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@Vanilla
Calm down again!
See what Dr.JJ has to say on Twitter:
"As soon as the regulatory files are completed for transmission to FDA, they will be able to be available to European regulators as well. Anyone who thinks we would endanger patients, simply because of the financial behavior of a collaborator is sadly mistaken."
Is everything clear now?
But it won't do him any good.
Reilief is taking giant strides to success with AdVita in Europe.
It is exactly like that ! In the USA, you have to stick to contracts too!
pegs1
Please keep Relief's answer to yourself. I can imagine what it says (I'm European!)
... but everyone should think about what Dr. JJ said on Twitter:
If the theft of the patent had happened in Delaware, one might believe that it would have caused a protracted argument (at these courts there !). But New York, strictly unbelievable ?!!
IHub uses the Chinese characters in "Post & Reply"-editor only!
Excuse me please !
Now, this is the translation:
2021-04-26 21:37:33 Taron 4884
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, confirmed the use of remdesivir in a phase III clinical trial of inhaled ZYESAMI at a press conference of the White House New Crown Response Team
News from China:
2021-04-26 21:37:33 ??4884
???????????????????·???????????????????????????????????ZYESAMI??????
At SWX RLF is UP: 0,234CHF +0,021 (+9,86%)
It's exactly the exchange rate US$ - CHF
Calm down, things will change quickly!
It looks like you are right !!
It's known as the eleventh commandment: "You shall not deceive yourself !"
Who is the White House?
Do you really think they know the background of Zyesami's making?
Shame on NeuroRx, who let their costs be paid and no longer want to know who financed everything.
... and the bill of 4mm was just a cheap excuse to break the contract !!!
I was just about to write the same !
It turns out slowly who the crook is!
.... and Dr. JJ will be very surprised if he thinks he can eliminate RELIEF in this way!
The last email I sent to wrdsrus@aol.com (Choyce Presnall) on 2010-03-14
Some topics about AdVita: www.advita-lifescience.com
AdVita Lifescience GmbH, Germany
We develop effective products and strategies to improve the therapy and diagnosis of rare lung diseases.
To do this, we use a drug with the active ingredient Aviptadil for inhalative/topical therapy.
Aviptadil (vasoactive intestinal peptide (VIP)) is an endogenous peptide that has already been approved for another indication (erectile dysfunction) with an excellent safety profile.
The preclinical for inhalation therapy is available. Studies and case reports show an excellent effectiveness and tolerance of the drug.
Patients with sarcoid and related diseases (e.g. beryllium disease) have already benefited significantly from treatment in off-label use, so that many health insurance companies cover the costs of the therapy.
The simple application takes place with a nebulizer of the latest generation.
PRESS RELEASE (Supplement to Post # 38719)
Geneva, Switzerland and Gundelfingen, Germany, April 22, 2021 - RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF)
Headline:
Relief and AdVita announce start of phase 2 study with inhaled RLF-100 formulation for the prevention of COVID-19-related acute respiratory distress syndrome
(Study - sponsored i.a. by well-known doctors - that is being carried out at major medical centers in Switzerland.)
[………………] inter alia:
Today Relief gives an update on the planned clinical development of RLF-100 in Europe also:
Relief is currently preparing a phase 2b / 3 study in Europe with intravenous RLF100 with COVID-19 patients. Once Relief's partner NeuroRx has submitted an Emergency Use Authorization (EUA) application to the US Food and Drug Administration (FDA) and a decision has been made, Relief will be on the best steps to take for further development of intravenous RLF-100 in Europe and other regions. Relief continues to see great value in RLF-100 in helping patients with COVID-19-related lung damage and hopes that an EUA of RLF-100 can accelerate the clinical trial of RLF-100 in Europe. The clinical development of intravenous RLF-100 in non-COVID-19-induced ARDS is also being considered.
My dear Vanilla!
