$RLFTF $NRXP DD (opinion) by Nashville-Chap on Yh0
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Posted On: 10/04/2021 9:45:17 PM
$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.**
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.**
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