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Facts matter, https://www.ahip.org/how-big-pharma-makes-big-profits-on-orphan-drugs
and
BS should be ignored.
88 % of orphan drugs cost more than $10,000 per year per patient. 7 /10 best-selling drugs in 2017 had orphan indications. 80 %+ is the gross profit margin for the rare disease industry.
The pharmaceutical industry average gross profit margin is 16%. Orphan drugs are being approved - and entering the market - at higher rates than ever before.
https://www.the-scientist.com/features/how-orphan-drugs-became-a-highly-profitable-industry-64278
"Between 2000 and 2012, orphan drug companies had a 9.6 percent higher return on investment than non-orphan drug producers.6 "I think the traditional model of a blockbuster drug, [such as] statin, where you've got low cost and [you're] prescribing to hundreds of millions of people, has changed," Hughes says."
https://justcareusa.org/orphan-drug-act-delivers-big-profits-to-drug-companies/
"Express Scripts, a drug benefits manager, told Kaiser Health News that it currently has four orphan drugs on its formulary with $70,000 price tags for a 30-day supply-$840,000 annually. Twenty-nine more orphan drugs have price tags of $28,000 for a 30-day supply-$336,000 annually"
https://www.novartis.com/news/novartis-receives-fda-orphan-drug-designation-nis793-pancreatic-cancer
Novartis receives FDA Orphan Drug Designation for NIS793 in pancreatic ...
Jul 27, 2021Novartis receives FDA Orphan Drug Designation for NIS793 in pancreatic cancer Jul 27, 2021 Novartis today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for NIS793 in combination with standard of care chemotherapy for the treatment of pancreatic cancer.
https://www.fiercepharma.com/pharma/celgene-bms-novartis-expected-to-top-2022-orphan-drug-sales-total-pool-worth-209b-report
More than 30 years ago, to foster drug innovation for rare diseases, Congress passed the Orphan Drug Act. The law helps drug companies make big profits on drugs that treat rare diseases–orphan drugs–which affect fewer than 200,000 people. As it turns out, the Orphan Drug Act also enables drug companies to drive up drug prices, along with profits, whenever they can show that their mass-market drugs treat rare diseases.
One in ten Americans has a rare disease, and there are more than 7,000 rare diseases. But, until 1983, drug companies had no profit motive to develop drugs to treat these diseases. The Orphan Drug Act gives drug companies substantial tax credits and seven more years of monopoly pricing power for drugs classified as orphan drugs after their patents expire. In 2016 alone, according to a Kaiser Health News Investigation, the drug companies received $1.76 billion in tax credits for their development and almost $50 billion in tax credits are projected between 2016 and 2025.
While the law has led to drug innovations to treat rare diseases, it also has led to a number of mass-market drugs being reclassified as orphan drugs, with all accompanying financial benefits. The Orphan Drug Act legally entitles them to these benefits as many times as they can show the FDA that a drug treats a rare disease. For example, Gleevec, a cancer treatment, has nine orphan drug approvals, even though it was originally intended to treat far more than 200,000 people. Novartis, its manufacturer, has successfully sliced up the population into small special needs groups and found ways to show that Gleevec meets their unmet needs.
To date, pharmaceutical companies have “developed” 450 new orphan drugs with billions of taxpayer dollars. Of those drugs, the FDA has classified more than 70 mass-market drugs, including seven of the top ten best-selling drugs, as orphan drugs. Crestor, which helps lower cholesterol, Abilify, which treats schizophrenia and depression, and Humira, which treats rheumatoid arthritis, are all now classified as orphan drugs. It’s no wonder that orphan drug sales are expected to account for more than 20 percent of all brand-name drug sales.
The prices for these orphan drugs are astronomical. The Kaiser Health News investigation reveals that in 2014, the yearly cost of an orphan drug was $111,820 instead of $23,331 for other drugs. Express Scripts, a drug benefits manager, told Kaiser Health News that it currently has four orphan drugs on its formulary with $70,000 price tags for a 30-day supply–$840,000 annually. Twenty-nine more orphan drugs have price tags of $28,000 for a 30-day supply–$336,000 annually. And sales of orphan drugs are growing rapidly, at a projected rate of 12 percent a year.
What fake news?
Agree Mike this one has sub penny written all over it. I guess if you can’t wait for 10-20yrs you should sell now?
Of course it can. I am in one stock I saved personally, that looked dead for 4 years, with a 1.5 Mil dollar hole in its balance sheet.
It now owns 74.85 acres of land, the buildings, the plant/factory, is fully funded, and can change the way the world feeds cattle. It was .0005 at the bottom. I am holding for $20/share.
I bought Tgtx in 2009 at .001, it was road kill, in 2021 it hit over $50/share.
