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Zacks AEMD: Progress on Ebola, U.S. HCV, ESI, Cancer...
New Zacks report out AEMD: Progress on Ebola, U.S. HCV, ESI, Cancer...
With no mention of DARPA sepsis program for - Whatever? - unknown reason. Otherwise, very thorough.
Enjoy dp
http://finance.yahoo.com/news/aemd-progress-ebola-u-hcv-150000228.html
Funny how no one seems to mention
the Fact that the Biotech sector got hammered last week down around 10%. Big, medium and small all got trashed with the smalls receiving the most pain. Hard environment for any stock to succeed, let alone one with a recent reverse split along with a secondary filing.
Enjoy dp
Invest in Exosomes Before Wall Street Does
Admittedly a little dated but content wise still as relevant, if not more so now that the exosome space is really heating up, than it was when it first came out Dec 30, 2013.
Enjoy dp
http://secfilings.com/News.aspx?title=invest_in_exosomes_before_wall_street_does&naid=636
Invest in Exosomes Before Wall Street Does
Published Monday, December 30, 2013 by Fred Zucker
Investors that aren’t catching wind of the power of exosomes are missing a rapidly growing science as it relates to diagnostics, drug delivery and novel disease treatments. Exosomes, nano-size extracellular vesicles secreted by nearly all somatic cells and found in body fluids, were grossly misunderstood historically, but that is all changing. A growing body of research is detailing the relevance of exosomes in cellular health and the important function that they serve in cellular communication by ferrying proteins and genetic materials between cells.
James McCullough, chief executive at privately-held Exosome Diagnostics, appropriately has dubbed exosomes as “the body’s Federal Express system.” Perhaps more succinctly, Dr. Douglas Taylor of Exosome Sciences, Inc., a subsidiary of Aethlon Medical, Inc. (OTCBB: AEMD) has said that exosomes are akin to the “Twitter of cells” because of the messages they deliver from cell to cell.
(Watch an interview with Dr. Douglas Taylor explaining the role of exosomes and the benefits of exosome diagnostics:
available at link or Exosome Sciences Website.)
Exosome Diagnostics is developing biofluid-based molecular diagnostic tests for use in personalized medicine, with their lead product being a test that captures exosomes in urine for analysis of ribonucleic acid (RNA) to detect mutations as an indication of prostate cancer.
A select few public companies have emerged as pioneers in the exosome space, including Life Technologies, Inc. (NASDAQ: LIFE), Aethlon Medical, and Eli Lilly & Co. (NYSE: LLY). By itself, Lilly is not really a player in the space, but it forged a partnership with Exosome Diagnostics in September to gain access to the company’s diagnostic tests to identify gene mutations and exosome expression levels in the blood that might help them better predict drug response and disease recurrence. Another way to try and benefit from Exosome Diagnostics’ test kit advancements is to take a look at QIAGEN N.V. (NASDAQ: QGEN) as the two companies partnered in July to develop and commercialize products for capturing and processing RNA and DNA from biofluid exosomes and other microvesicles. The companies hope to have co-branded kits commercialized in the first half of 2014.
The way that companies are quickly teaming-up to expedite development of technologies related to exosomes exemplifies the unique potential of these tiny, nucleic acid and protein-carrying sacs to revolutionize diagnostic procedures with greater efficiency and less invasiveness than biopsies that are conducted today. It also speaks to the best way to play stocks in the exosome industry: be in early and look for partnerships and cutting-edge developments.
Life Technologies is a leader in utilizing exosomes in diagnostics and a great resource for learning more about exosomes in general. The company has developed technologies for breaking down the process of capturing and isolating exosomes from body fluids and then subsequently isolating and analyzing the proteins or ribonucleic acid that they are carrying. The company sells a broad range of reagents and kits for total exosome isolation, whether from cell culture media, serum, plasma, urine or other body fluids. They also sell kits for isolating specific subpopulations, intact exosome analysis and cargo isolation and analysis.
Life Technologies is in the midst of being acquired by Thermo Fisher Scientific, Inc. (NYSE: TMO) as part of a $13.6 billion-dollar deal (plus assumption of $2.2 billion in debt) announced in April. Thermo is facing a few regulatory hurdles with buying Life because the combined company will control about half of the cell culture market, which could mean some divestures to gain regulatory approval. However, if the deal is completed, Life will bring a high-profit revenue stream to Thermo through its e-commerce channels that generate a significant portion of Life’s revenue.
Exosomes, whether increased in numbers due to a disease or not, do not define a condition, so it is necessary to see what is inside or to be able to test the surface of the exosome to detect a disease. To simplify and understand, think of plastic eggs (exosomes) floating down a river (body fluid). More eggs may indicate that there is a problem, but no matter what, it is necessary to net the eggs for examination and to open them up to interpret what is inside.
It’s this one-two punch of detecting and capturing exosomes that has created a very unique dynamic between Aethlon and its subsidiary Exosome Sciences. Built upon its ADAPT System, Aethlon has developed the Hemopurifier, a first-in-class medical device that has been documented to safely capture pathogens and exosomes in the circulatory system that underlie a variety of conditions and diseases, including colorectal cancer, lymphoma, melanoma, ovarian and breast cancer. Exosome Sciences is developing diagnostic tools with industry-leading sensitivity to detect and quantify the presence of exosomes in body fluids. The company’s scientific team is led by Dr. Douglas Taylor, one of the world’s foremost experts in exosomes and the man credited with the discovery of tumor-secreted exosomes. Dr. Taylor was pioneering research in exosomes in the 1970’s, long before the U.S. National Institute of Health acknowledged studies of scientists such as Dr. Taylor validating that exosomes are far more than simply cellular debris.
