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Dumbfounding. One would think after the first correction the FDA would say no we need XYZ. Very bizarre this vague back and forth. As stated either RVVTF is truly inept. Or the FDA is crooked. Both are believable IMO
Perhaps they don’t have any idea on how long it will take to reply?
Unlike previous News Releases this latest one doesn't provide a "goal date". It would be nice to have something to aim for even if the target date is missed, once again.
Weren’t they in constant communications with the FDA?
Something doesn’t seem to make sense
The back and forth between rvv and the fda for the past 6+ months has been extremely odd.
They were supposedly engaging in mutual consultations re the type c meeting to come to an agreed submission but lo and behold the most recent submission was once again deemed lacking in certain areas so its back to the drawing board as is said.
The question is, whos to '''blame"", per say, for past failings, and this most recent shortcoming......is the process being deliberately slow walked for some unknown reason???
Is it that the rvv med team keeps misunderstanding/ignoring the fda's instructions because of ineptitude, or is it that the fda is being vague and as such keeps using this confusion as cover to continuously "raise the bar" re the ep change???
IMO, the fda could simply state exactly what they expect from the submission, which rvv could then incorporate and then present for review so the process could then move to the data review stage.
Again IMO, it simply makes no sense why such a basic step is being prolonged for this length of time, especially when one looks at how much more complex issues (involving BP) have previously been rubber stamped.
Finally per your question, only time will tell since answering that would require actual insight into interactions between both parties, which none of us have.
@white chocolate 250.................was denied a $1M loan by the bank....but was told go add some zeroes to my assets and come back for review. lololololssssss
"Denied" (Deny) is a Synonym of "Turned Down" so you basically did state that the fda Denied rvv.........FALSE!!!!
SYNONYM: a word or phrase that has the same or nearly the same meaning as another word or phrase.
English 101....................
Would you prefer the words denied instead of turned down? They asked for endpoint change with two different endpoints and both times were told no those won’t work. Open your eyes.
Interesting
Didn’t RVVTF state this in November 2022?
“The FDA has now requested additional information, which would include clinical data, for them to agree on the Study’s revised endpoints. The Company plans to go over with the FDA the overall development plan for Bucillamine in COVID-19 and further review the Pre-Dose selection data that would support the appropriate endpoints.”
Are they going to provide the FDA with what they are looking for now?
i am trusting the science
Gatorade
The shot (aka) does not prevent the virus infection. Only in some cases somewhat mitigates the severity of the Chinese virus buy with numerous debilitating side effects.
and both times got turned down
Seems theres a serious issue with basic comprehension......rvv was never TURNED DOWN.
There were issues with their applications and the FDA made recommendations for changes and rvv complied, so the process continues.
I will reiterate......posting false info is deceptive.
As for the placebo issue, as I stated before I did my DD and found no such info but I chose not screech daily about it since I can neither confirm, nor deny that claim with 100% certainty.
I can however challenge the lie that rvv has been TURNED DOWN with full confidence!!!
:)) I remember that commercial like it was yesterday.
Rubber.....that was great.....almost pee my pants.
p.s How do you even find something like that.
Haha posting inaccurate information? First time was pcr and they told him to try again. Second time was 2 symptoms and they told him try again.
You want to talk about inaccurate information just look at the post claiming there was a death and multiple icu admissions. Yet when questioned these guys can’t produce the evidence. You didn’t comment on that inaccurate info did you?
theswordman...just seeing some here with long covid & a family member that has issues, it would be a great thing if we get approval and "B" works the way we hope. I never really understood all the technical lingo and appreciate it when people who do great DD put it in terms that a average joe can understand.
So this can be explained by viral persistence. There is a disconnect in medical community where a lot/most Drs (even Patterson et al) believe that as there is no replication (PCR negative) there is not a viral issue.
