Romans 12:19
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...same here from .60 sell to .90's buy-back.. up now though.. w/more shares.
$RLFTF (opinion) by Zaran on Yh0 - We've finally reached the stage of this "game" where therapeutics are going to start be-ing the "go-to" drug of choice.
If the vaccines can't keep pace with the variants and/or just aren't as effective as hoped for and anticipated then the therapeutics are, of course, next on the agenda.
As said recently, big Pharma and Governmental agencies have painted themselves into a corner and Zyesami is and has been patiently awaiting it's turn to be lead onstage for it's introduction to the World.
As basically the only therapeutic for the most critically ill and therefore for the moderate and severely ill, also, right? this drug is mandated by "all" criteria for an EUA within the next two weeks.
Saroja, as always bringing new, good news to light shines our focus on the inhaled trial, too, with it's August 15th. primary completion date.
The heat is building for the fire to begin and then to explode in flames stimulating increasing share valuation. We are very close to beginning this race to fill the medicine chests of the World's hospitals and Governmental agencies anxious to have a therapeutic to save the most seriously ill from Covid-19.
We are poised and ready, don't shoot your load too quickly as this story is in the early stages of unfolding. The taste of victory is sweet, sweet still is the taste of victory with patience and forethought.
$NRXP $RLFTF DD by Lars on Yh0
Here something nice to read
https://ichgcp.net/de/clinical-trials-registry/NCT04360096
$NRXP $RLFTF DD by Lars on Yh0
Here something nice to read
https://ichgcp.net/de/clinical-trials-registry/NCT04360096
$RLFTF $NRXP DD (opinion) by Equalizer on Yh0 - Dr J & Ram, hopefully someone on your staff will forward you this article;
it highlights the dangers that current mainstream Covid treatments such as steroids, antibiotics & others which are causing other unanticipated and serious issues for Covid patients.
versus RLF Aviptadil which causes none of these issues
incorporate this information into your submission, research, marketing and sales materials.
And get in touch with Sr Tom Chiller from the CDC.
When Covid-19 emerged, doctors found that the best tools in their arsenal to fight the virus were steroids, which happen to be immunosuppressants.
Wary of secondary bacterial infections in intensive care units, doctors often gave coronavirus patients broad-spectrum antibiotics as a precaution.
But the combination of lungs battered by Covid, impaired immune systems, and both good and bad bacteria wiped out by antibiotics left critically ill patients exposed to moulds and spores.
“It’s an unfortunate perfect storm for these organisms, and we’re seeing it,” said Dr Tom Chiller, the chief of the Mycotic Diseases Branch at the US-based Centers for Disease Control and Prevention (CDC).
From The Guardian, 7/1/21, Covid Perfect Storm
See link in comments
GLTA Longs
https://www.google.com/amp/s/amp.theguardian.com/science/2021/jul/01/covid-perfect-storm-as-more-patients-hit-by-fungal-infections
$NRXP $RLFTF DD (opinion) by Equalizer on Yh0 - Dr J & Ram, hopefully someone on your staff will forward you this article;
it highlights the dangers that current mainstream Covid treatments such as steroids, antibiotics & others which are causing other unanticipated and serious issues for Covid patients.
versus RLF Aviptadil which causes none of these issues
incorporate this information into your submission, research, marketing and sales materials.
And get in touch with Sr Tom Chiller from the CDC.
When Covid-19 emerged, doctors found that the best tools in their arsenal to fight the virus were steroids, which happen to be immunosuppressants.
Wary of secondary bacterial infections in intensive care units, doctors often gave coronavirus patients broad-spectrum antibiotics as a precaution.
But the combination of lungs battered by Covid, impaired immune systems, and both good and bad bacteria wiped out by antibiotics left critically ill patients exposed to moulds and spores.
“It’s an unfortunate perfect storm for these organisms, and we’re seeing it,” said Dr Tom Chiller, the chief of the Mycotic Diseases Branch at the US-based Centers for Disease Control and Prevention (CDC).
From The Guardian, 7/1/21, Covid Perfect Storm
See link in comments
GLTA Longs
https://www.google.com/amp/s/amp.theguardian.com/science/2021/jul/01/covid-perfect-storm-as-more-patients-hit-by-fungal-infections
... buying..