Exosome Sciences lead product is ELLSA, an acronym for an Enzyme Linked Lectin Specific Assay, which has been confirmed to identify the presence of exosomes in not only the aforementioned cancer lines, but also human immunodeficiency virus (HIV) and tuberculosis. The company is working to build-out the platform for additional assays using exosomes as a real-time biomarker for viral infections, pregnancy complications, birth defects and cardiovascular and neurodegenerative diseases. Paralleling other agreements in the industry, Aethlon intends to sell or license its technology to an established research diagnostics organization. Given the advanced stages of the flagship product and the extensive industry reach that is now afforded to Aethlon with Dr. Taylor joining the team in September, investors should remain attentive to developments on that front.
It has only been in the last few years that the scientific community has started rallying around the use of exosomes. With added attention comes additional possibilities and these companies cumulatively sit at the forefront of exosome research and initiatives within the scope of public entities. Popular Science recently looked ahead at 2014 and named work with exosomes to make cancer diagnoses less invasive as one of the 20 breakthroughs that will shape the world next year. If industry professionals are seeing the potential of exosomes and major biotechs and diagnostic tool makers are seeing it as well, it’s just a matter of time before Wall Street embraces it, providing a boon in value as they look to get a piece of companies with leadership positions in the space.
Reversal is Good on Aethlon Medical, Inc. (OTCMKTS:AEMDD)
Article from yesterdays Microcap Daily. Very quiet on all fronts for AEMDD today.
Enjoy dp
http://www.microcapdaily.com/reversal-is-good-on-aethlon-medical-inc-otcmktsaemdd/110365/
Reversal is Good on Aethlon Medical, Inc. (OTCMKTS:AEMDD)
By Carrie Rivers on April 20, 2015 Micro Cap Insider, Street Watch
Aethlon Medical, Inc. (OTCMKTS:AEMDD) has an extra D at the end of the ticker symbol affected after the 1-for-50 reverse stock split. The Reverse was made on speculation that management wants to seek listing on a higher exchange where they can attract institutional investors.
All in all the reverse has gone well and transformed Aethlon Medical into a respectable $12 stock (we all remember when this one was illiquid under a dime.)
The Company has been putting out some big news: On April 15 AEMDD announced it has entered into an investigator-initiated clinical trial agreement with the University of California, Irvine (UCI). Under the agreement, a clinical study protocol entitled, “Plasma Exosome Concentration in Cancer Patients Undergoing Treatment,” will seek to enroll five individuals in each of nine defined tumor types for a total study population of up to 45 subjects. The tumor types include the following forms of cancer; Breast adenocarcinoma, Colorectal, Gastric & Gastroesophageal, Pancreatic, Cholangiocarcinoma, Lung (NSCLC), Head & Neck (SCC), Melanoma and Ovarian adenocarcinoma. The principal investigator of the study is Edward Nelson, M.D.
Also on April 16 AEMD said that Dr. Robert Stern, professor of neurology, neurosurgery, and anatomy and neurobiology at Boston University School of Medicine (BUSM) has presented preliminary, unpublished findings related to research being conducted by Aethlon Medical’s majority owned subsidiary, Exosome Sciences, Inc. The presentation was given earlier today at the 5th Annual Traumatic Brain Injury Conference being held in Washington, D.C.
The findings are part of the Diagnosing and Evaluating Traumatic Encephalopathy using Clinical Tests (DETECT) study, a research project funded by the National Institutes of Health (NIH), being conducted at BUSM’s CTE Program. The DETECT study examines potential biomarkers for CTE by studying a sample of former professional American football players and a control group of same-age men without any history of brain trauma from contact sport involvement. In connection with the DETECT study, researchers at Exosome Sciences have been applying proprietary techniques to isolate microscopic exosomes that transport CTE associated tau protein (tausomes) across the blood brain barrier.
Aethlon Medical, Inc. (OTCMKTS:AEMD) is a Medical Device Company focused on creating innovative devices that address unmet medical needs in cancer, infectious disease and other life-threatening conditions.
To Get the Inside Scoop on Aethlon, Subscribe via email Right Now.
The Aethlon Adaptive Dialysis-Like Affinity Platform Technology System (ADAPT™) is a medical device platform that converges single or multiple affinity drug agents with advanced plasma membrane technology to create therapeutic filtration devices that selectively remove harmful particles from the entire circulatory system without loss of essential blood components.
Recently AEMD successfully used their bio-filtration device, the Aethlon Hemopurifier® to treat a critically-ill Ebola-infected patient in Frankfurt, Germany. The patient was a Ugandan Doctor, who was infected with Ebola in Sierra Leone where he was treating Ebola patients. At the time of treatment, which occurred at Frankfurt University Hospital, the patient was unconscious and suffering from multiple organ failure.
Recent date suggests a million Ebola viruses were captured within the Aethlon Hemopurifier® during treatment, a number verified by a post-treatment elution protocol. The patient is no longer infected with Ebola virus and is expected to make a full recovery.
The Hemopurifier® is a first-in-class bio-filtration device designed for the single-use removal of viruses and shed glycoproteins from the circulatory system of infected individuals. The device targets antiviral drug resistance and serves as a first-line countermeasure against Ebola and other viruses that are not addressed with proven drug therapies.
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Currently trading at an $82 million market valuation AEMD does have $2.7 million in the treasury, manageable debt and small revenues. AEMD is an exciting opportunity developing in small caps; the Company recently successfully treated a critically-ill Ebola-infected patient with the Aethlon Hemopurifier® and This was followed by the FDA approving a clinical protocol to treat Ebola-infected individuals in the U.S. with the Aethlon Hemopurifier®. We will be updating on AEMD on a daily basis so make sure you are subscribed to microcapdaily.com so you know what is going on with AEMD.
Exactly Bill. Exosome and Aethlon dogs circling
and sniffing up the right tree. Can't wait till the barking starts! LOL
Enjoy dp
You are missing Exosome Sciences diagnostic testing
Hard to keep up with all the irons in the fire eh? hopester.