BUT--if you read other papers/Drs--they show where even the PCR negative patient--tests are positive thru stool test. So even though there is no viral replication--there is viral persistence
Easy enough if you visualize the folds/turns just in 20+ ft of intestine alone. Add in some endothelial damage etc and any organ can be damaged. Happens fast--for some. For others it is taking time but will not end well, damage is damage. Slow or fast
A new study published in Nature Communications aims to shed at least some light on common long COVID symptoms. The study analyzed data from 154,068 people in the Veterans Health Administration system who had COVID-19 and compared it to about 5.6 million people with similar characteristics who did not have the virus. The researchers discovered that people who had COVID-19 were 36% more likely to develop long-term gastrointestinal issues they didn’t have before they got the virus. More than 9,600 of those patients who had COVID-19 developed issues with their digestion, intestines, pancreas, or liver.
Lets hope Bucillamine can be a great treatment for some of the issues with long covid.
New York City Rats Carry COVID-19, Study Finds
3
Simmone Shah
Fri, March 10, 2023 at 1:50 PM EST·2 min read
nyc-rat
insert-text-here
A rat is seen in a street of New York City on Oct. 19, 2022. Credit - Lokman Vural Elibol/Anadolu Agency—Getty Images
A new study has found that not even New York City’s rats are immune to COVID-19.
The study, published in mBio, the American Academy of Microbiology’s journal, found that wild rats in the city’s sewer system and elsewhere in the city have been exposed to SARS-CoV-2 and demonstrated that rats are susceptible to infection with Alpha, Delta, and Omicron variants of the virus.
“Our findings highlight the need for further monitoring of SARS-CoV-2 in urban rat populations and for evaluating the potential risk of secondary zoonotic transmission from these rat populations back to humans,” the authors wrote in the study.
The researchers wanted to understand whether the virus in humans had been transmitted to rats, as well as which variants rats were susceptible to. The team set up two trappings near locations surrounding wastewater systems and captured 79 rats from three sites in and around city parks in Brooklyn in the fall of 2021, when Delta was dominant.
Read More: Why Animals Are Less Vulnerable Than Humans to Omicron
Thirteen of the rats (about 16%) tested positive for COVID-19, and the researchers used genomic analyses to determine a possible link to the viruses that were circulating in humans during the early stages of the pandemic. “To the best of our knowledge, this is one of the first studies to show SARS-CoV-2 variants can cause infections in the wild rat populations in a major U.S. urban area,” said Henry Wan, director of the Center for Influenza and Emerging Infectious Diseases at the University of Missouri and the study’s principal investigator, in a news release.
By giving wild rats samples of different variants through the nose, the researchers also found that Alpha, Delta, and Omicron were able to infect the rats.
The U.S. Centers for Disease Control and Prevention says that there is little risk of animals spreading COVID-19 to humans. But Wan said the findings highlight the need for continued monitoring of rats to watch for potential evolution of new strains of the virus that could be a risk to humans.
“Overall, our work in this space shows that animals can play a role in pandemics that impact humans, and it’s important that we continue to increase our understanding so we can protect both human and animal health,” he said.
"He is also the one who has tried twice to change endpoints and both times got turned down"
Reading and Comprehension 101........................
Posting inaccurate and deceptive nonsense isnt a good look.
The attempts at crafting a certain narrative of possessing a full grasp of revive's position after a grand total of 8 posts is truly comical..
Give me a $1 a share and kick MF to the curb at this point
At this point take $500 million and run as far from frank as you can. No company will buy revive for billions. They are looking at frank right now and laughing at his incompetence. They would destroy him in any negotiation. You don’t see the bp CEO’s taking stupid photos or making idiotic videos. It’s called professionalism, which frank doesn’t have.
Thanks Blue. There will be some here that have been hit far worse than me, so let's wish for improved health and wealth for us all, courtesy of Bucillamine.
P.S. Soon would be nice Michael. Thanks.
I'm with you on the three years, it's been a 10,000 mile marathon without water.... I have to see this to the finish as well....
Wishing you improved health Rubber!
