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Giovanni...yes, and I've read somewhere that the FDA must recall 2,500+ (maybe this is a little high) drugs every year due to risks of injury. One may ask .... how does this happen? IMO, this happens because of PDUFA. The FDA receives $$$ (PDUFA fees) from every drug that is approved and sold on the market. This is a conflict of interest, and provides the FDA with an incentive to approve drugs that should have never been approved. These fees also result (IMO) in the FDA being biased towards the BPharmas that will generate the highest PFUFA fees....leaving the little biotech (ex: RVVTF, RLFFD, etc) out of the equation.
PDUFA fees came about so as to provide the FDA with $ resources to help expedite the approval of drugs (a good thing for consumers). But instead it's just provided a vehicle for corruption.
Congress should end PDUFA fees, thereby remove the incentive for corruption. IMO RVVTF is too small to generate a enough PDUFA fees to get the attention of the FDA. JMHO
Harvard University says: Prescription drugs are the 4th leading cause of death.
Risky Drugs: Why The FDA Cannot Be Trusted
July 17, 2013
by Donald W. Light
A forthcoming article for the special issue of the Journal of Law, Medicine and Ethics (JLME), edited by Marc Rodwin and supported by the Edmond J. Safra Center for Ethics, presents evidence that about 90 percent of all new drugs approved by the FDA over the past 30 years are little or no more effective for patients than existing drugs.
All of them may be better than indirect measures or placebos, but most are no better for patients than previous drugs approved as better against these measures. The few superior drugs make important contributions to the growing medicine chest of effective drugs.
The bar for “safe” is equally low, and over the past 30 years, approved drugs have caused an epidemic of harmful side effects, even when properly prescribed. Every week, about 53,000 excess hospitalizations and about 2400 excess deaths occur in the United States among people taking properly prescribed drugs to be healthier. One in every five drugs approved ends up causing serious harm, while one in ten provide substantial benefit compared to existing, established drugs. This is the opposite of what people want or expect from the FDA.
Prescription drugs are the 4th leading cause of death. Deaths and hospitalizations from over-dosing, errors, or recreational drug use would increase this total. American patients also suffer from about 80 million mild side effects a year, such as aches and pains, digestive discomforts, sleepiness or mild dizziness.
The forthcoming article in JLME also presents systematic, quantitative evidence that since the industry started making large contributions to the FDA for reviewing its drugs, as it makes large contributions to Congressmen who have promoted this substitution for publicly funded regulation, the FDA has sped up the review process with the result that drugs approved are significantly more likely to cause serious harm, hospitalizations, and deaths. New FDA policies are likely to increase the epidemic of harms. This will increase costs for insurers but increase revenues for providers.
This evidence indicates why we can no longer trust the FDA to carry out its historic mission to protect the public from harmful and ineffective drugs. Strong public demand that government “do something” about periodic drug disasters has played a central role in developing the FDA.2 Yet close, constant contact by companies with FDA staff and officials has contributed to vague, minimal criteria of what “safe” and “effective” mean. The FDA routinely approves scores of new minor variations each year, with minimal evidence about risks of harm. Then very effective mass marketing takes over, and the FDA devotes only a small percent of its budget to protect physicians or patients from receiving biased or untruthful information.34 The further corruption of medical knowledge through company-funded teams that craft the published literature to overstate benefits and understate harms, unmonitored by the FDA, leaves good physicians with corrupted knowledge.5 6 Patients are the innocent victims.
Although it now embraces the industry rhetoric about “breakthrough” and “life-saving” innovation, the FDA in effect serves as the re-generator of patent-protected high prices for minor drugs in each disease group, as their therapeutic equivalents lose patent protection. The billions spent on promoting them results in the Inverse Benefit Law: the more widely most drugs are marketed, the more diluted become their benefits but more widespread become their risks of harm.
The FDA also legitimates industry efforts to lower and widen criteria prescribing drugs, known by critics as “the selling of sickness.” Regulations conveniently prohibit the FDA from comparing the effectiveness of new drugs or from assessing their cost-effectiveness. Only the United States allows companies to charge what they like and raise prices annually on last year’s drugs, without regard to their added value.7
A New Era?