Enjoy dp
http://www.exosomesciences.com/newslist.aspx?newsid=7
Aethlon Medical and Exosome Sciences Announce the Advancement of a Broad-Spectrum Cancer Detection and Monitoring Platform
SAN DIEGO and PRINCETON, N.J., Sept. 8, 2014 /PRNewswire/ -- Aethlon Medical, Inc. (NASDAQ:OTCQB:AEMD), and its diagnostic subsidiary, Exosome Sciences, Inc. (ESI), announced today that ESI researchers have developed and initially validated a lectin-based diagnostic platform that is able to isolate exosome-based biomarkers underlying a broad-spectrum of oncology indications. Aethlon Medical develops targeted therapeutic devices to address infectious disease, cancer and other life-threatening conditions. ESI develops exosome-based solutions to diagnose and monitor cancer and neurodegenerative disorders.
In the validation studies, ESI researchers provided evidence that their diagnostic platform could identify the presence of cancer in analyzed blood samples from individuals suffering from glioblastoma, metastatic melanoma, breast cancer, ovarian cancer, colorectal cancer and pancreatic cancer. Beyond the potential implications in diagnosing cancer, ESI researchers believe the high-sensitivity of the platform will allow for effective monitoring of cancer progression and response to corresponding therapies. In oncology indications, the sensitivity of the ESI platform also represents an advancement over the ELLSA assay that was originally developed by Aethlon Medical to quantify changes in circulating exosome load resulting from the administration of Aethlon Hemopurifier® therapy. The Hemopurifier® is a first-in-class therapeutic device that targets the rapid elimination of circulating viruses and tumor-secreted exosomes, which in addition to being an oncology biomarker, suppress the immune system and contribute to the spread of metastasis in cancer patients.
Based on previously reported discoveries related to progressive neurodegenerative disorders, Aethlon further disclosed that the ESI team has initiated follow-on studies to advance a candidate blood test to identify and monitor the progression of Chronic Traumatic Encephalopathy (CTE). At present, CTE is only diagnosed through postmortem autopsy. CTE has been most commonly found at autopsy in former National Football League (NFL) players and has also been demonstrated to be prevalent in soldiers exposed to blast injury.
In previous disclosures, ESI researchers reported that they had successfully isolated brain-specific biomarkers that could have implications in the diagnosis, monitoring and treatment of Alzheimer's Disease (AD), CTE and Glioblastoma Multiforme (GBM). The studies provided evidence that the ESI platform could also detect exosomes as a basis for a "liquid biopsy" to diagnose neurologic conditions. While exosomes from the central nervous system had previously been identified in the cerebrospinal fluid, the ESI team identified exosomes carrying brain-specific markers tau, beta-amyloid, glycoprotein A2B5 and S100B protein that had been transported across the blood-brain barrier and into the circulatory system.
"I am immensely proud of the ESI research team as their considerable breadth of collected data reinforces the possibility that a single platform could detect and monitor a wide-range of disease conditions," stated Aethlon Medical CEO Jim Joyce, who also serves as Executive Chairman at ESI. Mr. Joyce founded ESI on behalf of Aethlon Medical shareholders as a means to explore if the lectin-affinity techniques underlying Hemopurifier® therapy could provide a basis for proprietary diagnostic applications.
In the oncology platform validation studies, 198 single point serum specimens (taken at the time of cancer diagnosis) were analyzed from patients with Glioblastoma, Metastatic Melanoma, Breast cancer, Ovarian cancer, Colorectal cancer and Pancreatic cancer, plus 20 age-matched, female and male non-cancer controls. In the studies, the ESI platform was consistently able to differentiate individuals afflicted with cancer as compared to non-cancer controls. The tested serum specimens were obtained from commercial and collaborative academic biorepositories. A breakdown of the analyzed cancer specimens include:
– Glioblastoma – 5 late stage
– Metastatic Melanoma – 20 late stage
– Ovarian cancer - 31 early stage and 114 late stage
– Colorectal cancer – 7 early stage and 7 late stage
– Pancreatic cancer – 2 early stage and 12 late stage
Based on the data collected, ESI plans to establish collaborations and clinical partnerships to further validate its platform and identify specific oncology and neurodegenerative indications where the platform offers to improve upon standard of care methods to diagnose and monitor disease progression.
Additional study details will be presented at the Exosomes & Single Cell Analysis Summit to be held on September 18th and 19th, 2014.
New Blood Test Shows Promise in Cancer Fight
Could it be that Aethlon Medical / Exosome Sciences is sniffing around the right tree...
Enjoy dp
http://www.nytimes.com/2015/04/20/health/blood-test-shows-promise-as-alternative-to-cancer-biopsy.html?_r=0
New Blood Test Shows Promise in Cancer Fight
By GINA KOLATA APRIL 19, 2015
In the usual cancer biopsy, a surgeon cuts out a piece of the patient’s tumor, but researchers in labs across the country are now testing a potentially transformative innovation. They call it the liquid biopsy, and it is a blood test that has only recently become feasible with the latest exquisitely sensitive techniques. It is showing promise in finding tiny snippets of cancer DNA in a patient’s blood.
The hope is that a simple blood draw — far less onerous for patients than a traditional biopsy or a CT scan — will enable oncologists to quickly figure out whether a treatment is working and, if it is, to continue monitoring the treatment in case the cancer develops resistance. Failing treatments could be abandoned quickly, sparing patients grueling side effects and allowing doctors to try alternatives.
“This could change forever the way we follow up not only response to treatments but also the emergence of resistance, and down the line could even be used for really early diagnosis,” said Dr. José Baselga, physician in chief and chief medical officer at Memorial Sloan Kettering Cancer Center.
Researchers caution that more evaluations of the test’s accuracy and reliability are needed. So far, there have been only small studies in particular cancers, including lung, colon and blood cancer. But early results are encouraging. A National Cancer Institute study published this month in The Lancet Oncology, involving 126 patients with the most common form of lymphoma, found the test predicted recurrences more than three months before they were noticeable on CT scans. The liquid biopsies also identified patients unlikely to respond to therapy.
Oncologists who are not using the new test say they are looking on with fascination. “Our lab doesn’t do it, but we are very interested,” said Dr. Levi Garraway of the Dana-Farber Cancer Institute.
