Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
OT: What happened with Monk anyways?
RPTP - Raptor Pharma Started At Mkt Outperform By JMP Securities
Hah that's funny Rain, I was thinking the exact same thing yesterday!
Haven't been here in a while, but it's great to see BMOD finally moving! Long since December '09.
Biomoda Completes Patient Enrollment and Sample Collection for Pilot Study
Cancer diagnostics company Biomoda, Inc. (OTC BB: BMOD) (www.biomoda.com) today announced that it has completed patient enrollment and sample collection for the pilot study to determine the clinical sensitivity and specificity of its CyPath(R) diagnostic assay for the early detection of lung cancer.
"We are working closely with Dr. Thomas Bauer, Principal Investigator of the CyPath(R) study, and Dr. Richard Holcomb of Quintiles to evaluate and report top-line results by the end of first-quarter 2011," Biomoda Chief Executive Officer Maria Zannes said. "We believe initial results will show that our assay can both identify and quantify lung cell characteristics that differ between groups of individuals at high risk for developing cancer and those who already have the disease."
The pilot study consisted of two cohorts: (1) a high-risk group of military veterans who smoked more than 20 "pack years" and (2) a smaller positive control group made up of patients diagnosed with lung cancer who have not started treatment.
"We are grateful to the lung cancer patients who participated in our pilot study at a difficult time in their lives," Biomoda President John Cousins said. "Thanks to their selflessness and the efforts of our partners at Christiana Care Health System and Waterbury Pulmonary Associates, we were able to meet our study requirements."
Currently for investigational use only, the CyPath(R) labeling solution binds to cancer cells and causes them to fluoresce under specific frequencies of light. Biomoda is seeking Food and Drug Administration (FDA) approval of its diagnostic technology as a Class III medical device.
About Biomoda
Biomoda (www.biomoda.com) is a cancer diagnostics company focused on the development of accurate, inexpensive and noninvasive tests for the early detection of cancer. In addition to its first product for lung cancer, diagnostic assays for cervical, breast, colorectal, bladder, and oral cancers are targeted for development.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on estimates, projections, beliefs and assumptions of Biomoda management at the time of such statements and are not guarantees of future performance. Forward-looking statements involve risks and uncertainties in predicting future results. Actual results could differ materially from those projected in these forward-looking statements due to a variety of factors, which are described from time to time in the Company's filings with the Securities and Exchange Commission, including those under the heading "Risk Factors" in the Company's Annual Report on Form 10-K filed with the SEC on March 30, 2010. Forward-looking statements are made as of the date of this press release and are subject to change without notice.
SOURCE: Biomoda, Inc.
Biomoda, Inc. Julie Anne Overton, 505-577-0918
FDA launches Medical Device Innovation Initiative
For Immediate Release: Feb. 8, 2011
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA launches Medical Device Innovation Initiative
DARPA-funded prosthetic is first test case
Today the U.S. Food and Drug Administration proposed the Innovation Pathway, a priority review program for new, breakthrough medical devices and announced the first submission: a brain-controlled, upper-extremity prosthetic that will serve as a pilot for the program. The FDA also announced plans to seek further public comment before the Pathway can be used more broadly.
The new proposed Innovation Pathway program for pioneering medical devices, highlighted in a report published on the FDA’s website today, is part of a broader effort underway in the FDA’s Center for Devices and Radiological Health (CDRH) designed to encourage cutting-edge technologies among medical device manufacturers.
The initiative will also seek to strengthen the nation’s research infrastructure for developing breakthrough technologies and advancing quality regulatory science. Proposed actions include:
• establishing a voluntary, third-party certification program for U.S. medical device test centers designed to promote rapid improvements to new technologies during a product’s development and clinical testing stages;
• creating a publicly-available core curriculum for medical device development and testing to train the next generation of innovators; and
• using more device experience and data collected outside the United States.
In addition, CDRH intends to engage in formal horizon scanning – monitoring medical literature and scientific funding in a systematic way to predict where technology is heading. CDRH will include public input in this process to prepare for and respond to transformative innovative technologies and scientific breakthroughs.
