Romans 12:19
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#Aviptadil RLF-100 $RLFTF The people need to KNOW - Former CDC Director Gives Alarming Statistic on Fully Vaccinated COVID Deaths https://townhall.com/tipsheet/katiepavlich/2021/10/19/former-cdc-director-gives-alarming-statistic-on-fully-vaccinated-covid-deaths-n2597628?1921
$RLFTF (opinion) by CA_Newby on Yh0 - So frustrating. I am a pharmacist with 33 years experience mostly in large medical teaching hospitals and participated in many investigational studies. The delay either means
1. FDA incompetence
2. NRX incompetence or intentional sabotage
3. Government intervention to intentionally delay non vaccine submissions
4. BP sabotage to delay which is stupid since vaccination rates have nothing to do with treatment solutions
5. Actual issues with the study data
The last is the least likely
$RLFTF Here's the video.. at minus -1:30 Dr. Surasky discusses therapeutics amid flu season, COVID variants - https://www.oann.com/dr-surasky-discusses-therapeutics-amid-flu-season-covid-variants/
$RLFTF OAN News Dr. Surasky : can't find a video clip but I'll jot down some things he said till you see for yourself.. should replay throughout the day..
Aviptadil "can even save the lives of patients near death"
Aviptadil "is unique because it was shown specifically to help those patients who were the sickest, they were essentially dying in the ICU ..the study showed 17 out of 21 of these very ill patients survived who were treated with this drug compared to just 5 who didn't get the medicines so that an 81% survival rate with Aviptadil compared to just 21% who received typical care like steroids, anticoagulants and conversant plasma now again these were the patients who were the absolute sickest who had multiple severe comorbidities they were all in the ICU and they were at the highest risk for death.
Interviewer Scott wheeler then said Dr. Surasky also said that the FDA should be moving faster to get these therapeutics approved and in the hands of Doctors to save lives..
$RLFTF FINALLY !!! 4:08 am just tuned on OAN News and this Dr. Surasky is talking therapeutics because "The Vaccine won't be the answer alone.. then it's yeah yeah yeah the pills mono whatever then He talks Aviptadil and says 81% survival w/it .. etc
I'm Hoping FDA will soon deal from the top of the deck approve EUA .. there will be a bunch of lives saved and money made.. RLFTF might struggle to get their cut (if it's not settled during the jolt of EUA) but in the long-run I suspect there are larger forces behind Dr. Javitt pulling the strings and he will be left as The Patsy / Fall guy.. it's clear with his blatant missteps that he's out of his league business/law wise. .maybe his family will be able to hide some funds.. but we and future patients will prosper from RLF-100 .. sadly his future does not look good IMO
$RLFTF DD by Synopic on Yh0 - Recent change again in shares held by institutions!
12/10/2021 (according to yho holder tab)
9.74% % of Shares Held by All Insider
28.96% % of Shares Held by Institutions
32.09% % of Float Held by Institutions
38 Number of Institutions Holding Shares
13/10/2021
9.74% % of Shares Held by All Insider
29.02% % of Shares Held by Institutions
32.15% % of Float Held by Institutions
38 Number of Institutions Holding Shares
Which means 2.646.000 shares were added recently by one or more institutional investor
$RLFTF Relief Reports that its U.S. Collaboration Partner has Announced Progress on Worldwide Commercial Scale Development of ZYESAMI(TM) (aviptadil)
GENEVA, SWITZERLAND / ACCESSWIRE / October 13, 2021 /
https://conferencecalltranscripts.com/summary/?id=305456&pr=true
..that's in 2020
$RLFTF $NRXP DD (opinion) by Nashville-Chap on Yh0 -
The CEO statement could have easily been written with 15 items noted as their own numbered bullet point. We have tremendous potential! Know what you own. This is not financial advice. NRXP strong!
1. Those who attended the FDA/NIH COVID-19 workshop heard Dr. Francis Collins speak about ACTIV3-b. He identified ZYESAMI as one of the few remaining viable treatment options from among the 750 screened by the NIH.
2. In fact, ZYESAMI is the only drug to our knowledge currently being tested by the NIH in the most critically-ill patients, those on ventilators.
