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wordman....thanks for posting ..............
Detail description.
Aviptadil was shown to restore barrier function at the endothelial/alveolar interface and to protect the lung and other organs from failure. In Europe, Aviptadil is approved for human use and has been shown to be safe in phase II trials for sarcoidosis, pulmonary fibrosis, bronchospasm, erectile dysfunction as well as in a phase I trial in ARDS in the past two decades. In the US, VIP has been given FDA Orphan Drug Designation for the treatment of ARDS and was admitted to the FDA Corona Virus Technology Accelerator Program.
In a phase I trial of Aviptadil performed by Sami Said in the early 2000s, eight patients with severe ARDS on mechanical ventilation were treated with ascending doses of intravenous VIP. Seven patients (88%) were successfully extubated and were alive at the five day time point. Six (75%) left the hospital and one (13%) died of an unrelated cardiac event. A phase II clinical trial using intravenous Aviptadil in patients with COVID-19 infection and ARDS has begun. Further, a phase II/III clinical trial will study the effect of inhaled Aviptadil for the treatment of non-acute lung injury in COVID- 19 and begins in June 2020. In Europe, two phase II trials of Aviptadil have been conducted. Further, studies with healthy volunteers have shown that inhaled Aviptadil is well tolerated with few adverse effects.
Thanks, Great Link panton.
Seems for a biotech, only a few times sales is pretty minimal, and
thats another reason to consider a substantial percentage increase in the longer run.
And with covid and all the other possibilities......tremendous potential.
A safe effective wonder drug, IMHO.
Excellent, excellent News, thanks Panton for the info on the RLF cancer med TD 011.
With a north american market value projected at over half a billion by 2028, it might be interesting
to speculate on the GLOBAL market value at that time or for this year. .
And thats not to mention other potential cancer applications for Relief Therapeutics.
Please refresh my thoughts on market value projections for CIP, ARDS or Sarcoidosis.
Thanks PW. Also....things are progressing as can be viewed in the link.
Never as quickly as I would like however. :)
https://www.relieftherapeutics.com/pipeline
G....you say you have moved on..
Obviously you have not.
You are still back here, and have NOT moved on and have NOT accepted your losses.
Good Luck. I hope you "move on" like you claim.
A worthwhile source of info on occasion.
https://twitter.com/search?q=Relief%20Therapeutics&src=typed_query&f=live
Thanks for all that post and share.
PW....After talking to several brokers at one of my accounts, it seems they have little information about the up coming 200 for 1 reverse split.
Do you have any info you could update us on as far as time frames and or costs to move into the new stock on the nazdaq. ? TIA.
PW.... thank you for all the info and posting the same.
Many Thanks to Bob and panton for sharing...... and all others also.
This link from Bert-Jan two days ago and on another board.
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06723-w
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
Abstract
Background
Despite the fast establishment of new therapeutic agents in the management of COVID-19 and large-scale vaccination campaigns since the beginning of the SARS-CoV-2 pandemic in early 2020, severe disease courses still represent a threat, especially to patients with risk factors. This indicates the need for alternative strategies to prevent respiratory complications like acute respiratory distress syndrome (ARDS) associated with COVID-19. Aviptadil, a synthetic form of human vasoactive intestinal peptide, might be beneficial for COVID-19 patients at high risk of developing ARDS because of its ability to influence the regulation of exaggerated pro-inflammatory proteins and orchestrate the lung homeostasis. Aviptadil has recently been shown to considerably improve the prognosis of ARDS in COVID-19 when applied intravenously. An inhaled application of aviptadil has the advantages of achieving a higher concentration in the lung tissue, fast onset of activity, avoiding the hepatic first-pass metabolism, and the reduction of adverse effects. The overall objective of this project is to assess the efficacy and safety of inhaled aviptadil in patients hospitalized for COVID-19 at high risk of developing ARDS.
Methods
This multicenter, placebo-controlled, double-blinded, randomized trial with 132 adult patients hospitalized for COVID-19 and at high risk for ARDS (adapted early acute lung injury score = 2 points) is conducted in five public hospitals in Europe. Key exclusion criteria are mechanical ventilation at baseline, need for intensive care at baseline, and severe hemodynamic instability. Patients are randomly allocated to either inhale 67 µg aviptadil or normal saline (three times a day for 10 days), in addition to standard care, stratified by center. The primary endpoint is time from hospitalization to clinical improvement, defined as either hospital discharge, or improvement of at least two levels on the nine-level scale for clinical status suggested by the World Health Organization.
Discussion
Treatment strategies for COVID-19 are still limited. In the context of upcoming new variants of SARS-CoV-2 and possible inefficacy of the available vaccines and antibody therapies, the investigation of alternative therapy options plays a crucial role in decreasing associated mortality and improving prognosis. Due to its unique immunomodulating properties also targeting the SARS-CoV-2 pathways, inhaled aviptadil may have the potential to prevent ARDS in COVID-19.
And too much more to post on here.... please follow the link
Hopefully the final results will be very favorable to RLF shareholders, with
a very considerable interest in the Neuro drug or significant monetary refunds.
>"On August 22, 2022, Relief announced that it has agreed to a tentative settlement of its pending litigation with NRx Pharmaceuticals and its subsidiary, NeuroRx, Inc. relating to Relief's September 2020 collaboration agreement with NeuroRx. The parties have agreed to work collaboratively to finalize the settlement within the next 30 days. Further, the parties have agreed to stay the litigation for an additional 60 days to allow for the negotiation and execution of the definitive settlement agreement and related terms. Terms of the settlement will be reported following execution of the definitive settlement terms. There can be no assurance that the settlement will be completed.<
Panton...lots to absorb here.... .Text of your link on artcle on Sept 15
GENEVA, SWITZERLAND / ACCESSWIRE / September 15, 2022 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY) ("Relief"), a Swiss, commercial-stage biopharmaceutical company seeking to provide patients therapeutic benefit from selected specialty, rare and ultra-rare diseases with high unmet need, today reported its results for the half-year ended June 30, 2022 and provided a corporate update.