“It’s exciting,” he added. “It’s a top priority.”
Researchers are finding out things about individuals’ cancers that astonish them. MarySusan Sabini, a fifth-grade teacher from Gardiner, N.Y., has lung cancer that resisted two attempts at chemotherapy and a round of radiation. Her doctors at Sloan Kettering saw cancer DNA in her blood when she began taking an experimental drug in October that was her last hope.
Four days later, the cancer DNA shards had vanished, a sign, the doctors hoped, that the treatment was working. But they dared not tell her the good tidings. The blood test itself was so new they were afraid to rely on it.
Within weeks, Ms. Sabini began to breathe easier. Months later, she had a CT scan, an X-ray test that uses a computer to assemble detailed images of slices of tumor tissue. It confirmed her tumors were shrinking.
“Every cancer has a mutation that can be followed with this method,” said Dr. David Hyman, the oncologist at Sloan Kettering who is leading the study of the experimental drug Ms. Sabini takes. “It is like bar coding the cancer in the blood.”
The idea for the test grew out of a discovery made years ago about fetuses: They shed little pieces of DNA into the bloodstreams of mothers-to-be. It turned out that all growing cells, including tumors, shed tiny DNA fragments.
But finding those minuscule bits of DNA, floating in a sea of other molecules, is not easy. They remain in circulation for just a couple of hours before they are metabolized. And the detection method became useful only when cancer researchers, using advanced methods for DNA sequencing, found hundreds of mutations that could serve as bar codes for cancers and developed the technology for finding a snippet of DNA.
The standard methods of assessing a treatment’s effectiveness have serious drawbacks. Doctors routinely monitor patients for symptoms like pain or shortness of breath, but some people do not have any. In those who do, it can take time for such symptoms to wane — the tumor can die, but the body has to heal.
Patients often have scans to determine if tumors are shrinking, but it can take weeks or months before a tumor looks smaller on a scan, in part because a scan shows not just the cancer but also connective tissue, immune system cells and scars at the site. Doctors can be fooled into thinking a tumor is present when, in fact, it is gone.
“When you are treating a patient — and we see this many times — your treatment is quite effective but there is some residual lesion on a scan,” Dr. Hyman said. “You take the patient to surgery for a biopsy, and all you see is scar tissue. There is no visible cancer there.”
The blood tests also allow frequent monitoring of tumors as they spread and mutate or develop resistance to treatment. The only other way to know is with biopsies.
“I cannot do a weekly liver biopsy and see how things are going,” Dr. Baselga said. “But I can do a blood test every week.”
Another possible application — early diagnosis of cancer — is trickier. If a blood test showed cancer DNA, what would that mean? Where is the tumor, and would it help to find and treat it early? Some cancers stop growing or go away on their own. With others, the outcome is just as good if the cancer is found later.
One early use for DNA blood tests may be helping doctors decide which patients with Stage 2 colon cancer need chemotherapy. Eighty percent of patients with these large tumors that have not spread outside the colon are cured by surgery alone; the rest have recurrences. Six months of intense chemotherapy reduces the risk the cancer will return, but there is no way to predict who needs the treatment.
Two Australian scientists, working with Dr. Bert Vogelstein of Johns Hopkins, wondered if a cancer DNA blood test might be predictive. They began with a study of 250 patients, looking for cancer DNA in blood after surgery. The tumors recurred in 80 percent of those with cancer DNA in their blood but only 6 to 8 percent of those whose blood did not have detectable cancer DNA.
Now the Australian researchers, Dr. Jeanne Tie and Dr. Peter Gibbs of the Walter and Eliza Hall Institute of Medical Research, are starting a study of 450 patients randomly assigned to have the blood test or not. Those who have it will get chemotherapy if the test finds cancer DNA. Those who do not have the blood test will get usual care, whatever their physician prescribes.
The patients will be told their blood test results, although the investigators worry how some will react.
“If you find DNA and tell the patient there is a very high risk of recurrence, that creates a lot of anxiety,” Dr. Gibbs said. “And we are not sure chemotherapy will be helpful.”
The blood test, they hope, will answer that question.
“This will be the first real test of whether circulating tumor DNA can be clinically useful,” Dr. Vogelstein said.
Call it Whatever you want but
A daily range of 42% (down 12% to 10.15 and up 30% to 14.90) is quite a wide range and I would think the term WILD RIDE fits just fine.
Enjoy (but hold on... LOL) dp
Quite the Wild Ride today
Last Price Today’s Change Bid (Size) Ask (Size) Day’s Range Volume
11.42 -0.080 (-0.70%) 12.56 x100 12.75 x200 10.15 - 14.90 62,000
First Hour Volume & Price Very Strong
Despite the wide spread , sometimes close to 10%, AEMDD has come out of the gate very stong. 50k new shares = 2.5 million old AEMD shares in first hour on an uptrend says ALL GOOD!
Best to all Longs dp
Last Price Today’s Change Bid (Size) Ask (Size) Day’s Range Volume
12.94 +1.44 (+12.52%) 12.00 x200 12.80 x200 10.15 - 12.95 51,546
CTE in Athletes following Repetitive Head Injury
Chronic Traumatic Encephalopathy in Athletes: Progressive Tauopathy following Repetitive Head Injury
Very thorough, concise and lengthy yet quite readable manuscript on the subject from 2010. In the authors credits among many others is Dr Robert Stern from BU who presented Exosome Sciences DETECT Study preliminary results yesterday.
Having personally spent close to a decade doing research in other neurological disorders focusing mostly on multiple sclerosis and Alzheimer's disease (and other dementia's) has paved much of the way for me to better understand this very related but causatively, totally different ailment. That said, after hearing the short presentation summary they put out today, combined with the research I've already done regarding CTE, I really think that they are well onto something very remarkable and possibly also very big and important here with the DETECT Study.
Hopefully, that hypothesis will also enthrall others, be understood as a great asset to Aethlon Medical and will be reflected in the share price sooner than later. Again, IMHO, I think today's CTE News was a fantastic starting point for both Exosome Sciences, Aethlon Medical and also for the patients that suffer from this very serious and oft times avoidable injury / ailment.