3. Over the past year, we have assembled a complete Investigational New Drug (IND) file and FDA has advised us in writing that no additional non-clinical data toxicity are needed in order file a New Drug Application (NDA). This foundation enables the study of important additional indications for ZYESAMI.
4. We are working with Mannkind (Nasdaq:MNKD) to adapt their dry powder insulin delivery system to deliver inhaled aviptadil in order to achieve a room-temperature stable, convenient to use medicine.
5. We are also working with TFF Pharmaceuticals (Nasdaq:TFFP) to develop a long-term stable reconstitutable form of ZYESAMI.
6. Although there is no statutorily mandated period within which the FDA must make a determination on EUA, the project manager who is supervising our EUA application advised us on Friday, October 1, that the review is ongoing and that the FDA is awaiting input from some members of its staff.
7. In the course of developing randomized prospective data in support of the EUA, we believe that we have fulfilled the requirements for Breakthrough Therapy Designation and have submitted that application to the FDA.
8. We may also meet the legal requirements for accelerated approval under section 506c of the Food, Drug, and Cosmetics Act, based upon the findings in two separate trials demonstrating a statistically-significant response on two biomarkers: Respiratory Distress Ratio and Cytokine IL-6.
9. As you know, ZYESAMI is one of three products in our pipeline with potential for approval in 2022, the other two being NRX-101 and the BriLife vaccine. Each product has the potential to save countless lives and to generate significant value for shareholders. We will provide updates about BriLife and NRX-101 in future communications.
In the coming year, we intend to initiate clinical trials for the following indications:
10. COVID “longhauler” syndrome: millions of Americans continue to suffer from reduced respiratory capacity and require home oxygen in order to maintain adequate blood oxygen levels.
11. Sarcoidosis: this chronic lung disease affects 185,000 Americans and causes pulmonary disability and death in 1% to 5% of those affected. The FDA has recognized Sarcoidosis as an orphan disease.
12. Acute Respiratory Distress Syndrome (ARDS): this is the condition that Prof. Sami Said first treated in the last years of his career, together with our Principal Investigator, Dr. J. Georges Youssef of Houston Methodist Hospital. Seven of the 8 patients they treated at Stonybrook University Hospital survived the Intensive Care Unit and 6 successfully left the hospital.
13. Checkpoint inhibitor pneumonitis: one of the most promising developments in cancer chemotherapy is the advent of checkpoint inhibitor drugs, of which Keytruda®(pembrolizumab) is the best-known example. While these drugs have shown promise in previously hopeless malignancies, they cause a highly unpleasant lung inflammation (pneumonitis) that is a challenge for patients and their families. There are reports in the medical literature of substantial relief being achieved with inhaled aviptadil.
14. Preservation of donor lungs both before and after transplant: There is a substantial pre-clinical literature on the effect of aviptadil in protecting donor lungs both while outside the body and after transplant. Dr. Youssef has treated some lung transplant patients under an investigator-sponsored IND with encouraging results.
15. Chronic Obstructive Pulmonary Disease (COPD): Highly provocative data have been shared with us regarding the potential for aviptadil to improve symptoms in patients with advanced COPD. More than 15 million Americans suffer from COPD and treatment at this time is largely
confined to custom-compounded off-label use of inhaled steroids and bronchodilators. Our manufacturing partner, Nephron Pharmaceuticals, is one of the nation’s largest suppliers of custom inhaled medicines.
**Thus, we have lots of work to do and many millions of patients who may require ZYESAMI.**
$RLFTF $NRXP DD (opinion) by Nashville-Chap on Yh0 -
The CEO statement could have easily been written with 15 items noted as their own numbered bullet point. We have tremendous potential! Know what you own. This is not financial advice. NRXP strong!
1. Those who attended the FDA/NIH COVID-19 workshop heard Dr. Francis Collins speak about ACTIV3-b. He identified ZYESAMI as one of the few remaining viable treatment options from among the 750 screened by the NIH.
2. In fact, ZYESAMI is the only drug to our knowledge currently being tested by the NIH in the most critically-ill patients, those on ventilators.
3. Over the past year, we have assembled a complete Investigational New Drug (IND) file and FDA has advised us in writing that no additional non-clinical data toxicity are needed in order file a New Drug Application (NDA). This foundation enables the study of important additional indications for ZYESAMI.
