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You don't have to ask for it every day!
It's just greed !!
In present, the deads don't count. People who die after sickness aren't profitable for BigPharma anymore. Neither do people, who get healed after taking Zyesami. .... and healthy people who refuse to be vaccinated because Zyesami exists when get sick, wont be wellcomed by BigPharma.
It is only 1% that is affected, but a lot of money !!!
That's why BigPharma is interested in ensuring that Zyesami comes to market when everyone is vaccinated.
FDA is BigPharma's puppet that`s the reason !
Any other questions?
Big Pharma accelerates the pressure currently day by day. Now there are vaccines that are used worldwide and how have been expanded their shares ?
The highlights are over, everyday's life has returned and there are just small profits. The FDA will be blocked as long as nothing changes for BigPharma.
Please think of, who they are ? BigPharma invests billions in advertising and PR and then a small European pharmaceutical company comes along and cancels the bill?
Really, so it doesn't work that way !! You misjudge the situation. Remdesivir succeeds because it is a failure !!
Gr€€d must remain victorious at all !!
You will still be amazed about, what is possible when the puppets are dancing on a string.
These are facts! Believe it or not!
Here another publication from an US newspaper:
• The formation of so-called “non-neutralizing antibodies” can lead to an exaggerated immune reaction, especially when the test person is confronted with the real, “wild” virus after vaccination. This so-called antibody-dependent amplification, ADE, has long been known from experiments with corona vaccines in cats, for example. In the course of these studies all cats that initially tolerated the vaccination well died after catching the wild virus.
• The vaccinations are expected to produce antibodies against spike proteins of SARS-CoV-2. However, spike proteins also contain syncytin-homologous proteins, which are essential for the formation of the placenta in mammals such as humans. It must be absolutely ruled out that a vaccine against SARS-CoV-2 could trigger an immune reaction against syncytin-1, as otherwise infertility of indefinite duration could result in vaccinated women.
• The mRNA vaccines from BioNTech/Pfizer contain polyethylene glycol (PEG). 70% of people develop antibodies against this substance – this means that many people can develop allergic, potentially fatal reactions to the vaccination.
• The much too short duration of the study does not allow a realistic estimation of the late effects. As shown in the narcolepsy cases after the swine flu vaccination, millions of healthy people would be exposed to an unacceptable risk.
There is no need to fear vaccination, but it's important to be well informed !
@Penny
I hope, your hopes will be fulfilled, but don't blame me, if it doesn't work out this way !
You're right ! But the US dont discriminate against Relief as a Swiss Company. If all vaccinations are finished (probably May / June) then there is no emergency at all.
.... and without an emergency there is no EUA. Zyesami will be approved under the usual circumstances, regardless of whether there are more deaths or not!
It looks like, that is exactly what will happen !!!
Of course, I read what J-Belford just posted and I also know the future uses of Zyesami. I'm long with RLFTF myself;
.... but I also know how US authorities deal with Europeans.
No US citizen who didn't immigrate knows that. You won't get any help if you don't know how to help yourself;
.... on the contrary, it's even more difficult. That's what I meant when I said: "USA complains about the unfair trade conditions with China"
.... but the USA is not different!
So you should not hope for any EUA in the near future (.... even if NeuroRx is an US-Company)!
I don't know the book "Faucian Bargain" but....
just as the Russian vaccine "Sputnik V" never be approved by the EMA, the European vaccine "Astra Zeneca" will never be approved by the FDA with an EUA. Only Europeans cannot expect drugs to be approved in the USA, for them to be released in Europe as an EUA immediately afterwards ..
.... and both, Europe und USA complain about the unfair trade conditions with China.
Maybe someone thinks that Zyesami is different ? Even if it is distributed by NeuroRx, it remains an European product and once everyone in the US is vaccinated there is no longer an emergency ! Faire facts ! EOM
Amen !
That's all you can say ?
Assume that there are people out there, who invested their last money in the hope of huge profits soon.
... and now they even lost half of it!
How are these poor people supposed to find a stock that will make up for the loss?
So for some, it would be time to move on and find a better investment !
