Reading up on rose bengal. Australian Professor RIchard Kefford appeared in a 2008 video talking about the benefits of PV-10. I then googled Richard Kefford and l found this 2013 article:
"An experimental drug with significant antitumour activity in advanced melanoma could be “the biggest thing in anticancer treatment in 30 years”, says a prominent Australian oncologist.
"Professor Richard Kefford, Director of Sydney’s Westmead Institute for Cancer Research, is co-author of research presented at ASCO last week showing a 38% response rate for the immune checkpoint inhibitor lambrolizumab in a cohort of 135 advanced melanoma patients.
The rate of confirmed improvement went up to 52% in those who had the highest doses of the drug and these responses were durable, with over 80% of patients still alive and on the drug at the time of publication.
"Adverse effects were mild and mainly consisted of fatigue, rash, pruritus and diarrhoea, with only 13% of patients..."
Then I found a 2013 article on the most promising cancer drugs. PV-10 was not among them. Nivolumab and Lambrolizumab were. Interestingly, Mr. Domingues, the Connecting the Dots blogger, in a recent entry in the "News" tab, compares these two drugs and others with PV-10 on a cost-basis. In the chart, PV-10, while being much cheaper, also has a much better CRR.
I still shake my head in disbelief, even after months of being long PVCT, that a drug with superior data to any other melanoma drug, including combination therapies, is rarely mentioned in cancer treatment conversations. Dr. Kefford, five years later, is calling Lambrolizumab the biggest thing in anti-cancer treatment in 30 years. What does that say about PV-10, which has better data? Is it politics? It certainly can't be ignorance; the benefits of PV-10 have been known for years. But what the data shows in the Domingues chart apparently no one else sees, or if they do, they don't want to talk about it (YMB pumpers would have you believe big pharma knows; hence, the surge in combination therapy drugs). Nor do you see it in the New England Journal of Medicine, like Lambrolizumab. Why? What gives? Even if no one wants to see it, PV-10 has been around so long they can't miss it, if it is so revolutionary. Why the silence?
BTD ... write up simple and FAST! I can write it for PVCT for faster approval.. They can reach me thru Yahoo boards.
FDA stipulation " that the study "need not be large," "be adequate and well-controlled"
4 out of 4 or 10 out of 10 will show that the if RB disoidum 10% solution causes pain after injection at melanoma lesions, the cure is guaranteed. The RB is an indicator as well as Curing agent. Two in One. What other medicine can do that.
First use it as an Indicator agent if the cure with 10% RB is possible.
If the response is blister, select those candidates and apply/inject more RB at every possible location. 100% success rate is guranteed. What other medicine can do this?
FDA will buy this logis and approve in no time.
The evidence is already there.
Pure and simple..
IF 10% RB does not blister and cause pain, there is no cure and no side effect. The Bystander effect is a Bonus for all patients.. What other miracle cure is there? to compare..
No pumps or dumps DD based on your skillset..
Contact Congressman Henry Waxmans office.. and complain about indirect way of killing Orphan drugs...
The hedgefunds and Big Pharmas found a way to kill orphan drugs by short selling the small companies with orphan drugs so they go bankrupt...
Washington, DC Office
2204 Rayburn House Office Building
Washington, DC 20515
Phone: (202) 225-3976
Fax: (202) 225-4099
After its passage in Congress, however, the Orphan Drug Act faced the threat of a veto by President Reagan. The Administration objected to the tax credits provided as incentives to companies that researched and developed orphan drugs under the bill. In response to this threat, rare-disease activists promptly took out full-page ads in major newspapers urging the president to sign the bill. Their efforts were successful, and on January 4, 1983, the Orphan Drug Act became law.
The Orphan Drug Act of 1983 provides financial incentives to drug companies that develop treatments for “rare diseases or conditions.” If a drug is granted orphan status, the Act provides three primary incentives for its development: 1) federal funding of grants and contracts for clinical trials; 2) a tax credit of fifty percent of clinical testing costs; and 3) exclusive marketing rights for seven years from the date of FDA marketing approval.
A critical aspect of the original law is that it did not compromise on the basis of FDA’s approval standard. Rep. Waxman knew that weakening FDA’s approval standard to let more drugs in would have done a grave disservice to patients suffering from rare diseases since they would be getting drugs that had not been shown to be safe and effective under FDA standards. Instead the bill offered a creative solution that provided for exclusivity, grants and tax credits, but retained the approval standard.