4. We are working with Mannkind (Nasdaq:MNKD) to adapt their dry powder insulin delivery system to deliver inhaled aviptadil in order to achieve a room-temperature stable, convenient to use medicine.
5. We are also working with TFF Pharmaceuticals (Nasdaq:TFFP) to develop a long-term stable reconstitutable form of ZYESAMI.
6. Although there is no statutorily mandated period within which the FDA must make a determination on EUA, the project manager who is supervising our EUA application advised us on Friday, October 1, that the review is ongoing and that the FDA is awaiting input from some members of its staff.
7. In the course of developing randomized prospective data in support of the EUA, we believe that we have fulfilled the requirements for Breakthrough Therapy Designation and have submitted that application to the FDA.
8. We may also meet the legal requirements for accelerated approval under section 506c of the Food, Drug, and Cosmetics Act, based upon the findings in two separate trials demonstrating a statistically-significant response on two biomarkers: Respiratory Distress Ratio and Cytokine IL-6.
9. As you know, ZYESAMI is one of three products in our pipeline with potential for approval in 2022, the other two being NRX-101 and the BriLife vaccine. Each product has the potential to save countless lives and to generate significant value for shareholders. We will provide updates about BriLife and NRX-101 in future communications.
In the coming year, we intend to initiate clinical trials for the following indications:
10. COVID “longhauler” syndrome: millions of Americans continue to suffer from reduced respiratory capacity and require home oxygen in order to maintain adequate blood oxygen levels.
11. Sarcoidosis: this chronic lung disease affects 185,000 Americans and causes pulmonary disability and death in 1% to 5% of those affected. The FDA has recognized Sarcoidosis as an orphan disease.
12. Acute Respiratory Distress Syndrome (ARDS): this is the condition that Prof. Sami Said first treated in the last years of his career, together with our Principal Investigator, Dr. J. Georges Youssef of Houston Methodist Hospital. Seven of the 8 patients they treated at Stonybrook University Hospital survived the Intensive Care Unit and 6 successfully left the hospital.
13. Checkpoint inhibitor pneumonitis: one of the most promising developments in cancer chemotherapy is the advent of checkpoint inhibitor drugs, of which Keytruda®(pembrolizumab) is the best-known example. While these drugs have shown promise in previously hopeless malignancies, they cause a highly unpleasant lung inflammation (pneumonitis) that is a challenge for patients and their families. There are reports in the medical literature of substantial relief being achieved with inhaled aviptadil.
14. Preservation of donor lungs both before and after transplant: There is a substantial pre-clinical literature on the effect of aviptadil in protecting donor lungs both while outside the body and after transplant. Dr. Youssef has treated some lung transplant patients under an investigator-sponsored IND with encouraging results.
15. Chronic Obstructive Pulmonary Disease (COPD): Highly provocative data have been shared with us regarding the potential for aviptadil to improve symptoms in patients with advanced COPD. More than 15 million Americans suffer from COPD and treatment at this time is largely
confined to custom-compounded off-label use of inhaled steroids and bronchodilators. Our manufacturing partner, Nephron Pharmaceuticals, is one of the nation’s largest suppliers of custom inhaled medicines.
**Thus, we have lots of work to do and many millions of patients who may require ZYESAMI.**
$RLFTF $NRXP DD by Season on Yh0 - Look at all the institutions buying..
https://fintel.io/so/ch/rlf
$RLFTF $NRXP DD by Season on Yh0 - Look at all the institutions buying..
https://fintel.io/so/ch/rlf
Oct 4, 2021
The following communication contains forward-looking statements as defined below. Such statements are aspirational in nature and cannot be relied upon for investment purposes. This letter discusses only our work with aviptadil. Our work with the BriLife vaccine and NRX-101 will be a topic of future communications.
To Our Shareholders,
We have received many inquiries from shareholders following the recent encouraging news regarding Merck’s Molnupiravir results in early COVID-19. We have also received various questions about the status of our application to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for ZYESAMI.
Needless to say, we are extremely encouraged by the news of the early stopping of recruitment into Merck’s clinical trial on the basis of overwhelming efficacy in treating patients with newly-diagnosed COVID-19. The 50% reduction in risk of hospitalization or death among patients in the early viral phase of the disease is some of the best news that has been seen in this phase of the disease since the outbreak of the pandemic. It’s critical to remember, however, that antiviral drugs work primarily in the earliest stage of the disease, when the SARS-CoV-2 virus is actively propagating throughout the body.