... if only they had the funds to do it.
They don't have it, so all they are able to do only ....is paid bashing !!
Don't be intimidated by know-it-alls (= naysayers)
The naysayers, who clearly have a hidden agenda are to be regretted actually. They believed to get rich immediately, have invested money that they need urgently themselves and have lost only.
Now they are all frustrated and express it this way !!!
... but unfortunately deleted!
Therefore, the FDA is in no rush to admit an EUA !!!
Don't forget budy! The stupid Europeans are 6 hours ahead of the smart US citizens.
.... and in Europe the PPS was 35% higher at 5:35 PM EMT already.
I am amazed that even you are saying something about that!
THATS WHY:
Even in the country of the own manufacturer, the vaccination strategy is changed with "AstraZeneca". Finland and Iceland are also following
There is no peace around the vaccine "AstraZeneca" from the British-Swedish pharmaceutical company: Finland, Iceland and Sweden are now changing their vaccination strategies. After potential complications after a corona vaccination with the vaccine, many countries are rowing backwards. No more people over 55 years of age will be vaccinated. 15 people have died last week and a lot suffer in hospital after been vaccinated.
Greatings from Europe !
If it is true that the EAP program will no longer continue, then some sentences from Dr. JJ's last interview are very easy to interpret, when he said among other things:
".... the ability to get this drug to any hospital over night is impressing ....!" and
".... wont need marketing and wont need to convince doctors"
It's up to you, to find out how this relates to the current situation.
... and the FDA cannot let thousands of people die, if their own behavior could prevent this. FDA will have to decide whether they have a responsibility to sick people or to big pharma.
In spring 2020, Donald TRUMP recommended the use of disinfectants to combat the pandemic. How that ended could be found out in the media shortly afterwards !
... but there are always people who follow such advice without thinking about the consequences.
.... and how are these pills taken when someone don't know himself that he is infected but is contagious to others already ?
Maybe I'm rash, slowly but surely it's enough !!!
It is time for the FDA to see how the deaths of thousands of people is challenging their reputation every day. The FDA doesn't seem to care about as long as vaccines remain to be approved.
It is likely, that these unfortunate people struggling with death no longer need these vaccines. It is not enough if Dr. JJ mentioned in an interview: ".... the ability to get this drug to any hospital over night is impressing ....!" whereas the FDA, as a government agency that is used to working at a snail's pace, can go back to it's business as usual. The FDA has taken on a responsibility that affects every single US citizen, especially at this time !!
FDA ....and what they deserve:
"Father don't forgive them, for they know exactly what they do !"
@changes_iv: thanks for this information !
Is there any more evidence needed why IMO the FDA is in bed with BigPharma? More and more people are suffering from anxiety, depression and other such disorders, such as hopelessness and despair, and the number of people has increased dramatically due to the COVID-19 pandemic.
….but read carefully what is going on:
The global anxiety disorders and depression treatment market size is projected to reach USD 13.03 billion by 2027, exhibiting a CAGR of 2.6% during the forecast period. Deterioration of mental health amid the COVID-19 pandemic will prove beneficial for this market postulates. Mental health has been one of the many casualties of the coronavirus pandemic, with anxiety, depression, and other such disorders becoming a commonplace occurrence in several parts of the world. According to a study conducted by the Boston University in September 2020, half of the adults surveyed by the researchers across the US displayed some signs of depression, such as feelings of hopelessness and failure, due to COVID-19.
Key prominent players covered in the Anxiety Disorders and Depression Treatment Market Research Report are:
Bristol-Myers Squibb (New York, U.S)
Johnson & Johnson (New Jersey, U.S)
Merck & Co. Inc. (New Jersey, U.S)
Pfizer Inc. (New York, U.S)
Eli Lilly and Company (Indiana, U.S)
AstraZeneca (Cambridge, U.K)
GlaxoSmithKline plc (Brentford, U.K)
H. Lundbeck A/S (Denmark, Europe)
and other key market players......
....they are all afraid of a drug that will bring back hope to everyone !