“Each year, millions of American patients benefit from innovative medical devices that reduce suffering and treat previously untreatable conditions,” said CDRH Director Jeffrey Shuren, M.D., J.D. “CDRH’s Innovation Initiative will help accelerate the development of and patient access to innovative medical devices, which often fulfill unmet public health needs.”
The FDA has accepted its first submission from the Defense Advanced Research Projects Agency (DARPA) to review a brain-controlled, upper-extremity prosthetic designed to restore near-natural arm, hand and finger function to patients suffering from spinal cord injury, stroke or amputation. The arm system uses a microchip implanted on the surface of the brain to record neuronal activity and decode the signals to actuate motor neurons that control the prosthesis. DARPA and the FDA have signed a Memorandum of Understanding addressing both the development and review of this project.
The proposed Innovation Pathway program includes the following features:
• products would have to be truly pioneering technologies with the potential of revolutionizing patient care or health care delivery;
• selected products would receive an Innovation Pathway memorandum from CDRH containing a proposed roadmap and timeline for device development, clinical assessment and regulatory review; and
• products would be assigned a case manager, their important scientific issues would be identified and addressed earlier in the development process, and they might be able to qualify for flexible clinical trial protocols.
Applications would be reviewed by the Center Science Council, a new oversight body currently being developed within CDRH comprised of senior managers and experienced scientists, who would facilitate this device development and evaluation process. Enrollment in the Innovation Pathway program would not change the scientific or regulatory standards that CDRH would use to evaluate device submissions and determine their appropriateness for marketing.
Because of the transformative nature of the devices that would be eligible for this pathway, CDRH expects them to generally be approval pathways intended for either high risk or novel products.
The FDA could conduct premarket reviews of products in the Innovation Pathway within 150 days, nearly half the time it currently takes the FDA to review most premarket approval applications.
CDRH has set up a public docket to solicit public comment on the Innovation Initiative and will host a public meeting on the topic on March 15, 2011 at the Center’s White Oak campus.
For more information:
* CDRH Medical Device Innovation Initiative at http://www.fda.gov/deviceinnovation
http://www.pharmpro.com/News/Feeds/2011/02/agencies-and-organizations-fda-fda-launches-medical-device-innovation-initiative/
NEOP APPROVED FOR LISTING ON AMEX
http://www.businesswire.com/news/home/20110207006768/en/Neoprobe-Common-Stock-Approved-Listing-NYSE-Amex
RPTP breaking out.
RPTP (3.84) - Wedbush initiates coverage on Raptor Pharmaceuticals (NASDAQ: RPTP) with a Outperform rating and $7 price target
http://www.streetinsider.com/New+Coverage/Wedbush+Starts+Raptor+Pharmaceuticals+(RPTP)+at+Outperform/6203059.html
RPTP (3.53) – Raptor Pharmaceuticals Phase 3 Results Expected
Under the radar biotech develops improved treatments for rare disorders.
30.2M O/S
Enrollment in Pivotal Phase 3 Clinical Trial in Cystinosis on Schedule for Completion in Q4 2010 with Results Expected Q1 2011
http://globenewswire.com/newsroom/news.html?d=199969
“In November 2009, Raptor completed its Phase 2b clinical trial of DR Cysteamine in cystinosis. DR Cysteamine demonstrated improved tolerability and the potential to reduce total daily dosage and administration frequency compared to immediate-release cysteamine bitartrate. Immediate-release cysteamine bitartrate is the only drug therapy approved for marketing by the U.S. Food and Drug Administration ("FDA") and European Medicines Agency ("EMA") for this indication. Despite being a standard of care, gastrointestinal side effects and a strict around-the-clock, every 6 hour dosing schedule for immediate-release cysteamine bitartrate create tolerability and compliance issues for cystinosis patients that DR Cysteamine is designed to address.”
Phase 2b results:
http://www.tradingmarkets.com/news/press-release/rptp_raptor-pharmaceutical-corp-announces-publication-of-results-from-phase-2a-trial-of-dr-cysteamine-fo-693428.html
“DR Cysteamine demonstrated improved tolerability and the potential to reduce total daily dosage and administration frequency compared to IR Cysteamine.
