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Article:
Why Is NRx Pharmaceuticals Stock Falling After Data From Suicidal Bipolar Depression Study
https://www.benzinga.com/trading-ideas/movers/24/04/38525975/why-is-nrx-pharmaceuticals-stock-falling-after-data-from-suicidal-bipolar-depression-study
Any thoughts on the vote for RS? I know about the theory behind it, but it seams like if they had confidence over the future of their three candidate drugs then the SP would easily and soon enough pop over the edge of a buck.
Elon Musk Says His Ketamine Prescription Matters to Investors
https://www.bloomberg.com/news/articles/2024-03-18/musk-says-ketamine-prescription-is-in-investors-best-interests
Elon Musk Says His Ketamine Prescription Matters to Investors Interesting article...
Elon Musk said that his prescribed use of ketamine alleviates periods of low mood and is in the best interest of investors in Tesla Inc. and the other companies he runs.
For Wall Street, “what matters is execution,” Musk said in an interview with former CNN anchor Don Lemon streamed Monday on YouTube. “From an investor standpoint, if there is something I’m taking, I should keep taking it,” he said referring to Tesla’s success.
Musk said he takes the drug as prescribed periodically to treat what he described as “chemical tides” that lead to depression-like symptoms. Doctors can prescribe ketamine to treat pain and depression and at higher doses, the drug acts as a sedative. It can also cause hallucinations, and overdosing can lead to unconsciousness and dangerously slowed breathing, according to the US Drug Enforcement Administration.
An article in the Wall Street Journal in January said that executives in the Tesla and SpaceX chief executive officer’s companies had grown concerned about his recreational drug use. Musk responded that he hadn’t failed drug tests and, in a post on his X social network, that “whatever I’m doing, I should obviously keep doing it!”
All projection for Tesla going into 2024 are good.. There is a reason for that.
Now... Motor vehicle thefts increased 29% in 2023, and have increased by 105% since before the pandemic. homicides are still 18% higher than they were in 2019. Yes.. some crime stats are lower slightly but lower from the worst it has ever been! And how wonderful is the no bail system now? Let em out in the AM to do more crimes.. And some lib inner-city DA's don't even prosecute or just lessen the charges.. Manipulated lowering of crime stats. Try leaving a nice car in DC or even driving around there... chances are some Black teenage street thug will point a gun at you and take your car.. You can see it first hand on any local nightly news station.. Looting clearing out the entire store and stores being closed... Homeless everywhere... using the street for the bathroom... illegals overwhelming city resources and even Dem Mayors bitching about it.. LOL We have a serious crime problem in the US that is not being addressed and it is affecting the economy.
Oil drilling.. about the same as the last year of trump but maybe slightly more.. Problem is check out what huge numbers Joe is exporting including natural gas? And imports... the past three years way lower and hence why the inflation and high gas prices.. A total net reduction of oil product in the US. Joe said he was going to kill fossil fuel and he is still trying to do so.
I watch all news stations but mostly the regular news.. You know the stations that actually report and show videos of criminals in action.. Mostly all Blacks looting stores and carjackings..
And Joe taxing corporations just kills research and development. People forget that corporations hire people who pay taxes and don't need welfare.. So yes.. Elon is waiting for sanity to return..
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Announces Completion of Enrollment of its Phase 2b/3 Trial of NRX-101 in Suicidal Treatment Resistant Bipolar Depression
January 22 2024 - 06:48AM
PR Newswire (US)
https://ih.advfn.com/stock-market/NASDAQ/nrx-pharmaceuticals-NRXP/stock-news/93100410/nrx-pharmaceuticals-inc-nasdaq-nrxp-announces-c
PR Newswire
Wed, January 17, 2024 at 3:48 AM PST
RADNOR, Pa., Jan. 17, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx" or the "Company"), a clinical-stage biopharmaceutical company developing therapies for suicidal depression, chronic pain, and PTSD, today announced that on January 16, 2024, the Company was notified by The Nasdaq Stock Market LLC ("Nasdaq") that the Nasdaq Hearings Panel (the "Panel") granted the Company's request for the transfer of its listing to The Nasdaq Capital Market, subject to the Company evidencing compliance with all applicable criteria for continued listing on the Capital Market tier, including the $35 million in market value of listed securities (MVLS) and the $1.00 bid price requirements. The Company believes it has already satisfied the market value of listed securities requirement and is working to evidence compliance with the minimum bid price requirement by April 16, 2024, as required by the Panel's decision. An issuer must evidence compliance with the minimum threshold for at least ten consecutive business days to be deemed by Nasdaq to have complied with the applicable requirement.
"NRx is pleased to share this encouraging news with our shareholders as we continue to meet our drug development milestones as set outlined in our recent communications (NRx Corporate Presentation). This quarter we aim to file our first New Drug Application for NRX-100 (ketamine) for treatment of acute suicidal depression and look forward to announcing top line results from our phase 2b/3 trial of NRX-101 (D-cycloserine/lurasidone) in the treatment of suicidal bipolar depression. These milestones, together with additional updates, are anticipated in advance of the Nasdaq compliance date," said Stephen Willard, JD, CEO of NRx.
