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Relief therapeutics Holding

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Djazz
0
Af en toe eens nieuws plaatsen tussen de (h)eerlijke discussies hier.

RELIEF REPORTS REGULATORY CLEARANCE IN GERMANY TO COMMENCE A MULTICENTER, DOUBLE-BLIND, RANDOMIZED PHASE 2 CLINICAL TRIAL TO EVALUATE INHALED AVIPTADIL FOR THE TREATMENT OF SARCOIDOSIS
Ad Hoc Announcement pursuant to Art. 53 LR,
02 September 2021
Relief Reports Regulatory Clearance in Germany to Commence a Multicenter, Double-blind, Randomized Phase 2 Clinical Trial to Evaluate Inhaled Aviptadil for the Treatment of Sarcoidosis
Geneva, Switzerland, September 2, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that its recently acquired German subsidiary, AdVita Lifescience GmbH (“AdVita”), has received regulatory clearance to commence a phase 2 clinical trial in Germany to evaluate inhaled aviptadil for the treatment of sarcoidosis.
Following a proof-of-concept trial in 20 sarcoidosis patients which demonstrated the suppression of inflammatory mechanisms of the lung in combination with amelioration of dry cough and exertional dyspnea, AdVita received clearance by the German medical regulatory authority Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) to conduct a randomized, double-blind, multicenter clinical trial in sarcoidosis patients.
Raghuram Selvaraju, Chairman of the Board of Relief, commented, “Receiving regulatory clearance to begin a phase 2 clinical trial of inhaled aviptadil marks another clinical milestone for Relief and our subsidiary, AdVita. Aviptadil is believed to be the only known experimental drug that could potentially suppress sarcoidosis-associated cough, one of the major symptoms reducing quality of life in this patient population. We look forward to initiating this trial and to further exploring the clinical utility of aviptadil across multiple pulmonary indications.”
MisterBlues
1
quote:

DeZwarteRidder schreef op 2 september 2021 09:32:


[...]

Het woord 'onzinmiddel' heb ik nooit gebruikt, maar het middel is overbodig en veel te laat.

En Relief zal er geen zak mee verdienen omdat NRX alles heeft ingepikt en NRX zal niks verkopen, want er zijn bijna geen patiënten meer.

Ondertussen gaat GEM stevig door met dumpen, want die willen deze waardeloze zooi zo snel mogelijk kwijt.


Je geheugen is weer te kort reikend - wellicht omdat je op te veel borden schaakt. Wel degelijk woorden van die strekking door jouw gebruikt, blader maar eens wat verder terug. Vorig jaar zomer.

Dat NeuroX nu alles probeert in te pikken was toen nog niet spelende, en dit kon helemaal niemand aan zien komen. Dit is echter wel de grootste bottleneck van Relief geweest en niet GEM. Mijn punt blijft dus staan dat je het maar half goed hebt gehad.

Ik denk dat GEM zeker nog wat plukkies bewaard voor het geval het juridisch gevecht nog iets gaat opleveren. Verder ben ik er allang uit en is Relief een goede investering geweest, voor velen die op tijd zijn uitgestapt. Het bedrijf heeft verder wel degelijk een bijdrage aan de 'peptide geneneeskunst' geleverd, ook al zou er voorlopig - of nooit - (n)iets op de markt komen.

De wereld is niet zwart wit.
Gerardke
0
leesvoer voor het weekend ...

Gem de gulle geldschieter ;-)

link naar S3 : sec.report/Document/0001104659-21-113...