Now the FDA is going even further. The New England Journal of Medicine has published, without comment, proposals by two senior figures from the FDA to loosen criteria drugs that allege to prevent Alzheimer’s disease by treating it at an early stage.8 The authors seem unaware of how their views about Alzheimer’s and the role of the FDA incorporate the language and rationale of marketing executives for the industry. First, they use the word “disease” to refer to a hypothetical “early-stage Alzheimer’s disease” that supposedly exists “before the earliest symptoms of Alzheimer’s disease are apparent.” Notice that phrasing assumes that the earliest symptoms will become apparent, when in fact it’s only a hypothetical model for claiming that cognitive lapses like not remembering where you put something or what you were going to say are signs of incipient Altzheimer’s disease. The proposed looser criteria would legitimate drugs as “safe and effective” that have little or no evidence of being effective and expose millions to risks of harmful side effects.
No proven biomarkers or clinical symptoms exist, the FDA officials note, but nevertheless they advocate accelerated approval to allow “drugs that address an unmet medical need.” What “unmet need"? None exists. This market-making language by officials who are charged with protecting the public from unsafe drugs moves us towards the 19-century hucksterism of peddling cures of questionable benefits and hidden risks of harm, only now fully certified by the modern FDA.9
The main reason for advocating approvals of drugs for an unproven need with unproven benefits, these FDA officials explain, is that companies cannot find effective drugs for overt Alzheimer’s. Their drug-candidates have failed again and again in trials. The core rationale of the proposed loosening of criteria is that “the focus of drug development has sifted to earlier stages of Alzheimer’s disease…and the regulatory framework under which such therapies are evaluated should evolve accordingly.” Yet they admit there are no “therapies” in this much larger market where (with the help of the industry-funded FDA) companies will not have to prove their drugs are effective. In fact, these FDA officers propose to approve the drugs without ever knowing if they are therapeutic or not. Their commercialized language presumes the outcome before starting. The job of the FDA, it seems, is to help drug companies open up new markets to increase profits for the FDA’s corporate paymasters.
These two FDA officials maintain that “the range of focus must extend to healthy people who are merely at risk for the disease but could benefit from preventive therapies.” Yet they admit we do not know who is “at risk,” nor whether there is a “disease,” nor whether anyone “could benefit,” nor whether the drugs constitute “preventive therapies.” Similar FDA-encouraged shifts have been made for drugs treating pre-diabetes, pre-psychosis, and pre-bone density loss, with few or no benefits to offset risks of harm. This week, based on policy research at the Edmond J. Safra Center for Ethics, a letter of concern was published in the New England Journal of Medicine. The authors write that approval for drugs to treat “early stage Altzheimer’s disease” must meet “a much higher bar – evidence of slowed disease progression.” But without clinical manifestations or biomarkers for an alleged disease, how will such progression be measured?
Advice to readers: Experienced, independent physicians recommend not to take a new drug approved by the FDA until it is out for 7 years, unless you have to, so that evidence can accumulate about its real harms and benefits.10
----
Disclaimer: The assessment and views expressed here are solely the author’s and do not necessarily reflect those of persons or institutions to which he is associated. The comments and suggestions of Gordon Schiff, an expert in prescribing at Brigham and Women’s Hospital, and Robert Whitaker are gratefully acknowledged.
References
1. Lexchin J. New drugs and safety: what happened to new active substances approved in Canada between 1995 and 2010? Archives of Internal Medicine 2012 (Nov 26);172:1680-81.
2. Hilts PJ. Protecting America's Health: The FDA, Business and One Hundred Years of Regulation. New York: Alfred A. Knopf; 2003.
3. Rodwin M. Conflicts of interest, institutional corruption, and Pharma: an agenda for reform. Journal of Law, Medicine & Ethics 2012;40:511-22.
4. Rodwin M. Reforming pharmaceutical industry-physician financial relationships: lessons from the United States, France, and Japan. Journal of Law, Medicine & Ethics 2011(Winter):2-10.
5. Sismondo S. Ghost management. PLoS Medicine 2007;4:1429-33.
6. Sismondo S, Doucet M. Publication ethics and the ghost management of medical publication. Bioethics 2010;24:273-83.
7. Schondelmeyer S, Purvis L. Rx Price Watch Report. Washington DC: American Association of Retired Persons 2012.
8. Kozauer N, Katz R. Regulatory innovation and drug development for early-stage Alzheimer's disease. New England Journal of Medicine 2013 (Mar 13);DOI: 10.1056/NEJMp1302513
9. Young JH. The Toadstool Millionaires: a social history of patent medicines in America before federal regulation. Princeton, NJ: Princeton University Press; 1961.
10. Schiff G, Galanter W, Duhig J, et al. Principles of conservative prescribing. Archives of Internal Medicine 2011;171:1433-30.
See also: Public Health, Donald Light
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People here told me the fda is corrupt and bias toward BP. And that revive never had a chance. Is it true?