Relief Therapeutics Holdings AG, Monday, September 12, 2022, Press release picture
Relief Therapeutics Holdings AG, Monday, September 12, 2022, Press release picture
"We achieved significant progress during the first half of 2022, continuing to execute on our goal of becoming a fully integrated, capital-efficient, commercial-stage biopharmaceutical company targeting rare and specialty disease indications. In particular, we have focused on preparations for the impending U.S. launch of PKU GOLIKE®, a differentiated medical food product engineered with the patent protected, proprietary Physiomimic drug delivery technology, for the dietary management of phenylketonuria ("PKU"), which is currently marketed in Europe, and we look forward to the U.S launch in the fourth quarter of this year, " stated Raghuram Selvaraju, Ph.D., Chairman of the Board of Directors of Relief. "The planned commercial introduction into the U.S. necessitated an expansion of our sales organization and commercial capabilities, and we were pleased to have appointed a number of highly seasoned biotech executives to lead this effort. These included Christopher Wick as Executive Director, Head of U.S. Sales; Drew Cronin-Fine, as Executive Director, Head of U.S. Marketing; and David McCullough, as Senior Director and Head of U.S. Market Access, all reporting to Anthony Kim, Senior Vice President, and Head of U.S. Commercial Operations. We also acquired from Meta Healthcare Ltd. the worldwide commercialization rights (except in the UK) for a novel dosage form of an already FDA-approved prescription drug, intended for the treatment of patients with PKU, adding to our offerings and solidifying our position in this market. We anticipate filing for registration approval through a 505(b)(2) NDA during 2023, further evidencing our cost-effective approach to drug development."
Dr. Selvaraju added, "Meanwhile, we continue to work closely with our partner, Acer Therapeutics Inc. ("Acer"), for a potential U.S. launch of ACER-001, a taste-masked, immediate-release, proprietary powder formulation of sodium phenylbutyrate (NaPB) to treat urea cycle disorders ("UCDs"). Acer resubmitted a New Drug Application ("NDA") to the FDA under the 505(b)(2) pathway for ACER-001 in UCDs in July 2022. The FDA accepted the NDA and assigned a Prescription Drug User Fee Act ("PDUFA") target action date of January 15, 2023. Assuming approval, we anticipate U.S. commercialization in the first half of 2023, marking an important milestone for the collaboration and representing our second commercialized product in the U.S. We also plan to submit a Marketing Authorization Application for approval of ACER-001 for the treatment of UCD in the U.K. and EU. Additionally, Acer submitted an Investigational New Drug ("IND") application to the FDA to evaluate the safety and efficacy of ACER-001 for the potential treatment of Maple Syrup Urine Disease ("MSUD"). We anticipate clinical studies to begin in the fourth quarter of 2022 and expect that data from these studies would be suitable for product registration in the U.S. and Europe. During the year, we also significantly strengthened the intellectual property portfolio of ACER-001 with receipt of patents covering methods-of-use claims for the potential treatment of UCDs and MSUD.
"We also made progress in our program targeting pulmonary diseases. Importantly, we announced promising three-month initial stability data on a new formulation of RLF-100®, which appears to be shelf-stable at temperatures suitable for shipping and long-term storage, thus, potentially having significant clinical and commercial value. We intend to continue to develop RLF-100® for a range of lung diseases. The inhaled formulation of RLF-100® is presently being evaluated in a European study for COVID-19-infected patients (the "Leuppi Study"), for which we expect to report top-line data sometime before year end 2022, subject to completion of patient enrollment. Additional indications include, pulmonary sarcoidosis, for which we have Orphan Drug Designation ("ODD"), and for which, during 2023 we plan to initiate a phase 2b dose-ranging study in 72 patients. We expect to schedule a pre-IND meeting with the FDA to confirm the efficacy and safety endpoints as well as the proposed dosing regimen and, based on a positive outcome, expect to begin this phase 2b study during 2023. We plan to also explore RLF-100® for checkpoint inhibitor-induced pneumonitis, for the treatment of non-COVID-19-related acute respiratory distress syndrome ("ARDS") and to conduct a European proof-of-concept of RLF-100® in the treatment of chronic berylliosis.
"In parallel to these activities, we continue to develop APR-TD011 for the treatment of epidermolysis bullosa ("EB"), for which we have received FDA ODD. Based on strong clinical results, GMP-grade pharmaceutical product is being prepared for clinical development under an FDA-authorized IND, with a clinical trial slated to start in the second quarter of 2023. Additionally, we will leverage our collaboration agreement with InveniAI LLC, a pioneer in the application of artificial intelligence which, we believe, will meaningfully complement our existing drug development expertise and generate numerous promising additions to our pipeline. We have also instituted an effort to pursue the inception and advancement of next-generation, disruptive genetic medicines, taking advantage of innovations in genetic technologies including gene therapy and genome editing to facilitate the development of potentially curative therapies for areas of high unmet medical need.
"Last year, we launched a Level 1 ADR program in the U.S. and are aggressively moving to a Level 3 ADR and an associated Nasdaq Stock Market listing, which we expect to occur in the fourth quarter of this year. To that end, on August 23, 2022, we filed an F-1 Registration Statement with the U.S. Securities and Exchange Commission to register our ADSs for sale in the United States. We ended June of 2022 with a solid cash position of CHF 29.9 million, providing a forecasted cash runway into the third quarter of 2023. We also expect that, with the launch of the PKU GOLIKE® franchise in the U.S. and a successful launch of ACER-001 in early 2023, Relief could achieve cash flow breakeven in late 2024 and positive operating cash flow in early 2025.
Today, we are a more mature, forward integrated, commercial-stage specialty drug company with a deep pipeline and multiple opportunities for growth and we will continue to actively pursue a strategy to diversify our pipeline and are continuously evaluating in-licensing and acquisition opportunities."
Key Clinical Development Highlights:
PKU GOLIKE®
In March 2022, APR Applied Pharma Research SA ("APR") announced that the International Journal of Molecular Sciences had published in vivo data on metabolic responses to formulations of amino acid mixtures for the treatment of PKU. The peer reviewed journal's paper indicated that prolonged release of amino acids, such as those present in formulations like PKU GOLIKE®, may have beneficial effects on the dietary treatment of PKU.