Investors have asked us for guidance regarding the potential effect of this development on the need for aviptadil to treat the lungs of patients who contract COVID-19. Unfortunately, we believe that patients will continue to need a drug that protects the lining of the lung for the foreseeable future. With over 110,000 new cases of COVID per day in the U.S alone, and nearly 2,000 COVID-19 deaths reported each day in the U.S. alone, reducing hospitalization from 14,000 to 7,000 new cases each day still leaves several million patients in the U.S. who desperately need a medicine that can help them return to their families.
While we hope that the addressable market for ZYESAMI™ (aviptadil) will be reduced by a lower incidence of respiratory failure in COVID-19, we anticipate that patients in the ICU with respiratory failure with COVID and other conditions will benefit from ZYESAMI for the foreseeable future. Indeed, we have always anticipated and advised investors that should ZYESAMI be deemed safe and effective, it is likely to be used as part of a cocktail, in the manner that HIV is treated today. As you know, the NIH is currently conducting a study of ZYESAMI plus remdesivir. Now that Molnupiravir has shown efficacy, we hope that NIH will consider a similar combination trial. Those who attended the FDA/NIH COVID-19 workshop heard Dr. Francis Collins speak about ACTIV3-b. He identified ZYESAMI as one of the few remaining viable treatment options from among the 750 screened by the NIH. In fact, ZYESAMI is the only drug to our knowledge currently being tested by the NIH in the most critically-ill patients, those on ventilators.
Were COVID to disappear tomorrow, which we view as highly unlikely, ZYESAMI has many critically-important treatment opportunities that we aim to address in the coming year. FDA offered public testimony in 2016 that the safety and efficacy of aviptadil was unknown because there was no pre-clinical or clinical safety data on file with FDA. Over the past year, we have assembled a complete Investigational New Drug (IND) file and FDA has advised us in writing that no additional non-clinical data toxicity are needed in order file a New Drug Application (NDA). This foundation enables the study of important additional indications for ZYESAMI.
In the coming year, we intend to initiate clinical trials for the following indications:
COVID “longhauler” syndrome: millions of Americans continue to suffer from reduced respiratory capacity and require home oxygen in order to maintain adequate blood oxygen levels.
Sarcoidosis: this chronic lung disease affects 185,000 Americans and causes pulmonary disability and death in 1% to 5% of those affected. The FDA has recognized Sarcoidosis as an orphan disease.
Acute Respiratory Distress Syndrome (ARDS): this is the condition that Prof. Sami Said first treated in the last years of his career, together with our Principal Investigator, Dr. J. Georges Youssef of Houston Methodist Hospital. Seven of the 8 patients they treated at Stonybrook University Hospital survived the Intensive Care Unit and 6 successfully left the hospital.
Checkpoint inhibitor pneumonitis: one of the most promising developments in cancer chemotherapy is the advent of checkpoint inhibitor drugs, of which Keytruda® (pembrolizumab) is the best-known example. While these drugs have shown promise in previously hopeless malignancies, they cause a highly unpleasant lung inflammation (pneumonitis) that is a challenge for patients and their families. There are reports in the medical literature of substantial relief being achieved with inhaled aviptadil.
Preservation of donor lungs both before and after transplant: There is a substantial pre-clinical literature on the effect of aviptadil in protecting donor lungs both while outside the body and after transplant. Dr. Youssef has treated some lung transplant patients under an investigator-sponsored IND with encouraging results.
Chronic Obstructive Pulmonary Disease (COPD): Highly provocative data have been shared with us regarding the potential for aviptadil to improve symptoms in patients with advanced COPD. More than 15 million Americans suffer from COPD and treatment at this time is largely confined to custom-compounded off-label use of inhaled steroids and bronchodilators. Our manufacturing partner, Nephron Pharmaceuticals, is one of the nation’s largest suppliers of custom inhaled medicines.
Thus, we have lots of work to do and many millions of patients who may require ZYESAMI. We are working with Mannkind (Nasdaq:MNKD) to adapt their dry powder insulin delivery system to deliver inhaled aviptadil in order to achieve a room-temperature stable, convenient to use medicine. We are also working with TFF Pharmaceuticals (Nasdaq:TFFP) to develop a long-term stable reconstitutable form of ZYESAMI.
