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.
Agreed. If they had questions you'd think they'd ask them by now. Looking good IMO.
Nov. 10th
"Pursuant to Section 510(k), the FDA has 90 days in which to either clear the Class II medical device for commercial distribution or to seek additional information. The FDA previously confirmed that it would review the product as a medical device. Following notification of FDA clearance, the Company would immediately have the right to commence manufacturing, marketing and sales of the product in the United States and its possessions subject to FDA jurisdiction".
You can't call something deceptive when it's written in the filings in plain English. It's not the company's fault people don't read them. I don't own any shares but believe this company has potential in the long term. Just need to eat through these shares and pay off their debt IMO. The higher the volume the quicker that will be. GL
He reads the filings. More people should IMO
Reasons for the Amendment
"Based upon our information, we believe that the loans will be converted in consideration of 697,000,000 restricted shares of common stock. We currently do not have enough authorized shares of common stock to satisfy the option exercises and the conversion of debt to common shares. It is in our best interest to convert the debt to equity in that it will eliminate debt in the amount of $967,346. Other than the plan to issue shares upon the exercise of options and convert the debt to shares of common stock, we have no plans or arrangements to issue any additional shares of common stock".
From the 10-q. Talking about K
"At the conclusion of the Phase 1 study we will engage in discussions with the hospital as to the logistics and costs, net of grants, to move this project forward into Phase 2 studies of renal cell carcinomas".
Can somebody ask Leo about this next week. Thanks.
Check out the CEO speak at TED conference a while back. Very sharp mind IMO.
49 not 29. Thank you. Appreciate it.
Where is your 50 million share number from? I thought it was 29mill and change. Thank you.
Weekend reading. Oldie but a goodie From PolyMedix. Assets bought by CTIX. The birth of the Defensin Mimetics Platform! And more
"One of the holy grails of medicine is to come up with a stable, simple and easy to synthesize organic molecule, one that could be taken orally as a pill, and would function like a protein itself. This truly is one of the great holy grails of pharmaceutical research. The technology and Bill DeGrado and Mick Klein have developed achieves exactly this, using a variety of computational algorithms to mathematically design compounds which mimic the activity of proteins themselves. These compounds can be polymers, which are larger compounds that can be used as materials, and oligomers and small molecules, which can be used as drugs. Thus, biomimetics. When I had seen the success that they had achieved just the early stages of a year ago, it was light years beyond what I believe any other company has ever been able to achieve. I couldn't say no, so we had to do this".
[...]
"Our first commercial focus is on novel antibiotic drugs and bactericidal materials. Any computational technology is only as good as the products that it generates. The only thing that matters is, does it work. In the last 20 years there have probably been over 100 different companies that have been started trying to come up with rational drug design, ways of designing drugs on first principles, compared with the old fashioned way of using combinatorial chemistry and high throughput screening, which was basically making compounds by the hundreds of thousands and throwing a lot of things against the wall and seeing what sticks. But that doesn't work, and time and history have proven that the brute force methods don't work, and the big pharmaceutical companies acknowledge that it doesn't work either. The reason it doesn't work is that the total potential number of molecules that can exist is so huge. It's been estimated that the total number of drug compounds that could possibly exist, the total number of drug structures that could possibly be designed, is about 1083, or one followed by 83 zeros. In the entire history of the pharmaceutical industry all the companies in the world in the last century have together made about 100 billion compounds. That as a percentage of total space is .000000000000000000000000000000000000000000 0000000000000000000000000000001% of all possible structures. So brute force doesn't work and brute force will never work. Rational drug design is the only way that will ultimately work. While there have been many companies that have tried rational drug design, but most of those attempts haven't been very successful. So the only value of a computational technology is not the theory, but does it work? We have a lot of very complicated molecular dynamics, course grain, and force field algorithms underlying PolyMedix, but the only thing that matters is whether they work. Is it accurate, reliable, reproducable and consistent? Can we quickly, efficiently and cost-effectively get active molecules out of it? The first target we've picked to focus on is to develop novel classes of antibiotic drugs, and with polymer derivatives, self-sterilizing materials. The target we've picked to work on is the human defenses. All multicellular life forms, all higher life forms, have what are called host defense proteins. This is the body's first life of defense against bacterial, fungal, and now known to be also viral infection. These proteins are produced in every living creature at the site where bacteria or fungi enter the body. They're potent, broad spectrum, and work uniquely by directly disrupting and rupturing bacterial cell membranes, so it's virtually impossible for bacteria to develop resistance to them. But because these are proteins, they have the same limitations that I mentioned a few moments ago of the difficulties in developing them as protein drugs. Several companies over the last decade and a half have tried to develop