In April 2022, APR received a Notice of Allowance from the USPTO for Patent Application No. 15/303,121, entitled, "Modified Release Orally Administered Amino Acid Formulations." The allowance covers certain formulations of PKU GOLIKE® in APR's product line and supplements APR's PKU GOLIKE® intellectual property portfolio, which includes U.S. Patent No. 10,500,180.
ACER-001
In February 2022, Relief announced that Acer was issued U.S. patent 11,202,767 from the USPTO covering methods of use claims related to ACER-001's multi-particulate dosage formulation for oral administration for the potential treatment of UCD and MSUD. The patent builds upon previous issuance of U.S. patent 11,154,521, covering pharmaceutical composition claims of ACER-001.
In June 2022, Acer and Relief announced that the FDA had issued a Complete Response Letter ("CRL") regarding the New Drug Application ("NDA") for ACER-001 for UCD. The CRL stated that the FDA could not approve the NDA for ACER-001 for UCD in its current form due to an incomplete inspection of Acer's third-party contract packaging manufacturer. The FDA did not cite any other approvability issues in the CRL related to the NDA. Acer noted that it was actively working with its third-party contract packaging manufacturer and cooperating with the FDA to address the CRL and stated its intent to resubmit an updated NDA for ACER-001 for UCD in early-to-mid Q3 2022.
Subsequently, in July 2022, Relief announced that Acer had resubmitted its NDA for ACER-001 for the treatment of UCD to the FDA. Acer has advised Relief that the resubmission addressed, in full, the items raised by the FDA in the CRL. Later that same month, Relief and Acer announced the resubmitted NDA was accepted for review by the FDA, which designated the NDA as a Class 2 resubmission and set a PDUFA target action date of January 15, 2023.
In July 2022, Acer and Relief announced the submission of an IND application to the FDA to evaluate the efficacy and safety of ACER-001 for the potential treatment of MSUD.
In August 2022, Relief and Acer announced that the European Commission had granted orphan medicinal product designation in the EU to ACER-001 for the potential treatment of patients with MSUD.
APR-OD32
In March 2022, APR announced the acquisition of the worldwide commercial rights (excluding UK) from the UK-based company Meta Healthcare Ltd. ("Meta") for a novel, differentiated dosage form of a prescription drug already approved by the U.S. FDA and intended for the treatment of patients with PKU. This improved product is expected to enhance patient acceptance and compliance as well as enable easier, self or caregiver administered dosing and dispensing.
In July 2022, the final agreement was executed. Pursuant to the final agreement, Meta shall transfer to Relief all data, know-how, as well as any intellectual property related to "APR-OD32" as developed or generated by Meta. Relief shall only be responsible for funding the remaining development activities as well as for filing and obtaining a new drug application in all countries worldwide except for the UK where Relief shall grant a license back to Meta, enabling Meta to market the product in that country.
RLF-100® (aviptadil)
In April 2022, Relief reported that the Swiss Patent Office IPI issued a patent WO2020/225246 entitled, "Vasoactive Intestinal Peptide (VIP) for the Use in the Treatment of Drug-induced Pneumonitis," to Relief's subsidiary, AdVita Lifescience GmbH ("AdVita"). The patent provides intellectual property protection to Relief's inhaled formulation of RLF-100® into at least 2039.
In May 2022, Relief provided a corporate update noting that it intends to continue clinical assessment of both inhaled and IV formulations of RLF-100® for pulmonary indications, including (1) the continuation of the European study of inhaled RLF-100® for COVID-19-infected patients (2) the initiation of a clinical trial of RLF-100® in early 2023 in patients with sarcoidosis (3) the exploration of RLF-100® for checkpoint inhibitor-induced pneumonitis (4) testing of RLF-100® in the treatment of non-COVID-19-related ARDS and (5) conducting a European proof-of-concept of RLF-100® in the treatment of chronic berylliosis.
Sentinox
In March 2022, APR Applied Pharma Research SA ("APR") reported final data from its clinical trial of Sentinox in SARS-CoV-2 infected patients. Although the primary endpoint was not achieved, the results suggest the potential efficacy of Sentinox, with a better response in subjects dosed 3 times per day versus the control group, in the reduction of the nasal viral load, negativization and infectivity and confirmed its safety and tolerability.
CAMBIA
In January 2022, APR received a Notice of Allowance from the USPTO for Patent Application No. 16/713,052 entitled, "Ready to Use Diclofenac Packs." Diclofenac potassium is an off-patent, potent non-steroidal anti-inflammatory drug ("NSAID") widely used therapeutically for inflammatory conditions and pain management.
Management and Board Additions
Relief expanded the Board of Directors with highly experienced life science industry executive Michelle Lock.
To match its fast pace of development, Relief has appointed seasoned executives to newly created roles including, Christopher Wick, as Executive Director, Head of U.S. Sales; Drew Cronin-Fine as Executive Director, Head of U.S. Marketing, and David McCullough as Senior Director and Head of U.S. Market Access.
Additionally, Relief appointed Serene Forte, Ph.D., MPH, to the newly created role of Senior Vice President, Head of Genetic Medicine, to spearhead Relief's new genetic medicine initiatives.
Business Update
On July 20, 2022, Relief's Registration Statement on Form 20-F under the Securities Exchange Act of 1934 became effective, and Relief is now a publicly reporting company in the United States.
In August 2022, Relief filed a Registration Statement on Form F-1 under the Securities Act of 1933 for a proposed offering of its ordinary shares in the form of American Depositary Shares ("ADSs"). The number of ADSs to be offered and the price range for the proposed offering have not yet been determined. As part of the registration process, Relief plans to apply to list its ADSs on the Nasdaq stock market, and such listing is expected to become effective on effectiveness of its registration statement. There can be no assurance that Relief's Form F-1 registration statement will become effective, that Relief will successfully complete an offering of its ADSs, or that Relief will be successful in its efforts to up-list its ADSs to the Nasdaq Stock Market. Any offering, if made, will only be made by an effective prospectus.