$POETF $PTK Poet Technologies Home
https://poet-technologies.com/index.html
..Im sorry they felt the need to put that news out.. you should put in a complaint w/IR
$RLFTF (related) DD by Mt on Yh0 - RELIEF AND APR APPLIED PHARMA RESEARCH SIGN AND CLOSE DEFINITIVE AGREEMENT FOR RELIEF TO ACQUIRE ALL OUTSTANDING SHARES OF APR
https://relieftherapeutics.com/newsblog/relief-and-apr-applied-pharma-research-sign-and-close-definitive-agreement-for-relief-to-acquire-all-outstanding-shares-of-apr
---
Check the corporate presentation:
https://www.apr.ch/wp-content/uploads/2021/05/20210406-APR-Presentation-NC.pdf
Huge pipeline, great revenue...
$RLFTF (related) DD by xuehanyu on Yh0 - From APR's website, "To sum up APR is a profitable, debt-free corporation with a positive cash flow."
https://www.apr.ch/applied-pharma-research/pharmaceutical-customers/ xuehanyu on Yh0 - From APR's website, "To sum up APR is a profitable, debt-free corporation with a positive cash flow."
https://www.apr.ch/applied-pharma-research/pharmaceutical-customers/
$RLFTF $NRXP Serge on Yh0 - This is an extract from contract. NRX is binded to Relief, whatever they do with aviptadil-RLF100 or Zyesami.
All IP, including all Patents or Information, that is related to the Collaboration or the Product and (a) is or was created, developed, invented, made or enhanced by NeuroRx, any of its Affiliates, Dr. Javitt, or any Third Party vendor or service provider for or on behalf of NeuroRx, any of its Affiliates or Dr. Javitt, (b) is owned or licensed by NeuroRx, any of its Affiliates or Dr. Javitt, or (c) the creation, development, invention, making or enhancement of which was funded in any manner by Relief (all such IP, “Prior IP”) is set forth on Schedule A hereto.
$RLFTF $NRXP Serge on Yh0 - This is an extract from contract. NRX is binded to Relief, whatever they do with aviptadil-RLF100 or Zyesami.
All IP, including all Patents or Information, that is related to the Collaboration or the Product and (a) is or was created, developed, invented, made or enhanced by NeuroRx, any of its Affiliates, Dr. Javitt, or any Third Party vendor or service provider for or on behalf of NeuroRx, any of its Affiliates or Dr. Javitt, (b) is owned or licensed by NeuroRx, any of its Affiliates or Dr. Javitt, or (c) the creation, development, invention, making or enhancement of which was funded in any manner by Relief (all such IP, “Prior IP”) is set forth on Schedule A hereto.
$RLFTF $NRXP DD (opinion) by Mt on Yh0 - Maybe not new (June 5th), but if you doubt about our ability to get EUA :
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8179120/
"Currently, two available commercial dosage forms of synthetic VIP (Aviptadil in intravenous and inhaled formulation) are under two clinical trials for COVID-19 patients with respiratory failure (clinicaltrials.gov: NCT04311697 and NCT04360096).
Considering all the above-mentioned advantages, besides the exceptional safety profile of VIP and the affordable manufacturing of its synthetic forms, VIP could have the potential as a preventive measure and even therapeutic agent for patients with COVID-19 infection."
Critical covid is only the first step.
$RLFTF $NRXP DD (opinion) by Mt on Yh0 - Maybe not new (June 5th), but if you doubt about our ability to get EUA :
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8179120/
"Currently, two available commercial dosage forms of synthetic VIP (Aviptadil in intravenous and inhaled formulation) are under two clinical trials for COVID-19 patients with respiratory failure (clinicaltrials.gov: NCT04311697 and NCT04360096).
Considering all the above-mentioned advantages, besides the exceptional safety profile of VIP and the affordable manufacturing of its synthetic forms, VIP could have the potential as a preventive measure and even therapeutic agent for patients with COVID-19 infection."
Critical covid is only the first step.
$RLFTF (related) $NRXP ZYESAMI™ (Aviptadil acetate), a synthetic form of human Vasoactive Intestinal Peptide, an endogenous substance produced by the body that amongst other functions helps protect cells against inflammatory conditions.
(VIP) has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA)for the treatment of Critical COVID-19 with respiratory failure, and is now in clinical trials.
Rapid recovery from Critical COVID-19 with respiratory failure has been reported in patients treated with open label VIP under an FDA Emergency Use IND and/or the Expanded Access program.
It must also be noted that Administered as an intravenous infusion the key side effects seen in the Expanded Access Program as well as the placebo controlled trial are diarrhea (~ in 1/3 of patients), hypotension (lowering of blood pressure). Emerging data indicates that VIP binds uniquely to receptors on Alveolar Type II cells in the lung, the same cells that bind the SARS-CoV-2 virus via their ACE2 receptors.