host defense proteins themselves as drugs, and have not succeeded because of the limitations of these proteins. Many companies have tried to come up with organic biomimetics of these host defense proteins, but have not succeeded either. Coming up with a new mechanism of action for antibiotics is a major unmet medical need. Death due to secondary bacterial infections, what are called nosocomial infections, where you check into a hospital for something and pick up a bacterial infection and die of it, is now astonishingly the fourth leading cause of death in this country. After heart disease, cancer and stroke, you have a greater chance of dying from picking up a bacterial infection in a hospital than you do of anything else. Unfortunately, there isn't a single antibiotic in use anywhere in the world today to which bacteria cannot develop, or have not already developed resistance. There are infectious disease experts who are predicting that at the rate that bacteria are developing resistance to conventional drugs, in 10-15 years the world will be at risk of uncontrollable bacterial plagues, basically epidemics of bacterial infections for which there will be no effective treatment, like the Black Death of the 14th century that wiped out half the world's population. So this is a major medical need and also a huge commercial opportunity ' coming up with a novel way of killing bacteria using a mechanism to which bacteria cannot develop a resistance. The defensin mechanism of directly disrupting bacterial cell membranes, sort of like a needle going into a balloon, is such a mechanism. Despite billions of years of evolution, bacteria are still susceptible to being destroyed by host defense proteins. That's the reason why life was able to evolve on earth. So it's a proven mechanism of action, but one that is crying out for a biomimetic compound, because the proteins themselves are just too unstable and not useful as drugs. And that's exactly what we did. We've designed oligomer and small molecule compounds that do indeed replicate the function of defensins. They've potent and broad spectrum. We've tested them against more than 25 different bacterial strains, including strains of bacteria that are resistant to antibiotics, and they work against all of them. They also have antifungal and antiviral properties and are very inexpensive and very easy to make. They're safe, selective for bacterial cells, and don't harm mammalian cells. Polymer derivatives of these compounds have been made, and we've shown that we can add them to paints, plastics and textiles to create products and surfaces that are intrinsically and permanently self-sterilizing by virtue of the material itself. The first program that we've applied this technology to addresses a tremendous market opportunity, a huge medical need, and the first one that we'll be commercializing and focused on developing. This will be the beginning for PolyMedix. Our goal is to develop these antibiotic products internally, to keep North American rights and use this as a core for building a specialty infectious disease business, and find partners to out-license international rights to. We will also out- license all the materials applications to the polymers to materials and consumer products companies, and use that cash flow as a source of near- term revenues. In the future, as we generate revenues we can apply this basic computational technology to other protein/protein targets".
[...]
"Another reason we picked the anti-infective applications for the first product is that, relatively speaking ' and studies have shown this ' this is one of the shortest paths to getting a drug on the market. There are many reasons for this, but primarily because the clinical trials are short. This isn't a two- or three-year trial, as we often have to do in a chronic degenerative disorder like Alzheimer's or cancer. It's a very short clinical trial with a clearly defined endpoint. For someone who is in the hospital with a serious bacterial infection, like drug-resistant Staph, which we've already shown activity against, we expect the duration of dosing of the drug will be a week or two. So it's a relatively short trial, and the end point is also relatively straightforward. We're not trying to interpret whether a person's memory is a little better or a little worse. It's pretty clear: either the person is dead or alive. If you've cured them, they walk out of the hospital. Additionally, the antibiotic market is also one where a small company can successfully market a product with a relatively modest sales force and marketing effort. With a total sales and marketing force of less than 100 people, one can reach most of the hospital market. This is much more feasible for a small company ' we cannot hope to compete directly with the major pharmaceutical companies and their multi-thousand person sales forces that are needed to reach office-based primary care physicians".
[...]
"In the first program, the antibiotic drugs, we computationally designed, synthesized and tested about 200 compounds. Of those about 70%, or 140, were biologically active, and of those about 40 or 20% were potent, broad spectrum, and nontoxic. This report card, this quantitative success rate of 70% for designing hits and 20% for coming up with druggable leads, is by any objective measure nothing short of remarkable. The typical success rate with brute force is, if you're lucky, one in 10,000 will be a hit".
[...]
"If you look out five to 10 years from now at what PolyMedix could be doing, what diseases we would be developing treatments for, most diseases have as their underlying target a protein- protein interaction or a membrane-protein target. Biomimetic compounds for these difficult and important targets could revolutionize medicine. Our antibiotics are the first of what could be many significant new drugs. We selected antibiotics from among many possible programs because it's a huge market opportunity and an enormous unfilled medical need, and also because it's relatively fast, inexpensive, and low risk to develop".