Pharmacokinetic evaluation showed that DR Cysteamine had a terminal half-life more than three times longer than the terminal half-life of IR Cysteamine.
Twice-daily DR Cysteamine may achieve the same pharmacodynamic result while using a total daily dose 30% lower than IR Cysteamine administered four times daily.
No adverse events recorded during the clinical trial were determined by the principal investigator to be possibly or probably related to DR Cysteamine. Nine adverse events recorded in the clinical trial were determined to be possibly or probably related to IR Cysteamine.”
Financials:
As of August 24, 2010, the Company has approximately $17.2 million in cash and cash equivalents taking into account approximately $14 million of proceeds, net of placement agent fees and expenses, the Company received in a private placement financing which closed on August 12, 2010. The Company anticipates that its cash and cash equivalents will support planned operations and its planned clinical development programs, into December 2011.
Pipeline:
Two research analysts have price targets of $5 and $6.
Any thoughts? Thanks.
That has been up there for a while. It is nothing new.
CONGRATS EVERYBODY!!!!
Gekkowire leaving key data out once again, just as he did with ALXA last week.
http://www.gekkowire.com/?p=5125
"In the past the company has touted that the CyPath assembly has 100% sensitivity, but that appears to be in question today after the company’s CEO announced that, “We have had to exclude samples from a significant number of participants in the positive control group from our analysis.” This opens the door to questions from investors as to how or why the company is having trouble in the positive control group. For example, is the device not working as specified? Is the device still 100% accurate? What are the problems with the control group?"
Yes Mr. Gekkowire, they excluded samples because:
"It has been difficult to recruit diagnosed pre-treatment patients who are able and willing to give their truly precious time to our study. We thought we had secured sufficient samples, but further investigation showed that some of these lung cancer patients do not fit the FDA-approved criteria for inclusion in the positive control group. Some of the patients' cancer is located outside the lung cavity. Under the protocol submitted to the FDA, these patients must be excluded from the study,"
I agree with you Rainmaker. Sure does seem like it is one or two people under many different names. Go BMOD!
I think they post them after the company is done presenting.
I was wondering the same. I can't find one. They have a lot of the other companies listed, but not us.
Interview with John Cousins from BioMedReports
Pending completion and publication of pilot study has CEO feeling bullish about Biomoda
Written by Patrick Crutcher
Monday, 13 September 2010 20:45
Last week, we alerted our subscribers about Biomoda's (OTC:BMOD)'s pending top-line results for their Phase 2 trials and we outlined their value proposition. As readers of BioMedReports know, BMOD has been on many investors radar for their innovative diagnostic test in lung-cancer which is performed in clinical reference laboratories using body-fluids. We continue to be bullish on BMOD as we anticipate positive results from the study.
While our bullishness has been based on past statements and actions from the company, we reached out to the President, CEO and Director of Biomoda, Inc., John Cousins in order to have him answer questions which were on the minds of investors. The following is a transcript of that exclusive interview:
BiomedReports: It has been a while since we first spoke to you. From a science and technology perspective, are there any developments to report?
Cousins: We have made significant progress since we last spoke. Perhaps the most important news for investors and cancer research overall is that we are completing our pilot study of Biomoda’s diagnostic assay for the early detection of lung cancer. Our pilot study, which is similar to the Phase II clinical studies required for new drugs, is the basis for moving forward with a pivotal study -- the third and final phase of clinical study that leads to Food and Drug Administration (FDA) approval and commercialization. We are seeking FDA approval of our CyPath® assay as a Class III medical device. The requirements are quite rigorous. The results of our pilot study have not been announced, but we have stated our belief that the results will be statistically significant enough to move into a pivotal study. We are beginning work on the pivotal clinical study, including responding to questions from the FDA about the pilot study protocol and design, hiring a Clinical Research Organization (CRO) and establishing key collaborations that we will be announcing soon. We will continue research and development to optimize our assay, incorporating improvements such as automation that will lead to larger scale use at lower cost.