Best to ALL Longs. Enjoy dp
(and Happy reading if you do so choose)
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2945234/
Overview of IVD Regulation
Since it seems like the Exosome Sciences Diagnostic Tools are moving ahead below is an overview of In Vitro Device Regulations for those that are interested in the particulars of the process.
Great News Today on the CTE tau detection proof of concept. The story here just keeps getting scientifically better. Let's hope that the financials can keep up...
Best to ALL Longs. Enjoy dp
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm123682.htm
Overview of IVD Regulation
This section provides an overview of how FDA regulates IVDs. It does not operate to bind FDA or the Public. Manufacturers can find detailed information about complying with the Food, Drug and Cosmetic Act from the Device Advice: Device Regulation and Guidance section. For more information, see IVD Guidance Documents.
What is an in vitro diagnostic product (IVD)?
How are IVDs classified?
What is a General Purpose Reagent?
What are Analyte Specific Reagents?
What are General Controls?
What are the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88)?
What is the "Pre-Submission" Process for IVDs?
What is an Investigational Device Exemption (IDE)?
What is a Premarket Notification [510(k)]?
What is the 510(k) Paradigm?
What is De Novo Classification for IVD devices?
What is a Premarket Approval (PMA)?
How does FDA regulate OIVD classified devices in clinical laboratory automation?
What are the requirements for IVD labeling?
How does FDA look at Quality Control?
What is Establishment Registration?
What is Medical Device Listing?
What are Good Manufacturing Practices (GMPs) and Quality System Regulations (QSRs)?
What is Medical Device Reporting?
What happens to products that are in violation of laws administered by FDA?
How does OIVD ensure compliance with the Federal Food, Drug, and Cosmetic Act?
What is the Medical Device User Fee and Modernization Act of 2002 (MDUFMA)?
5th Annual Traumatic Brain Injury Conference
Hopefully there will be a presentation transcript and view of the related poster session available sometime.
Enjoy dp
Link to today's TBI Conference Agenda: http://tbiconference.com/home/index.php/agenda
11:00 am Detecting Tau: State of the Art Potential Biomarkers for Chronic Traumatic Encephalopathy
Chronic traumatic encephalopathy (CTE) is a neurodegenerative disease associated with a history of repetitive brain trauma. At this time, the diagnosis of CTE can only be made through neuropathological examination. However, in order to investigate critical issues pertaining to CTE, such as its incidence and prevalence and specific risk factors, as well as to conduct clinical trials for the prevention and treatment of the disease, it is necessary to develop accurate methods of in vivo diagnosis. A hallmark feature of the neuropathology of CTE is the deposition of hyperphosphorylated tau (p-tau) as neurofibrillary tangles (NFT) beginning perivascularly and at the depths of the cortical sulci. This talk will present data from the DETECT study of former professional American football players, focusing on preliminary findings of two potential biomarkers for p-tau in CTE: (1) a blood-based measure of brain-derived exosomal tau (Exosome Sciences) and the T807 (AV1451) PET tau radiotracer (Avid Radiopharmaceutical).
Charts as of close:
Both are looking very strong.
Daily:
http://stockcharts.com/h-sc/ui?s=AEMDD&p=D&b=5&g=0&id=p11335627573
Weekly:
http://stockcharts.com/h-sc/ui?s=AEMDD&p=W&b=5&g=0&id=p64046468349
Positive and encouraging Exosome CTE results tomorrow sure would Help continue the trend.
Best to ALL longs.
Enjoy dp
Unfortunately, you can't take "if's and thinks" so
easily to the Bank, but it's always good to imagine that you could.
Best to ALL Longs & Enjoy! dp
Flew through the 1 dollar barrier like
a hot knife through butter! Off we GO!!
Last Price Today’s Change Day’s Range Volume
1.05 +0.2452 (+30.47%) 0.82 - 1.13 1,680,970
Enjoy dp
Still in conversion process on etrade also eom
E-Trade showing Bid 10.25 Ask 10.40 Now
Looking stronger than earlier for open, whenever it comes.
Best to ALL Longs.
dp
Tausome
https://trademarks.justia.com/865/16/tausome-86516168.html
TAUSOME - Trademark Details
Status: 630 - New Application - Record Initialized Not Assigned To Examiner
Image for trademark with serial number 86516168
Serial Number
86516168
Word Mark
TAUSOME
Status
630 - New Application - Record Initialized Not Assigned To Examiner
Status Date
2015-02-06
Filing Date
2015-01-27
Mark Drawing
4000 - Standard character mark Typeset
Attorney Name
Robert J. Hilton
Statements
Goods and Services
Medical devices for extracorporeal therapeutics and diagnostics
Classification Information
International Class
010 - Surgical, medical, dental and veterinary apparatus and instruments, artificial limbs, eyes and teeth; orthopedic articles; suture materials. - Surgical, medical, dental and veterinary apparatus and instruments, artificial limbs, eyes and teeth; orthopedic articles; suture materials.
US Class Codes
026, 039, 044
Class Status Code
6 - Active
Class Status Date
2015-02-06
Primary Code
010
Current Trademark Owners
Party Name
Exosome Sciences, Inc.
Party Type
10 - Original Applicant
Legal Entity Type
03 - Corporation
Address
8910 University Center Lane, Suite 660
San Diego
CA
92122
Correspondences
Name
ROBERT J. HILTON
Address
KNOBBE, MARTENS, OLSON & BEAR, LLP
2040 MAIN ST FL 14
IRVINE, CA 92614-8214
Trademark Events
Event Date
Event Description
2015-01-30 NEW APPLICATION ENTERED IN TRAM
2015-02-06 NEW APPLICATION OFFICE SUPPLIED DATA ENTERED IN TRAM
I saw r/s scheduled for tomorrow
http://otce.finra.org/DailyList
and assumed AEMDD was the up listing symbol to NASDAQ that would come with it.