I thought AMDA could sell up to 29million shares. Thought it started early Oct. they have to be close to finishing by now IMO.
Somebody trading this is a toots and the maytals fan. I keep seeing 54 and 46 share trades. Weird.
Yup. Nice timing.
"Pursuant to Section 510(k), the FDA has 90 days in which to either clear the Class II medical device for commercial distribution or to seek additional information. The FDA previously confirmed that it would review the product as a medical device. Following notification of FDA clearance, the Company would immediately have the right to commence manufacturing, marketing and sales of the product in the United States and its possessions subject to FDA jurisdiction".
“Porous silicon nitride is the first synthetic material to demonstrate spinal fusion outcomes that are similar to the patient’s own bone,” said Dr. Sonny Bal, chairman and CEO of Amedica Corporation. “These outcomes are consistent with our investigations of the surface chemistry and nano-topography of silicon nitride. This 24-month data has been submitted to the FDA in support of our application seeking clearance to commercialize our composite cervical interbody fusion device. Achieving clearance for this product is very important to us, as it furthers our mission to improve patient health through the enhancement of clinical outcomes for those patients who utilize our products, which is why we invested the necessary time in data gathering and analysis to ensure that we had it right before FDA submission.”
"Amedica's spine products are FDA-cleared, CE-marked, and are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its growing private label and OEM partnerships".
Cyber Monday Sale going on. Get yourself or a loved one an entire Defensin Mimetics Platform for under two bucks.
"Cellceutix’s defensin mimetic compound CTIX1278, was efficacious as compared to a carbapenem antibiotic that is widely used as a last line of defense against drug-resistant, Gram-negative bacteria, including Klebsiella pneumoniae. A second study is now being conducted at multiple dosing levels with various infusion parameters with the goal of increasing efficacy and further defining a treatment protocol for the compound".
Wonder how that second study is going. Wonder what they'll call CTIX1278. CTIX has a potential platform in its Pipeline. A Defensin Mimetic Platform! How many companies can say that?
I agree it's too much compensation but the CEO didn't drive the company into the ground and they are not dying but are slowly turning it around IMO. It's Just taking more time than traders would like. The CEO has been pretty clear about the length of time it would take. Not sure why people who hold no position here care what this company or CEO does or doesn't do. At least he didn't string people along for 3 years with a revolutionary solar cell that hasn't seen the light of day.
"Most OTC penny stock would-be biopharma tend to overstate the prospects of their pipeline, and CTIX is no exception".
Please give some examples of CTIX overstating the prospects of their pipeline.
"Other than the plan to issue shares upon the exercise of options and convert the debt to shares of common stock, we have no plans or arrangements to issue any additional shares of common stock".
Here's some business fundamentals:
“After a rigorous review process, the towns chose RGS Energy as the primary solar installer that will work with residents through the end of the program which concludes on February 15, 2016,” said Karen Stewart, community outreach manager of SmartPower. “One reason they selected RGS Energy is because the company has 11 Rhode Island employees and a proven track record of more than 450 installations in the state. Last year, RGS Energy was the chosen installer for the Solarize North Smithfield program, which resulted in more than 55 contracts.”
IMO - Ignore the Traders and Chartists the company is turning itself around.
Full PR:
RGS Energy Selected to Expand Solar Adoption in Barrington and Middletown, Rhode Island
LOUISVILLE, Colo., Nov. 11, 2015 (GLOBE NEWSWIRE) -- RGS Energy (RGSE), a rooftop solar company since 1978, has been selected as the primary solar installer by Solarize Rhode Island to bring solar electricity to home and business owners in Barrington and Middletown, Rhode Island.
Solarize Rhode Island is a community-supported discount buying program that uses tiered-pricing, town-supported education and outreach, competitively selected installers and access to flexible financing to dramatically reduce the cost of solar. The more residents sign up for the program, the more the cost comes down. Residents and business owners have begun signing up for the programs.
Solarize Rhode Island is based on a proven residential model that has worked successfully in over 100 communities in Massachusetts, Vermont and Connecticut. The program was created through a partnership between the Office of Energy Resources, Commerce Rhode Island and non-profit marketing firm SmartPower to encourage adoption of solar using the power of a group buying and a grass-roots community outreach plan.
“After a rigorous review process, the towns chose RGS Energy as the primary solar installer that will work with residents through the end of the program which concludes on February 15, 2016,” said Karen Stewart, community outreach manager of SmartPower. “One reason they selected RGS Energy is because the company has 11 Rhode Island employees and a proven track record of more than 450 installations in the state. Last year, RGS Energy was the chosen installer for the Solarize North Smithfield program, which resulted in more than 55 contracts.”