Relief has now decided to focus on further treatment options with Avaptadil and hopefully your disease will be among them. But it's doubtful whether the drugs will then be available in the USA.
Read what Relief will focus on in the future:
Relief, a biopharmaceutical company with its lead compound RLF-100TM (Aviptadil) in advanced clinical development to treat severe COVID-19 patients, and AdVita Lifescience GmbH ("AdVita"), a Germany-based, privately held pharmaceutical company developing effective products and strategies to improve the treatment and diagnosis of rare lung diseases, today announced the companies have signed a binding term sheet for Relief. The customary conditions as well as legal and securities regulatory approvals is expected to occur in Q2 2021.
Amongst the AdVita assets being acquired in this transaction, Relief will gain further pending intellectual property rights that may cover RLF-100TM inhaled formulation specificationsand the potential application of inhaled Aviptadil in the treatment of Acute Respiratory Distress Syndrome (ARDS) and Checkpoint Inhibitor-induced Pneumonitis (CIP).
"AdVita's intellectual property around inhaled formulations of Aviptadil and its team's expertise with Aviptadil will be invaluable as we move forward with the development of the inhaled formulation of RLF-100(TM) for the treatment of COVID-19-related ARDS, as well as other potential lung disease indications, such as pulmonary Sarcoidosis and Chronic Beryllium Disease," said Jack Weinstein, CFO and Treasurer of Relief. "We look forward to initiating the development of inhaled RLF-100(TM) in Europe within the coming months for COVID-19 patients using inhaled Aviptadil. Furthermore, we plan to re-start a clinical development program for RLF-100TM in pulmonary Sarcoidosis later this year."
Dorian Bevec, Ph.D., CSO of AdVita, commented: "We are excited to combine our specific expertise in inhaled formulations of Aviptadil with Relief's comprehensive scientific catalog of the compound and its uses in respiratory diseases."
In the previous posts you can see how valuable VIP is to humanity ... only the FDA is not yet convinced of it. But leave them alone, there are others - also in this forum - who have already recognized this.
Scientists and other major investors have been trying to establish a partnership with RLF for a long time also.
... the winners are certainly not those who are now trying to bring RLF to its knees (with the help of the FDA?)
... Finally, there is no point in changing anything, if the FDA thinks, RLF has to go in their direction.
In my post # 36749 I tried to communicate that Dr. JJ certainly doesn't wait for the FDA, until they feel called to give an EUA.
Only one user understood Dr. JJ's words (see # 36756)
.... and now you will have to learn German in order to follow the further development:
https://advita-lifescience.com/
Something worse has to happen for the FDA to wake up from sleep and take note of good news (see Post # 36769 and 36774).
This is exactly the point I made in my previous posts. Zyesami is a very valuable and successful drug for the treatment of Covid19. But not only for Covid19, if you think on PAH, COPD, asthma and other lung diseases.
The clinical application of VIP is only possible by specialists and will be continuously improved. .... and that costs a lot of money and as you say rightly: the only way to obtain funds is to get the EUA.
But: "... the Tigers come at night" (from "Les Miserables").
IMO together with the FDA, BigPharma is waiting to swallow the goldfish. Will that work? I don't know, but Dr. JJ doesn't care! Its ultimate goal is not Covid19. Follow the video (from 44:41), then you know what's going on:
I hope I expressed myself well, my mother tongue is not English!
What did Dr. JJ mean:
I hope you are up to date and know what Zyesami could be used for. NeuroRx has applied for EUA for a treatment of Covid19 only!
.... but FDA requires all clinical test data. WHY ?? Dr. JJ knows why he says only that he wont need marketing and wont need to convince doctors.
The data he is holding back is secret for further developments!
Conclusion: FDA will have to give the EUA ..... sooner or later!
Now Pfizer's problem: They are very well marketed, have enormous acceptance and have the experience of vaccinating an entire population of a state. Their success is greater than the competition has. Today I read a post: "If Zyesami is on the market, I wont get vaccinated!" That's the point! .....and Pfizer fights for each single vaccine (together with the FDA?).