Sorry if that is not the case and if we might possibly have to wait further to be qualified. 1st r/s involved for me so IDK ?? the specific particulars of the process as it applies here.
Best to ALL longs either way, dp
Looks like Up listing to NASDAQ tomorrow
Best to ALL Longs.
Enjoy dp
http://otce.finra.org/DailyList
Summary
Date Event Type Eff/Ex Date Symbol Issue Name Market
04/13/2015 14:27:25 Reverse Split/Cusip Change 04/14/2015 00:00:00 AEMD Aethlon Medical Inc. Common Stock Other OTC
Details
Previous Value Current Value
Symbol AEMD AEMDD
Issue Name Aethlon Medical Inc. Common Stock Aethlon Medical Inc. Common Stock
Class
Maturity Date
Market Category Other OTC Other OTC
Unit of Trade 100 100
Regulatory Transaction Fee Yes Yes
Financial Status Indicator
Current Value
Daily List Date 04/13/2015 14:27:25
Event Type Reverse Split/Cusip Change
Effective/Execution (Eff/Ex) Date 04/14/2015 00:00:00
Subject to Corporate Action CD
Offering Type No Restrictions
Daily List Comment
Forward Split Ratio
Reverse Split Ratio 1:50
Dividend Type Reverse Split
Percentage 0
Cash Amount 0
Declaration Date
Record Date
Running again and looking strong!
0.811 +0.1412 (+21.07%) 0.685 - 0.83 653,372
Thanks for bringing up important details Murph
Will have to dig further in also but appreciate your summary.
Looks like the stars might just be lining up for us...
Best to all Longs this week. May it be a Good one.
Enjoy dp
SPHS Maybe Not A Left-For-Dead Biotech
Long and detailed article from Seeking Alpha on SPHS and PRX302 at the link below.
Enjoy dp
http://seekingalpha.com/article/3058166-sophiris-bio-maybe-not-a-left-for-dead-biotech
Aethlon Medical (OTCQB:AEMD) SEC Filing Alert 8-K
New SEC 8-K confirming this mornings HUD submission to FDA for Hemopurifier to treat Ebola virus.
Enjoy dp
http://app.quotemedia.com/data/downloadFiling?webmasterId=101533&ref=10201479&type=HTML&symbol=AEMD&companyName=Aethlon+Medical+Inc&formType=8-K&dateFiled=2015-04-09&cik=0000882291
ITEM 8.01 OTHER EVENTS.
On April 9, 2015, Aethlon Medical, Inc. (“we”) issued a press release announcing that we had submitted a Humanitarian Use Device (“HUD”) submission to the U.S. Food and Drug Administration (“FDA”) to support market clearance of the Aethlon Hemopurifier® as a treatment for Ebola virus. If the HUD application is designated by the FDA, we then may submit a Humanitarian Device Exemption marketing application to the Center for Devices and Radiological Health for marketing review. We cannot assure you that we will receive approval to market the Hemopurifier as a treatment for Ebola virus. A copy of the press release is filed as Exhibit 99.1 hereto.
CREW requests SEC investigate Adam Feuerstein
Several Companies have been the victim of Adam F. Although he retains his Biotech Blog on thestreet.com his credibility has long been questioned and his credentials to analyze Biotech are actually none other than that is what he does. He has had no formal medical education or training whatsoever.
Google him and view some the the hits and click on the link below for more information.
Enjoy dp
http://www.citizensforethics.org/legal-filings/entry/crew-sec-investigation-manipulation-drug-company-biotech-stock-feuerstein
July 29, 2014
SECWashington, D.C. — Citizens for Responsibility and Ethics in Washington (CREW) today requested the Securities and Exchange Commission (SEC) investigate possible illegal manipulation of stock prices in Northwest Biotherapeutics, a biotechnology company developing cancer treatment drugs. Strategically released blog posts by well-known biotech stock analyst and senior columnist for TheStreet.com Adam Feuerstein seem designed to cause the price of the company’s stock to fall at times when short sellers were financially overexposed. CREW has asked the SEC and the U.S. Attorney for the Southern District of New York to conduct a full investigation of the timing of Mr. Feuerstein’s posts and their relationship to short seller financial interests.
Read CREW's letter to the SEC and supporting exhibits.
“When several drug companies repeatedly see big stock price dips due to a negative articles published at critical moments — especially when those dips benefit the financial interests of short sellers — it should raise serious questions at the SEC. Given the suspicious timing of Mr. Feuerstein’s articles, which include misinformation and innuendo, there should be an inquiry into whether there was a deliberate effort to manipulate the market for profit,” CREW Executive Director Melanie Sloan said.
CREW’s request for an investigation highlights several examples where Mr. Feuerstein’s blog posts and Twitter communications appear intended to send the stock prices plummeting of three pharmaceutical companies — Northest Biotherapeutics, GTx, and Mannkind — at a time when short shares were at a peak.
On June 18, 2014, Northwest Biotherapeutics’ stock was trading at $8.97, a near record high for the stock. Prior reporting from SmithonStocks.com noted the “intense shorting program” aimed at the company’s stock and that the rising stock prices set the stage for a “major short squeeze.” The following morning, before trading began, Mr. Feuerstein posted a series of tweets hinting the company had received bad news related to testing of its promising cancer drug. He then posted a blog item criticizing the company for releasing interim testing data, and quoting a doctor not involved with the study who suggested the company’s release of data was both highly unusual and inappropriate. As a result, by the close of trading on June 19, the stock lost 20 percent of its value and has continued to slide.
CREW’s letter to the SEC also notes similar suspicious timing related to Mr. Feuerstein’s reporting on drug companies GTx and Mannkind. As GTx’s stock reached near-record levels in July 2013, Mr. Feuerstein published an article predicting the failure of a critical drug trial, citing an unnamed short seller as a source. Mr. Feuerstein refused to correct the multiple errors in his article despite a point-by-point refutation by a GTx investor posted on seekingalpha.com. Similarly, in March 2014, Mr. Feuerstein published an article predicting a 60-percent chance the Food and Drug Administration (FDA) would reject the company’s new drug, Afrezza. By the end of the day, Mannkind’s shares were trading at a 10-month low. Contrary to Mr. Feurstein’s prognostication, on April 1, an FDA advisory committee granted marketing approval for Afreeza by a vote of 13 to 1.