As of August 30, 2021, Relief Therapeutics has reimbursed us for approximately $10.9 million of expenses, but has not paid approximately $10 million in invoiced costs associated with conduct of the Relief Product clinical trial, reformulation, and manufacture of ZYESAMI. Additionally, Relief Therapeutics has declined to approve the budget and has not funded the costs of the inhaled trial. We have advised Relief Therapeutics that we are funding those costs with capital provided by other investors. This lack of funding on the part of Relief Therapeutics, therefore, does not negatively impact our ability to continue development of ZYESAMI. We reaffirm our commitment to honoring our collaboration agreement with Relief Therapeutics and are committed to resolving these issues with Relief Therapeutics in an amicable manner, although these circumstances may lead to a dispute with Relief Therapeutics regarding what share of profits Relief Therapeutics should be entitled to receive based upon its reduced participation in the project.
Gerardke
0
Sharing of Intellectual Property

Under the Relief Agreement, each party has a broad right to use the other party’s intellectual property to develop and commercialize the Relief Product in its respective territory. To the extent necessary, each party is required to grant, or obtain from third parties, cross-licenses to allow the other party to use its intellectual property in the other party’s territory.

Each party will continue to own the intellectual property it possessed prior to the collaboration, and any intellectual property that is developed jointly by the parties relating to the Relief Product will be owned jointly by the parties and each party will have the right to use any joint intellectual property in its territory. Each party is responsible for filing and prosecuting applications for patents, trademarks and other intellectual property in their respective territories and for the protection, maintenance, and enforcement of such intellectual property in such territory.

94

Table of Contents

Commercialization

Under the Relief Agreement, each party will develop a commercialization plan for the Relief Product in its territory, which is subject to approval by the other party, and each party is obligated to use commercially reasonable efforts to commercialize the Relief Product in its territory consistent with the approved commercialization plan. Each party will have full rights to commercialize the Relief Product in its territory, subject to the approved commercialization plan, including the right to work with licensees, distributors, research organizations, marketing organizations and other third parties. Each party has agreed not to commercialize the

Relief Product in the other party’s territory. Relief Therapeutics retains the right to identify commercialization partners for countries outside the parties’ territories, and any arrangements with such commercialization partners will be subject to the terms of the Relief Agreement.

Division of Profits

Pursuant to the terms of the Relief Agreement, the parties will share the net profits from the sale of the Relief Product as follows:

Gerardke
0
10.000.000 voor Zyesami , how offers more ?

Nu de PR op maandag afwachten van Relief ...

pagina 94 : sec.report/Document/0001104659-21-113...

Sharing of Intellectual Property and
Commercialization
DeZwarteRidder
0
Samenvatting: Relief is een TOTAAL mislukt bedrijf, dat ruzie heeft met alle zakenpartners.

De koersstijging van bijna nul naar ca 60 cent, was dus een gruwelijke vergissing.

NRX wordt natuurlijk ook niks
Gerardke
1
quote:

DeZwarteRidder schreef op 4 september 2021 08:57:


Samenvatting: Relief is een TOTAAL mislukt bedrijf, dat ruzie heeft met alle zakenpartners.

De koersstijging van bijna nul naar ca 60 cent, was dus een gruwelijke vergissing.

NRX wordt natuurlijk ook niks


Neen , Relief is alles behalve waardeloos.
Ram en Javit zijn top maar narcisten die hun gelijk willen halen.
Gem heeft trouwens 20 milj betaald aan Nrx om door te gaan en het onderzoek te financieren
Je mag gerust stellen dat Gem hier niet de boosdoener is dat ze alles doen om er geld gaan mee verdienen, ja , maar dat wil tegenwoordig iedereen.

De rekening van Gem is eigenlijk snel gemaakt , aandelen gekocht aan 0.01 hebben in juli 100 milj verkocht aan x20 , daarmee hebben ze 6 % van Nrx ( @ 10 €) en al 50 % winst erop aan de huidige koers .. je zou er jaloers van worden.

aan ons moesten ze het geld niet komen vragen ;-)


DeZwarteRidder
0
DeZwarteRidder
0
quote:

DeZwarteRidder schreef op 4 september 2021 13:01:


Relief is waardeloos, het is slechts een kwestie voordat dat duidelijk wordt.