Any drug or vaccine devours huge sums of money before they are developed to the point where they can be safely used. Every unexpected effect, whether positive or negative, is valuable for further development and improvement. ..... and the more result data are available in a short time, the more successful the treatment and above all, the acceptance will be. .... and acceptance means sales and profits.
What have you heard from Moderna and Astra Zeneka so far?
Isn't it possible for a single person to obtain Zyesami through a court order? I am sure that this would be of mutual benefit. If this makes pegs healthy, it would be a huge success for NeuroRx also.
Sorry, I meant the video in post # 36662 instead of # 36656
My sarcasm was against the FDA. I understand your need and I deeply regret your situation. On the other hand, it is certainly also due to Dr. JJ, who does not disclose his data in full. Please read my post # 36667 and afterwards 36656 so you know what I mean. Go back in the video to 41:44 and hear exactly what JJ says.
I'm also sure FDA will eventually have to clear it, but right now there is a battle going on between NeurRx / RLF, FDA and Pfizer.
The FDA doesn't care about sick people who urgently need new drugs. What do you actually imagine to make such demands?
Sarcasm off !!!
Watch the video again, listen carefully to what JJ is saying, and figure out what he might mean by that !
Today I read a report in a German newspaper:
Millions of vaccination records from Israel: a bargain for Pfizer
The state passes on anonymized data to the pharmaceutical giant. Israeli Prime Minister Benjamin Netanyahu knew it from the start: "Our agreement with Pfizer will make Israel a global model state for quickly vaccinating an entire country." The data could have been sold too cheaply. In other words: Pfizer made a bargain. Vaccination data that flow from Israel's vaccination world record to the pharmaceutical giant are already worth more than the ten million ampoules of the Covid vaccine from Biontech / Pfizer that Israel has ordered.
Once again it is confirmed that the FDA has no responsibility to the sick, but is listening to BP's command. While vaccines continue to be approved very quickly, thousands die who no longer need them.
If I do not help injured people after an accident, it says: "Omission of help" (in Europe it's a crime! In the US?) At the moment there is a long line of people who are urgently looking for help. .... but the FDA refuses, because they don't know what they are doing!
Someone, who doesn't look after a dog won't understand!
IMO the FDA should finally understand what is being neglected through their fault!
Read the translation from a German newspaper (02/24/2021):
The US authorities are currently on high alert because of corona mutants. These mutations, discovered in New York and California, are more contagious and aggressive than the original pathogen.
According to scientists, the New York mutation is a variation called B.1.526. This was first detected in November 2020, as reported by the New York Times.
Scientists from the California Institute of Technology and Columbia University did research on the mutant. The involved immunologist Nussenzweig then expressed concern that the mutant could weaken vaccinations and also people who have already had an infection with the virus could become ill again.
Meanwhile, in California, B.1.427 and B.1.429 cause fear and horror. Both variants are also more contagious and aggressive than the previously known type.
According to a study by the University of California at San Francisco, infection with the mutant makes a patient five times more likely to need intensive care. In addition, the probability of death is eleven times higher.
An expert told the Los Angeles Times: "This mutant will probably account for 90 percent of all infections in California by the end of the month."
It's quite OK what you say, but is an EUA from the FDA necessary for worldwide approval?
Why they do not bother about approvals outside USA?
They should let the FDA alone! FDA don't know what to do if BP does not agree!
They need another halfmillion people died, to understand!
Yes! I agree 100% !
It's time for that board to get rid this rat forever.
Whatever ownsnap has to offer, the facts are:
The British virus is spreading surprisingly fast in Europe. The number of people suffering from Covid19 is increasing rapidly and the third lockdown is already under discussion!
.... and the Europeans are so stupid and wait until the FDA approves urgently needed drugs!
As already mentioned before: ... because they don't know what they do!
PS: Hungary showed the EU (a lame duck) how to act in this case. They bought vaccines in Russia and don't care about European Union approval.
Read Post# 36238 !
BP is not interested in drugs being released until the vaccines are sold. Who will be vaccinated if medication is also helpful?
Hopefully the last message?