Well they did hand revive a phase 3 based on safety data from a phase 2 trial done 4 years prior. In 2020 the fda didn’t care what you wanted to try as long as they knew your product wasn’t going to kill anyone. That’s not exactly a deep dive into the product. Fda was desperate.
Benson's a bottom feeder, who enjoys feeding on other's misfortunes. You can tell a lot about a person from the language they use such as, "bro and dude."
OMG LOL! Wrong yet again. And if you really believe the FDA merely handed Revive this opportunity without doing any due diligence of their own then in fact you are the deluded, clueless one.
The two are joined for now however, most of us invested in Revive’s Bucillamine not in Michael Frank per se.
Bet you don’t even know what Bucillamine is and represents. Too much technical detail for $7 postings isn’t it.
Enjoy the dreary basement couch life, sweetheart..and “ciao” for now from Las Vegas!!
You are absolutely correct. The FDA was kind to Revive and allowed them to bypass Phases 1 and 2. Revive did not "progress" to anything. In fact they were spoon-fed a handout from the FDA. Narcissistic amateur is a perfect assessment for this completely incompetent CEO. Some of us saw it a long time ago but so many others worshipped him and still do apparently.
Progressing to a phase 3? Fda was handing those out like candy in 2020. If they actually progressed, meaning going from phase 1 and getting to phase 3, then this would be different however they were given a chance to start at 3 and still couldn’t do anything with it. Being given a phase 3 doesn’t mean anything when you have a narcissistic amateur leading the company.
rick...Unfortunately I have to agree with you. That PR clearly implied that a NEW trial is needed IF the FDA approves the new metric goals. They are back to "Base One" I'm afraid. This is several years away from final FDA approval on anything (at best).
With the O/S over 300M and climbing, I just don't see how the salaries and overall compensation plans can be sustained without an R/S in either 2023 or 2024. All bad news I'm afraid. I've seen this happen far too many times with penny stocks.
Revive Therapeutics staying the course on Phase 3 trial of Bucillamine in Covid-19 patients after meeting with FDA
That "proactive" clown either doesnt know how to read, has somehow received a different Pr to the rest of the public, or yet again Revive has put out an incomplete Pr, because the one I read (multiple times) indicates no such thing.
Revive isnt "staying the course" with the old P3 buccy trial but rather IS ENDING IT!!!
The Pr couldnt be any clearer but somehow that joker puts out this erroneous garbage.
The plan going forward is clearly to assess the data set in hand and then, based on that evaluation, approach the fda re the potential for repurposing and reformulating buccy, in addition to commencing new trials for covid and/or non-covid related disorders
Whether false info is pro Revive or anti Revive (goof crew) is wholly irrelevant......the point is that its inaccurate and should be exposed as such.
That guy is full of shite..............................
The Fat Lady remains silent.
Fudsteerville can kma. We were right
https://www.proactiveinvestors.com/companies/news/1016408/revive-therapeutics-staying-the-course-on-phase-3-trial-of-bucillamine-in-covid-19-patients-after-meeting-with-fda-1016408.html
$RVVTF is staying-the-course-on-phase-3-trial-of-bucillamine-in-covid-19-patients-after-meeting-with-fda
Ohhhhhh I see. He's handing out Participation Trophies.
Close only counts in horseshoes and hand grenades
He wants this chalked up as a victory because they “tried”? I can tryout for the Yankees as a hack. Doesn’t mean sh*t
Revive progressing to an FDA Phase III trial is no mean feat. What have you achieved? ..<crickets>..Thought so.
“Do” a phase 3 trial implies that they actually did one. They did not finish therefore they did jack all. Would you say they did a phase 3 if they enrolled 1 patient?
Steaming Bullshite
a little update from an analyst... I don't think they is anything too new her, but ... "develop a defined recruitment plan" - implies that they are back to Base one IMO.
https://www.proactiveinvestors.com/companies/news/1016408/revive-therapeutics-staying-the-course-on-phase-3-trial-of-bucillamine-in-covid-19-patients-after-meeting-with-fda-1016408.html
That's a great accomplishment bro, where's the money?
Dude...when MF was funding that last round I just shook my head. Unbelievable.
Do not confuse "borderline useless" foul noise making non shareholders with a real Public CEO, running one of the few, possibly the only OTC stock, $RVVTF , to ever fund and do a phase III drug trial in US History, as an OTC stock
Do not confuse the routine use of SEC/FDA/Legal mandated legalize language with a sell signal. That is an amateur mistake. Even stocks like Pfizer, Amazon and Google use the same language.
This is super bullish.