Investors ask us on a daily basis when the FDA will grant EUA to ZYESAMI for the treatment of Critical COVID-19. As you know, the FDA wrote to us in December 2020 and advised that they required randomized prospective data to consider granting EUA. Dr. Peter Stein of the FDA stated that the FDA remained committed to working with us on our investigational medicine and advised us that the FDA would review any submission of randomized prospective data “promptly.” Although there is no statutorily mandated period within which the FDA must make a determination on EUA, the project manager who is supervising our EUA application advised us on Friday, October 1, that the review is ongoing and that the FDA is awaiting input from some members of its staff.
In the course of developing randomized prospective data in support of the EUA, we believe that we have fulfilled the requirements for Breakthrough Therapy Designation and have submitted that application to the FDA. We may also meet the legal requirements for accelerated approval under section 506c of the Food, Drug, and Cosmetics Act, based upon the findings in two separate trials demonstrating a statistically-significant response on two biomarkers: Respiratory Distress Ratio and Cytokine IL-6.
The statute states that the FDA may grant accelerated approval to:
. . . a product for a serious or life-threatening disease or condition . . . upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.
As you know, ZYESAMI is one of three products in our pipeline with potential for approval in 2022, the other two being NRX-101 and the BriLife vaccine. Each product has the potential to save countless lives and to generate significant value for shareholders. We will provide updates about BriLife and NRX-101 in future communications.
On behalf of the entire NRx team, we thank you for placing your trust in us as we work tirelessly to improve patients’ health and save lives. We look forward to sharing further results in the coming months.
Best Regards,
Jonathan C. Javitt, MD, MPH
Chairman and CEO of NRx Pharmaceuticals
Cautionary Note Regarding Forward-Looking Statements
This statement of NRx Pharmaceuticals, Inc. includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company’s strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company’s management. The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above.
https://www.nrxpharma.com/
$RLFTF $NRXP Oct 4, 2021
The following communication contains forward-looking statements as defined below. Such statements are aspirational in nature and cannot be relied upon for investment purposes. This letter discusses only our work with aviptadil. Our work with the BriLife vaccine and NRX-101 will be a topic of future communications.
To Our Shareholders,
We have received many inquiries from shareholders following the recent encouraging news regarding Merck’s Molnupiravir results in early COVID-19. We have also received various questions about the status of our application to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for ZYESAMI.
Needless to say, we are extremely encouraged by the news of the early stopping of recruitment into Merck’s clinical trial on the basis of overwhelming efficacy in treating patients with newly-diagnosed COVID-19. The 50% reduction in risk of hospitalization or death among patients in the early viral phase of the disease is some of the best news that has been seen in this phase of the disease since the outbreak of the pandemic. It’s critical to remember, however, that antiviral drugs work primarily in the earliest stage of the disease, when the SARS-CoV-2 virus is actively propagating throughout the body.
Investors have asked us for guidance regarding the potential effect of this development on the need for aviptadil to treat the lungs of patients who contract COVID-19. Unfortunately, we believe that patients will continue to need a drug that protects the lining of the lung for the foreseeable future. With over 110,000 new cases of COVID per day in the U.S alone, and nearly 2,000 COVID-19 deaths reported each day in the U.S. alone, reducing hospitalization from 14,000 to 7,000 new cases each day still leaves several million patients in the U.S. who desperately need a medicine that can help them return to their families.
While we hope that the addressable market for ZYESAMI™ (aviptadil) will be reduced by a lower incidence of respiratory failure in COVID-19, we anticipate that patients in the ICU with respiratory failure with COVID and other conditions will benefit from ZYESAMI for the foreseeable future. Indeed, we have always anticipated and advised investors that should ZYESAMI be deemed safe and effective, it is likely to be used as part of a cocktail, in the manner that HIV is treated today. As you know, the NIH is currently conducting a study of ZYESAMI plus remdesivir. Now that Molnupiravir has shown efficacy, we hope that NIH will consider a similar combination trial. Those who attended the FDA/NIH COVID-19 workshop heard Dr. Francis Collins speak about ACTIV3-b. He identified ZYESAMI as one of the few remaining viable treatment options from among the 750 screened by the NIH. In fact, ZYESAMI is the only drug to our knowledge currently being tested by the NIH in the most critically-ill patients, those on ventilators.