..................kwestie van tijd............
DeZwarteRidder
0
Pursuant to the SSF agreement dated 20 January 2021, GEM

committed to provide up to CHF 50

million to Relief in exchange of Relief shares over the

period from 20 January 2021 to 20

January 2024 at the discretion of Relief. Relief's sale

position is calculated based on the

closing price of its ordinary share on the SIX Swiss

Exchange Ltd on 28 July 2021 (CHF 0.23),

applying the agreed 10% discount, and on the current SSF

balance available (CHF 50 million),

resulting in a maximum of 241'545'894 shares. However,

future issue prices of Relief shares

under the SSF will be fixed at the moment of issue. So the

actual number of shares to be

issued under the SSF cannot be exactly established at

present. For further details, please see

the press release dated 21 January 2021.
DeZwarteRidder
0
Relief en GEM gaan nu tegen elkaar op dumpen, dus de koersdaling zal steeds sneller gaan.
vastbijter
2
jij waarschijnlijk ook met je commentaar, en maak je geen zorgen om mij, ik heb de buit allang binnen!
Gerardke
0
Relief Therapeutics Comments on Certain Statements Made by NRx Pharmaceuticals in its Registration Statement on Form S-1 Filed on September 3, 2021



Geneva, Switzerland, September 07, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) ("Relief" or the "Company"), commented today on statements made by NRx Pharmaceuticals, Inc. ("NRx"), the parent corporation of Relief's collaboration partner for RLF-100™ (aviptadil) in the United States, NeuroRx, Inc. ("NeuroRx"), in NRx's Registration Statement on Form S-1 filed on September 3, 2021 (the "Registration Statement"). In the Registration Statement, NRx makes several assertions that Relief believes require a public comment so that the marketplace has relevant information about the pending disputes between Relief and NeuroRx. Among other issues in dispute, based on currently available information, are the following:

The Registration Statement includes numerous statements of purported fact setting forth NeuroRx's version of the history of the relationship between the companies that led to the signing of the Binding Collaboration Agreement, dated September 18, 2020 (the "Collaboration Agreement"). While Relief believes that many of the statements made by NRx in the Registration Statement on this topic are false or misleading, Relief does not believe that it is necessary to lay out that historical record in public reporting, since it has no application to the current and ongoing relationship between the parties. Relief notes that the Collaboration Agreement expressly states that it "supersedes any and all prior understandings or agreements, whether written or oral, and there are no promises, agreements, condition, undertakings, warranties or representations (whether oral or written, express or implied) between them other than as [herein set forth]." Therefore, the history of what discussions led up to the parties' entry into the Collaboration Agreement has no application to the parties' rights and responsibilities presently in force and effect.


In the Registration Statement, NRx accuses Relief of misleading them and Relief's public shareholders about the stability of the formulation of aviptadil that Relief brought to the parties' collaboration. Relief reiterates, once again, that in its opinion, there is no truth to these allegations, and that NeuroRx was expressly tasked with developing a stable formulation of aviptadil under the Collaboration Agreement. Further, Relief reiterates, once again, that it never guaranteed that it already had an 18-month shelf stable product, and no such statements are made in the Collaboration Agreement, which contains the entire agreement between the parties. Finally, Relief once again reiterates its belief that the version of aviptadil that was and is being used by NeuroRx in its clinical trials is the drug version covered by the Collaboration Agreement.


NRx continues to state in the Registration Statement that Relief has not paid certain amounts due to NeuroRx relating to the collaboration. While the amount allegedly owed by Relief to NeuroRx according to the Registration Statement has grown exponentially when compared to the amounts stated in NRx's earlier public filings, Relief reports, once again, that not only has it met all of its financial obligations under the Collaboration Agreement, but that it has not received invoices documenting amounts anywhere close to the amounts that NeuroRx claims are allegedly due. Relief continues to have no idea of how the amount allegedly owed that is set forth in the Registration Statement is calculated and has demanded that it be allowed to perform a forensic audit on NeuroRx's books and records to determine the accuracy of the financial information provided to Relief (which NeuroRx has, to date, refused to allow).


In the Registration Statement, NRx states that Relief has "declined" to fund certain expenses relating to the development of the formulation of aviptadil and NeuroRx's clinical trial evaluating inhaled aviptadil for the treatment of patients with moderate to severe COVID-19. In fact, for some months, Relief has repeatedly requested information that is reasonably necessary to make a decision on whether or not to fund these expenses. Until sufficient information is provided so that Relief can make the decision whether or not to fund these expenses, the Collaboration Agreement does not allow NeuroRx to bring in another source to directly fund these expenses.


