Interesting... I emailed Aegis about 8 months ago begging them to call Nic. Their specialty is the rs and raise. They did wonders for SGYP. They emailed me back saying they were going to look into it.
THIS is why the bump...
Gingrey to introduce antibiotics bill
By Sam Baker - 06/14/11 04:23 PM ET
Rep. Phil Gingrey (R-Ga.) will introduce a bill Wednesday that aims to combat the rise of drug-resistant diseases.
The bill would give drugmakers new incentives to develop treatments for certain pathogens that have become resistant to existing antibiotics. The “Generating Antibiotic Incentives Now” Act, or GAIN Act, drew bipartisan support last year, and Democrats are expected to sign on again when Gingrey reintroduces the measure Wednesday.
Gingrey’s bill targets a handful of drug-resistant pathogens — including the strain of bacteria known as MRSA, which often spreads through hospitals. The bill would give pharmaceutical companies extra incentives to tackle MRSA and other antibiotic-resistant pathogens, and it would give the agency the power to extend those incentives to other treatments.
Qualifying drugs would get a fast-track review from the Food and Drug Administration. The agency would have to decide whether to approve a new product within six months, compared with the standard 10-month window. Once approved, the drugs also would get an extra five years of protection from generic competition.
Drugs that are developed with a companion tool for diagnosing antibiotic-resistant conditions would get another six months of market protection.
Analysts are focused not on today’s bottom line but the potential sales market for the drug it’s seeking to get approved for sales next year. WBB Securities LLC on Thursday raised its 12-month share price target to $8.50, well above the 52-week high of $5.14 reached shortly after the study results were released.
That’s based on a “conservative” estimate of $500 million in sales in 2013, said Steve Brozak, president of the Clark, N.J.-based firm, which recently bought some stock in Neoprobe for the first time. The study results will allow premium pricing. Also, Lymphoseek distributor Cardinal Health Inc. (NYSE:CAH) of Dublin dominates the radioactive pharmaceuticals market.
Update on Symphony...
Patent issued for the Symphony CGM system in April... xhttp://goo.gl/C09Jo
(remove the x)
Download the pdf file for more details.
more from JMP...
The market opportunity remains substantial. Despite the availability of other CGM systems, penetration into the Type 1 market is limited to 3-5%. Moreover, the hospital inpatient market remains devoid of any CGM solutions that balance the accuracy, speed, and cost requirements of that environment. We believe the market opportunity is, at minimum, $1.2B but could easily be 10x that given the increasing call for tighter glycemic controls in the inpatient setting.
• Milestones. We expect FDA approval of the company's Prelude SkinPrep system by the end of 2011, completion of the next pilot trial within second half of 2011, initiation of the company's IDE
trial for the Symphony tCGM system in the first quarter of 2012, completion of the IDE trial by mid 2012, and approval of the Symphony by the end of 2013.
• Management believes that the company may be required to perform a 200 patient study, each
of whom will have blood draws every 15 minutes for 36 hours. We expect this trial to be
completed by mid 2012. As a comparison, Dexcom only studied 91 patients in its pivotal trial.
• In addition, we would not be surprised to see the company need to perform a "repeated use
and replacement" trial. In practical use, the Symphony requires moving the sensor to another
part of the abdomen every day; this at least raises the question as to whether this introduces a
source of variability. Dexcom had to run similar clinical trials in 2005/2006.
• The FDA may require the company to perform separate PMAs for the personal CGM and the
hospital markets given that the needs (and the product design for each market) are different.
In terms of reimbursement, the environment has gotten better but remains far from ideal.