Were COVID to disappear tomorrow, which we view as highly unlikely, ZYESAMI has many critically-important treatment opportunities that we aim to address in the coming year. FDA offered public testimony in 2016 that the safety and efficacy of aviptadil was unknown because there was no pre-clinical or clinical safety data on file with FDA. Over the past year, we have assembled a complete Investigational New Drug (IND) file and FDA has advised us in writing that no additional non-clinical data toxicity are needed in order file a New Drug Application (NDA). This foundation enables the study of important additional indications for ZYESAMI.
In the coming year, we intend to initiate clinical trials for the following indications:
COVID “longhauler” syndrome: millions of Americans continue to suffer from reduced respiratory capacity and require home oxygen in order to maintain adequate blood oxygen levels.
Sarcoidosis: this chronic lung disease affects 185,000 Americans and causes pulmonary disability and death in 1% to 5% of those affected. The FDA has recognized Sarcoidosis as an orphan disease.
Acute Respiratory Distress Syndrome (ARDS): this is the condition that Prof. Sami Said first treated in the last years of his career, together with our Principal Investigator, Dr. J. Georges Youssef of Houston Methodist Hospital. Seven of the 8 patients they treated at Stonybrook University Hospital survived the Intensive Care Unit and 6 successfully left the hospital.
Checkpoint inhibitor pneumonitis: one of the most promising developments in cancer chemotherapy is the advent of checkpoint inhibitor drugs, of which Keytruda® (pembrolizumab) is the best-known example. While these drugs have shown promise in previously hopeless malignancies, they cause a highly unpleasant lung inflammation (pneumonitis) that is a challenge for patients and their families. There are reports in the medical literature of substantial relief being achieved with inhaled aviptadil.
Preservation of donor lungs both before and after transplant: There is a substantial pre-clinical literature on the effect of aviptadil in protecting donor lungs both while outside the body and after transplant. Dr. Youssef has treated some lung transplant patients under an investigator-sponsored IND with encouraging results.
Chronic Obstructive Pulmonary Disease (COPD): Highly provocative data have been shared with us regarding the potential for aviptadil to improve symptoms in patients with advanced COPD. More than 15 million Americans suffer from COPD and treatment at this time is largely confined to custom-compounded off-label use of inhaled steroids and bronchodilators. Our manufacturing partner, Nephron Pharmaceuticals, is one of the nation’s largest suppliers of custom inhaled medicines.
Thus, we have lots of work to do and many millions of patients who may require ZYESAMI. We are working with Mannkind (Nasdaq:MNKD) to adapt their dry powder insulin delivery system to deliver inhaled aviptadil in order to achieve a room-temperature stable, convenient to use medicine. We are also working with TFF Pharmaceuticals (Nasdaq:TFFP) to develop a long-term stable reconstitutable form of ZYESAMI.
Investors ask us on a daily basis when the FDA will grant EUA to ZYESAMI for the treatment of Critical COVID-19. As you know, the FDA wrote to us in December 2020 and advised that they required randomized prospective data to consider granting EUA. Dr. Peter Stein of the FDA stated that the FDA remained committed to working with us on our investigational medicine and advised us that the FDA would review any submission of randomized prospective data “promptly.” Although there is no statutorily mandated period within which the FDA must make a determination on EUA, the project manager who is supervising our EUA application advised us on Friday, October 1, that the review is ongoing and that the FDA is awaiting input from some members of its staff.
In the course of developing randomized prospective data in support of the EUA, we believe that we have fulfilled the requirements for Breakthrough Therapy Designation and have submitted that application to the FDA. We may also meet the legal requirements for accelerated approval under section 506c of the Food, Drug, and Cosmetics Act, based upon the findings in two separate trials demonstrating a statistically-significant response on two biomarkers: Respiratory Distress Ratio and Cytokine IL-6.
The statute states that the FDA may grant accelerated approval to:
. . . a product for a serious or life-threatening disease or condition . . . upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.
As you know, ZYESAMI is one of three products in our pipeline with potential for approval in 2022, the other two being NRX-101 and the BriLife vaccine. Each product has the potential to save countless lives and to generate significant value for shareholders. We will provide updates about BriLife and NRX-101 in future communications.