On August 22, 2022, Relief announced that it has agreed to a tentative settlement of its pending litigation with NRx Pharmaceuticals and its subsidiary, NeuroRx, Inc. relating to Relief's September 2020 collaboration agreement with NeuroRx. The parties have agreed to work collaboratively to finalize the settlement within the next 30 days. Further, the parties have agreed to stay the litigation for an additional 60 days to allow for the negotiation and execution of the definitive settlement agreement and related terms. Terms of the settlement will be reported following execution of the definitive settlement terms. There can be no assurance that the settlement will be completed.
Financial Highlights for the Six Months Ended June 30, 2022
Results of Operations
In the first six months of 2022, Relief generated CHF 3.24 million of revenue from product sales, licensing fees, and royalties. Prior to the business combination with APR at the end of June 2021, Relief did not generate any revenue.
Other gains were CHF 1.3 million for the six months ended June 2022, compared to CHF 0.9 million for the six months ended June 2021. In the current period, other gains consisted mainly of a change in the fair value of provisions for contingent liabilities and an impairment reversal following the repayment of a loan issued to NeuroRx in 2020 and for which Relief had recorded a complete impairment allowance. In the comparative period, other gains related to write-offs of liabilities.
External research and development expenses increased to CHF 10.6 million for the six-month period ended June 30, 2022, from CHF 8.3 million for the six months ended June 30, 2021, an increase of CHF 2.3 million primarily due to higher expenses incurred by Acer under the license and collaboration agreement and secondarily due to the addition of in-process programs through the acquisition of APR in June 2021. The increase in expenditures associated with ACER-001 and other in-process programs was partially offset by a reduction of CHF 5.7 million in development expenses associated with RLF-100.
Personnel expenses increased to CHF 5.8 million in the six-month period ended June 30, 2022, compared to CHF 3.4 million for the six-month period ended June 30, 2021, an increase of CHF 2.4 million mainly due to an increase in employee headcount resulting from the acquisitions of APR and AdVita and the establishment of our U.S. sales force. As of June 30, 2022, Relief had 57 full-time equivalents on its payroll.
Other administrative expenses increased to CHF 4 million in the six-month period ended June 30, 2022, compared to CHF 3.2 million for the six-month period ended June 30, 2021, an increase of CHF 0.8 million primarily attributable to expanded activities with the addition of APR and AdVita. Consulting expenses associated with the preparation of the market launch of PKU GOLIKE® in the U.S. further contributed to the increase. Legal fees remain flat as costs related to Relief's effort to become a publicly reporting company in the United States and to list its ADSs on Nasdaq were offset by a reduction in costs incurred for other legal and regulatory matters.
Relief conducted an impairment test of intangible assets as of June 30, 2022, and concluded that the carrying amount of certain assets, mainly intangible assets associated with PKU GOLIKE® and Sentinox™, exceeded their recoverable amount. As a result, the company recognized a non-cash impairment charge on intangible assets of CHF 8.2 million in the current period. The impairment charge reflects a reduction of estimated future net cash flows from PKU GOLIKE® following changes in market assumptions, and, for Sentinox™, a one-year delay in the estimated launch date.
Amortization and depreciation expenses were CHF 2 million for the six-month ended June 2022 and were nil for the six months ended June 2021. Prior to the acquisition of APR in June 2021, Relief did not have amortizable intangible assets nor material property, plant, and equipment assets on its balance sheet.
Financial expenses increased to CHF 1.1 million in the six-month period ended June 30, 2022, compared to CHF 0.3 million for the six-month period ended June 30, 2021, an increase of CHF 0.8 million primarily due to the recognition of an interest expense of CHF 0.7 million in relation with contingent liabilities that may become due upon achievement of milestones contractually agreed with the former shareholders of APR and AdVita.
Income taxes were a gain of CHF 1.6 million in the six months ended June 2022, compared to income tax expenses of CHF 0.01 million for the six-month period ended June 30, 2021. The income tax gain resulted mainly from the amortization of intangible assets and a corresponding reduction in the temporary difference between the carrying amount of these assets and their tax base.
Net loss for the period was CHF 26.5 million, compared to a net loss of CHF 14.7 million for the same period last year.
Relief's Half-Year 2022 Report, including the interim consolidated financial statements, is available for download here.
ABOUT RELIEF
Relief is a Swiss, commercial-stage, biopharmaceutical company focused on identification, development and commercialization of novel, patent protected products intended for the treatment of rare and ultra-rare diseases including metabolic disorders, pulmonary diseases and connective tissue disorders. Relief's diversified pipeline consists of assets that have the potential to effectively address significant unmet medical needs, including PKU GOLIKE®, engineered with the proprietary Physiomimic technology, which is the first prolonged-release amino acid product commercialized for the dietary management of phenylketonuria ("PKU"). Relief has a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001 (sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including Urea Cycle Disorders ("UCDs") and Maple Syrup Urine Disease ("MSUD"). Relief also continues to develop aviptadil for several rare pulmonary indications. Further, Relief is in clinical development for APR-TD011, a differentiated acid oxidizing solution of hypochlorous acid intended for the treatment of epidermolysis bullosa ("EB"), a group of rare, genetic, life-threatening connective tissue disorders; APR-TD011 has been granted Orphan Drug Designation by the FDA. Finally, Relief is commercializing several legacy products via licensing and distribution partners.
RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY.
For more information, visit www.relieftherapeutics.com. Follow Relief on LinkedIn.
CONTACT:
RELIEF THERAPEUTICS Holding SA
Panton...Thanks for keeping us informed of the timely news articles.
Very much appreciated..
Deadlines are here .....Lotsa info here... and some fairy tales.
Thanks in large part to Wonger.......
https://iapps.courts.state.ny.us/nyscef/ViewDocument?docIndex=2bYm1JUXLAgZ8/LgWyOe/g==
Selling timed perfectly with a broker recommendation and a $2 price target ??
Or all a big simple coincidence ??
https://finance.yahoo.com/screener/insider/JAVITT%20DANIEL%20C
panton, thanks for consistently keeping us updated with developments and news.