Reimbursement was initially a limiting factor in the growth and adoption of CGM technologies because these were such a novel devices that CMS did not have established coding and billing procedures in place. Dexcom, Medtronic, and Abbott have all worked together with key payors to improve the environment. Patient-focused organizations like the Juvenile Diabetes Research Foundation (JDRF) have also driven support for these products, even going as far to fund clinical trials to drive the reimbursement process. At present, reimbursement exists for Type 1 patients, but hurdles still remain for Type 2 diabetics due to the lack of data in this population. Moreover, CGM products are not approved under a national coverage decision by Medicare. As of 4Q10, the seven largest private thirdparty payors cover CGM, but each company in the space has reimbursement specialists to help patients navigate the process. In general, patient copays for CGM range from 10-20% of the total price. Reimbursement for physicians is well established. CGM training Medicare reimbursement is $128, interpretation of CGM data is $40, and pre-/post CGM evaluation is $92-125.
JL - pretty good road map from the JMP Securities research report...
The FDA has recently classified all continuous glucose monitoring systems into a newly created medical device category called Class IIb. Unlike the 510(k), which was deemed too easy, the Class IIb set of devices require clinical information, manufacturing information, and potentially additional evaluation in the post market setting. The key issue for the agency was how to entice manufacturers to improve meter accuracy while balancing the needs of the patient population.
Under the FDA's current requirements for point of care (POC), readings may register up to 20% when measuring glucose concentrations of >75 mg/dL. For blood glucose values less than this level, the FDA permits deviations up to 15% from standardized concentrations. Unfortunately, this error allowance forPOC meters renders them unable to reliably detect hypoglycemia, a potentially deadly consequence for diabetics. Similarly, the allowance permits some normal levels of glucose values to incorrectly display concentrations suggestive of hypoglycemia, which may result in unnecessary and potentially dangerous insulin treatment of hospitalized patients.
For companies like Echo and Dexcom (which is currently in the midst of developing a next generation CGM), this heightened awareness on the part of the FDA of the need for greater accuracy in all CGM systems raises the bar for approval. In the past, these companies would simply file a 510(k), but, given the regulatory environment, we fully expect Echo to run a PMA for the Symphony. While Dexcom has paved the way with its Gen 4 device discussions with the FDA, we need to be absolutely clear on the point that the FDA has not yet cemented its requirements for an approval of a new CGM system. This is one of the key reasons we assume that the Symphony may not be approved until the end of 2013. That said, we believe that the data published to date and an improving (albeit still amorphous) regulatory environment give us confidence that pursuing a personal use CGM has a high likelihood of ending in an approval.
Management has already established an ongoing dialogue with the FDA about its upcoming
clinical trials and remains optimistic that the tenor of the conversation remains both positive and
collaborative. In our opinion, an approval in the hospital setting is harder to obtain than an approval for personal use, but we also view the risk as worth it. The FDA does view CGM as being potentially beneficial to inpatients, but the same error allowances that may be tolerable in the personal CGM market can lead tomuch more severe consequences when dealing with patients who are in recovery. Moreover, the FDA is concerned that anemia, shock, dehydration, and a host of other things could cause erroneous readings in any point-of-care or CGM system - something that would not normally be an issue outside the hospital. The gold standard clinical chemistry glucose measurement tools in the hospital are stillclinical chemistry machines like the YSI. There are no CGM devices approved for use in the U.S., and Dexcom/Edwards have hosen to pursue the European market before trying to get approval for their devices in the U.S.
A non-invasive system may have a lower hurdle because of the lower risk/reward profile. Unlike
invasive systems, the Symphony carries no risk of infection or cross-contamination, and that may play a role in the company's discussions with the FDA may ultimately help shape the company's PMA strategy. While DexCom's pivotal trial for its first generation can serve as a guideline, we are conservatively assuming that the approval hurdle may likely be higher than the one set in 2005 when DexCom's first product was approved.
Thanks JL... Thie best explanation I've found is from the Scientific American article...
As the Prelude removes skin and hair that could interfere with the biosensor's reading, it passes tiny electric pulses into the skin, says Echo Therapeutics chairman and CEO Patrick Mooney. Based on the response to these pulses, the Prelude can determine when it has reached live underlying skin cells that allow the biosensor to provide a more accurate reading. The patient then applies the disk-shaped biosensor to the patch of skin prepped by the Prelude. The membrane on the biosensor's surface detects glucose as it diffuses out of the body's capillaries. The sensor contains an enzyme that reacts with the glucose and relays the indication as an electric signal. The impulse passes wirelessly to a handheld device, which records the information and monitors the readings. Each sensor can be used for two days before being replaced by a fresh one, and then either used in the same spot or another Prelude-treated location.