I wonder about those who funded the last dilution round at .15 and never saw green. Lost 2/3rds in a matter of weeks
That’s not deer looking at headlights
That’s road kill bro
You're an idiot! Don't text me again.
So many assumptions made by you idiots!
You are absolutely correct. 100%. Stringing investors along has been the clear and obvious strategy by MF for a very long time and it has made him a very good living. A country club living in fact. The vast majority of this board are deer in the headlights.
Revive's Bucillamine is still by far one the best opportunities across the dire OTCM at present. At this stage of their trials (and related FDA & industry exposure) plus the current low share price, the risk/reward is well worth me continuing taking personally.
I believe in Revive's Bucillamine. Now sell me your cheap shares and good luck!
Dude the ceo is borderline useless at this point. He is going to push this back another month just to get initial results? That is ridiculous. He doesn’t have a clue what he is doing which is why everything takes 3x as long as it should. He should have taken the help that was offered. I hope he gets fined 10x as much as he has made “running” this company for all his lies and stringing shareholders along.
With this news and at the current share price, I will not sell a single share. I know of several penny stocks with so much promise that took years for them to take off. Revive is no different and at least things are happening, What's another couple of years LOL, GLTA!
The Company "believes"
"could" support further discussions
"potential" new clinical studies
He's been doing this to you for 3 years now. What's it going to take?
Cw,
I did like this part,The Company plans to complete its initial evaluation of the Study’s data with an independent biostatistician team by the end of June. The Company believes that once it has completed the evaluation of the Study’s data, it could support further discussions with the FDA on potential new clinical studies and allow the opportunity to work with potential domestic and international pharmaceutical partners to determine a suitable regulatory pathway for approval of Bucillamine based on the evaluated Study’s data.
Ps.. expect the data by the end of June . Hopefully..
Pps. We wait some more and more lol :) holding not selling any this low unless I have to....
The wheels are still in motion, albeit slow motion.
https://revivethera.com/2023/05/revive-therapeutics-provides-update-of-phase-3-clinical-study-for-bucillamine-in-the-treatment-of-covid-19-4/
Revive Therapeutics Provides Update of Phase 3 Clinical Study for Bucillamine in the Treatment of COVID-19
https://www.stocktitan.net/news/RVVTF/revive-therapeutics-provides-update-of-phase-3-clinical-study-for-cftqzipsz44v.html
Rubberneck doing dd :)
Ps. I buy cnna if we are down with outcome there are connections to make money back:)
But holding my Balls to;)
Ps. I think I need more edibles for the wait lol
Some interesting listening.....
This is the most important video you will watch this year. Millions were killed with Covid-19 for profit.
— Kim Dotcom (@KimDotcom) May 25, 2023
“Covid-19 was an act of biological warfare perpetrated on the human race. It was a financial heist. Nature was hijacked. Science was hijacked.” pic.twitter.com/1sYnVMaIRN
Yeah like lemmings over the cliff. A rabbit hole cult that has nothing left except shooting the messengers.
No cliff here yet. Just in your own head.
Sheep here Joe. They followed a pumper over a cliff
Let me spell it out for you pal. You...are...not...getting...your...money...back.
"What is toxic positivity? Toxic positivity is the pressure to only display positive emotions, suppressing any negative emotions, feelings, reactions, or experiences. It invalidates human experience and can lead to trauma, isolation, and unhealthy coping mechanisms."
-Betterup.com
China is bracing for a massive new wave of COVID cases. What it means for the rest of the world
BYERIN PRATER
May 24, 2023 at 4:00 AM EDT
People visit a traditional spring festival flower market, which reopened after closure due to the spread of COVID, in Guangzhou, China, on Jan. 20. Cases of Omicron variant XBB are mounting in China, forming a new wave expected to crest around 65 million cases a week by the end of June.
PHOTO BY STR/AFP VIA GETTY IMAGES
Cases of Omicron variant XBB are mounting in China, forming a new wave expected to crest around 65 million cases a week by the end of June.
Infections will likely reach 40 million per week by the end of the month, senior health adviser Zhong Nashan told attendees at a biotech conference in Guangzhou, according to Bloomberg.
The wave could swell to become the country’s second largest, experts tell Fortune. It will undoubtedly pale in comparison to the country’s first major wave late last year, during which an estimated 37 million people were infected on one day—Dec. 20—alone.
That wave—equivalent to the early days of the pandemic for the rest of the world—occurred after the country abruptly abandoned its yearslong “zero COVID” policy, effectively letting the virus “rip” through a population that had been largely sheltered from the it—and that was vastly undervaccinated.