This hopefully is especially promising with tremendous potential.
A link to your news......
https://www.marketscreener.com/quote/stock/RELIEF-THERAPEUTICS-HOLDI-5527488/news/Relief-Therapeutics-Announces-Promising-Initial-Stability-Data-on-a-New-Formulation-of-RLF-100-R-41176782/
Looks like its Time for approval of aviptadil....
https://rumble.com/search/video?q=Dr%20Robert
https://rumble.com/search/video?q=Dr%20Peter
https://rumble.com/search/video?q=vaccine%20injuries
https://rumble.com/v1817sw-covid-vaccine-injuries-overwhelm-courts.html
https://rumble.com/search/video?q=vaccine%20deaths
https://rumble.com/search/video?q=Front%20Line%20Doctors
Looks like its Time for approval of aviptadil.... WHY NOT ?
And they are giving this to small children and infants, not to mention
pregnant women along with perfectly healthy citizens.
https://citizenfreepress.com/breaking/the-vaccine-will-eventually-be-known-as-biggest-scandal-in-medical-history/
How about approval of a safe effective med like RLF Aviptadil. ????
https://thelibertydaily.com/flip-flopping-fascist-fear-fuhrer-fauci-admits-he-lied-about-covid-natural-immunity/
Not lookin good for Neuro or .....a guy that is a "consultant" , .....
Time to settle with RLF and pronto ?
https://ir.stockpr.com/neurorxpharma/sec-filings-email/content/0000950142-22-002222/eh220269223_8k.htm
Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.
On July 12, 2022, the Company received a written notification (the “Notice”) from the Nasdaq Stock Market LLC (“Nasdaq”) indicating that the Registrant was not in compliance with Nasdaq Listing Rule 5450(a)(1), as the Registrant’s closing bid price for its common stock was below $1.00 per share for the last thirty (30) consecutive business days.
FOUR CLOT SHOTS and still going.....yep.....safe, effective, & free
we were told by the gobrmint that spent one billion tax $$$ telling us so. .
https://citizenfreepress.com/breaking/biden-infected-with-covid/
Maybe time for another booster shot, eh Jose ?
Or approval of RLF that is safe and effective.
From Guiseppe 5 hours ago on another b board.....
at you who
https://www.researchgate.net/publication/361024336_European_Journal_of_Pharmaceutical_and_Medical_Research_243_AVIPTADIL_IN_ACUTE_RESPIRATORY_DISTRESS_SYNDROME_ASSOCIATED_WITH_COVID-19_INFECTION_SJIF_Impact_Factor_6222_EUROPEAN_JOURNAL_OF_PHARMACEUTIC
Conclusion: Use of Aviptadil was safe and effective in improving the
resolution of respiratory failure, shortening the time to recovery, decreasing respiratory distress and preventing
death in respiratory failure patients. The rapidity and magnitude of clinical effect suggests a highly specific role of
Aviptadil in combating the lethal effects of Acute Respiratory Distress Syndrome associated with COVID-19.
Another New CEO for Neuro Installed !!!
Call me skeptical at best.
A desperate attempt to re float a sinking ship ??
https://finance.yahoo.com/news/nrx-pharmaceuticals-announces-appointment-stephen-111500208.html
NRx Pharmaceuticals Announces the Appointment of Stephen Willard, Chief Executive Officer and Director
Wed, July 13, 2022 at 6:15 AM
In this article:
NRXP
-8.72%
NRXPW
-3.85%
Extensive experience in Law, Finance, and Management of Public and Private Biotechnology Companies
Proven track record of creating value for shareholders
National Science Board Presidential Appointee, 2018-2024
Former roles at Federal Deposit Insurance Corporation (FDIC) and E*Trade Financial
RADNOR, Pa., July 13, 2022 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP): ("NRx Pharmaceuticals", or the "Company"), a clinical-stage biopharmaceutical company, today announced the appointment of Stephen Willard, as its Chief Executive Officer ("CEO") and a member of the Company's Board of Directors. The Company's interim CEO, Robert Besthof, will continue to support the Company and return to his roles as Head of Operations and Chief Commercial Officer.
Stephen Willard, Chief Executive Officer, Director, NRx Pharmaceuticals, Inc.
Stephen Willard, Chief Executive Officer, Director, NRx Pharmaceuticals, Inc.
@NRXP Board Appoints BioPharma Veteran and National Science Board Presidential Appointee to Lead NRx Pharmaceuticals, Inc.
"We are delighted to have attracted a candidate like Steve whose background and experience align with NRx Pharmaceuticals' current needs. Steve's passion to provide breakthrough therapies to address critical unmet needs positions the Company for success," said Patrick Flynn, a member of the Company's Board of Directors. "We look forward to Steve's leadership of the Company in the next stages of growth to benefit patients, our shareholders, and the broader NRx team."
Mr. Willard brings a wealth of experience in the management of publicly traded biotechnology companies, together with his background in law and finance. Most recently, Mr. Willard served as CEO of Cellphire Therapeutics, where he grew the company and shepherded their revolutionary human platelet platform through key clinical trials, growing the company and significantly increasing the share price. Prior to Cellphire, he served as CEO of publicly traded Flamel Technologies now known as Avadel Pharmaceuticals. Mr. Willard is currently serving a six-year term from 2018-2024 as a presidential appointee to the National Science Board.
Mr. Willard's career in financial services includes government service as Associate Director of the Federal Deposit Insurance Corporation (FDIC), where he served in the United States Senior Executive Service (SES) from 1991-1994, and on the board of E*Trade Financial Services from 2000-2014. He has practiced law in New York, London, and Washington, D.C. Mr. Willard earned his undergraduate degree from Williams College and attended Yale University where he earned a JD in law.
PW.....Its my hope that RLF will possibly be in a position to force favorable control of Neuro in one way or another, and have the NRX-101 BTD compound for Bipolar Depression at a bargain price. ( assuming its not another bogus NRX product and the class action can not attach assets under development )
Seems thats about all Neuro has left, except massive liabilities.
Failed mediation..... .. Courtesy of poster on another board... ....y who ?