“Where there is smoke, there’s often fire. Maybe it’s just a coincidence that Mr. Feuerstein’s unduly negative articles appear at critical moments for these companies, but it certainly merits an investigation,” Ms. Sloan said.
Read CREW's letter to the SEC and supporting exhibits.
Wouldn't releasing Hemopurifier shipment details to a Hospital
that recently got an ebola patient in for treatment which was previously publicized, as is the case with the NIH Bethesda patient, be violating the patient / Doctor / Hospital confidentiality agreement? I would think that it would and couldn't be released legally until after the fact along with the other details of treatment, patient identity etc.
Enjoy dp
Well it's ? or get off the pot time
Either it works for our benefit or not.
Place your bets and let it roll...
Best to All Loyal Longs.
Enjoy dp
If timing is everything...
I would think that this RS is timed to get the most out of the upcoming CTE News and Whatever? else is going to come out soon.
I, for one, Have no problem with it in anticipation that the GOOD NEWS that is expected to propel the share price through this turmoil will indeed be exactly What is needed to move onto the next, and very desirable, NASDAQ listing level.
Best to all Longs and... Ahead and Upward for AEMD!
Enjoy dp
All Lives Matter So, Why different Ebola Care?
In response to those here that said How miserably AEMD failed by not having the Hemopurifier utilized over in Africa.
Not only does the story below give the answer, the photographs also paint a picture of explanation. Just click on this google link and view Images of African Ebola Hospitals (below) to see the technological differences in care facilities and the difficulties I'm sure that reality presented everyone.
https://www.google.com/search?q=Pictures+of+African+Ebola+Hospitals&tbm=isch&tbo=u&source=univ&sa=X&ei=8t4jVe6qHIWqsAX-qIBA&ved=0CB4QsAQ&biw=1384&bih=766
Enjoy dp
(click on links provided for pictures and additional articles, information)
http://www.slate.com/articles/health_and_science/medical_examiner/2015/04/ebola_treatment_in_sierra_leone_and_united_states_who_decides_where_doctors.html
All Lives Matter - Why do Sierra Leonean and American clinicians with Ebola get different care?
By Karin Huster
I was there.
I was there when our clinician collapsed at the Port Loko Government Hospital in Sierra Leone a few weeks ago. And I was nearby when we were informed soon after that a Sierra Leonean colleague was suspected of having Ebola. As head of the medical team in Port Loko for Partners in Health, a global health nonprofit, I worked alongside these two clinicians.
When our American colleague fell ill, he was initially transferred to Kerry Town, a first-class Ebola treatment center run by the British Defense Ministry, and from there flown to the National Institutes of Health clinical center in Bethesda, Maryland. When our Sierra Leonean colleague, an employee of the Ministry of Health, fell ill, we helped secure his admission to the same British-run treatment facility—the best option available to Sierra Leonean health care workers.
In these differences in options for care, the stories of these two colleagues abruptly split, with one receiving arguably the best Ebola care in the world and the other receiving the best Ebola care available in one of the poorest countries in the world.
A recent article called into question Partners in Health’s commitment to fighting Ebola shoulder to shoulder with our Sierra Leonean colleagues from the Ministry of Health. I have been deeply involved in the day-to-day activities of the organization in Sierra Leone and know this can’t be further from the truth. All of us at Partners in Health worked hard to ensure both men had prompt access to the best care available. We understood the potentially fatal complications of Ebola all too well.
Should we have sent the 800 infected West African health care workers to the United States for care?
I joined Partners in Health in November to be a part of its Sierra Leone Ebola response team, when the Ebola epidemic was raging and the international community was terrorized. Partners in Health, whose mission is to provide world-class health care for the poor, was the only nongovernmental organization working in the ravaged Port Loko district, fighting the disease alongside our Sierra Leonean counterparts from the Ministry of Health at the Maforki Ebola treatment center.
Despite incredibly difficult conditions, despite risking our lives day in and day out, there was an unwavering commitment from everyone in the organization to do our best to care for the sick. And when Partners in Health co-founder Paul Farmer visited us on Thanksgiving and told us we could save more lives with more aggressive care, we pushed harder to do so. It was absolutely clear to everyone that Sierra Leonean lives mattered as much as ours.
Ebola Treatment Unit, Port Loko, Sierra Leone.
Partners in Health recruit Dr. Dana Clutter tends to a patient in the triage area of the Maforki Ebola treatment center on Jan. 15, 2015.
Photo by Rebecca E. Rollins/Partners In Health
Despite that commitment, not everyone’s life-threatening illness receives the same care. More than 800 health care workers across West Africa who contracted Ebola were unable to receive the same level of care our American colleague is receiving. It simply wasn’t, and isn’t, available. Horrifyingly, some 500 of them died.
They died not because we at Partners in Health didn’t care. Or because we cared less about our Sierra Leonean colleague than our American colleague. Rather, they died because Ebola afflicts and kills a disproportionate number of people in poor countries. Spare-no-expense medical care, available in the West, would certainly enable the vast majority to survive.
So who is to blame for this iniquity? What can we do differently? Should we have sent the 800 infected West African health care workers to the United States for care? What about all 25,000 Ebola patients?
These are profoundly tough and troubling questions. Ebola demands soul-searching discussions—on access to treatment, on standards of care, on how much one person’s life is worth compared with another’s.
Let’s get that discussion started.
I don’t have readymade answers. But Partners in Health is committed to improving the health of all Sierra Leoneans. I am in the field working on that very mission every day, helping the Ministry of Health create permanent, premier health facilities in Sierra Leone over the next decade.