NRX received the FDA QUIDP for the NRX-101 in Complicated Urinary Tract Infection and Pyelonephritis
From the FDA: III. QIDP DESIGNATION DEFINED
47
48 Section 505E(g) of the FD&C Act provides for the designation by FDA of certain
49 antimicrobial products as QIDPs. A QIDP is defined in section 505E(g) as: "an
50 antibacterial or antifungal drug for human use intended to treat serious or life-threatening
51 infections, including those caused by –
52
53 (1) an antibacterial or antifungal resistant pathogen, including novel or emerging
54 infectious pathogens; or
55
56 (2) qualifying pathogens listed by the Secretary under" section 505E(f) of the
57 FD&C Act.
58
59 The Agency has codified the list of qualifying pathogens at 21 CFR 317.2.
60
61 For a drug product to be designated a QIDP, the sponsor is required to demonstrate that the drug
62 is an "antibacterial or antifungal drug for human use intended to treat serious or life-threatening
infections."3 63 A sponsor requesting a QIDP designation may also include documentation that the
64 product is intended to treat an "antibacterial or antifungal resistant pathogen, including novel or
emerging infectious pathogens"4 65 or a qualifying pathogen as part of the designation request;
66 however, such documentation is not required.
NRx Pharmaceuticals Announces Signing of a Data and Technical Information Agreement with Columbia University Accessing Key Data Demonstrating Efficacy and Safety of Intravenous Ketamine for the Treatment of Suicidal Depression
https://ir.nrxpharma.com/2023-12-19-NRx-Pharmaceuticals-Announces-Signing-of-a-Data-and-Technical-Information-Agreement-with-Columbia-University-Accessing-Key-Data-Demonstrating-Efficacy-and-Safety-of-Intravenous-Ketamine-for-the-Treatment-of-Suicidal-Depression
NRx Pharmaceuticals Announces FDA Clearance of its Investigational New Drug (IND) Application for NRX-101 in the Treatment of Complicated Urinary Tract Infections
https://ir.nrxpharma.com/2023-12-18-NRx-Pharmaceuticals-Announces-FDA-Clearance-of-its-Investigational-New-Drug-IND-Application-for-NRX-101-in-the-Treatment-of-Complicated-Urinary-Tract-Infections
News Release Issued: November 6, 2023 (6:48am EST)
https://ir.nrxpharma.com/2023-11-06-NRx-Pharmaceuticals-and-Nephron-Pharmaceuticals-Announce-Joint-Agreement-to-Develop-Intravenous-Ketamine-to-Treat-Suicidal-Depression
NRx Pharmaceuticals (NRXP) Enters Development Agreement for the Manufacture of Ketamine to Treat Suicidality and Depression
https://www.google.com/url?rct=j&sa=t&url=https://www.streetinsider.com/Corporate%2BNews/NRx%2BPharmaceuticals%2B%2528NRXP%2529%2BEnters%2BDevelopment%2BAgreement%2Bfor%2Bthe%2BManufacture%2Bof%2BKetamine%2Bto%2BTreat%2BSuicidality%2Band%2BDepression/22335240.html&ct=ga&cd=CAEYACoTMjEzNzQyMTU5MTEzNDcwMTg0NzIaNWMyNTMyOTNiYTRkNjY3Mjpjb206ZW46VVM&usg=AOvVaw24Sh_M_p_xsQry2Kr-cHf1
https://www.google.com/url?rct=j&sa=t&url=https://beststocks.com/nrx-pharmaceuticals-obtains-fda-clearance-for/&ct=ga&cd=CAEYASoUMTA4NTcxMjE2NTM3NTEzNTI1ODQyGjVjMjUzMjkzYmE0ZDY2NzI6Y29tOmVuOlVT&usg=AOvVaw3I13qCUdkzlu8VSOMer8TF
NRx Pharmaceuticals Obtains FDA Clearance for Human Trials of NRX101 A Groundbreaking Treatment for Chronic Pain
RADNOR, Pa., Oct. 2, 2023 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that FDA has given the company clearance to proceed with human trials to treat Chronic Pain under the Investigational New Drug (IND) application filed with the U.S. Food and Drug Administration (FDA) for the use of NRX-101. The IND application leverages pioneering research on the use of D-cycloserine (a key ingredient of NRX-101) in the treatment of chronic pain and the recent licensure by NRx of a US Patent for the use of D-cycloserine in the treatment of pain.
NRX Pharmaceuticals Announces Data Sharing Agreement Demonstrating Efficacy and Safety of Intravenous Ketamine for the Treatment of Suicidal Bipolar Depression
September 15 2023 - 06:46AM
PR Newswire (US)
Ketamine, an NMDA blocker, was highly effective in Bipolar subgroup (p<0.001)
NRx plans to present the data to FDA with a goal of identifying a path to an NDA
RADNOR, Pa., Sept. 15, 2023 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it has signed a data sharing agreement with the study leadership of a randomized, placebo-controlled trial of 156 patients hospitalized for Acute Suicidality and Depression in 7 French Government Hospitals.
This trial, conducted under International Good Clinical Practices and Helsinki standards demonstrated a dramatic and statistically-significant reduction in suicidal ideation and depression (P<.0001) among patients randomized to intravenous racemic ketamine, compared to those randomized to placebo. The trial reached its primary endpoint for all patients and demonstrated the largest effect among the subgroup with bipolar depression (84% vs 28% remission, drug vs. placebo; p<0.0001; Odds ratio 14).
The top line data from this trial were published in the British Medical Journal (BMJ 2022; 376 doi: https://doi.org/10.1136/bmj-2021-067194) and additional data reports are planned. The efficacy demonstrated confirms earlier, smaller trials conducted in the United States and elsewhere.
As disclosed previously, NRx met with the FDA in January 2023 at which time the FDA requested randomized, placebo-controlled data in support of intravenous ketamine for acute suicidality in the inpatient setting. Such trials are extraordinarily complex to organize and generally require Government support. In this case, NRx approached the Fondation FundaMental, led by Prof. Marion Leboyer, MD, PhD, who served on the NRx Scientific Advisory Board and facilitated establishing the current Data Sharing Agreement.