From....
dnctrk 20 hours ago
The judge approves…
https://iapps.courts.state.ny.us/nyscef/ViewDocument?docIndex=IM0RLpwBQajIfItvpr_PLUS_3tA==
From....
Wong 20 hours ago
Pressure is on NRXP. Is this why JJ's brother just donated 2 million shares to his personal foundation? Executives usually do this before a steep drop in the SP. NRXP has shown itself to be very "clairvoyant" in the past.
https://www.relieftherapeutics.com/newsblog-detail/?newsID=2293059
Relief Therapeutics Files Amendment No. 4 to its Registration Statement on Form 20-F with the U.S. Securities and Exchange Commission
Relief Therapeutics Holding SA / Key word(s): Miscellaneous
04-Jul-2022 / 07:15 CET/CEST
Release of an ad hoc announcement pursuant to Art. 53 LR
The issuer is solely responsible for the content of this announcement.
Relief Therapeutics Files Amendment No. 4 to its Registration Statement on Form 20-F with the U.S. Securities and Exchange Commission
Geneva, Switzerland, July 4, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), announced today that it has filed Amendment No. 4 to its Registration Statement on Form 20-F ("Registration Statement") with the U.S. Securities and Exchange Commission ("SEC"). The Registration Statement is intended to register Relief as a reporting company under the Securities Exchange Act of 1934. The Registration Statement has been filed as part of an ongoing program to convert Relief's Level 1 American Depositary Receipt ("ADR") program in the United States to a Level 2 ADR program, and is part of Relief's ongoing efforts to list its ADRs on the NASDAQ Stock Market. The NASDAQ listing will only occur after the Registration Statement has become effective, which is subject to a continuing review of the Registration Statement by the SEC, and the filing by Relief of a listing application with the NASDAQ (which has not yet occurred).
Yes, PW, and plenty of other areas that could use some development.
And why not use a BP partner to move these other programs forward ??
PW...Ok...."CYNICAL" that sounds reasonable, all things considered.
https://nypost.com/2022/06/29/dr-fauci-reveals-covid-rebound-after-pfizers-paxlovid-treatment/?utm_campaign=SocialFlow&utm_medium=SocialFlow&utm_source=NYPTwitter
Perhaps a third course of the ol PAX LOVE and or a 5th clot shot in the rear end, in the bone head, or even the throwing/ pitching arm....you never know what might work.. it is kind of experimental, but clearly not as advertised...(.safe, effective, free )
Wish someone at RLF would make that call and offer him some adviptadil.
Interesting how "rebound" now has a meaning of "reinfection"
..
Evidently No Aviptadil or RLF-100 for the Flip Flopper.........
............ Evidently the shots do not work as advertised, ie...safe, effective, and free
Maybe Triple Masks and or a Ventilator / Remdesvir. ???
https://abcnews.go.com/US/fauci-taking-2nd-paxlovid-experiencing-rebound-antiviral-treatment/story?id=85922417
<The Food and Drug Administration also says that “there is no evidence of benefit at this time for a longer course of treatment … or repeating a treatment course of Paxlovid in patients with recurrent COVID-19 symptoms following completion of a treatment course.”>
< Earlier this month, Pfizer also reported new clinical trial data that showed that Paxlovid did not significantly reduce the risk of going to the hospital or dying in people with standard risk of developing severe illness. However, the company said the treatment still works well in high-risk individuals.>
Sounds Confusing......One, Two, three or, four courses ????
https://finance.yahoo.com/news/acer-therapeutics-announces-initiation-pivotal-123000936.html
Acer Therapeutics Inc.
NEWTON, Mass., June 27, 2022 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER), a clinical stage pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today announced the initiation of patient screening in its Phase 3 DiSCOVER (Decentralized Study of Celiprolol on vEDS-related Event Reduction) clinical trial of EDSIVO™ (celiprolol) for the treatment of patients with COL3A1-positive vascular Ehlers-Danlos Syndrome (vEDS).
“With no approved treatments available for vEDS, ongoing clinical evaluation of EDSIVO™ (celiprolol) is an important step that we hope could lead to the first available treatment option for this fatal disorder,” said Adrian Quartel, MD, FFPM, Chief Medical Officer of Acer. “The innovative, decentralized study design will allow for greater access and ease of administration for vEDS patients, mobile nurses, remote clinical research coordinators and investigators. We'd like to thank all the patients, their family members, the advocacy groups and clinicians who have expressed interest in learning more about participating in the study, and look forward to rapidly enrolling the trial.”
Evidently ...Dal Bosco vs NRXP class action lawsuit dismissed
Interesting only as a lawsuit that I had not ever even known about.
https://finance.yahoo.com/news/class-action-suit-against-nrx-223300879.html
https://www.prnewswire.com/news-releases/class-action-suit-against-nrx-pharmaceuticals-dismissed-301573556.html
EXCLUSIVE: Shocking microscopy photos of blood clots extracted from those who “suddenly died” – crystalline structures, nanowires, chalky particles and fibrous structures
https://www.naturalnews.com/2022-06-12-blood-clots-microscopy-suddenly-died.html
And our gov. spent one billion dollars advertising ' its safe efeective and free."
Get your clot shot today..........
How about RLF-100 ????????.
https://www.wnd.com/2022/06/pathologist-covid-19-shots-causing-foot-long-blood-clots/
Pathologist: COVID-19 shots causing foot-long blood clots
'Too many people are silent, and silence is compliance'
A pathologist who heads one of America's leading labs is finding unusually long blood clots, as long as one foot, in the bodies of deceased people who received COVID-19 vaccines.
Dr. Ryan Cole of Cole Diagnostics in Boise, Idaho, said his lab is "seeing mushy organs, we're seeing incredibly inflamed organs."
"We know the spike protein causes all the ... bad outcomes that the virus did in 2020," he said in an interview with Greg Hunter for USAWatchdog reported by Just the News.
Cole said that in people with comorbidities – serious chronic diseases – the synthetic spike protein in the mRNA vaccines produced by Pfizer and Moderna are "causing inflammation in the lung, the brain, the liver, the kidneys, the heart; it's causing the same damage that the virus was causing."