RGS Energy Regional Manager Tom Camplin commented: “RGS Energy is honored to be selected for the Solarize programs. By partnering with the Rhode Island Office of Energy Resources, Commerce RI, and SmartPower for the second time, we can help raise community awareness of the benefits of conservation, efficiency, and the benefits of renewable energy, specifically solar energy. We will work closely with the Town of Barrington and Middletown to help achieve their renewable energy objectives.”
“Our more than 37-years of experience serving the residential and small commercial solar markets gives us confidence in our plan to grow sales, reduce cost of goods sold, and optimize acquisition costs, as well as attract investors on favorable terms. In all, we believe the continued execution of our turn-around plan will put us in the position to deliver 20 megawatts of installation revenue and overall breakeven results for 2016.”
It's necessary and I don't think it will be much. Still a low float here. Even after a little fund raising. IMO.
Unlike the last couple of years with the massive El Niño set up, this winter is already looking to be a mild one so east coast sales and installation should be be better than normal. Not everything is doom and gloom IMO. GL
This sounds good to me!
“Our more than 37-years of experience serving the residential and small commercial solar markets gives us confidence in our plan to grow sales, reduce cost of goods sold, and optimize acquisition costs, as well as attract investors on favorable terms. In all, we believe the continued execution of our turn-around plan will put us in the position to deliver 20 megawatts of installation revenue and overall breakeven results for 2016.”
I was on the call. Didn't sound horrible to me. Turn around still in play. No threat of BK. Doing what they need to do. Overreacting in the AH IMO. If people sell this down tomorrow I may have to add if price is right. Price seems right right now but I'm long. GL
Great idea. I would ask why they don't do more PR's. If Jim Nelson over at $LTD sneezes the company PR's it. It works most time for them. It's good to keep your shareholders abreast of what's going on with the company. Thanks for taking this on.
Occam's razor.
"In this case, Leo got the facts wrong, likely from a rattled guy at the hospital with an Indian accent while he himself was traveling".
I can imagine Leo was quite busy himself. Probably got back to his hotel room later that night. Sits down to prepare the PR. Tired. Tries to remember what meeting Menon was talking about. I'm sure the phone call was more focused on Menon's health and details of the accident. Leo Grabs the schedule from the conference to find something that jogs his memory. Finds "Resistance in Antibiotics -- Panel Discussion Animal Feeding of Antibiotics" and runs with it. Non issue IMO. What should be questioned is Which city was Leo in? What meetings was he having?
A little known fun fact: The real number is 616. 666 was a result of a mistranslation. So you're already wrong. CTIX
This needs to be highlighted:
"The combination of Kevetrin with chemotherapy drugs resulted in synergistic apoptosis at a much lower concentrations than with each agent individually. Thus, Kevetrin holds promise to maximize tumor cell killing when used in combination therapies".
If this continues to be the case as K moves through trials, I wonder how many companies will want to partner with CTIX. History in the making IMO!
When the sentiment changes back to positive (and it will IMO) this thing is going to run hard and fast in my opinion. I am still a staunch believer in the pipeline and so I continue to accumulate as we fall. Someone please show me something wrong with the science and I will sadly sell my shares and walk away with a lifelong lesson. Anyone?
Add to that somebody called the home office yesterday to ask what happened to Dr. Menon and said a young woman answered and told them she could not comment on the matter. Why couldn't she comment about Menon being asked to sit on a round table discussion?
In all seriousness I hope the good Dr. Is fine and we find out soon enough what happened.
You're negating the group of us who rarely feel the need to post even when they read the misinformation coming out from people who did not even read Leo's response to Dr. KSS. If you polled the quiet ones who read as many post as possible I bet the company sentiment is still very much positive. Just my opinion.
Easier to just sell your shares and move on.
This part of his career fits well with the Barron's speculation of a partnership with Pfizer for global trials of Brilicidin IMO.
"Dr. Jorgensen has held senior leadership positions in the Global Research and Development Division at Pfizer, Inc"
This prospectus relates to the sale, transfer or distribution of up to 29,527,560 shares of our common stock, par value $0. 01 per share, of Amedica Corporation by the selling stockholders described herein. The price at which the selling stockholders may sell the shares will be determined by the prevailing market price for the shares or in negotiated transactions.
Our common stock is listed on The NASDAQ Capital Market under the symbol “AMDA”. On October 1, 2015, the closing price of our common stock was $0.31 per share.
Nope. Just a deflated heart.
No, that's not what it's like. Its about value not expense.
No, Leo's running a company. Apparently Some Investors are playing "dangerous" games with their money. Everybody has a choice. Leo is not forcing anyone to be here. Good luck