VIP protects those cells and the surrounding pulmonary epithelium by blocking cytokines, preventing cytopathy (cell death), and upregulating the production of surfactant, the loss of which is increasingly implicated in COVID-19 respiratory failure. Furthermore, emerging preclinical data suggests that VIP inhibits the replication of the SARS-CoV2 virus. https://www.nrxpharma.com/
$NRXP ZYESAMI™ (Aviptadil acetate), a synthetic form of human Vasoactive Intestinal Peptide, an endogenous substance produced by the body that amongst other functions helps protect cells against inflammatory conditions.
(VIP) has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA)for the treatment of Critical COVID-19 with respiratory failure, and is now in clinical trials.
Rapid recovery from Critical COVID-19 with respiratory failure has been reported in patients treated with open label VIP under an FDA Emergency Use IND and/or the Expanded Access program.
It must also be noted that Administered as an intravenous infusion the key side effects seen in the Expanded Access Program as well as the placebo controlled trial are diarrhea (~ in 1/3 of patients), hypotension (lowering of blood pressure). Emerging data indicates that VIP binds uniquely to receptors on Alveolar Type II cells in the lung, the same cells that bind the SARS-CoV-2 virus via their ACE2 receptors.
VIP protects those cells and the surrounding pulmonary epithelium by blocking cytokines, preventing cytopathy (cell death), and upregulating the production of surfactant, the loss of which is increasingly implicated in COVID-19 respiratory failure. Furthermore, emerging preclinical data suggests that VIP inhibits the replication of the SARS-CoV2 virus. https://www.nrxpharma.com/
$RLFTF $NRXP DD (opinion) by WONG on Yh0 - Seeing the stark difference between tertiary hospitals and regional hospitals we now have our answer as to why Aviptadil was selected for the ACTIV-3b trial.
The NIH wants to see how well Aviptadil works in a controlled setting. It is basically a continuation of our trial with real time data streaming in.
This proves that they believe it is safe and MAY be effective. By putting Aviptadil in this trial and allowing the EAP to continue is all I need to know to feel confident that an EUA will be issued. Hold or load.
$NRXP $RLFTF (w/link) Kpags on Yh0 - NRx Pharmaceuticals and Nephron Pharmaceuticals believe that the mechanism by which aviptadil rapidly degrades in solution has been identified and formulation, manufacturing, and container closure innovations have been developed to counter this degradation.
As of June 15, 2021, NRx Pharmaceuticals has initiated GMP manufacturing of ZYESAMI™ and anticipates a long-term stable formulation that will have the potential to be stockpiled should ZYESAMI™ be deemed safe and effective by the FDA.
From the filing today.
https://ir.stockpr.com/neurorxpharma/sec-filings-email/content/0001193125-21-200558/d175615ds1.htm
$NRXP $RLFTF Kpags on Yh0 - NRx Pharmaceuticals and Nephron Pharmaceuticals believe that the mechanism by which aviptadil rapidly degrades in solution has been identified and formulation, manufacturing, and container closure innovations have been developed to counter this degradation.
As of June 15, 2021, NRx Pharmaceuticals has initiated GMP manufacturing of ZYESAMI™ and anticipates a long-term stable formulation that will have the potential to be stockpiled should ZYESAMI™ be deemed safe and effective by the FDA.
From the filing today.
https://ir.stockpr.com/neurorxpharma/sec-filings-email/content/0001193125-21-200558/d175615ds1.htm
Hi Pegs.. best to respond to one of my posts so I'm alerted.. almost missed this one.. the best answer I could give you would be to contact Dr Javitt directly.. I hear he reads and responds.. ;) https://www.nrxpharma.com/ or maybe through link-edin ..twitter..
$RLFTF $NRXP DD (opinion) post by Jonty on Yh0 - Being a physician, we have been using Tocilizumab very frequently since March and we have seen patients surviving. However the problem is while most don’t die immediately, many of them remain on high amounts of OptiFlow at 60 liters oxygen with 100% FiO2 for long time with no improvement in their respiratory status.
They can’t even talk without getting out of breath. Some end up going on ventilator eventually and either die or end up going for lung transplant. So while Tocilizumab may be preventing immediate deaths, it is not necessarily improving survival as it has no protective effects on lung damage that would still take place. Plus we are starting to see high amounts of fungal infections in patients who have got Tocilizumab.
That is when Aviptadil comes into play. We have seen so many case reports so far with patients making recovery. I sincerely wish that FDA doesn’t get stuck on nitpicking data and delay or deny EUA to this life saving drug. The evidence is overwhelming and I hope so many case reports are not brushed aside as being anecdotal evidence.