IMO, the current $RVVTF share price has nothing to do with Covid19 trial and status.
Snpw in 2020 hit .0005, and rallied it, with my own DD to .345 in 8 trading days. Perfect timing, with the right DD, on an OTC stock with billion shares float. It still 2 years later trades in 1 cents range the last 6-9 months. With a billion share float on no revenue.
There is MM/shorts BS games going on right now with RVVTF, and obvious fake news attempts to drive the share price down. And it has nothing to do RVVTF drug trials and its future.
Been in stocks for 45 years and OTC for 15 years...So I know what to look for, and I am one of the few with real science and engineering background, patents, grants and so on, that public company experience and stock market investing experience...
MF listed that as option 4
Of course if your down 5figures or worse it probably doesn’t make sense to sell and hope for some sort of partnership
The fact that it’s option 4 and some how MF now concludes this is the 4th option doesn’t entice me to buy. I made a trade on the dip and short lived rip
I don’t think a partnership will happen anytime soon but if I thought there was a real chance I will consider when this gets to .02 or lower
My eyes see that on the horizon before any big move north.
My opinion only Mike (Frank)
BS, Novartis gets, charges 1 Million dollars for its new drug, for each dose.
Facts Matter.
Keep up the good work Ecomike.
I continue to be a buyer also.
Keep up the good work Ecomike.
I continue to be a buyer also.
lol nice one
Ric is the only reason we aren’t at .02. He keeps collecting garbage rvv. Lossless
You’re using a 3 year old post from Pumper Mike as your basis?! LOL
He’s threatening people that email him over on the reddit boards with his lawyer. Laughable CEO behavior
MF he not stupidity or ignorance he 's full of craps.
Noticing a calculated trend by a bunch of FR??DS trying to CONvince everyone using misinterpretation, misquotations and blatantly false statements, that the only option is to sell out on the dirt cheap to BP........#scammers!!!
LIE #1 : You said it yourself. The only options here are to sell off to BP
I did??? I made no such comment. All I stated was that the handling of the ep process by RVV was inept but the fact remains that RVV has ZERO control over what the FDA requests so basically they were at the mercy of the FDA. One can only wonder IF the requests were valid, OR CONtrived to force RVV to capitulate, ie constantly raising the bar to ensure failure!?!?
LIE #2 : made a submission that was flawed, inadequate and thus doomed to fail? You mean like the pcr request which was explicitly outlined in fda documents as not an adequate endpoint?
Again, reread what I posted.....the pcr result ep usage was made prior to the type c consultations and therefore had nothing to do with RVVs decision to end the ep change quest. I clearly stated that they did not go forward because that would mean the trial data would need to be unblinded and since the original trial did not contain the data the fda requested it would have obviously failed solely on that basis. The false equivalence is purely asinine to put it mildly and the fact that being asked by the fda to REVISE a submission is falsely being referred to as FAILED, me thinks some should purchase a Dictionary. I am fully aware why its all being pushed in this hyper negative light so have at it..........
LIE #3 : Only option 4 re: strategic partnership is viable in terms of stockholder value and clearly no one believes that talks are happening cause the pps continues its downward spiral
What the market does is many times irrelevant to the actual value of a stock. As people panic seeing the fall in the pps they sell thus further depressing the pps even lower. None of this changes the fact that Buccy may still have great value as the science clearly shows. No one has control over what MMs, Hedgies or Board Agitators post in their attemmpts to create a narrative that RVV is worthless.
The screeching at this point is asphyxiating and the fact that its only intensifying speaks volumes, but by all means do CONtinue as I will be gobbling up as much as I can afford at this time!!! lololsss
Post from 2020 seems applicable now so w'ell see...................
Wednesday, December 16, 2020 6:50:03 PM
Post# 19945 of 35264
Before BIG NEWS breaks I expect a coordinated ""attack"" similar to or worse than today's drop off to 45.
When that happens it will involve a combination of Shorting, Misinformation via Media/Msg Board(s) and a coordinated sell-off by a "Team" of holders.
Today was just a test run IMO....witnessed it happen before.
WHEN GREED IS INVOLVED...EXPECT ANYTHING!!!!
@Eco.........no I dont, sorry.
He has been spineless for a year. He thinks he is this tough guy who is so great at his job but when it comes down to it he has done nothing for 3 years and when someone points that out he pouts and hides from shareholders. He doesn’t have the balls to face questions because all his lies would unravel.
CEO Michael Frank must address shareholders (at this alarming point). To not do so would be utterly spineless. And costly to all.
What kind of time table do you think this little company has with their limited resources to do all these things that you even admit takes BP years to complete Mike?
You want a 50-1 reverse stock split? How else do you imagine they avoid cash burn on the ~$3 million they have and the declare bankruptcy for BP to pick up for pennys?