Under this agreement, NRx has translated the clinical study report, which will be submitted to FDA and is converting the electronic, patient level data files to a form suitable for FDA review. NRx plans to meet with FDA in the coming months to discuss a regulatory path for the use of ketamine to treat patients with Bipolar Depression and Acute Suicidal Ideation and Behavior.
"We at NRx are honored that the study leadership has agreed to share these landmark data so that they may be submitted to and reviewed by the US FDA," said Dr. Jonathan Javitt, Founder and Chief Scientist of NRx Pharmaceuticals. "We look forward to a fruitful ongoing collaboration with Prof. Abbar and his study team leadership for the benefit of patients everywhere."
I signed up for Chaikin Power Pulse and here is what they say about NRXP .. I rarely join these services, but it was a free trial. I did not expect that rating. My META and TSLA are just listed as bullish.. But they are not recommending a buy yet on NRXP just listing it as a "wait".. So we shall see.
NRXP - VERY BULLISH
NRx Pharmaceuticals, Inc.
$0.25
0.01
(+4.17%)
As of 09/11/23 00:28AM EDT
INDUSTRY
Pharmaceuticals
EARNINGS
POWER GAUGE RATING
As of 09/11/23
NRXP is Very Bullish
Financials
Earnings
Technicals
Experts
The Chaikin Power Gauge Rating for NRXP is Very Bullish due to very positive expert activity, attractive financial metrics and strong earnings performance. The stock also has weak price/volume activity.
Expert activity for NRXP is very positive which is evidenced by insiders purchasing stock and relative strength of the stock's industry.
PRE-TRADE CHECKLIST
Strength
2/3
Power Gauge Rating Very Bullish
Rel. Strength vs SPY Weak
Industry Strength Strong
So they are claiming that NRX will do three things.. Miracle drug? or... are they just trying to get something to stick to the wall? I do not trust the FDA to keep their profit agenda and or politics out of all this.
If just one of these options works and is approved then it could be a good thing.
NRx Pharmaceuticals Announces the Licensure of a US Patent to Support Use of NRX-101™ for Chronic Pain
NRx Pharmaceuticals Reports Minutes of Recent U.S. Food and Drug Administration (FDA) Meeting on the Development of NRX-101 to Treat Severe Bipolar Depression in Patients with Suicidality
NRx Pharmaceuticals Announces Potent Antibacterial Activity of NRX-101 Against Common, Antibiotic Resistant Urinary Pathogens
Perhaps that is why the SP has jumped so much since Dec... People in the know.
They did not pay the FDA enough to approve it...
More info:
https://relieftherapeutics.com/images/Instructions-for-Converting-Relief-Therapeutics-ORDs-to-ADRs-FINAL
Do I have to convert my Ordinary Shares into ADSs?
No, the Company’s Ordinary Shares will continue to trade on the SIX Exchange in
Switzerland. If you do not wish to hold ADSs but wish to remain a holder of Relief
Therapeutics Ordinary Shares then no action is required.
Inhaled aviptadil for the possible treatment of COVID-19 in patients at high risk for ARDS: study protocol for a randomized, placebo-controlled, and multicenter trial
https://rdcu.be/cV1X7
Inhaled aviptadil for the possible treatment of COVID-19 in patients at high risk for ARDS: study protocol for a randomized, placebo-controlled, and multicenter trial
https://rdcu.be/cV1X7
Bottom line... It is starting to look like it all depends on how they apply the testing and how they look at the test results. India approved its emergency use authorization and one of the involved doctors who was at the top of the testing told me in an answer to my email question that it is most effective withing the first days... and he said it works.
This article below claims it helps significantly if used during a certain time period. How much of this is political? How much of this was just incorrect procedures during testing? Something is strange here....
https://pubmed.ncbi.nlm.nih.gov/36044317/
From the National Library of Medicine
2022 Aug 31.
The Use of IV Vasoactive Intestinal Peptide (Aviptadil) in Patients With Critical COVID-19 Respiratory Failure: Results of a 60-Day Randomized Controlled Trial
Jihad Georges Youssef 1 2, Philip Lavin 3, David A Schoenfeld 4, Richard A Lee 5, Rainer Lenhardt 6, David J Park 7, Javier Perez Fernandez 8, Melvin L Morganroth 9, Jonathan C Javitt 10 11, Dushyantha Jayaweera 12
Affiliations expand
PMID: 36044317 DOI: 10.1097/CCM.0000000000005660
Abstract
Objectives: Respiratory failure is a lethal complication of COVID-19 that has remained resistant to drug therapy. Vasoactive intestinal peptide (VIP) is shown in nonclinical studies to upregulate surfactant production, inhibit cytokine synthesis, prevent cytopathy, and block replication of the severe acute respiratory syndrome coronavirus 2 virus in pulmonary cells. The study aims to determine whether Aviptadil (synthetic VIP) can improve survival and recovery in patients with COVID-19 respiratory failure compared with placebo and demonstrate biological effects in such patients.
Design: A multicenter, placebo-controlled trial.
Setting: Ten U.S. hospitals: six tertiary-care hospitals and four community hospitals.
Patients: A total of 196 patients with COVID-19 respiratory failure.
Interventions: Participants were randomized 2:1 to receive 3 days of IV Aviptadil or placebo.