I've been ignoring you since November. Lately I've been reading your posts again because its content is important. Therefor I’ve „unignored“ you again !
..... but if you mention:
... but if they don't, it's their fault if they both go under !
... and it will be so if they keep accusing themselves !
1) NeuroRx together with its investor Big Rock Partners Acquisition.
2) Relief because they lose valuable time in working with new European partners
... but remember: Aviptadil is the tell and Relief owns the patents !
Now, at SWX: RTF is up 11,68 %
Session closed already !
It is certainly not time to argue about little things when an entire project is on the brink. I can understand that NeuroRx is demanding an equal partnership and not just wants to be a contractor after all what NeuroRx has done to be sucessfull, while Relief could only watch over that. However, NeuroRx is also on very smooth ice, if they think to be right in this case.
Topics of the ongoing disputes include that, according to Relief, NeuroRx is refusing to share data from its recently completed Phase IIb/III clinical trial with Relief. These data must be made available to Relief in accordance with the provisions of the cooperation agreement.
In addition, NeuroRx has denied its contractors dealing with Aviptadil development issues to provide Relief with information that Relief needs for the development of its Aviptadil product in its sales territories (including the EU and the UK). As a result, Relief has reportedly believed that NeuroRx has defaulted on its obligations under the Collaboration Agreement and that NeuroRx's failure to develop and implement a clinical and regulatory strategy for its territories will severely affect Relief's ability to develop and implement a clinical and regulatory strategy for its territories.
NeuroRx also claims that Relief owes approximately $ 4 million in unpaid bills. "Unfortunately, many of these alleged expenses were not backed up by valid, verifiable invoices", Relief commented in a press release. There is also disagreement between the parties, whether expenses that exceed the budget set in the cooperation agreement are reimbursable.
IMO, both should consider what they will lose if they don't come to a setlement in no time.
I had written a similar message already today, but then deleted again.
Now let me add a few words, although your post# 38660 already says it all:
The German company AdVita Lifescience GmbH and its business model:
However, you should consider who first announced the merger with another company !
FYI
Disclaimer
Relief Therapeutics Holding AG published this content on April 19, 2021
and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on April 19, 2021 05:09:05 UTC.
Geneva, Switzerland, April 19, 2021 - RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF)
('Relief' or the 'Company'), commented today on certain statements made by NeuroRx, Inc., its collaboration partner for the development of RLF-100TM (aviptadil) pursuant to that certain binding collaboration agreement, dated September 18, 2020 (the 'Collaboration Agreement'), in Amendment No. 1 to the Form S-4 of Big Rock Partners Acquisition Corp.'s ('BPRA') that was filed on Friday, April 16, 2021 (the 'Amendment'). The Amendment was filed by BRPA with respect to the proposed merger between NeuroRx and BRPA.
NeuroRx has elected to make statements in the Amendment with respect to pending disputes between Relief and NeuroRx under the terms of the Collaboration Agreement. As a result, Relief has concluded that it must inform the public about the nature of the pending disputes and its views regarding the positions regarding these issues taken by its collaboration partner. The issues currently in dispute include the following:
NeuroRx has refused to share clinical trial data from its recently completed Phase 2b/3 trial with Relief, which data are required to be provided to Relief under the Collaboration Agreement. 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 Relief requires to develop its aviptadil product in its territories (including the E.U. and the U.K.). As a result, Relief believes that NeuroRx is in default under the Collaboration Agreement, and that NeuroRx's failure to provide this data is impairing Relief's ability to develop and execute a clinical and regulatory strategy for its territories.
NeuroRx states in the Amendment that Relief owes it approximately $4,000,000 in unpaid invoices. Unfortunately, many of these alleged expenses have not been substantiated by valid, verifiable invoices that support that these expenses are reimbursable under the Collaboration Agreement. Further, there are disputes between the parties over whether expenses exceeding the budget established in the Collaboration Agreement are reimbursable. With respect to this information, Relief has been seeking information from NeuroRx in order to establish what may be due to NeuroRx under the Collaboration Agreement, and, accordingly, Relief intends to exercise its rights under the Collaboration Agreement to conduct a forensic audit of NeuroRx's books and records in order to determine the accuracy of the expense information that has been provided.