Under the original legislation, to qualify for orphan drug status, a manufacturer had to demonstrate that sales of a particular orphan drug would not be adequate to recoup the costs of the research and development on that drug. Manufacturers were required to submit—and FDA was required to review—extensive financial information, regardless of the size of the orphan drug population. To lessen the administrative burden on both the companies and on FDA, in 1984, the law was amended to establish a numeric threshold as alternative means of qualifying for orpha
Soon after this hearing, Rep. Waxman conducted an extensive survey of pharmaceutical companies, Federal research agencies, the FDA, and several independent university scientists to identify and gather information on the then-existing drugs for rare diseases. The survey identified 134 drugs for rare diseases, and found that only 47 of those drugs were approved for use in the United States. Only 10 of those drugs had been developed and marketed solely by pharmaceutical companies i.e., without the support of a government agency or a university. That survey also provided other important information about orphan drugs. For example, it showed that many orphan drugs were not profitable for the pharmaceutical companies and that many were not patentable. It further revealed the clinical trials necessary to prove the effectiveness of these drugs were extremely difficult to conduct because there were so few people with any given orphan disease.
Armed with this knowledge, in 1981, Rep. Waxman introduced the original Orphan Drug Act (H.R. 5238). Soon after its introduction, Rep. Waxman promptly held another hearing to get input from stakeholders on the bill. Jack Klugman himself testified along with victims of rare diseases and representatives from the pharmaceutical industry. The hearing attracted even greater media attention and garnered great popular support for the legislation.
However, in the months following the hearing, the Orphan Drug Act stalled in Congress. When Mr. Klugman learned of this inactivity, he produced a special episode of Quincy in which he asked 500 people living with rare diseases or disorders to serve as “extras” on the show. By the time the show actually aired in 1982, the House had passed the bill, but it was still being held up in the Senate. Soon thereafter, the bill passed the Senate as well.
After its passage in Congress, however, the Orphan Drug Act faced the threat of a veto by President Reagan. The Administration objected to the tax cr
Prior to 1983, people afflicted with rare diseases had little hope that pharmaceutical treatments and cures would be developed. Although many potential treatments were waiting in laboratories, drug companies were not developing them because the small population in need of the treatments failed to provide an adequate market.
Rep. Waxman was the principal author of the original Orphan Drug Act, which drastically improved this situation. Originally enacted in 1983, the Orphan Drug Act provides novel market and tax incentives to companies willing to develop drugs for small patient populations. Since 1983, Rep. Waxman has written and helped enact a series of laws that have made significant improvements to the original legislation.
II. The Orphan Drug Act – Enactment and Legislative Efforts in the 1980s
During the late 1970s, there were very few pharmaceutical treatments and cures for rare diseases on the market. Scientists had discovered some promising new treatments, but pharmaceutical companies were not interested in seeking their approval by the FDA because these products were not aimed at large and lucrative markets. The high cost of drug research and development was driving pharmaceutical companies away from investing in products with small potential sales, such as treatments for rare diseases. These products became known as “orphan drugs” because no drug companies were willing to develop and market them.
A 1980 call from a constituent first exposed Rep. Waxman to the grave problem posed by the lack of promising medicines for those with rare diseases. Adam Seligman was a young boy with a rare disease called Tourette’s syndrome, a neurological disorder characterized by irregular motor tics and vocalizations. In 1980, Adam’s doctor prescribed a drug that was approved in Canada—but not in the United States—and arranged to bring the drug into the country for Adam. His doctor felt that this was necessary because there were no viable alternative treatments in the United States at the time.
After having successfully received several shipments of these medications from Canada, Adam’s drugs were suddenly seized at the Canadian border. Fearful for her son’s health, Adam’s mother made a desperate call to Rep. Waxman’s office, begging him to do something to make sure that Adam could get his medications.
Deeply disturbed by the Seligmans’ story, Rep. Waxman set out to determine why there were no safe and effective treatments for rare conditions like Adam’s available in the United States. First, in June 1980, as Chairman of the House Energy and Commerce Committee’s Subcommittee on Health and the Environment, Rep. Waxman held a preliminary hearing to learn more about the problems faced by victims of orphan diseases. Adam Seligman himself testified and provided emotional testimony about his experiences. The hearing itself did not attract wide attention, but an L.A. Times reporter attended and wrote a story on the problem. Jack Klugman, the actor who starred in the hit TV medical drama, “Quincy,” read the article. Moved by what he learned in the L.A. Times article, Mr. Klugman decided to highlight the issue in two separate episodes of "Quincy". Viewers from all over the country wrote to Mr. Klugman asking how they could help.