Measurements and main results: The primary end point (alive and free from respiratory failure at day 60) did not reach statistical significance (odds ratio [OR], 1.6; 95% CI, 0.86-3.11) for patients treated with Aviptadil when controlling for baseline ventilation status as prespecified in the protocol. There was, however, a statistically significant two-fold odds of improved survival (OR, 2.0; 95% CI, 1.1-3.9) at 60 days (p = 0.035). There was significant improvement in respiratory distress ratio and reduced interleukin 6 cytokine release (p = 0.02) by day 3.Subgroup analysis identified a statistically significant likelihood of achieving primary end point among those treated with high-flow nasal oxygen at baseline (p = 0.039). Subjects on mechanical ventilation also experienced a 10-fold increased odds of survival with drug versus placebo (p = 0.031).
Conclusions: The primary end point did not reach statistical significance, indicating that there was no difference between Aviptadil versus placebo. However, Aviptadil improves the likelihood of survival from respiratory failure at day 60 in critical COVID-19 across all sites of care. Given the absence of drug-related serious adverse events and acceptable safety profile, we believe the benefit versus risk for the use of Aviptadil is favorable for patient treatment.
Bottom line... It is starting to look like it all depends on how they apply the testing and how they look at the test results. India approved its emergency use authorization and one of the involved doctors who was at the top of the testing told me in an answer to my email question that it is most effective withing the first days... and he said it works.
This article below claims it helps significantly if used during a certain time period. How much of this is political? How much of this was just incorrect procedures during testing? Something is strange here....
https://pubmed.ncbi.nlm.nih.gov/36044317/
From the National Library of Medicine
2022 Aug 31.
The Use of IV Vasoactive Intestinal Peptide (Aviptadil) in Patients With Critical COVID-19 Respiratory Failure: Results of a 60-Day Randomized Controlled Trial
Jihad Georges Youssef 1 2, Philip Lavin 3, David A Schoenfeld 4, Richard A Lee 5, Rainer Lenhardt 6, David J Park 7, Javier Perez Fernandez 8, Melvin L Morganroth 9, Jonathan C Javitt 10 11, Dushyantha Jayaweera 12
Affiliations expand
PMID: 36044317 DOI: 10.1097/CCM.0000000000005660
Abstract
Objectives: Respiratory failure is a lethal complication of COVID-19 that has remained resistant to drug therapy. Vasoactive intestinal peptide (VIP) is shown in nonclinical studies to upregulate surfactant production, inhibit cytokine synthesis, prevent cytopathy, and block replication of the severe acute respiratory syndrome coronavirus 2 virus in pulmonary cells. The study aims to determine whether Aviptadil (synthetic VIP) can improve survival and recovery in patients with COVID-19 respiratory failure compared with placebo and demonstrate biological effects in such patients.
Design: A multicenter, placebo-controlled trial.
Setting: Ten U.S. hospitals: six tertiary-care hospitals and four community hospitals.
Patients: A total of 196 patients with COVID-19 respiratory failure.
Interventions: Participants were randomized 2:1 to receive 3 days of IV Aviptadil or placebo.
Measurements and main results: The primary end point (alive and free from respiratory failure at day 60) did not reach statistical significance (odds ratio [OR], 1.6; 95% CI, 0.86-3.11) for patients treated with Aviptadil when controlling for baseline ventilation status as prespecified in the protocol. There was, however, a statistically significant two-fold odds of improved survival (OR, 2.0; 95% CI, 1.1-3.9) at 60 days (p = 0.035). There was significant improvement in respiratory distress ratio and reduced interleukin 6 cytokine release (p = 0.02) by day 3.Subgroup analysis identified a statistically significant likelihood of achieving primary end point among those treated with high-flow nasal oxygen at baseline (p = 0.039). Subjects on mechanical ventilation also experienced a 10-fold increased odds of survival with drug versus placebo (p = 0.031).
Conclusions: The primary end point did not reach statistical significance, indicating that there was no difference between Aviptadil versus placebo. However, Aviptadil improves the likelihood of survival from respiratory failure at day 60 in critical COVID-19 across all sites of care. Given the absence of drug-related serious adverse events and acceptable safety profile, we believe the benefit versus risk for the use of Aviptadil is favorable for patient treatment.
Well... as having filed for and I received a patent for an invention... and also filed a couple "provisional patent" applications.. there is a huge difference between the two. A patent when granted is good for 18 years of protection.. A provisional patent application can basically be written up and drawn up on a napkin... very informal. But you can then claim "patent pending." The reason for that is you can use a provisional patent application to hold a design or invention for one year when then you have to actually file a formal patent application. It allows you to prove that you are first to invent in court. It is a good tool, but in the end, unless you file for an actual patent, your invention will not be protected. Hopefully they will file an actual patent application before the year passes. It may take time considering the dept of the patent subject in this case.
Thanks! I will check it out...
Hang in there Pegs! No one will advocate better for you than you! I took all the shots like a good 71 year old... but got a cold in Nov,,, then again in January! I hardly ever had any colds or was sick my whole life! Pretty healthy.. But.. The last one totally clogged up my entire head! Had to have a sinus clearing operation to get all the solid glue out! Not fun! It has been since Jan and they still do not know why I have some fluid and coughing from my lungs. Totally not bad but irritating! None of the doctors admitted anything because they honestly said...No one knows enough yet! But my issues are no where near what you are going through... One day at a time!
Also wishing you all the best Pegs! You sound like a fighter and are on top of things.. Take care!
I respectfully disagree. You have not lost a penny until you sell. And yes you win some and you lose some when messing in the market, but there is something that really really stinks about this with regard as to the testing and the results. Still needs to be investigated and hopefully they will do just that soon enough. Too much conflicting testing results from different agencies and over time. The Dr. in India where it did receive an EUA had nothing but good things to say about it in the email the Dr sent to me answering my question. (I posted their response earlier)
I actually averaged down a lot so that it will not take a huge spike in SP to get even. I have done this before.