However, he added, "in the body, the shots are persisting and making more spike protein than if you had a natural infection."
Cole, whose laboratory receives tissue samples from morticians across the country, cited a Stanford University study published in the journal Cell that found the vaccine's spike protein remains in the body for at least eight weeks.
........The morticians, Cole said, ended up pulling out "six-inch clots, 12-inch clots, two to three-foot-long clots."
"Because, you know, from the hip down into the leg, you have a long vein called the saphenous vein. And so they were pulling long clots out of your longer veins. And ... they hadn't seen anything like this previously."
In February, as WND reported, a veteran embalmer told Kirsch he and more than a dozen colleagues in the industry had been noticing strange blood clots in most of their cases.
SO>>>> IS it About Time for a safe therapeutic like AVIPTADIL. RLF-100 , eh ?????
Relief Therapeutics Needs A Lawfirm Like This One.....
.........Boyden Gray & Associates
https://www.zerohedge.com/covid-19/doctors-suing-food-and-drug-administration-over-ivermectin
Very similar situation for RLF-100 as a safe effective med that has been previously approved for a long time.
the FDA had violated well-established law that allows doctors to prescribe an FDA-approved drug as an off-label treatment.
Ivermectin was no different, he said. It was approved by the FDA in 1966.
“Congress recognized the importance of letting doctors be doctors and expressly prohibited the FDA from interfering with the practice of medicine,” Gray said.
“That is exactly what the FDA has done time and time again throughout this pandemic, assuming authority it doesn’t have and trying to insert itself in the medical decisions of Americans everywhere.”
Evidently nothing definite, absolute, or set in stone on the dates.
https://www.fool.com/investing/stock-market/market-sectors/healthcare/pharmaceutical-stocks/pdufa-date/
Prion Disease and the old clot shot or so called vax.
https://twoplustwoequalsfournews.wordpress.com/2022/03/05/steve-kirsch-proof-covid-vaccines-cause-prion-diseases/
https://www.legitgov.org/studies-link-incurable-prion-disease-covid-19-vaccine
https://www.theepochtimes.com/studies-link-incurable-prion-disease-with-covid-19-vaccine_4511204.html
Time for some safe therapeutic drugs like RLF-100 eh ?
JJ.... how much, if any stock, do you still retain stock in neuro ??
Thanks rollup....Great Find from the results in India.
And For emphasis..........
https://storage.googleapis.com/journal-uploads/ejpmr/article_issue/1653986940.pdf
ABSTRACT
Aim: This study is aimed at evaluating efficacy and safety of Intravenous Aviptadil as an add-on to the “Standard
of Care” treatment in severe COVID-19 patients with respiratory failure. Design, Setting and Participants: A
randomized, multicentric, double-blind, placebo-controlled, comparative Phase III clinical trial was conducted at 8
geographically distributed sites across India between April 2021 to October 2021. The study enrolled 150
participants who were tested and confirmed cases of severe COVID-19 with respiratory failure and acute
respiratory distress syndrome. Interventions: 12-hour intravenous infusions of Aviptadil over 3 successive days in
ascending doses given as 0.166 mcg/kg/hr on Day 1 (equivalent to one 10 mL vial of 150 mcg), 0.332 mcg/kg/hr
on Day 2 (equivalent to two 10 mL vials of 150 mcg each) and 0.498 mcg/kg/hr on Day 3 (equivalent to three 10
mL vials of 150 mcg each). Methodology: Severe COVID-19 patients with respiratory failure were randomized in
two groups in a ratio of 1:1, to receive either Aviptadil or Placebo. Both the study drugs were given as an add-on to
the standard of care (SOC). The SOC was kept as close as possible to the COVID-19 treatment guidelines specified
by the Government of India. The study site staff, investigator and patients were masked to the treatment allocation.
The primary endpoint of the study was resolution of respiratory failure whereas the secondary endpoints were
improvement in WHO 7-point ordinal scale, improvement in PaO2:FiO2 ratio, survival of the patients and
incidences of adverse events. Results: After the completion of treatment in Aviptadil group, an improvement was
observed in the primary outcome of resolution of respiratory failure. Proportion of patients on Aviptadil
demonstrated statistically significant odds, 2.1-fold, (p=0.0410) of being free of respiratory failure (no oxygen
requirement) at Day 3 and 2.6-fold (p=0.0035) at day 7 as compared to the placebo group. An earlier resolution
from the respiratory failure, with a median duration of 7 days was noted in the Aviptadil-treated group as compared
to 14 days in the placebo group. A higher proportion of patients on Aviptadil shifted to the milder clinical state
(32.43% vs 17.80%; p=0.0410 on Day 3 and 70.27% vs 45.21%; 0.0035 on Day 7) without the requirement of
oxygen than the placebo group. A reduction of severity (based on WHO 7-point ordinal scale) in clinical status
were also observed on Day 14 (p = 0.0005 by Wilcoxon rank sum test) and Day 28 (p = 0.0009 by Wilcoxon rank
sum test). There were 68.42% Aviptadil-treated patients who showed 2 or more points improvement on the WHO
7-point ordinal scale as compared to 44.59% in the placebo group (p=0.003; Pearson chi2 test; odds ratio, 2.69;
95% CI, 1.38-5.24) on Day 7. On day 28, patients in the Aviptadil group had higher odds (1.38) of an improvement
on WHO 7-point ordinal scale as compared to placebo with SOC. Aviptadil reduced the risk of death by 20%
(relative risk 0.80; 95% CI: 0.35, 1.66) in ARDS. Patients treated with Aviptadil demonstrated significant
improvement in PaO2/FiO2 ratio vs. placebo from day 2 to over the week (p<0.05) and beyond. There were 15
deaths in the Aviptadil group and 18 deaths in the placebo group. No deaths were attributed to the Investigational
products. COVID-19–related mortality occurred in 22% patients of the study population, due to respiratory failure
caused by underlying medical conditions. Conclusion: Use of Aviptadil was safe and effective in improving the
resolution of respiratory failure, shortening the time to recovery, decreasing respiratory distress and preventing
death in respiratory failure patients. The rapidity and magnitude of clinical effect suggests a highly specific role of
Aviptadil in combating the lethal effects of Acute Respiratory Distress Syndrome associated with COVID-19
Instead Something is up.... additional big cheese are exiting. Lots of speculation.
