info and you don't list formal scientific training), but has more gravitas than most, and mostly because he has leearned what he needs to know.

AF has also learned more about biotech (and investing) than most. That's why people listen.

JM2C,

AJ

ISIS: I suspect a cool response from the market even if the FDA approval comes through. Elevated liver enzymes and increased tumor growth risks will likely limit the number of doctors willing to prescribe and number of patients willing to take the treatment. My original interest was to see Kynamro approved and see how far physicians would prescribe off-label for heterogeneous HL and non-genetic HL.

I switched ISIS out for SPPI 3 months ago. I considered SPPI a better risk/reward play. The latest news supports my justifications/rationalizations. Time will tell, with some help from quarterly revenue reports ;)

aj

ISIS: Isis Falls on Concerns Over Abnormal Growths With Kynamro

"Isis Pharmaceuticals Inc. (ISIS) fell the most in 20 months after U.S. regulators raised concerns about abnormal growths, some harmful, linked to the company’s drug for a rare genetic disease.

Isis, which is partners with Paris-based Sanofi (SAN) on the medicine, declined 14 percent to $11.19 at 9:45 a.m. New York time after decreasing to $10.95 in the biggest intraday drop since February 2010. The Carlsbad, California-based company had risen 68 percent in the year through yesterday.

In clinical trials, the growths, or neoplasms, developed in 3.1 percent of patients treated with the drug Kynamro and 0.9 percent of patients who took a placebo, Food and Drug Administration staff said in a report released today before an Oct. 18 meeting of agency advisers. The interpretation of the data is limited by a small sample size and a short treatment time, the staff said. The injection, Isis’ lead product candidate, helps lower LDL, or bad, cholesterol in patients who have very high levels, FDA staff said today.

“This imbalance in neoplasms will need to be assessed further in on-going and future studies and post-marketing (if approved),” FDA staff wrote.

The malignancies are a “new concern” and the reason for weakness in the shares, Eric Schmidt, an analyst with Cowen & Co. said in an e-mail.

The FDA is scheduled to make a final decision on the drug
by the end of January.
Nine of the 23 growths in patients treated with Kynamro were malignant, according to the report. One of the two growths in the patients treated with placebo were harmful. There were a total of 749 patients who took the drug and 221 on placebo.

Liver Cells

Kynamro, also known chemically as mipomersen, targets a disease known as homozygous familial hypercholesterolemia that causes abnormalities in liver cells responsible for clearing LDL, or low density lipoprotein, particles from the blood. The disease can lead to heart attack or death at an early age, according to the National Institutes of Health.

The FDA staff also said it is concerned about the treatment’s effect on the liver and that the harm can be mitigated with a risk plan that targets patients.

A risk plan would “support appropriate use of mipomersen, allowing it to be approved for use in the targeted patient population, a patient population with life threatening illness and limited therapeutic options,” staff wrote.

FDA staff yesterday said a plan to manage the risk of a similar drug from Aegerion Pharmaceuticals Inc. (AEGR) supports its approval in adults with the genetic disease. The agency is scheduled to decide on the treatment, lomitapide, by the end of December.

LDL Reduction

Isis says its drug reduced LDL cholesterol by 25 percent in patients with homozygous familial hypercholesterolemia in two late-stage trials, compared with 3.3 percent for those on placebo. In four late-stage trials, 8 percent of patients treated with Kynamro experienced elevated levels of an enzyme that indicates liver damage.

People with homozygous familial hypercholesterolemia can have cholesterol levels two to four times higher than normal and don’t respond to standard cholesterol-lowering drugs such as Pfizer Inc. (PFE)’s Lipitor. Isis and partner Paris-based Sanofi, France’s largest drugmaker, may draw $480 million in worldwide sales, Schmidt said. He has a neutral rating on Isis and owns Aegerion stock in a personal account.

Isis in a 2008 agreement with Sanofi will get 30 percent to 50 percent of Kynamro profits based on drug sales. Isis may generate $183 million in U.S. sales in 2016 from Kynamro, according to the average estimate of four analysts surveyed by Bloomberg."


http://www.bloomberg.com/news/2012-10-16/isis-falls-on-concerns-over-abnormal-growths-with-kynamro.html?cmpid=yhoo

NGNM: Steve Jones, Director and single biggest personal investor, sold 60,800 shares. Michael Dent (founder) sold 75,000 and Bob Gasparini sold 30,000. All sales were in the last week of Sept. above $3.

http://finance.yahoo.com/q/it?s=NGNM+Insider+Transactions

aj

I don't think these sales have any measning except that the directors need/want some cash.