Thankfully, today both of our colleagues are improving. Our Sierra Leonean friend was discharged a week ago from the Kerry Town facility, and our American clinician was upgraded to “fair” a few days ago. We are doing our best to make sure everyone with this horrible disease has a chance to recover.
Read more of Slate’s Ebola coverage.
Karin Huster is a registered nurse with a master’s in public health. She has worked on humanitarian emergencies in Liberia and Sierra Leone, Gaza, and with Syrian refugees in Leban
I greatly appreciate you valid and informative posts
You bring up Good points and Good information much of it unknown to me and I would imagine, to most here. No sense not saying it and us not hearing it when it can have impact on How the hemopurifier and How the Company might do ahead in the future.
If you want to see "worthless negativity" it abounds over on the AEMD IV board. They can sometimes just repeat complaints over and over ad nauseam with little or no regard to the repetitiveness and destructive nature of their comments without providing any real educational benefits after the first time if there originally was any.
I like it better over here. Actually seems to be more real and valuable AEMD information than personal opinions and unsubstantiated takes on information that is oft times not actually valid.
Best to you and all. Ten days and counting down to CTE Study info...
Enjoy dp
just to clarify bkbbk5
What was erroneous and false in your post (that was directed as a reply to me) was that because I posted a chart with TA comments it bundled me under your the blanket statement "Every time it's ... a trader trying to drive sp for a trade." That could very well be your opinion but since it doesn't apply to me, it was false and I wanted that reality to be known. Anytime you say every time there will usually always be exceptions. This was one of them.
No problem either way, just wanted to set the record straight.
Enjoy dp
Thanks for your well thought out yet erroneous reply Bill.
>>Every time I have seen a poster put up a TA chart with either very positive or negative analysis on a penny like AEMD it tells me it's a trader trying to drive sp for a trade.<<
This statement in response to me and my posted chart and TA interpretation thereof is false and totally wrong. I am not a trader, I'm an investor so as such I'm not trying to drive the share price anywhere for a trade. I'm sharing information as I see it exactly as you share information exactly as you see it. Our commonality is that they are both opinions of ours from different viewpoints on the same subject which is Aethlon Medical.
>>I would caution less experienced investors not to use this type of technical analysis in their investing decisions with AEMD.<<
As helpful as that statement is intended to be, I would at the same time urge investors not to use only fundamental analysis to evaluate their investment choices no matter What size the market cap is. Whether it's a penny stock, a Berkshire Hathaway or anything in between.
To do so is limiting your vision like closing one eye or putting blinders on. When driving down the road one looks forward through the windshield, sideways through the windows and to the rear using the rear view mirror keeping a lookout in all directions. I also like to look at the weather forecast, refer to a map, check the oil and tires and have clean windows among other inputs to see what is expected weather, terrain and car wise in order to better equip myself for a safe passage. By taking all these "driving" related variables into consideration and evaluation, I am probably more assured of having a Good, Safe Journey than the driver that ignores all these additional inputs and just jumps in the car, points it in the desired direction and looks ahead toward the destination. To eliminate valuable input of any kind on an issue is IMHO a very limiting proposition and a foolish thing to voluntarily do.
And one final thing which is 100% factual no matter how you desire to view it. Interpretations of future events can often be erroneous just as everything else in life is (including fundamental analysis) however, as a historical recording of the share price movement of any particular equity of any size:
- CHARTS DON'T LIE -
Best to you and Thanks for all your valuable fundamental input here. It is really appreciated and I Hope that you feel the same.
Best week to all. Enjoy dp
Would agree with your analysis hopester
It would be great to see it technically primed for News on the 16th for the Exosome CTE presentation. Two weeks away is a lot of chart time, we'll have to wait and see but whatever the chart looks like I'm sure it will react strongly if the News is Good.
And funny: it's currently above the 20, 50 & 200 DMA on my chart but if you change it to the 100 DMA, it's below the .28 that is sitting at. Sure would be a powerful base and great if they were all converging and lined up for crossover by presentation day. Looking Good and Strong regardless...
Enjoy! dp
http://stockcharts.com/h-sc/ui?s=AEMD&p=D&b=5&g=0&id=p46335968480
OK Thanks I was thinking 4th quarter 2015 as
Oct to Dec 2015 and not physical 4th quarter 2015 April through June 2015. I see 52 week trial started Oct 28, 2013, Interim Analysis issued Dec 15, 2014 but still confused as in the the Dec 15, 2014 PR they state:
>>Sophiris plans to initiate a Phase 2 proof of concept study of PRX302 for the treatment of localized low to intermediate risk prostate cancer prior to the end of the first quarter of 2015<<
http://investor.sophiris.com/releasedetail.cfm?ReleaseID=887602
So if they "plan to initiate" meaning forward looking and as you say April begins 4th quarter 2015 it just doesn't make sense because that would seem to indicate they are talking calender quarters as in starting the above >>Study<< between Jan 2015 and April 2015 since 1st physical quarter 2015 was already passed when they issued the PR.
See what I mean? Whatever it is, I'm just glad to see some positive traction again but I am not fully convinced results are expected soon (this quarter) and not more toward the end of this year.
Thanks again for you explanation and time.
dp
Not exactly the initial reaction you'd expect for
finally bringing this Plant on line. Hopefully this Good News can eventually get the share price headed back up again. There's a great gap with very little resistance @ 1.75 if it can get past the 1.50 zone.
Enjoy dp
Thanks Tdash but I see no connection
between that old news and 4th quarter 2015 that's specific to today's movement. Last two times it was street.com mention and previously it just looked like TA triggered a Buy that just took off to the races. Sure shows how fast this can move!
Enjoy dp
So, Why the move? I see no News
What do you see? or anyone?
dp
Upgrade appears to have been made sometime between
close last night and open this morning which would coincide with the release of Thomas Jefferson University / Exosome Sciences Inc. partnership collaboration News. Makes sense to me.
Enjoy dp
SPHS on the move again
Up 28% to .76 on volume 700k shares so far.
Enjoy dp