NeuroRx has alleged in the Amendment that Relief has elected not to fund the recently initiated clinical trial evaluating inhaled aviptadil for the treatment of patients with moderate to severe COVID-19. In fact, Relief has requested certain information required for it to determine whether or not to fund this trial, and NeuroRx has refused to provide the requested information that is needed by Relief to make a decision on whether or not to fund this trial. It is Relief's position that until it is provided with sufficient information to make this decision, NeuroRx cannot bring in another source to specifically fund this trial.
NeuroRx has stated in the Amendment that Relief's failure to fund expenses may result in a dispute with Relief over whether Relief's share of the net profits from sales of aviptadil in NeuroRx's territory should be less than that set forth in the Collaboration Agreement. Relief believes that the net profit splits between Relief and NeuroRx that are set forth in the Collaboration Agreement are not affected by any of these funding issues (including the recent warrant exercise reported in the Amendment by GEM Yield Bahamas Limited, a significant stockholder of Relief).
NeuroRx makes allegations in the Amendment that raise questions about the formulation of aviptadil that Relief has contributed to the parties' collaboration. Relief notes that while there are stability issues with the formulation that Relief brought to the collaboration, all of these problems were understood by all parties at the time of the execution of the Collaboration Agreement and that efforts to resolve those issues were contemplated by the Collaboration Agreement. In all respects, Relief believes that the version of aviptadil which is in evaluation in NeuroRx's clinical trials is, in all respects, the drug product covered by the Collaboration Agreement.
Relief intends to continue its efforts to resolve amicably the pending disputes with NeuroRx over the Collaboration Agreement. However, if such disputes are not resolved amicably, Relief intends to take all necessary actions to enforce its rights under the Collaboration Agreement. While there can be no assurance, Relief believes that it will prevail in any such actions to enforce its rights under the Collaboration Agreement.
You better keep spooning wisdom.
You will need it in future !
After you have sold all of Relief stocks, the PPS will decrease (depending on the large number). A better way to buy cheap Relief stocks afterwards. I am counting on that !
Tiger, I'm so sorry for you. You are based in the USA, believing you have eaten wisdom with a spoon and don't know that all of Europe has known for weeks what is being played here.
Instead of answering stupidly, you'd better should read my posts:
I come back to what I said earlier:
... when she looks in the mirror, she laughs crookedly herself !
Who can do something about it ?
The problem in this case is, that nobody thinks outside the box.
Read my post# 38435 again and put yourself in Relief Therapeutics' shoes and make your own DD. I would like to emphasize again: This is an original Relief-Email.
IMO, it looks like Relief Therapeutics is waiting for pending data from the US trial for RLF-100 (inhaled), for which they provided the funds, and NeuroRx is afraid to hand them over before an EUA is issued.
They may also be prevented from doing so. Who knows that ?
In your opinion, Europeans are lazy! That's OK, if this is your opinion.
In my long experience with USA I noticed, that many US citizens think this way and moreover they think the Europeans are stupid ! ... until they find that the opposite is the case.
But from the beginning they are not so stupid that they are willing to be ripped off. Dr. JJ may be a great scientist, but he has no idea about the brutal business world that prevails in the US. Relief Therapeutics pulled the plug in time. There is no more money and NeuroRx must look for new investors. May be Big Rock Partners Aquisition Corp. is one of them. You can place a bet that the patent will stay with Relief Therapeutics. No way for others to make a lot of money with it !
.....and finally: how long do you think the new investors will be available ?
If the way you express yourself, reflects your opinion ..... then I really feel sorry for you !
IMO it would be a big mistake to sell RLFTF now.