There are other drugs on the horizon with Relief and also NRX if you had invested with them as well.
Everyone has to make their own decisions and that is good, but for me... this is a long term thing.
All the best to ya and good luck!
I had an active patent...I wrote it and got it approved myself. It ran for 18 years and I licensed the product and it was produced. I have a couple patent pending. They are only good if someone actually wants to use them to make a product. But.. the kicker is that the patent office must be convinced that the patent "claims" are valid. You have to prove that. You have to list those claims and they have to be beyond the current state of the art for the field of invention and they cannot be obvious to the average person. So it all depends if the product is worth producing. Foreign patents are expensive and sometimes not worth the paper they are written on. China can still cheat... but not sell the product in the US and probably get away with it.. China cheats a lot! Remember if your patent is infringed, you take them to court.. but that can take years and many many thousands of dollars. Some huge corporations have run out the clock after stealing a patent and the little guy patent holder just gets over spent and wiped out. It sucks! So... Some do not bother with patents... they just have a great logo and go for it and people stick with that now famous brand. I do not know anything about medical patents and processes. But it seems that they think protection is worth it so that is a good thing.
I sent an email to the NRX "Right to Try" page to see if they are still allowing its use. We shall see.
All this is so strange and conflicting because right at the beginning of 2022 we were informed of this:
NRx Receives Initial Report of Patient Safety and Survival from Right to Try use of ZYESAMI® (aviptadil) during Omicron Surge
-A Southwestern hospital has reported safety data collected under the Federal Right to Try law indicating that 16 of 19 patients (84%) with COVID-19 respiratory failure treated with ZYESAMI® by Dec 31, 2021 have survived the ICU.
-No Serious Adverse Events were reported
-Patients were treated during the Omicron Surge
-Patients were treated at first onset of respiratory failure after exhausting remdesivir and other approved therapies
-Data are being included provided by NRx to FDA in support of ongoing application to FDA for Emergency Use Authorization
https://www.prnewswire.com/news-releases/nrx-receives-initial-report-of-patient-safety-and-survival-from-right-to-try-use-of-zyesami-aviptadil-during-omicron-surge-301468389.html
So, the question is, what suddenly caused the positive results to flip to negative? Will this be addressed during the shareholders meeting?
This was sent out by NRX: (In part)
You are cordially invited to attend the 2022 Annual Meeting of Stockholders of NRx Pharmaceuticals, Inc. to be held on July 18, 2022, at 11:00 a.m., local time, in virtual format at:
https://www.cstproxy.com/nrxpharma/2022
Exactly right PennyW! It cannot be that both results are true. And we had earlier results that stated how well it worked. So we went from good results to it totally failed in one swell swoop? All while India a gave it an EUA and the Dr saying how well and fast it works! This is outrageous! Both NRX and RLF need to join forces and investigate! We need to demand that they do!
Thanks once again for posting information. Perhaps here is another "hint"... Why would they state this in the report if it were not applicable?
"The DSMB stated there were no safety concerns for aviptadil"
Thank you for posting that... Very interesting... So what that is saying is exactly what the Dr. from India explained about the "initial first few days" of treatment results.. So in effect, Aviptadil can seriously reduce the hospital stay time speeding up recovery and perhaps, with that benefit, also save lives.
We also know that the new variant is less severe and with the vaccine, even less so.
Perhaps the term futile simply meant, as you posted here, it is useless to study longer because enough data has been gained at that end point.
Welcome... I sent the information and a request for an answer regarding the DSMB's action to Mr R Bestof NRX... We shall see if he responds. I doubt he will other than through the "official" channels.
After receiving the latest NRX news release regarding the cancellation of further trials due to the failure of Aviptadil and remembering that India actually issued an EUA for this very same drug, I knew that something was different somewhere. So I decided to contact one of the several doctors in India who were directly involved with the testing of Aviptadil. The Dr preferred to not be named and I will respect that, but I can say that the Dr was one of many who was at the top of the testing process. The Dr was kind enough to answer my questions although the Dr did not directly address as to why the US recent DSMB testing was labeled as "futile." The Dr did indicate that after a certain length of time if Aviptadil is not helping covid recovery, then "other" health factors could be the causation of death. Or, that is at least my understanding of the Dr's response and I could be misunderstanding some of it. As far as the DSMB statement goes, I am sure that not much can be said because the Dr. has no access to US testing data that was reviewed by the US DSMB.
I will share here and will lay it out in this order: My first introductory email to the Dr and the Dr's first response. Then below that will be my next response email to the Dr and the Dr's final response.
It is apparent to me at least that a different approach to testing as well as the target goals of the testing plus the duration of the testing may be the difference that caused the US DSMB to be so negative and different from the testing and results performed by India's health agencies. We will have to wait and see if NRX studies the US results and provides any comments or explanations to all of us shocked shareholders. I hope so... They owe us that much at the very least.
==============================================================
26 May 2022
Dear Dr. XXXXXXX
I am reaching out to you in regard to the approval of Aviptadil in India. I am a shareholder of NRP and RLFTF. As you may already know, we have been notified that the DSMD has cancelled testing in the US of Aviptadil because they basically said it is worthless.
We shareholders are surprised and shocked. We have no idea as to why they made this decision. Previous studies fully indicated that this drug functioned well and saved lives. We had been waiting for a US EUA.
I know you are probably very busy, but if you would kindly offer your opinion as to why you think this has happened I would really appreciate your thoughts.