You laid out next steps that could take years. A large long Covid study? 2 years? 3? It took that long for this study and then was when there were millions of subjects as possibilities
LOL No criticizing of an executive and company that has driven the stock price and shareholder wealth to all time lows.
Just shut up and do as told comrades.
And this perspective is why someone like MF who is out over his heels deserves criticism for not seeking out assistance. They brought in Biomedical Trader for consultation and then IGNORED his advice.
The orphan drug indication is a niche. They aren’t doing tens of thousands of these procedures a year.
Minimal revenues
If Revive is continuing the trial maybe they can add symptoms check this time to the protocol and give the FDA what they want for the next 700 patients. Nobody is going to the hospital whether they gulp down a placebo or Buccy.
ps. I hope none of us longs die before we are unblinded. That would suck.
The ceo was also not ready to launch the trial once the FDA gave the green light....even though he had many months to prepare in advance. Months got lost in him setting up and launching trial after the FDA gave the go ahead. That was the big red warning light for me! I knew then that his priorities were backwards and all about shrooms.
Eco, this is all fine and good but can Revive stay in business for the long haul??
Neither.
MF spending investor money in all the wrong places
Imagine if you participated in the offering at .15 just 10-12 weeks ago.
I’d call that a rug pull
Hmm yet mf said he was going to turkey. Enrolment would be starting mid February 2022. And yet he backtracked on that as well. If it was so cheap why wouldn’t he have started that trial and got the remaining patients he needed? Stupidity or ignorance? Probably both.
Of course I have no idea getting to 800 is enough if they go with high risk only lol .and how many they need ro go hospital in placebo. Maybe if we are merk they might let it pass lol.....
But I do agree with Bmt need a partner:)
Thanks for the cheap shares peeps. #averagingdown.
Do you think 100 patients at high risk is sufficient for the FDA? Seems too small a sample size. Plus we know how slow revive moves. Getting to 1,000 could take them a year to enroll. “Time kills all deals”
Not to mention the cash burn.
Thanks Rubber the main worry is funding;) 3.m maybe left for what? Maybe get to 800 with high risk... then can that data get partner ?
Ps. I believe what Bmt saying is true we need a partner to hopefully get to 1000.
I sold my trading position for a small gain
Offsetting the ~1300.00 bag I hold
All those big shots talking about buying the dip lol
Don’t be a sheep… oh for many too late
All options were laid out by RVVTF in this press release. As you stated the only viable option at this point would be a BP buyout.
They do not have the resources to continue the study or start fresh. They never were able to get Turkey going. They weren’t even able to get to their target enrollment with the US/Turkey.
Their current and revised endpoints have been rejected by the FDA.
They admitted their study does NOT contain/meet the suggested endpoints from the FDA.
There is nothing left but bankruptcy. Dropping Bucci for covid and pivoting fully to shrooms or psychedelics which will be years of waiting for recovery of the SP.
Or
BP buyout.
Take $.10-20 cents and call it a day. Let the investors recoup some losses.
The market has spoken
Fake news? As in factual press releases FROM RVVTF
No BP is interested
Your not seeing anything but hope and prayers
Your missing it again
The market reacted to the next steps. Only option 4 re: strategic partnership is viable in terms of stockholder value and clearly no one believes that talks are happening cause the pps continues its downward spiral
Speaking as an uneducated (in this game) ruminant, the prospect of that cheap buyout is what keeps me here. Taking a step back from the emotions of recent disappointment it appears likely that such a plan is in the works.
We shall see.
Baaaah.
For what it’s worth one should not forget that this is a ultra high risk penny stock. Like soooo many others on the otc, the vast, vast majority in this category fail or R/S which wipes out the SH. I personally have war wounds. IMO only $ one can afford to lose should be invested here. Ihub used to have a ‘OTC Graveyard’ board. It was huge. They finally removed it due to it negative connotations. JMHO.
This sounds like a claim that and recognition that $RVVTF #Bucillamine can be taken market.
Hmm
"By the way, i agree with Biomedical Trader who stated a few days ago that the only good thing that can happen at this point is for Revive to partner with a company who knows how to take a drug to market."
If the market does not trust MF and $RVVTF then market should sell and move and molest some other actual POS stock.
I am buying more shares.
There is company, OTC company that is doing their study in India for just 1 Million dollars.
A lot can be done wit 4.3 Million dollars
What I want to know is which BP firm is paying to try to extort a deal with the $RVVTF CEO for a cheap buy out using hedge fund backed MM naked shorts and buzzard bait fake news thoughts to keep trying to drive the share price down for an oversold buy out/deal
It is all too obvious to one who has the things I have seen
Exactly. Our only hope is letting BP step in. Their funding is mostly gone. They have no patients to continue a study with new EPs.