On behalf of the entire NRx team, we thank you for placing your trust in us as we work tirelessly to improve patients’ health and save lives. We look forward to sharing further results in the coming months.
Best Regards,
Jonathan C. Javitt, MD, MPH
Chairman and CEO of NRx Pharmaceuticals
Cautionary Note Regarding Forward-Looking Statements
This statement of NRx Pharmaceuticals, Inc. includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company’s strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company’s management. The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above.
https://www.nrxpharma.com/
..your response was reactive and offered nothing to the post.. don't bother next time
800 is the float .. I decided to buy on monday...
3 bil shares 2 R/S's in past, see toxic debt was removed, Good products .. but did they change their ways? .. maybe a FDA YES flip.. but who's paying for production..
Dividends & Splits OTC Markets
SPLIT DATE SPLIT TYPE SPLIT RATIO REC DATE PAY DATE
06/30/2017 Reverse 1:20 — 06/30/2017
shs decreased by 1 for 20 split
03/26/2015 Reverse 1:2000
$NRXP $RLFTF DD by Franz on Yh0 -FDA is reviewing our submission.
We are part of some big clinical trials, one is a NIH-sponsored trial.
We are virtually the only drug for treating critical covid, and with great hopes for treating moderate covid with the inhaled version.
Our clinical data results are huge.
We settled important partnerships with great companies (supply chain).
Don't let people spam you with Merck's pill or about FDA's delay.
And if it's not enough, tell you this is only about RLF-100.
The APR and Advita acquisitions, the partnership with Acer Therapeutics, all these things are strong.
I came here for RLF-100 months ago. I'll stay here for the huge pipeline.
You have the right to be worried about your money and your loss. I am. But we will recover, sooner or later.
Do your own DD, take a breath, and enjoy your weekend.
$NRXP $RLFTF DD by Franz on Yh0 -FDA is reviewing our submission.
We are part of some big clinical trials, one is a NIH-sponsored trial.
We are virtually the only drug for treating critical covid, and with great hopes for treating moderate covid with the inhaled version.
Our clinical data results are huge.
We settled important partnerships with great companies (supply chain).
Don't let people spam you with Merck's pill or about FDA's delay.
And if it's not enough, tell you this is only about RLF-100.
The APR and Advita acquisitions, the partnership with Acer Therapeutics, all these things are strong.
I came here for RLF-100 months ago. I'll stay here for the huge pipeline.
You have the right to be worried about your money and your loss. I am. But we will recover, sooner or later.
Do your own DD, take a breath, and enjoy your weekend.
$NRXP $RLFTF Zorro on Yh0 - Just to again review, the criteria for an EUA:
"Consideration of a drug for an EUA requires a finding that it is "reasonable to believe" that the drug "may be effective" "to prevent, diagnose, or treat serious or life-threatening diseases or conditions that can be caused by a [chemical, biological, radiological, and nuclear] agent(s)" or to mitigate a disease or condition caused by an FDA-regulated product ... used to diagnose, treat, or prevent a disease or condition caused by" such an agent.[1]"
They recommended continuing recruiting for Activ 3b after 232 patients. I think it is reasonable to believe it is safe & effective!
https://ir.nrxpharma.com/news-events/press-releases/detail/89/nrx-pharmaceuticals-announces-second-favorable-safety
$RLFTF $NRXP Zorro on Yh0 - Just to again review, the criteria for an EUA:
"Consideration of a drug for an EUA requires a finding that it is "reasonable to believe" that the drug "may be effective" "to prevent, diagnose, or treat serious or life-threatening diseases or conditions that can be caused by a [chemical, biological, radiological, and nuclear] agent(s)" or to mitigate a disease or condition caused by an FDA-regulated product ... used to diagnose, treat, or prevent a disease or condition caused by" such an agent.[1]"
They recommended continuing recruiting for Activ 3b after 232 patients. I think it is reasonable to believe it is safe & effective!
https://ir.nrxpharma.com/news-events/press-releases/detail/89/nrx-pharmaceuticals-announces-second-favorable-safety
$NRXP $RLFTF "findings are soon to be published in a peer-reviewed journal.' https://ir.nrxpharma.com/news-events/press-releases/detail/88/nrx-pharmaceuticals-announces-improved-survival-at-one-year
$RLFTF DD by Relief on Yh0 - Recruiting in Swiss study for inhaled use of Aviptadil is closed since 21.09.2021
https://www.kofam.ch/de/studienportal/nach-klinischen-versuchen-suchen/?sid=134416
$RLFTF What is the truth about COVID-19? As chaos and confusion grip people around the globe, where can you turn to find answers?