I read that India approved your EUA for this drug and I know that you also have stringent requirements. India is a leader in medical research. So I am just wondering what the difference may be.
Thank you so much for any info or opinion on this subject.
Take care!
Bob
====================================================================
27 May 2022
In a message dated 5/27/2022 12:38:56 AM Pacific Standard Time, xxxxxxxx writes:
Dear Bob,
Aviptadil is a highly effective drug and it can reverse the ARDS (Acute respiratory distress syndrome) condition promptly. If you look at the USFDA website you'll find that USFDA has approved Vasoactive intestinal peptide (Aviptadil) as an orphan drug for acute respiratory distress syndrome. Aviptadil is also approved as an orphan drug by FDA for Pulmonary hypertension, which is a condition directly linked to ARDS. The same has also been approved by EMA (European Medical agency). Another condition directly linked to ARDS is Acute lung injury, which is also an orphan drug status approved indication for Aviptadil in both the regions.
We have found excellent results of the drug during clinical trials in Indian patients.
Indian Drug regulatory agencies with help of their Subject expert committees scrutinized the clinical trial data for several months and had several review meetings for the scientific discussions with us before granting the EUA permission.
Our clinical trial, is under publication and will come online by first week of June.
Hope the above information is helpful to you.
Kind Regards
Dr. XXXXXXXX
========================================================================
27 May 2022
Dear Dr XXXXXXXX,
Thank you so very much for your response to my question. I appreciate you taking the time out of your busy day!
As I mentioned, I am a shareholder with NRXP and RLFTF. They both for some time now have been trying to obtain a US EUA. Then last Wednesday we all received a News Release from NRX announcing the cancellation of further testing because the DMSB said Aviptadil did no better than the placebo results. We are confused and shocked because earlier test results showed, just as you have also indicated that Aviptadil saves lives. We have no idea as to why the test results for this current testing were are they were reported.
I posted the news release and the link below. If you have time, can you review the data and provide your opinion on this please? I am saddened mostly because people are dying when all this time Aviptalil could have prevented much of that loss.
And out of respect, am I free to share your opinion on this subject?
Once again I sincerely thank you for responding!
I wish you all the best and take care!
Bob
===============================================================
28 May 2022
NOTE: The Dr approved release but prefers to remain anonymous.
Dear Mr. XXXXXXX,
Scientifically speaking the effect of Aviptadil needs to be observed for the first week only (Acute phase), which is most critical period for saving life of patient. After that other factors become overwhelming in deciding the outcome of the patient's condition. Immediate improvement in oxygen saturation is the clear cut proof of it. In simpler words, since aviptadil is a short acting drug, we either need to infuse it repeatedly or give through nebulizer for managing a chronic condition. The clinical trials in Covid-19 shouldn't have focused on the clinical outcome longer than 1 week outcome after aviptadil infusion, other wise repeated doses need to be given.
Even in our clinical trial, the quick relief from the symptoms has lead to the long term improvement in clinical condition, since the "Standard of care" was being given along with for long term management.
The PO2:FiO2 ratio starkly improved on day2 onwards and that played a major role in overall clinical improvement. The critical level is 100, once the patient achieves level above 100 for the ratio, generally the survival becomes better, and same was observed in our clinical trial.
Kind Regards
Dr. XXXXXXXXX
After receiving the latest NRX news release regarding the cancellation of further trials due to the failure of Aviptadil and remembering that India actually issued an EUA for this very same drug, I knew that something was different somewhere. So I decided to contact one of the several doctors in India who were directly involved with the testing of Aviptadil. The Dr preferred to not be named and I will respect that, but I can say that the Dr was one of many who was at the top of the testing process. The Dr was kind enough to answer my questions although the Dr did not directly address as to why the US recent DSMB testing was labeled as "futile." The Dr did indicate that after a certain length of time if Aviptadil is not helping covid recovery, then "other" health factors could be the causation of death. Or, that is at least my understanding of the Dr's response and I could be misunderstanding some of it. As far as the DSMB statement goes, I am sure that not much can be said because the Dr. has no access to US testing data that was reviewed by the US DSMB.
I will share here and will lay it out in this order: My first introductory email to the Dr and the Dr's first response. Then below that will be my next response email to the Dr and the Dr's final response.
It is apparent to me at least that a different approach to testing as well as the target goals of the testing plus the duration of the testing may be the difference that caused the US DSMB to be so negative and different from the testing and results performed by India's health agencies. We will have to wait and see if NRX studies the US results and provides any comments or explanations to all of us shocked shareholders. I hope so... They owe us that much at the very least.
==============================================================
26 May 2022
Dear Dr. XXXXXXX
I am reaching out to you in regard to the approval of Aviptadil in India. I am a shareholder of NRP and RLFTF. As you may already know, we have been notified that the DSMD has cancelled testing in the US of Aviptadil because they basically said it is worthless.
We shareholders are surprised and shocked. We have no idea as to why they made this decision. Previous studies fully indicated that this drug functioned well and saved lives. We had been waiting for a US EUA.
I know you are probably very busy, but if you would kindly offer your opinion as to why you think this has happened I would really appreciate your thoughts.
I read that India approved your EUA for this drug and I know that you also have stringent requirements. India is a leader in medical research. So I am just wondering what the difference may be.
Thank you so much for any info or opinion on this subject.
Take care!