Tufts Medical Center in Boston spent several years as a clinical site testing Echo's Symphony tCGM. "We frequently during surgery take blood samples for instantaneous testing" of blood glucose levels, regardless of whether the patient is diabetic, says Michael England, the center's chief of adult cardiac anesthesia. Continuous monitoring is particularly important during surgery because patient insulin levels vary. "Regular insulin we give people during surgery could take 45 minutes to an hour to take effect," he says.
England co-authored (along with three Echo researchers) a July 2008 study in the Journal of Diabetes Science and Technology indicating the accuracy of Symphony's blood glucose measurements was comparable with the more common practice of drawing and testing blood samples. This finding was consistent with the results of a Symphony tCGM study that Echo announced in November. Using about 900 Symphony tCGM glucose readings paired with reference blood glucose measurements (taken using blood samples), Echo claimed its technology was 97 percent accurate.
First... Google this name... Dr. Robert Langer
Dr. Langer holds over 700 issued or pending patents and is head of the Langer Lab at M.I.T. which is the largest bioengineering lab in the world. Dr. Langer has authored over 1100 scientific papers and is considered by many to be the world’s foremost authority on transdermal drug deilvery and tissue engineering.
Dr. Langer’s wiki page... http://en.wikipedia.org/wiki/Robert_S._Langer
Dr. Langer is the Chairman of the Scientific Advisory Board for Echo and the inventor of the Prelude Skin Prep System - Echo has the exclusive license.
some DD to check out...
Interview with Dr. Langer … Dr. Langer discusses Echo Therapeutics Prelude™ SkinPrep device as well as their Symphony™ trandermal continuous glucose monitoring (tCGM) system.
Echo Therapeutics' Needle-Free Symphony Continuous Glucose Monitoring System
Scientific American - Wireless Sensor Promises Diabetics Noninvasive Blood Sugar Readings - Echo Therapeutics is testing a biosensor system that reads glucose levels without breaking the skin.
Uri Landesman of Platinum Partners (Hedge Fund) on Bloomberg Radio on ECTE (also check out his comments on Implant Sciences IMSC)
ECTE.OB PR in DiabetesHealth.com
ECTE.OB wins Federal Research Grant
Uri Landesman on ECTE on Bloomberg Radio ( approx @ 7:20 )
Uri Landesman on CNBC Squawkbox mentioning ECTE.OB (approx @ 2:00)
M.I.T. Langer Lab
Morgan Joseph research report
JMP Securities research report
Lifetech Capital research report
I've been following your posts on iHub and Yahoo and your background and knowledge are impressive. I appreciate your input on AMRN and still hold a semi-large position based partly on your input.
Echo Therapuetics (ECTE) developed a skin permeation platform called Prelude which they licensed to Ferndale Pharmaceutical for the application of lidocaine in cosmetic skin procedures. In their presentation a claim is made that the current procedure is the application of a cream based lidocaine which takes up to an hour before the anesthetic takes effect. Lidocaine applied with the Prelude system becomes effective within 5 minutes. Ferndale is also targeting the pediatric market for vaccines and other injections.
The inventor of the Prelude technology is Dr. Robert Langer of M.I.T. (Langer Lab) who you’re probably familiar with. Dr. Langer is the Chief of the Scientific Advisory Board for Echo.
The cosmetic/pediatric market is estimated @ $1B+ but the real nugget is the diabetic market. Echo’s other product using the same skin prep platform is called Symphony. Symphony is a wireless, non-invasive, continuous glucose monitoring system. Echo claims Symphony is much cheaper to manufacture and much more accurate than current CGM systems.