Science doesn’t belong to a group of people. It’s open for everyone to contribute & it’s always evolving as we learn new information. So I really hope that these bureaucratic agencies look at it with open mind and approve the drug & stop letting people die. We have waited longer than we should have in the name of trial and data but in the middle of the pandemic, we can’t afford to have a clean & pure data at the expense of people’s lives. Approve it quickly and start saving lives.
$RLFTF $NRXP DD (opinion) post by Jonty on Yh0 - Being a physician, we have been using Tocilizumab very frequently since March and we have seen patients surviving. However the problem is while most don’t die immediately, many of them remain on high amounts of OptiFlow at 60 liters oxygen with 100% FiO2 for long time with no improvement in their respiratory status.
They can’t even talk without getting out of breath. Some end up going on ventilator eventually and either die or end up going for lung transplant. So while Tocilizumab may be preventing immediate deaths, it is not necessarily improving survival as it has no protective effects on lung damage that would still take place. Plus we are starting to see high amounts of fungal infections in patients who have got Tocilizumab.
That is when Aviptadil comes into play. We have seen so many case reports so far with patients making recovery. I sincerely wish that FDA doesn’t get stuck on nitpicking data and delay or deny EUA to this life saving drug. The evidence is overwhelming and I hope so many case reports are not brushed aside as being anecdotal evidence.
Science doesn’t belong to a group of people. It’s open for everyone to contribute & it’s always evolving as we learn new information. So I really hope that these bureaucratic agencies look at it with open mind and approve the drug & stop letting people die. We have waited longer than we should have in the name of trial and data but in the middle of the pandemic, we can’t afford to have a clean & pure data at the expense of people’s lives. Approve it quickly and start saving lives.
$NRXP $RLFTF Here is the NeuroRX SEC filing from today.
https://ir.stockpr.com/neurorxpharma/sec-filings-email/content/0001193125-21-200558/d175615ds1.htm
x993231 and proto are set as mo-ds and can lock in DD posts at the top at -th-e other----
$RLFTF $NRXP (related) Bert-Jan on Yh0
Interesting article about the relation between VIP and diabetes:
https://cysticfibrosisnewstoday.com/2021/06/24/low-vip-hormone-early-cf-related-diabetes-mouse-study/
$RLFTF (related) DD by Lars on Yh0 - Active substances
Drug containing the active ingredient Aviptadil for inhalation/topical therapy.
Aviptadil (Vasoactive intestinal peptide (VIP)) is a peptide in the body that is already approved for another indication (ectile dysfunction) with an excellent safety profile.
The preclinic for inhalation therapy is available. Studies and casuistics show excellent efficacy and compatibility of the drug
Patients with sarcoidosis and related diseases (e.g. Berylliosis), have already benefited significantly from off-label treatment, so that many health insurance companies bear the treatment costs.
The simple application is done with a nebulizer of the latest generation.
In addition to product development for human medicine, products for veterinary medicine (especially for horses) are also to be developed.
https://advita-lifescience.com/wirkstoffe/
$RLFTF $NRXP (reminder-active) 4-22-21
Clinical trial of therapeutics for severely ill hospitalized COVID-19 patients begins
Patients with acute respiratory failure may now enroll in NIH-sponsored trial.
https://www.nih.gov/news-events/news-releases/clinical-trial-therapeutics-severely-ill-hospitalized-covid-19-patients-begins#:~:text=The%20trial%20will%20test%20Zyesami%20and%20remdesivir%20%28alone,unable%20to%20maintain%20sufficient%20oxygen%20in%20the%20blood.
----
https://www.prnewswire.com/news-releases/dr-anthony-fauci-confirms-zyesami-phase-3-trial-with-remdesivir-at-press-briefing-by-white-house-covid-19-response-team-301276787.html
$RLFTF $NRXP DD (related) by rk on Yh0 - On how long the FDA took on previous EUA approvals:
-Redemsivir with Baricitinib request filed 10/07/20, approved 11/19/20 (44 days or 6 weeks, 2 days)
-Casirivimab with Imdevimab request filed 10/09/20, approved 11/21/20 (44 days or 6 weeks, 2 days)
-Bamlanivimab request filed 10/08/20, approved 11/09/20. (33 days or 4 weeks, 5 days)
-Bamlanivimab and Etesevimab -
Blaze Trial ended 1/26/2021 EUA approved 02/09/2021. (15 days from trials end)
-Sotrovimab filed 3/10/ 2021 or later in March, approved 5/26/2021 (78 days or 11 weeks + 1 day)
So we have 44 days twice, 33 days 78 days (or less), 15 days from end of a trial.