While most main stream and social media outlets have decided to censor doctors who offer treatment options for COVID-19, we want you to hear them first-hand and be empowered to make informed decisions about your health https://covid.daystar.com/
$RLFTF $NRXP (related) DD by Zorro om Yh0 - DisCoVeRy Trial Results Mean More Bad News for Remdesivir — No Clinical Benefit
INSERM, a successor to the French National Institute of Health, recently had results from the Phase 3 DisCoVeRy clinical trial published in The Lancet, Infectious Diseases. The major French investigation explored the antiviral efficacy of remdesivir, the only therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19. A controversial move by the FDA as the pivotal American clinical trial included controversial moves by the sponsor—the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH)—to change the primary endpoint toward the end of the study. It turns out that the drug didn’t meet this endpoint, so as directed by NIAID Director Anthony Fauci, the apex government research institute worked with the industry sponsor, Gilead, to merely modify the endpoint to reduce the duration of hospitalization. The final results in that American trial weren’t impressive—a mere few days reduction in hospitalization. Meanwhile, the World Health Organization (WHO) Solidarity trial concluded remdesivir brought no benefit.
a-boy-went-to-a-covid-swamped-er-he-waited-for-hours-then-his-appendix-burst
https://www.msn.com/en-us/news/us/a-boy-went-to-a-covid-swamped-er-he-waited-for-hours-then-his-appendix-burst/ar-AAOsBZq?ocid=msedgdhp&pc=U531
a-boy-went-to-a-covid-swamped-er-he-waited-for-hours-then-his-appendix-burst
https://www.msn.com/en-us/news/us/a-boy-went-to-a-covid-swamped-er-he-waited-for-hours-then-his-appendix-burst/ar-AAOsBZq?ocid=msedgdhp&pc=U531
$RLFTF $NRXP DD by Harvey Speculator on TwtR Interesting observation on the disclaimer from Relief's PR on Thursday confirming the safety update from the Activ-3B trial. Every PR that has mentioned NRX since the EUA submission has included a disclaimer with the language on top. Is EUA no longer a risk?
Interesting observation on the disclaimer from Relief's PR on Thursday confirming the safety update from the Activ-3B trial. Every PR that has mentioned NRX since the EUA submission has included a disclaimer with the language on top. Is EUA no longer a risk?$RLFTF $NRXP pic.twitter.com/T53WrwO3gr
— Harvey Speculator (@HarveySpecTrade) August 21, 2021
$RLFTF $NRXP DD by Harvey Speculator on TwtR Interesting observation on the disclaimer from Relief's PR on Thursday confirming the safety update from the Activ-3B trial. Every PR that has mentioned NRX since the EUA submission has included a disclaimer with the language on top. Is EUA no longer a risk?
Interesting observation on the disclaimer from Relief's PR on Thursday confirming the safety update from the Activ-3B trial. Every PR that has mentioned NRX since the EUA submission has included a disclaimer with the language on top. Is EUA no longer a risk?$RLFTF $NRXP pic.twitter.com/T53WrwO3gr
— Harvey Speculator (@HarveySpecTrade) August 21, 2021
$NSAV Net Savings Link, Inc. (OTC Pink: NSAV) VirtuaBroker 19, 2021
$NSAV Net Savings Link, Inc. (OTC Pink: NSAV) VirtuaBroker 19, 2021
.. I see you're looking towards the up-list.. maybe the news driven little guys will carry us until those better figures..
"revenue numbers for the last 4 quarters" ?? ..they're growing the Company.. what will the the next 4 1/4 look like?
"which explains the decline from the high" ..most if not all solar + (new green energy plays came down with this from the initial Biden jump.. No?
I expect this to move back up + and hold in the future .. ;)
..could it be that the FDA (Big Pharma) is just holding this up and that's all there is to it.. ? ..they just don't want you in the way..
Who wants to be a millionaire.. ?