White Chocolate....not really blaming them....just saying there is enough of money/market for everyone and In my opinion I do think there is some under table dealings that go on....you see it in every department of government.....so to get back to my post,yes I think BP needs to stop being so greedy but would love them to buyout this company for a nice 8-10 billion.
Its coming on three years of holding this ticket. Holding on to the bitter end or glorious finale.
I have great faith in treatments that may not necessarily be prescribed by mainstream medical. With your advice I may be back to my old self before Bucillamine has its day, although I'd be happier throwing it into the mix too.
Really? You’re blaming bp for this? It’s time you look at the ceo. He is the one that was handed a phase 3 trial and couldn’t get more than 715 people in over two years. He is also the one who has tried twice to change endpoints and both times got turned down. And one time he blatantly went against fda guidelines. And I don’t want the excuse that it’s not him looking at the data and choosing the endpoints. He is the ceo. He brought in the band of idiots that can’t read and can’t get the right endpoint the fda will accept. If he wouldn’t have the ego he does this would have been done long ago. He is at fault here.
And the mother in law? ;)
As always, your advice is appreciated Eco. That's quite a shopping list but I'll give it a go.
Some times, now the best action is to let shorts and flippers over play their hand, while beasts and whales load up, before they just rush the ask, because they can, even with no news, to bear trap the shorts and flippers and make them chase and panic cover. Seen it on lot of stocks lately..
Never show the whiners and shorts your hand in advance....
Especially in this market.
That is over 100% more hospitalized in the placebo group than the Paxlovid group. How is that bad?
Friend of mine that knew, I knew, how to beat covid19 (improve the odds), used several of the key supplements I told him to take, starting the day after he tested positive for covid19. He panic called me the day he got it from his parents (Rather than have it before hand, and take it daily for prevention of serious covid)..
He took them for 2 days, felt so good, (And he hated taking pills, to like so many antivaxers hate shots) he stopped taking them, and days later ended up on a ventilator for 12 weeks.
Docs were about the pull the plug and let him die, and were discussing it in the room he was in, we woke up, sat at, pulled the ventilator out.... And shocked the MDs.
Days later the MD Spanish Inquisition interrogated him, wanting to know what had been doing recently, LOLOLLLLLssssss.
Turned out the premature birth lung damage he had for almost 60 years, and the expected crushed glass lung damage from Covid19 (Delta) and ventilator they expected to see, were not there. In fact his lungs looked brand new.
He knew the MDs would not believe him, so he laughed....
The mega D-3, Vit C, Zinc and copper, and most importantly IMO, the NAC, was a key, main thing he took those first 2 days that made the extra difference.
That might help you?
Also, 2 months on a ventilator from Covid19 is sort of a long haul covid deal... And Bucillamine is 16X more active than NAC.
Oh, add to my earlier list the Vit D-3, I am sure you take already, 5,000 IU /day minimum
One does not shred and toss out a life changing lottery ticking, before the winners are announced.
A famous American once said "We have nothing to fear, but fear itself"
"I still have constant rushing in my ears" ,
Add 3 mg/day copper gluconate to the daily dose of 50 mg/day of zinc gluconate
"reduced lung function/energy"
NAC 600 mg one to two times a day, as needed. Liposmal CO-Q10 and Magnesium Gluconate with Calcium Gluconate (1:2 ratio)
"and difficulty grabbing bits of information from my brain at times"
300 mg/day of CDP Choline (or up to 500 mg/day of Alpha GPC Choline) for over night photographic memory (taking antihistamines increases the need to take more Choline). TH brain needs Choline to make acetyl Choline that the brain uses to store memory
"Blood tests from my last two Annual medicals indicate my liver shows signs of damage that is inconsistent with my lifestyle".
The liver needs absorb-able magnesium (Chelated) because hundreds of liver enzymes need it to work their magic. But it must 2 part calcium to one part magnesium for proper hearts and other muscle operations.. (Google human heart + Calcium + magnesium Pump).