NeuroRx continues to refuse, despite repeated demands by Relief requesting this information, to share with Relief the full clinical trial data set, including details on the statistical analysis performed, from its recently completed phase 2b/3 trial, which data and information is required to be provided to Relief by NeuroRx under the Collaboration Agreement. To date, Relief has only received a high-level summary of the clinical study report and has not been provided with, among other information, access to the 53,909 individual case reports, the raw data from the clinical trial, or the data on the multiple statistical analyses performed. NeuroRx has likewise refused to share with Relief any of the correspondence between NeuroRx and the FDA. Further, NeuroRx has refused to allow NeuroRx's contract partners dealing with issues relating to the development of aviptadil to share information with Relief that it requires to develop RLF-100™ (aviptadil) in its territories (including the European Union and the United Kingdom). The failure of NeuroRx to provide this information is seriously impairing Relief's ability to develop and execute a clinical and regulatory strategy for RLF-100™ (aviptadil) in its territories.


Relief reminds NeuroRx that under Section 5.1 of the Collaboration Agreement, neither party may engage in any development activities for any drug or related product or treatment intended to be used to treat, combat, ameliorate, prevent or mitigate the effects of COVID-19 that can or may reasonably be expected to compete against or reduce sales (or other monetization) of aviptadil.


Relief believes that it has satisfied all of its obligations under the Collaboration Agreement and that as a result, all revenue/profit splits set forth in the Collaboration Agreement remain in full force and effect.
Relief intends to continue to seek an amicable resolution of its pending disputes with NeuroRx relating to the Collaboration Agreement. However, if such disputes are not resolved to Relief's satisfaction, Relief intends to take all actions necessary to enforce its rights under the Collaboration Agreement. While there can be no assurance, Relief believes that it will prevail in any such legal action to enforce its rights under the Collaboration Agreement.
DeZwarteRidder
0
quote:

vastbijter schreef op 6 september 2021 21:45:


jij waarschijnlijk ook met je commentaar, en maak je geen zorgen om mij, ik heb de buit allang binnen!


Ja, jij bent binnengelopen met Pharming........!!!!(i)
DeZwarteRidder
0
quote:

Gerardke schreef op 7 september 2021 07:48:


Relief Therapeutics Comments on Certain Statements Made by NRx Pharmaceuticals in its Registration Statement on Form S-1 Filed on September 3, 2021

Geneva, Switzerland, September 07, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) ("Relief" or the "Company"), commented today on statements made by NRx Pharmaceuticals, Inc. ("NRx"), the parent corporation of Relief's collaboration partner for RLF-100™ (aviptadil) in the United States, NeuroRx, Inc. ("NeuroRx"), in NRx's Registration Statement on Form S-1 filed on September 3, 2021 (the "Registration Statement"). In the Registration Statement, NRx makes several assertions that Relief believes require a public comment so that the marketplace has relevant information about the pending disputes between Relief and NeuroRx. Among other issues in dispute, based on currently available information, are the following:

The Registration Statement includes numerous statements of purported fact setting forth NeuroRx's version of the history of the relationship between the companies that led to the signing of the Binding Collaboration Agreement, dated September 18, 2020 (the "Collaboration Agreement"). While Relief believes that many of the statements made by NRx in the Registration Statement on this topic are false or misleading, Relief does not believe that it is necessary to lay out that historical record in public reporting, since it has no application to the current and ongoing relationship between the parties. Relief notes that the Collaboration Agreement expressly states that it "supersedes any and all prior understandings or agreements, whether written or oral, and there are no promises, agreements, condition, undertakings, warranties or representations (whether oral or written, express or implied) between them other than as [herein set forth]." Therefore, the history of what discussions led up to the parties' entry into the Collaboration Agreement has no application to the parties' rights and responsibilities presently in force and effect.