EcoMike touts the $3-$4 million they have from their latest offering as if you can fund a new trial or scramble to extend the current with everything that is needed to be done on that little sum of money.
Biomedical trader has been right every step of the way. I choose to trust him over Mikes claims of buying opportunities and market manipulation as the reason this thing may go to 2 cents in the next week.
The fat lady has sung
Yes and per your words in red this is done. You said it yourself. The only options here are to sell off to BP to try to salvage this or pivot to long covid which would likely need a new trial and years and millions of dollars in funding that they do not have. The fat lady has sung
Lol made a submission that was flawed, inadequate and thus doomed to fail? You mean like the pcr request which was explicitly outlined in fda documents as not an adequate endpoint?
It seems very obvious that many here screeching daily never actually read, and most importantly UNDERSTOOD what the PR actually stated...............pay special attention to the WORDS IN RED.
"After a further in-depth review and analysis of the FDA recommendations with members of the Company’s clinical trial team, including its statistician, regulatory affairs, medical affairs, and clinical research advisors, the Company has decided that in the best interest of the Study to preserve and not compromise the integrity of the Study and keep the blinded data intact to support a potential FDA approval in the future. As such, the Company will remain with the current Study protocol’s primary endpoint of proportion of patients meeting a composite endpoint of hospitalization or death from time of first dose through Day 28 following randomization. Although the Study was originally designed for a ‘hospitalization or death’ primary endpoint, and it completed enrollment of almost three-quarters of the Study’s recruitment goal and recorded specific clinical symptoms (i.e. cough, fever, heart rate, and oxygen saturation), the Study was not designed to take into account all of the symptom assessments and supporting data outlined in the FDA guidelines to warrant a primary symptom-based endpoint for COVID-19 studies."
According to the RVV team (NOT ME), the reason they decided against going with the FDA's ep parameters is solely because the original trial was NOT DESIGNED to collect the data the FDA was requesting.
Essentially what would have happened if the rvv team had accepted those ep parameters and the trial data unblinded and presented for review, the ep change submission would have FAILED and as such been rejected by the FDA since it could never satisfy the standards set, ie you cant pass an English test by answering in Greek!!!!
I can only imagine the Nuclear Meltdown that would have occurred if they had decided to ignore the data deficiencies and knowingly made a submission that was flawed, inadequate and thus doomed to fail.
I am simply restating the official position of the company from the PR, not my own, but if you or any of the other banshees have evidence that their claim is untrue do feel free to present same instead of posting incoherent nonsense.
I have already indicated that the handling of this whole ep process has been, IMO, inept so I am by no means an apologist for those responsible for this farcical waste of 6-8 valuable months.
Now, TRY AGAIN!!!
I said the same thing
Management is so incompetent
Meanwhile if rvv just moved forward with the new end points. The data could be unblinded for all to see
Instead MF keeps you and the sheep in the dark hiding in plain sight
Horrible outcome here for all you 24-36 bag holders
Keep us posted and I think if investors was in the offering at .15 they are down 70%
Just saying
By the way, i agree with Biomedical Trader who stated a few days ago that the only good thing that can happen at this point is for Revive to partner with a company who knows how to take a drug to market.
Unfortunately, i agree with you. I'm not expecting a response from Michael Frank but this is what i sent to him today.
===================================================================
Mr. Michael Frank,
Per the latest Press Release…
“After a further in-depth review and analysis of the FDA recommendations with members of the Company’s clinical trial team, including its statistician, regulatory affairs, medical affairs, and clinical research advisors, the Company has decided that in the best interest of the Study to preserve and not compromise the integrity of the Study and keep the blinded data intact to support a potential FDA approval in the future. As such, the Company will remain with the current Study protocol’s primary endpoint of proportion of patients meeting a composite endpoint of hospitalization or death from time of first dose through Day 28 following randomization.”
It would appear that the clinical trial with it’s current primary endpoint is essentially ‘dead in the water’ because the current primary endpoint is essentially outdated and it’s apparent that Revive can’t pivot to another meaningful primary endpoint that would meet the FDA’s guidelines. For someone who explicitly became a shareholder in 2020 based solely on Revive initiating this Phase III trial, it’s an understatement for me to say that i’m extremely disappointed with Revive’s management, more so when i’m looking at my unrealized +90% loss.
The best hope that shareholders have at this point is for Revive to do a deal, collaboration, or a partnership with a bigger more experienced pharmaceutical company who could then try to help salvage this trial and navigate Bucillamine through the FDA approval process.
XXXXX XXXXXXXXX
Revive Therapeutics Shareholder
(By the way, do you believe the individuals who participated in Revive’s Offering months ago are just as extremely disappointed when looking at their +50% loss?)
===================================================================
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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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