$RLFTF Relief Announces the Results of the Annual General Meeting 2021 of RELIEF THERAPEUTICS Holding AG: All Proposals Approved by a Large Majority
https://relieftherapeutics.com/newsblog/relief-announces-the-results-of-the-annual-general-meeting-2021-of-relief-therapeutics-holding-ag-all-proposals-approved-by-a-large-majority
$RLFTF (opinion) by Laidbackupright on Yh0 - Has anything at all changed over the last two weeks? Or months?
$NRXP submitted their EUA app, backed it up with EAP results, and now we’re stuck in the FDA waiting room endlessly reading and rereading a two-week old copy of USAToday.
$RLFTF $NBLX DD by RR on Yh0 - Good Evening Relief Family! As many on the site have all ready copy and pasted responses from Relief in regards to the patent situation in India, I also received basically the same, but with an extension from what has all ready been posted. I'm copying and pasting below. Have a great evening and let's stay positive for this coming week in the hopes to finally hear something out of the FDA!
Dear XXXXX:
Thank you for your inquiry.
We at Relief are concerned about the dramatic COVID-19 situation in India. There is a major need for additional treatment options for patients with COVID-19 in that country, and we know that the Indian pharmaceutical industry is working on various potential therapies to address this acute situation. Relief was not involved in Biophore’s work on aviptadil. We await with interest the outcome of Biophore’s EUA submission for India.
Relief holds a patent covering potential formulations of RLF-100 in various markets around the world. However, this does not include India. Please note the following: Relief holds a patent covering potential formulations of RLF-100™ in the United States valid until at least July 2029, with extension opportunities up to five years as well as in the EU and Rest of World (Great Britain, Germany, Turkey, Spain, Switzerland, Netherlands, Denmark, Ireland, Austria, PRC and Mexico) valid until at least 2026, excluding extension opportunities comparable to the U.S. In part to further build the IP portfolio, Relief and AdVita Lifescience GmbH signed a binding term sheet in January 2021 for Relief to acquire all shares of AdVita. Relief will gain access to all AdVita assets including future pending IP rights that may cover RLF-100™ inhaled formulation specifications for the potential application of inhaled aviptadil in the treatment of lung diseases such as ARDS and pulmonary sarcoidosis.
Kind regards,
Relief Therapeutics
..just continue to post solid DD about the company and they'll stay/
$RLFTF Relief Therapeutics Website
https://relieftherapeutics.com/
$NBLX NRX Pharmaceuticals
https://www.nrxpharma.com/
$RLFTF WONG Yh0- Articles all from Jan say phase 3 nod for injection All articles also mention RLF-100
Articles out this week about EUA application in India all vary on delivery.
I have read it's a pill. I have read it is injection and I have also read it is nasal spray.
Point being nobody seems to know what is going on in India even it's journalists.
I'm giving up on trying to get to the bottom of this and wait for clarification from our company which so far says they have nothing to do with India.
$RLFTF $NRXP (opinion) Post by OU on Yh0 - The news from Biophore is tremendous. It validates the efficacy of not the infused version but the INHALED version of Aviptadil. Think about this for a minute. If the inhaler actually works (which is implied by Biophore jumping to EUA) then we can now conclude we have a treatment that can be distributed widely and used for in home treatments. Folks, this could mean all the dreams of multi-billion dollar valuations are a reality, translating to many dollars per share in stock price ($8-$12 is not out of the question for RLFTF). Why such a valuation? Because a successful inhaled version of Aviptadil that is stable and effective is the equivalent of penicillin for the lungs, which the world desperately needs not just for Covid, but for many other lung indications. I will be buying more with this news and at these ridiculously low prices.
Furthermore, how does the FDA ignore this request for EUA in the US now? If India approves and it’s successful, then the US will need to seriously consider the drug. Note that the US EUA is for IV version not inhaled, and we still showed results. FDA cannot ignore this drug for much longer and not appear biased. Thank you Biophore!
This is an amazing buying opportunity.
Go INHALED Aviptadil
OU
$RLFTF $NRXP (opinion) Post by GS3k on Yh0 - Guys, we're currently in a large trial for the inhaled version of aviptadil.
The government wants it. This is like a free real time study. If the inhaled version of an inferior formulation in India not only stops COVID but also has different uses which are amazing and has an extremely safe drug profile we've won.
This is like getting hundreds of thousands of free guinea pigs and large scale trials for all of the indications we've been begging them to investigate. When we finally do apply for our inhaled version EUA we'll not only have trials to point to but actual real world results to back up the data, it's going to be a formality at that point.
This is honestly one of the best things that could have happened for us - it's going to put aviptadil on the map in a country where we would not have stood to profit and were not equipped to serve.