Bob
======================================================
27 May 2022
In a message dated 5/27/2022 12:38:56 AM Pacific Standard Time, xxxxxxxx writes:
Dear Bob,
Aviptadil is a highly effective drug and it can reverse the ARDS (Acute respiratory distress syndrome) condition promptly. If you look at the USFDA website you'll find that USFDA has approved Vasoactive intestinal peptide (Aviptadil) as an orphan drug for acute respiratory distress syndrome. Aviptadil is also approved as an orphan drug by FDA for Pulmonary hypertension, which is a condition directly linked to ARDS. The same has also been approved by EMA (European Medical agency). Another condition directly linked to ARDS is Acute lung injury, which is also an orphan drug status approved indication for Aviptadil in both the regions.
We have found excellent results of the drug during clinical trials in Indian patients.
Indian Drug regulatory agencies with help of their Subject expert committees scrutinized the clinical trial data for several months and had several review meetings for the scientific discussions with us before granting the EUA permission.
Our clinical trial, is under publication and will come online by first week of June.
Hope the above information is helpful to you.
Kind Regards
Dr. XXXXXXXX
========================================================
27 May 2022
Dear Dr XXXXXXXX,
Thank you so very much for your response to my question. I appreciate you taking the time out of your busy day!
As I mentioned, I am a shareholder with NRXP and RLFTF. They both for some time now have been trying to obtain a US EUA. Then last Wednesday we all received a News Release from NRX announcing the cancellation of further testing because the DMSB said Aviptadil did no better than the placebo results. We are confused and shocked because earlier test results showed, just as you have also indicated that Aviptadil saves lives. We have no idea as to why the test results for this current testing were are they were reported.
I posted the news release and the link below. If you have time, can you review the data and provide your opinion on this please? I am saddened mostly because people are dying when all this time Aviptalil could have prevented much of that loss.
And out of respect, am I free to share your opinion on this subject?
Once again I sincerely thank you for responding!
I wish you all the best and take care!
Bob
=======================================================
28 May 2022
NOTE: The Dr approved release but prefers to remain anonymous.
Dear Mr. XXXXXXX,
Scientifically speaking the effect of Aviptadil needs to be observed for the first week only (Acute phase), which is most critical period for saving life of patient. After that other factors become overwhelming in deciding the outcome of the patient's condition. Immediate improvement in oxygen saturation is the clear cut proof of it. In simpler words, since aviptadil is a short acting drug, we either need to infuse it repeatedly or give through nebulizer for managing a chronic condition. The clinical trials in Covid-19 shouldn't have focused on the clinical outcome longer than 1 week outcome after aviptadil infusion, other wise repeated doses need to be given.
Even in our clinical trial, the quick relief from the symptoms has lead to the long term improvement in clinical condition, since the "Standard of care" was being given along with for long term management.
The PO2:FiO2 ratio starkly improved on day2 onwards and that played a major role in overall clinical improvement. The critical level is 100, once the patient achieves level above 100 for the ratio, generally the survival becomes better, and same was observed in our clinical trial.
Kind Regards
Dr. XXXXXXXXX
Things do NOT add up regarding the stated results and the cancellation of the ongoing testing. As typical, it takes time for questions to be answered. Here is an interesting article that may provide a "peek" into some questionable connections. Could this be about class action suits and sheltering people? Or is it stock manipulation? Is it a part of the ongoing bad blood between NRXP and RLFTF and those negotiations? This may take time to get to the bottom...
https://www.politico.com/news/2020/09/17/andy-harris-coronavirus-neurorx-board-417329
Mask skeptic lawmaker takes on side gig overseeing drug company trial
Several bioethicists question Rep. Andy Harris' lack of experience.
Rep. Andy Harris
Rep. Andy Harris is one of three members of the data and safety monitoring board for the trial run by NeuroRx, a small Delaware company whose CEO and founder has longstanding ties to the congressman. | Al Drago/Pool via AP
By ZACHARY BRENNAN
09/17/2020 06:13 PM EDT
Rep. Andy Harris, a Maryland Republican and medical doctor, has broken with the scientific mainstream during the coronavirus pandemic — decrying stay-at-home orders and warning of a “cult of masks.”
Now the five-term congressman has joined the hunt for coronavirus treatments with an unpaid side gig overseeing a drug company trial. Harris is one of three members of the data and safety monitoring board for the trial run by NeuroRx, a small Delaware company whose CEO and founder has longstanding ties to the congressman.
The members of the board are responsible for monitoring safety and efficacy data from the ongoing trial, which started in May, and have the power to end the study if problems arise. The drug in question, aviptadil, was created in 1970 to treat lung inflammation, but never reached the market. NeuroRx is now investigating whether it can help Covid-19 patients with acute lung failure.
Harris’s role is an unusual one: Former FDA Commissioner Scott Gottlieb told POLITICO that he’d never heard of a sitting member of Congress serving on a data monitoring committee for any drug. The arrangement doesn’t appear to run afoul of House ethics rules because Harris is not being paid by NeuroRx and does not own a stake in the company. But several bioethicists questioned his lack of experience in evaluating data from drug trials, and said that his close ties to NeuroRx CEO Jonathan Javitt could complicate matters if problems arose with the company’s study.
“The concern about bias wouldn’t arise unless the decision-making [on data from the trial] was difficult,” said Susan Ellenberg, a biostatistician at the University of Pennsylvania, whose research focuses on the ethical issues related to clinical trials. “If the data are such that it’s a hard call as to whether to stop the study or not, that’s when the personal connections seep into consciousness,” added Ellenberg, a former FDA staffer who wrote the agency’s guidance document on data monitoring committees.
In a statement to POLITICO, Harris — an anesthesiologist who still practices part-time — brushed aside any suggestion that he is not qualified to serve on the data board.