NGNM: New Coverage by B. Riley & Co.

I am not a subscriber to their research so have just the public notice of their coverage, which was initiated today. The PR reads as follows:

"NeoGenomics, Inc. is a high-complexity cancer genetics laboratory that addresses the anatomic pathology and oncology markets’ inquiries related to diagnosis, prognosis, and therapy selection for hematologic and solid tumor cancers. The company's testing services include cytogenetics, fluorescence in-situ hybridization (FISH), flow cytometry, morphology studies, anatomic pathology and molecular genetic testing. The company markets its services to pathologists, oncologist, urologists, hospitals, and other clinical laboratories. The company was founded in 2001 and is headquartered in Fort Myers, Florida."

Coverage initiated as a "buy" with a price target of $4.60. This may explain the volume and price move last week.

http://brileyco.com/research/coverage_list/neogenomics_inc/

aj

PPHM: Can you say "dead cat bounce"? With the number of zealots holding the bag, I'm sure that the notion of averaging down is driving the buys.

CORX: Blade, I'm sure you're talking about CX-717, which was put on clinical hold. Wikipedia is not always the best reference, but here is what they had to say:

In April 2007 Cortex Pharmaceuticals submitted two large data packages to the FDA regarding CX717. One data set went to the FDA's Division of Neurology Drug Products for the treatment of Alzheimer's disease, while the other went to the Division of Psychiatry Products where the company filed a second CX717 IND for the treatment of ADHD. According to a Cortex Pharmaceuticals press release, the submitted data package "provides clear evidence that the specific histopathological changes seen in animal toxicology studies, which previously caused the FDA to put CX717 on clinical hold, is a postmortem fixation artifact and is not found in the tissue of the animal when it is still living".[4]

Roger G Stoll PhD, Chief Executive Officer of Cortex, stated,


“When CX717 was removed from clinical hold on October 6, 2006 by the Neurology Division a dose was permitted for continuing a study in patients with Alzheimer's disease, but that dose was too low to permit the assessment of the drug in patients with ADHD. Further information was needed to better understand the cause of the histopathological changes. We now have a substantial data base which clearly documents the fact that the histological changes of concern occur postmortem when the fixative solution is used to prepare the slides of the tissue specimens.”

However, in October 2007 the FDA denied Cortex's IND application for a Phase IIb study of CX717 for treatment of ADHD, based on the same animal toxicology results. Cortex responded by inactivating the application, although it will "continue its plans to develop CX717 for the acute treatment of respiratory depression (RD) and continue its study of CX717 in its Alzheimer’s disease PET scan study. Cortex believes that the IND application previously filed with the Division of Neurology Products of the FDA for the treatment of Alzheimer’s disease will not be affected by the actions of the DPP."[5] The company hopes that after the use of the compound in treating a high-risk acute condition is approved and well-established, the risks of longer-term use at higher doses, such as for treatment of ADHD, will be shown to be less than the FDA had concluded.

Bladerunner,

I don't know what happened at the FDA, but I do know the potential activity of Ampakines. The problem with the drug (at least the one I was involved with research wise, CX 516) were the consistent psychotic-like side effects of the drug and the seeming downplay of the side effects by COR. When confronted by patients who reported the unpleasant side effects to a significant degree then have the study abruptly stopped without identifying the problem, left investors without the information necessary for an investment, IMO, which is why many lost alot of money and fits the definition of scam, in my book. Then to have the co. continue to promulgate study after study without usable results, seemed to me to be an exercise in futility and way for corporate insiders to make money, keep their jobs, and fleece the investing public by stringing them on.

It’s one of the longest-running biotech scams in the history of the industry. I can think of only two or three that are longer.

I would submit Cortex Pharma has been one.

Funny, I can recall that we had a brief thread, years ago Dew, where I said that saw both of these in the same light and you agreed that they were similar scams.

aj