The pilot study analyzes samples from about 170 individuals including military veterans at high risk for cancer and individuals who have been diagnosed with cancer but had not yet begun treatment. I know you and others are very interested in knowing the ‘top-line’ results and summary data, and of course we will share those results when they are ready for release. Right now most important for us at Biomoda, and for our experts working on all phases of the clinical study, is the assurance that we have thoroughly analyzed the data and developed the most accurate assay possible. We want to provide an accurate picture of our assay and its performance. A rush to announce results might lead to increased funding opportunities in the immediate future and a short-term pop in the stock, but it can also lead to problems later on, when end points for the pivotal study are not met because the study data from the pilot study wasn’t sufficiently analyzed or the assay was not fully optimized based on lessons learned from
the pivotal study. We will not make those mistakes.
It’s worth mentioning that the Board of Directors elected Maria Zannes as Chairman of the Board. Maria has been the executive overseeing our pilot clinical trial and will continue to provide oversight throughout the pivotal trial. She’s working closely with Connie Dorian, our Vice President of Operations, in development of the assay and conduct of the clinical trials. They are a great team. Connie is an excellent clinical researcher, very detail oriented, and Maria provides a steady, long-term, focused and strategic vision as we move forward.
BiomedReports: Are Phase 2 results still coming this quarter?
Cousins: Biomoda chose one of the toughest cancers when we decided to develop our assay for the detection of lung cancer. We believe the assay platform will be applicable for many cancers. We are nearing completion of the pilot clinical study data analysis and preparing for publication of the results.
We expect results of the pilot clinical study will be sufficient to launch the pivotal trial. We are designing the pivotal study on the foundation of the pilot study and adherence to the FDA’s rigorous requirements. We have a number of steps to complete before the pivotal can begin, including submission of a Pre-IDE to the FDA, the Agency’s response and, if necessary our follow-up to FDA comments. Our pivotal study will be a multi-state, multi-site study. It’s no surprise to anyone who follows our company that we are looking at Ohio and Nebraska as potential sites, and we intend to investigate sites and funding in Texas. I think researchers in those states are awaiting results of our pilot study.
BiomedReports: How is the development of Phase 3 registration coming along? When do you expect to enroll patients? Any developments on money to fund the trial via Nebraska or Ohio?
Cousins: New Mexico provided an excellent model for funding. Biomoda is headquartered in a progressive state for research. We have two national laboratories that conduct impressive research, and, in fact, Biomoda’s technology began at Los Alamos National Laboratory. Our legislature has been very supportive of our veterans who participated in the pilot study. There are other states, including Ohio and Nebraska that have shown an interest in the potential of our technology and are waiting for results of the pilot study. We have established contacts in both states and will be sharing our information with them. Ohio, in particular, has the Third Frontier Initiative established to fund the type of research and development Biomoda is proposing, so we are hopeful we’ll be working in the Buckeye State as well as Nebraska.
I’ve already discussed a bit of the work to be done as part of the pivotal study. This will be a large study, and patient enrollment will take place after FDA review and approval by an independent Review Board (IRB) of our protocol. We’ll be selecting sites at the same time and setting up participant enrollment and sample collection. We intend to advertise for the study, so those interested in the study will have an opportunity to participate. If individuals are interested in enrolling in the pivotal, they can sign up now on our web site, www.biomoda.com, and we will contact them when we begin to interview potential participants to determine if they meet the criteria for study enrollment.
BiomedReports: When do you expect to file for CE mark?
Cousins: We are securing necessary patents in the European Union to protect our intellectual property and trademarks, and we are studying the European market to determine the best countries to target initially. It is arguably easier and quicker in Europe to commercialize a medical device, but that’s not all there is to success. Understanding the European market means making some strategic decisions on the most efficient path to market, making sure there is a fit within national healthcare systems and/or reimbursement codes for each country, knowing the details of your competition and setting an attractive price point -- all work that will be underway shortly.
BiomedReports: Do you have a manufacturing facility for CyPath®?
Cousins: There are several readily available manufacturers for TCPP, the compound that comprises CyPath®, so we don’t see any obstacle to its manufacture. The amount of TCPP necessary for the assay is small, and a little goes a long way. The issue is not manufacturing, but rather making sure we have the certified laboratories to support sales. Our requirement for CLIA-certified laboratories, trained researchers and qualified technicians leads us not only to New Mexico, but also to Ohio, Nebraska and other states that have strong medical/biotech communities and economic development programs focused on creating high-paying jobs.