Also, take Liposmal Milk Thistle (Life extension has it now) for the liver.
My liver number are perfect, in spite of the of the weekly chemo-RA drug I take, Methotrexate.
Also get Ultrasound and check the Gal Bladder and Bile ducts for gall stones, blocking the liver bile drainage plumbing...
CW
And they just keep churning out the commercials. They have no shame.
Wouldnt hurt to hear something.....how much worse can it get right now.At least some kind of time line......is it a couple weeks away or a couple months away.......for me it dont really matter Im not selling anything I will just hang on....I could sell and get back $21,000 of my $60,000 but right now in my life that $21,000 aint going to change much for me....worth the wait and see.
I don't believe that is too much to ask.
What difference will it make.
CEO Michael Frank, please address shareholders in a personalized note. Firmly believe this is wise and merited at this point. Many of us long term once continue to place considerable faith in you and are holding on with vast paper losses. Time-sensitive at this point I would say. Please give us at least a ‘team pep talk’.
Who else from the investor side agrees hearing from MF is more than appropriate at this time?
Been invested for over 2 years and so far after all this waiting I lost 2/3’s of my money. So sad to see something with so much promise not get recognized. I blame it on BP and FDA, GLTU!
It’s unfortunate no doubt. We need MF to consider his responsibility to shareholders which I don’t see evidence of yet
If the drug really works like the pumps say why not partner?? Think how many millions would be made in such a scenario
If we sitting in the same spot 6 months from now a nickel might be too optimistic
All my opinion only
It would be nice if BP would stop being so greedy....there is enough for everyone,this is never going away
lets hope our data is great and we can start moving up................Coronavirus Mutates To Escape Immune System
The virus often mutates by simply deleting small pieces of its genetic code. The mutations "disguise" the virus from antibodies
Your nickel prediction may come sooner than getting back to double digits. Such a shame. I hate losing money!
Dr Boulware thinks pax. Is only useful for high risk elderly or immunocompromised
likely near zero benefit if vaccinated/survived prior infection.
So what's my overall take away?#Paxlovid is useful for high risk elderly or immunocompromised.
— David Boulware, MD MPH (@boulware_dr) March 16, 2023
Actual absolute high risk, not the CDC basket of higher relative risk.
If age <60yo and with a normal immune system, likely near zero benefit if vaccinated/survived prior infection.
So Pfizer can put out a crap product and make billions in profit,while we sit here with
one of the best product to help people and keep getting pushed back.Maybe they were
waiting to put this report out before letting us fly......maybe Pfizer will buy us out and
label bucillamine as Paxlovid.
p.s Thought Pfizer said it was 90% effective......seen this - In its initial clinical trials, Paxlovid was nearly 90% effective at preventing hospital stays or death due to COVID-19 in high-risk people. Other studies suggest that the benefits of Paxlovid are especially evident for older adults.Feb 6, 2023
Stop the bleeding...give us something to hang our hats on. I can't keep dumping money in this penny stock, need something more to go on. Being down 73% is tough to swallow.
but at least it's 50% more likely to keep you out off the hospital (3 for pax vs 7 with placebo).
For those who haven't seen the numbers: It makes you worse.
#Paxlovid effect on reducing #COVID19 hospitalizations in vaccinated population finally revealed to the public by FDA. #IDTwitter 0.9% (3/317) paxlovid vs. 2.2% (7/314) placebo
Here's to hoping for some dollars for you and a treatment for your sister.
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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.
| Psilocin Pharma Corp. has developed production solutions for the active compound Psilocybin. Our process encompassed with our intellectual property cover methods of production of Psilocybin based formulations. Psilocin Pharma Corp’s range of products have been engineered to work synergistically with the body's own natural pathways of absorption while offering a contemporary approach to consumption. Psilocin Pharma also has strong relationships with specific lab partners in certain areas like Brazil, where these formulations are legally approved and plan to sell products in these jurisdictions. | |
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