FDA likes to do permutation/combination game with other drugs to see adverse reaction or phenominal ccure that no one thought of , at the expense and pain of the original drug inventor/manufacturer. This works both ways. If the result with one drug is one time and with combination, it is 10 times, FDA says "Eureka" ... go get that cure right away...
just google tissue Sparing.png and see the results... to see if RB is real or not..
correction Approve from apprive .. Next time I need to spellcheck before posting. LOL
Sentiment: Strong Buy
Second, market opportunity. "Three fourths of worldwide liver cancer cases in males and two thirds in females occur in the fifteen Asian countries." Sorafenib is not well liked in Asia for its utility (more so than in the U.S.). Sorafenib/Nexavar's price certainly is not liked there either. Nevertheless, the drug is the standard of care, until it is not.
"The drug, which is particularly effective on late-stage kidney and liver cancer, costs approximately $69,000 per year in India, so in March 2012 an Indian court granted a license to an Indian company to produce to the drug at a 97 percent discount" (quote source, and for the two quotes below, is here) "Nexavar costs approximately $96,000 per year in the United States, but Bayer assures “western patients” that they can have access to the drug for a $100 copay." [Bold and underlined emphasis is mine.] "In an interview with Bloomberg Businessweek, Bayer CEO Marijn Dekkers said that his company’s new cancer drug, Nexavar, isn’t “for Indians,” but “for western patients who can afford it.”"
A generic version of Nexavar may hurt Bayer/Amgen. PV-10 reducing Nexavar to near obsolescence certainly won't kill Bayer/Amgen, but the companies certainly will miss the sales (and that will impact earnings to an extent balance sheet financial engineering cannot fix). For example, in the U.S., $96,000 per year for Sorafenib/Nexavar, or a $20,000-30,000 "one shot, one kill," single use (multiple injections, if necessary) 100 mL vial of PV-10. The issue of treatment cost, in the U.S. and around the world, is far from resolved. The market opportunity for liver cancer for PV-10 still remains a very, very large addressable market times PV-10's likely very large market share times some price per treatment.
The lack of drug-drug interaction makes possible the combination of PV-10 and other drug therapies (chemotherapy, immunotherapies). That's, um, Pfizer and Provectus' joint patent application (Combination of Local and Systemic Immunomo
Sentiment: Strong Buy
level2 shows ask 1.80 bid 1.41 and somebody is dumping it hard..
They are taking down all stop loss ask in your accounts.. Cramer style... couple of million to tak all stop loss orders
Executive compensation is once again making its way in the spotlight with reports that Hospital Corporation of America CEO Richard Bracken received $48 million in pay and stock gains last year.
Good summary. The Bystander effect did blow the minds of FDA and many Cancer specialists. BTD will be submitted and approved before 60 days and the short sbetter do all the damage before that if they can kill the company and get the company for pennies. Pfizer won't allow that...
you stole all my secret data! LOL
What I did not share, you put it out in the Open. Darn...
12:54 pm Provectus Pharma (recent high volatility stock) announces PV-10's assessment for drug-drug interaction potential is subject of article published by Xenobiotica; 'drug-drug interaction is likely minimal' (PVCT) : Co and XenoTech, a preclinical CRO and pioneer in collaborative research surrounding in vitro drug metabolism and pharmacokinetics (:DMPK) services, announced that an article describing a study to determine the potential of rose bengal disodium to cause drug-drug interactions has been published by Xenobiotica, a peer-reviewed scientific journal that publishes comprehensive research papers on pharmacokinetics (the study of distribution, metabolism, disposition and excretion of drugs). The published research indicated that the risk of PV-10 causing clinically relevant drug-drug interactions is likely minimal. PV-10, a 10% solution of rose bengal that is currently under clinical investigation as a novel cancer therapeutic, is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, minimizing the potential for systemic side effects.
As the results indicate, if you have pain right after the injection, it is good nes and you manage that with advil? In 14 weeks you see the lesions healing completely. In few hrs the effects begin to take place. Visual indication is awesome.. 3 patients with 64 lesiions ? healing ? see the video.. Cost of cure will be lot cheaper than other drugs..