In the Registration Statement, NRx accuses Relief of misleading them and Relief's public shareholders about the stability of the formulation of aviptadil that Relief brought to the parties' collaboration. Relief reiterates, once again, that in its opinion, there is no truth to these allegations, and that NeuroRx was expressly tasked with developing a stable formulation of aviptadil under the Collaboration Agreement. Further, Relief reiterates, once again, that it never guaranteed that it already had an 18-month shelf stable product, and no such statements are made in the Collaboration Agreement, which contains the entire agreement between the parties. Finally, Relief once again reiterates its belief that the version of aviptadil that was and is being used by NeuroRx in its clinical trials is the drug version covered by the Collaboration Agreement.

NRx continues to state in the Registration Statement that Relief has not paid certain amounts due to NeuroRx relating to the collaboration. While the amount allegedly owed by Relief to NeuroRx according to the Registration Statement has grown exponentially when compared to the amounts stated in NRx's earlier public filings, Relief reports, once again, that not only has it met all of its financial obligations under the Collaboration Agreement, but that it has not received invoices documenting amounts anywhere close to the amounts that NeuroRx claims are allegedly due. Relief continues to have no idea of how the amount allegedly owed that is set forth in the Registration Statement is calculated and has demanded that it be allowed to perform a forensic audit on NeuroRx's books and records to determine the accuracy of the financial information provided to Relief (which NeuroRx has, to date, refused to allow).

In the Registration Statement, NRx states that Relief has "declined" to fund certain expenses relating to the development of the formulation of aviptadil and NeuroRx's clinical trial evaluating inhaled aviptadil for the treatment of patients with moderate to severe COVID-19. In fact, for some months, Relief has repeatedly requested information that is reasonably necessary to make a decision on whether or not to fund these expenses. Until sufficient information is provided so that Relief can make the decision whether or not to fund these expenses, the Collaboration Agreement does not allow NeuroRx to bring in another source to directly fund these expenses.

NeuroRx continues to refuse, despite repeated demands by Relief requesting this information, to share with Relief the full clinical trial data set, including details on the statistical analysis performed, from its recently completed phase 2b/3 trial, which data and information is required to be provided to Relief by NeuroRx under the Collaboration Agreement. To date, Relief has only received a high-level summary of the clinical study report and has not been provided with, among other information, access to the 53,909 individual case reports, the raw data from the clinical trial, or the data on the multiple statistical analyses performed. NeuroRx has likewise refused to share with Relief any of the correspondence between NeuroRx and the FDA. Further, NeuroRx has refused to allow NeuroRx's contract partners dealing with issues relating to the development of aviptadil to share information with Relief that it requires to develop RLF-100™ (aviptadil) in its territories (including the European Union and the United Kingdom). The failure of NeuroRx to provide this information is seriously impairing Relief's ability to develop and execute a clinical and regulatory strategy for RLF-100™ (aviptadil) in its territories.

Relief reminds NeuroRx that under Section 5.1 of the Collaboration Agreement, neither party may engage in any development activities for any drug or related product or treatment intended to be used to treat, combat, ameliorate, prevent or mitigate the effects of COVID-19 that can or may reasonably be expected to compete against or reduce sales (or other monetization) of aviptadil.

Relief believes that it has satisfied all of its obligations under the Collaboration Agreement and that as a result, all revenue/profit splits set forth in the Collaboration Agreement remain in full force and effect.
Relief intends to continue to seek an amicable resolution of its pending disputes with NeuroRx relating to the Collaboration Agreement. However, if such disputes are not resolved to Relief's satisfaction, Relief intends to take all actions necessary to enforce its rights under the Collaboration Agreement. While there can be no assurance, Relief believes that it will prevail in any such legal action to enforce its rights under the Collaboration Agreement.


Dus regelrechte oorlog met NeuroRX; dit is niet gunstig voor de koers......!!!

En Relief moet nog meer aandelen dumpen om aan geld te komen voor de advocatenkosten.

Dit is de nagel aan de doodskist van Relief.
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Vertraagd 1 dec 2021 17:30
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