A ‘largely invisible’ wave
XBB, the “first major highly immune-evasive” group of COVID variants, “will sweep through China,” but the wave will be “largely invisible” due to low rates of testing and reporting, Raj Rajnarayanan, assistant dean of research and associate professor at the New York Institute of Technology campus in Jonesboro, Ark., and a top COVID-variant tracker, tells Fortune.
When it comes to XBB variants, “the rest of the world has seen them all.” But up until recently, “China hasn’t,” he says, adding that the country has a substantial population at high risk of severe outcomes from COVID due to age, immune status, and co-morbid conditions.
Increased circulation of XBB variants in China—and elsewhere—is likely to result in the evolution of new XBB variants, Rajnarayanan said. So far, XBB spawn have remained relatively innocuous for those not at increased risk of severe disease, according to the World Health Organization’s latest situation report, released Thursday.
‘Go back for regular check-ups’
It remains to be seen whether hospitalizations will rise in China, Rajnarayanan and fellow variant tracker Ryan Gregory—a Canadian biologist who has assigned “street names” to so-called “high flying” variants like XBB.1.5, dubbed “Kraken”—tell Fortune.
Hospitalizations can, however, be expected to rise if variants that combine the transmissibility of XBB with the lung involvement of Delta catch on, in China or elsewhere. Trackers are eyeing variants that have a mutation in the spike protein that could cause such a phenomenon. So far, such variants are only prevalent in New Zealand and the European Union, Rajnarayanan says.
The evolution of a veritable XBB-Delta combo isn’t an inevitability, though, Rajnarayanan says.
And while the virus is capable of pivoting at any point, evolving into a more lethal version of itself, it so far hasn’t–—and the chance of it doing so isn’t any greater in China that it is in the rest of the world, where the virus is also spreading unchecked, Dr. Ali Mokdad, a professor at the University of Washington’s Institute for Health Metrics and Evaluation, tells Fortune.
While caution is always warranted when it comes to COVID, people everywhere need to “go back for regular check-ups, and bring their kids in for vaccinations,” Mokdad said.
COVID precautions “saved a lot of lives,” he added. “It’s time for us to go back to normal and make sure it’s not at the expense of other preventative programs.”
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Thanks Gator I appreciate the info.
Solid buying for the day…nice.
Ah. That is where the risk factor comes into play. We are hoping that Buccy is the undiscovered wonder drug. If everyone knew about it, and it was used in 50 countries, we could not have the opportunity to make serious money off this stock. If it was so easy, we would have a triple crown winner every year.
ps. I realize we are not making money off this stock at the moment.
pps. Good luck to all even a pissed off and frustrated Snoopy.
ppps. Come on Doug Flutie. We need that Hail Mary more than ever.
There is also a somewhat new face book chat in the F-book group many are positive there, a few good people there also : ) lately not much talk in any of the groups lol because of course just waiting on the data as u know.
ps. holding of course but ignoring the Negative u know whats lol.....
I think Bucillamine could help with something like but we will see.
📌Post-COVID-19 symptoms can linger for 2 years and are associated with prolonged inflammation.
— Outbreak Updates (@outbreakupdates) May 23, 2023
Patients with prolonged inflammation showed elevated terminally differentiated memory T cells in their blood; 54% had symptoms at 12 months. https://t.co/v02bnYT5xf
China’s New Covid Wave Set to See 65 Million Cases a Week ⚠️ https://t.co/4PVEi0SPI1
— Jess (@MeetJess) May 22, 2023
Gaps always fill…..I’m hoping however that we continue upward. May 12 we had a gap down…it’s filling in.
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Scientific Rationale of Bucillamine
Preclinical and clinical studies have demonstrated that reactive oxygen species contribute to the destruction and programmed cell death of pulmonary epithelial cells.1 N-acetyl-cysteine (NAC) has been shown to significantly attenuate clinical symptoms in respiratory viral infections in animals and humans, primarily via donation of thiols to restore antioxidant and to reduce the activity of cellular glutathione 2,3,4,5. Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine) has a well-known safety profile and is prescribed in the treatment of rheumatoid arthritis in Japan and South Korea for over 30 years. Bucillamine, a cysteine derivative with two thiol groups, has been shown to be 16 times more potent as a thiol donor in vivo than NAC 6. The drug is non-toxic with high cellular permeability. The basis of the clinical study will analyze if Bucillamine has the potential, via restoration of glutathione activity and other anti-inflammatory activity, to lessen the negative consequences of SARS-CoV2 infection in the lungs.
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