“I have a Master of Health Science degree from the Hopkins school of public health, which involves training in biostatistics (that’s a matter of public record, which you probably already knew),” he said. “I have been an investigator on numerous NIH grants and published numerous papers that involved complex statistical analysis, and have been involved in clinical research studies as a principal investigator.”
The congressman said that he plans to report the NeuroRx position on his next annual ethics filing, which is due in May, and that he does not interact with FDA as part of his data board service. He did not respond to a question about whether he had sought advice from the House Ethics Committee on the NeuroRx role before he had accepted it.
null“My only hope was to volunteer my expertise to help America find our way out of this pandemic, as every American who has a skill set to offer hopefully should be willing to do,” Harris said in his statement.
Harris met NeuroRx’s CEO, Javitt, more than two decades ago when they worked together at Johns Hopkins University. Javitt was then a surgeon, while Harris specialized in obstetric anesthesiology.
The two have kept in touch over the years. Javitt, who donated $2,000 to Harris’s campaign in 2010, said he’d visited Harris at his House office in recent years to discuss NeuroRx’s other drug in development, for suicidal bipolar depression.
Javitt — who is also vice chairman of the board of directors at Relief Therapeutics, which holds the patent on aviptadil — told POLITICO that he selected Harris for the data committee because of the congressman’s experience in critical care settings. Javitt also said that the FDA signed off on the trial knowing that Harris would be involved with the committee.
The aviptadil trial started in May at four U.S. sites, and aims to enroll more than 100 participants. The FDA has granted the drug “fast track” status, which is designed to speed the availability of drugs to treat serious diseases. NeuroRx is also offering aviptadil through an FDA-approved expanded access program for hospitalized patients at the same sites in Houston, Kentucky, Florida and California that are hosting the current trial.
The data board that Harris is part of has already made at least one crucial decision — recommending in July that the trial continue after analyzing preliminary data from 30 patients, Relief Therapeutics said in press release this week.
FDA’s guidance for data monitoring committees recommends that at least one member is a “biostatistician knowledgeable about statistical methods for clinical trials and sequential analysis of trial data.” But neither Harris nor the other two members of the NeuroRx panel fit that bill.
Alfred Sommer is the dean emeritus of the Johns Hopkins Bloomberg School of Public Health, with training in ophthalmology and epidemiology. Rita Colwell, an aquatic biologist, led the National Science Foundation under presidents Bill Clinton and George W. Bush. She now holds joint appointments at the University of Maryland and Johns Hopkins.
Colwell told POLITICO that she had served on data monitoring committees for other clinical trials. Sommer and Harris had never done so before joining the NeuroRx panel.
But all three of the NeuroRx panel members have professional or personal relationships with Javitt. Sommer, the chair of the data committee, worked with Javitt at Johns Hopkins; the pair have known each other for about 40 years. Javitt met Colwell during her tenure leading NSF, when he was a fellow at the non-profit Potomac Institute for Policy Studies providing support to the agency.
“It seems like a strange collection of people and when you think about the documents this committee would need to review — are they going to understand the adverse event reports? You want them to be informed enough to ask questions on if the adverse events are caused by the drug,” said Leigh Turner, an associate professor at the University of Minnesota Center for Bioethics.
In some cases, the data monitoring board for a trial would be faced with deciding whether to stop that study. “You don’t want three well-intentioned friends being spoon-fed information from the trial and who can’t look at it critically,” Turner added.
Ellenberg -- who wrote the FDA guidelines for data monitoring committees while on staff at the agency -- echoed those concerns. “Neither Harris nor Colwell is known for clinical trials expertise,” she said. “Members of a DMC should all be very familiar with clinical trials.”
Javitt said that an outside biostatistician is working with the committee, but is not a member of it. He also downplayed the panel’s role in the trial. “Unless there are unexpected severe adverse events to take action on, the committee doesn’t have much to do,” he said.
Asked specifically about the unusual decision to include a sitting member of Congress on the data monitoring board, Javitt said it shows Harris’ commitment to fighting the coronavirus and finding effective treatments.
Holly Fernandez-Lynch, an assistant professor of bioethics at the University of Pennsylvania’s Perelman School of Medicine, said there is no shortage of specialists in critical-care medicine who have the biostatistics skills to serve on a Covid-19 drug data monitoring committee.
“Other COVID drugs — and there are many under study — presumably have done so without going to members of Congress,” she said.
Walter Shaub, the former director of the Office of Government Ethics, said “it’s concerning” that Harris is involved with a company regulated by FDA, given his position on the House appropriations subcommittee that controls the agency’s purse. “FDA officials may feel nervous about holding the company to high standards if a member of their appropriations subcommittee is involved in the trial,” he said.
Still, Harris’s involvement with NeuroRx does not appear to violate House ethics rules.
“The only thing that’s prohibited is outside earned income,” said Richard Painter, the former chief ethics lawyer for President George W. Bush who is now a law professor at the University of Minnesota. “House ethics rules are pretty loosey goosey.”
Painter said that Harris should recuse himself from any bills targeted at NeuroRx, but not necessarily the pharmaceutical industry as a whole. He also said that the congressman should recuse himself “from any company involvement with the FDA,” including any interventions on NeuroRx’s behalf.
But Henry Greely, a law professor and chair of the steering committee of the Center for Biomedical Ethics at Stanford University, saw no obvious problems arising from Harris’s work with NeuroRx.
“It’s strange but I don’t think it’s an ethical issue unless Harris tries to use his influence with FDA on behalf of the company,” Greely said. “It would be a closer question for me if he were somehow generally advising the firm, but a [data monitoring board] has a pretty discrete and specific task.”