From HODL 6 hours ago ......Y board.
Resignation of Alessandra Daigneault as Chief Corporate Officer, General Counsel and Corporate Secretary
On May 19, 2022, Ms. Alessandra Daigneault tendered her resignation as Chief Corporate Officer, General Counsel and Corporate Secretary of NRx Pharmaceuticals, Inc. (the “Company”) effective on July 18, 2022 or such earlier date as may be agreed with the Company. Ms. Daigneault is leaving the Company to pursue other personal and professional interests.
The Company’s interim Chief Executive Officer, Mr. Robert Besthof, expressed his thanks to Ms. Daigneault for her outstanding contributions to the Company, including overseeing the merger of NeuroRx, Inc, and Big Rock Partners Acquisition Corp in May 2021, which resulted in the formation of the Company.
Mr. Michael Kunz, the Company’s Deputy General Counsel, is expected to assume the duties of General Counsel and Corporate Secretary.
Resignation of Mr. Ira Strassberg as Chief Financial Officer and Treasurer
On May 19, 2022, Mr. Ira Strassberg tendered his resignation as Chief Financial Officer and Treasurer of the Company effective July 18, 2022. Mr. Strassberg is leaving the Company to pursue other personal and professional interests. Mr. Strassberg will continue to fulfill his duties as Chief Financial Officer and Treasurer of the Company until his departure. The Board will be conducting a search for a successor.
The Chairman of the Company’s Audit Committee, Mr. Patrick Flynn, and Mr. Besthof, expressed their thanks to Mr. Strassberg for his meaningful contributions to the Company, including the establishment of robust internal controls and a strong finance and accounting function at the Company.
At this low low price, insiders sb buying millions of shares ...IF
there is a bright future for Neuro, imho. .
Why are the big insiders not buying in at low prices ???? Where is bowtie ???
FY...Interesting From Zaran....13 hours ago on the Y board.
The confluence of timing and events is rapidly approaching. Disgruntled former and current Dept. of Health and Human Resource employees are enumerating issues we each have learned about through our involvement here and in the public tackling of the Covid-19 pandemic.
On May 26th. the DSMB of the ACTIV 3b Clinical Trial monitoring the results of the Aviptadil vs.
Remdesivir vs. Placebo comparisons is going to meet to review all of the data from those trial participants who have completed 90 days post infusion to date. We are being told that they will also consider all other data available to them, including (my belief) the information / data packages included with the EUA and BTD, most recent filings. If the drug works as we believe, then, these board members will see "again," not only the safety of VIP in this IV version, but it's overwhelming efficacy compared to Remdesivir and placebo. Remembering that the April DSMB meeting was "delayed' so that precisely and specifically MORE data would be available for them to REVIEW! This is an extremely important meeting. As we were lead to believe earlier this year, the preponderance of trial participants for the Aviptadil portion had a higher percentage of patients so all the better for safety and efficacy readings at this critical juncture.
What do they do when they update their knowledge with these possible results? Good question needing to be placed in context to the above mentioned internal ongoing inquiry and to the external Congressional investigations which are becoming increasingly strident in "demanding" working therapeutics and now, preparation for subsequent (think, Fall) Seasons of Covid infections. Funding for the Covid Pandemic War is also concurrently in full swing in Congress. Results are being demanded by both republicans and democrats, and is in no small way a part of this funding process. Yes, even CongressPeople are investigating and becoming dis-satisfied in their analysis of results. Add to this mixture... Preparation of any new therapeutic by a small organization like our own and "now" collaborator NRXP, is as has been said by Dr. Harris in his most recent public conversation with Dr. Fauci, going to take a few months for initial production and dissemination under BARDA's stewartship to reach hospital ICU's across our country. The rest of the world not even considered, yet!
Throw in the fact that our trial is the only one left in ACTIV 3b for critically ill patients. Throw in that the newest EUA granted for Olumiant is only marginally better (2 or 3 percent) than it's comparison to Remdesivir not 4X better like our racehorse Aviptadil. Throw in that more recent studies have found that Remdesivir "does not work" for late stage covid. And, recommendations that it be moved to being an earlier stage therapeutic. Keep everybody happy, right?
Consider that on April 22nd. India issued an EUA for Aviptadil with a report of outstanding results on all measures. Consider that the Swiss Inhaler Trial has ended recruiting and results will be forthcoming as final results are tabulated. Are we the USA, the premier Medical Establishment, or what? Late to the Party?
And, perhaps more important than anything else is that 300 people here in the USA are dying needlessly everyday from respiratory complication of Covid-19. I say that just having gotten over the disease. Fortunately for me, it was mild, but for those who can't breathe, hello? what in god's name are we waiting for?
We've all been waiting and if lucky, we've learned patience and have a better understanding of how our government works and certainly how the medical establishment does it's thing. So, we are wiser and smarter for everything we have gone through. Don't get me wrong, no where did I say easy or fun, it's been hard I'm sure on all of us. But, there comes a time, an event is created by multiple interactions, a black swan event is just this very thing. Seemingly, disparate occurrences happening create. This is a time now when many related areas of importance to us shareholders and believers in this drug that are acting in synchronicity. Is there enough momentum to get us over the hump? If the results of the IV infusions in the ACTIV 3b trial are as anticipated, I think we get our EUA now. Trial stopped, immediate approval.
Why? It's getting awfully hot in Washington with the bickering and CongressPeople aren't stupid. They know about Big Pharma, too, and get compensated by lobbyists and in donations to their PAC's and campaigns. Nothing new here, but a rising tide of trust has been turned into a rising tide of dis-satisfaction and questions of betrayal and selling out. Bottom line, voters are people like you and me. All the things mentioned above.
Don't fail to see that the spring is wound very, very tight. If we were to get an EUA, this stock is going to explode. Market caps are as much extrapolations as data, expect lunacy.