Echo made a presentation yesterday at the Noble Financial Capital Markets Equity Conference...
Anyway - I thought this is a company right down your alley and am curious what you think.
BTW - I'm Trade2Profit on iHub...
Looks like the market likes the new member of the BOD.
SOUTH SAN FRANCISCO, Calif. --(BUSINESS WIRE)-- Fluidigm Corporation (NASDAQ:FLDM) today announced that Patrick S. Jones has been appointed to Fluidigm's Board of Directors. Mr. Jones fills the vacancy created by the resignation of Jeremy Loh , which was effective on March 10, 2011 . Mr. Jones will also join and chair the Board's audit committee.
"We are excited to add Patrick to our Board," said Sam Colella , Chairman of Fluidigm's Board. "Patrick brings a wealth of experience and practical skills that we believe will add value and perspective to the Board as we seek to help Fluidigm grow and increase its contributions in the life science and Ag-Bio communities."
"I am looking forward to using my international experience and semiconductor background to help Fluidigm's management team achieve its long-term objectives," said Mr. Jones. "Together, we hope to maximize the potential of Fluidigm's integrated fluidic circuit solutions and bring outstanding results to our target markets and to Fluidigm investors," he concluded.
Mr. Jones, age 66, has been a private investor since March 2001 . He currently sits on the boards of several leading public companies including Epocrates , a provider of clinical solutions to healthcare professionals and interactive services to the healthcare industry; Novell, Inc. , a leading enterprise infrastructure software provider; Lattice Semiconductor Corporation , a fabless semiconductor company; and Openwave Systems , a telecom infrastructure software provider. From June 1998 to March 2001 , Mr. Jones was the Senior Vice President and Chief Financial Officer of Gemplus International S.A. (now GEMALTO N.V. ), a provider of solutions empowered by smart cards. Prior to Gemplus, from March 1992 to June 1998 , he was vice president and corporate controller at Intel Corp. , a producer of microchips, computing and communications products. Prior to that, Mr. Jones served as Chief Financial Officer of LSI Logic, a semiconductor company.
Mr. Jones fills a vacancy created by the resignation of Dr. Loh, who is a Vice President (Investments) at San Francisco Centre for EDB Investments Pte Ltd , Singapore .
"We thank Jeremy for his service to Fluidigm during the critical time in which we readied ourselves for an initial public offering. His contributions to the Board helped us achieve the key milestone of becoming a publicly traded company," said Gajus Worthington, president and chief executive officer of Fluidigm .
Article with 4 min video in today's edition of The Guardian...
The science fiction of yesterday happens to be a lot of the medicine of today, says Anthony Atala, MD, the Institute's co-director. It is the imagination that allows us to seek these solutions that someday in the future become a reality.
Some of the more informed comments are from David Miller of Biotech Stock Research. I was tipped off to PYMX from his newsletter.
He posts on iHub regularly...
and you can sign up for his tweets here...
BSR is the best bio-newsletter I've found. It's not cheap @ $695/yr but it's worth it.
Wow - a single injection reduced monthly MACE rate by 84%. Zero deaths in the treated group vs. 13.3% in the control group. This will become the gold standard treatment for heart failure.
>Analyses of time-dependent hard efficacy endpoints showed that a single injection of Revascor™ significantly reduced the number of patients who developed any severe adverse cardiac events over the follow-up period from 93.3% in the control group to 44.4% in the treated patients (p=0.001). Revascor™ also significantly reduced the number of patients who developed any major adverse cardiac events (MACE, defined as the composite of cardiac death, heart attack, or coronary revascularization procedures) from 40% to 6.7% (p=0.005). A single injection of Revascor™ reduced the overall monthly event rate of a MACE by 84% compared with controls (p=0.01), and every dose tested demonstrated a similar protective effect. Death from cardiac causes was reduced from 13.3% to 0% over this period (p=0.059) and the overall monthly rate of cardiac-related hospitalizations was reduced by 48% (p=0.07). <