BiomedReports: What does the current financial situation look like?
Cousins: Small public companies often walk a fine line between securing financing sufficient for
operations without “giving away the store,” so to speak. We look for opportunities with value investors who understand the medical market and are committed to Biomoda’s success. We expect increased value will provide more opportunities to access the capital markets. And we are very lucky to have shareholders who are committed to the company and understand long-term investment.
BiomedReports: What are your short- and long-term plans moving forward?
Cousins: Completion and publication of the pilot study is the most immediate short-term goal, setting a foundation for our mid-term goal of launching a pivotal study. At the same time, we will be investigating CyPath’s use as a diagnostic for other cancers to develop a portfolio of assays that ultimately will lead to a diversified revenue stream. I mentioned our work in Europe, as well as our expansion into other states that will be coordinated with the work on our pivotal study. I expect that once our pivotal study has begun, there will be increased emphasis on penetrating the medical market, and perhaps identifying suitable strategic partnerships and other opportunities.
BiomedReports: What are your biggest challenges as a company at this point?
Cousins: Interestingly, I would say managing expectations is a big challenge for any small public company. It is particularly more challenging when you are working in the medical field where there is significant promise and more than a bit of uncertainty in conducting clinical trials. For example, we had expected that enrolling patients in the current pilot trial could be accomplished in a much shorter timeframe than it actually took to enroll and close out the study. This led to expectations we could not meet, despite a very well-run study and robust data set.
BiomedReports: You offer an interesting value proposition for investors. Can you talk about that?
Cousins: We currently have a market cap of less than $20 million. Analysts have pointed to comparable companies with a market value well over $100 million. I think we have a terrific company with a strong in-house team and an experienced medical advisory and consulting team along with truly promising technology. We are on a path to prove that our technology can help people live longer, fuller lives, and when we do, the market will respond favorably. As an analyst, you can compare Biomoda to other biotech R&D companies in similar stages of development, and I think the analysis would show Biomoda is undervalued.
BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read at the bottom of / About Us / Section
My prediction was always that the news was going to come out the 3rd week of August. Lifetech said it takes a month to analyze data samples of this size, so figure it took them all of July, then add on two weeks for lost time, and paperwork, validation, PR's, finding a medical journal to post results in, etc. All IMHO.
Ok thanks for the reply Brick.
Hey Brick, are you planning on playing BMOD again? Phase II results are due out before the end of the month.
Here's your mega reload time lol
Hey Quick, you getting back in on BMOD anytime soon?
SHORT VOLUME .. 7/21/2010
Date|Symbol|ShortVolume|TotalVolume|Market
20100721|BMOD|130186|243200|O
I agree Rain
Short Volume 7/20/10
Date|Symbol|ShortVolume|TotalVolume|Market
20100720|BMOD|78248|103048|O
Same goes to me RAIN!
Thanks
That's exactly what he's doing.
BMOD is my largest holding also!
I would assume after, since the share price would be much higher. (knock on wood) Plus, it will be controlled dilution, like the big boys do. They're not going to dilute all at once like some of those scam shell companies do.
http://www.nytimes.com/2010/03/29/health/policy/29fda.html
Theres the CT Scan article if anyone wants to read.
Video: Cousins @ OneMed
http://www.ustream.tv/recorded/7994766
Gosh you guys scared me. I come back and theres 20 new posts, I thought the results were out. I need to buy more shares before then! :p
I agree! I will be holding shares for a long time!
Thanks for all your DD Rainmaker, it's very appreciated!
I will be buying more BMOD when my money frees up!
In that case, make sure you sell all your shares the minute phase II results come out please. Thanks. ;)
Panic much?
Don't forget, they usually put out a 1 on 1 interview with the CEO afterwards sometime. (They did it at the last OneMed Conference). We should see it tomorrow or this week I would think.
www.onemedplace.com/forum/webcast.php
Cousins @ 3:20 ET
Cool, thanks for your thoughts!
Hey Rain, how long do you think it takes to analyze those samples?