Relief Therapeutics are not lazy Europeans. But they wont be fooled, if others try to buy their patent piece by piece. The cooperation with AdVita is now so successful that they care about the result of the clinical evaluation of their new study only and it doesn't matter whether NeuroRx is successful in case of EUA or not.
Relief originally funded the NeuroRx costs, but now it's game over. It is now up to Big Rock Partners whether they continue to show interest in Zyesami.
Penny !
Thank you for your prompt reply ! Now I'm informed best.
... and now it's me to send you an email from RELIEF and I hope I've translated well, so that you are able to read it well too. It's not clear from the German text also, whether NeuroRx has submitted an EUA or not. As far as I can judge, they need the data from the U.S. Phase 2b/3 trial only, for approval by the EMA. From another article I learned that their partnership with AdVita is so successful that they are now researching more in this direction, while NeuroRx is supposed to take care of the EUA.
I regret my short answer in post# 38350. Nevertheless, you should take note of the following:
E-Mailed from: Relief Therapeutics <relief@mc-services.eu>
Sent: Thursday, April 15, 2021 07:04 EMT
(Quote in excerpts)
Outlook for 2021:
Relief expects to make continued progress with its development programs and in advancing its business in the months ahead.
Pipeline
Looking first to RLF-100 (IV), as our partner NeuroRx executes plans to file for EUA for the treatment of critically ill patients with COVID-19, followed by an NDA, Relief is preparing for clinical assessment and potential commercialization in Europe and other territories. Once Relief has received and analyzed the full data set from the U.S. phase 2b/3 trial, the Company will decide on the best path forward for the development of RLF-100 in Europe and other territories.
Turning to RLF-100 (inhaled), the acquisition of AdVita is expected to close in Q2 2021. Additionally, Relief is hopeful that its partner NeuroRx will have results from the ongoing U.S. phase 2b/3 trial evaluating inhaled RLF-100 in H2 2021.
Our second late-stage program in collaboration with Acer Therapeutics for ACER-001 is expected to progress quickly in 2021. A pre-NDA meeting is scheduled to occur between Acer and the FDA in Q2 2021 to discuss the results of the clinical study of ACER-001 in UCDs. Provided no additional data are requested by FDA during the meeting and ongoing development activities are successfully completed, Acer expects to submit a 505(b)(2) NDA for ACER-001 for the treatment of UCDs in mid-2021, with a potential regulatory decision in H1 2022. Relief plans to initiate discussions with European regulatory authorities regarding ACER-001 in UCDs in Q3 2021. Clinical studies in MSUD could start later in 2021.
Relief plans to continue its strategy to aggressively pursue opportunities to expand its pipeline with attractive late-stage clinical assets that would drive the evolution of the Company into a mature, diversified biopharmaceutical company.
Have a nice weekend !
Penny, please help me!
My mother tongue is not English and and I fear to have misunderstood something..
Within the link in post # 38413 I found no entry for an EUA in chapter "Drug and Biological Therapeutic Products".
You mentioned that you were informed once in an email from FDA, that RLF-100 would be approved and then:
It is all the more time for the FDA to act. These mutual shiftings of requirements and announcements from JJ and the FDA must come to an end. It has now been proven that Zyesami saves lives and has no side effects. The length of stay as an intensive care patient is shortened also. All conditions for an EUA are fullfilled !
What else is required ?
It's not a fairy tale:
Once there was a stock (I forgot its name) that initially traded at $ 0.02 in May 2009.
It rose to $ 1.75 slowly and then fell back to $ 0.04 steadily. Many sold/bought at this price.
All of a sudden ... IMO the buyers were lucky. It was September 2009 that stock hit $ 20.00 within a week.
There were people who owned millions of this stock. It became the share of the year.
.... and for everyone who thinks that USA is No.1
Think about who owns the patent for the BioNTech / Pfizer vaccine.
You can choose between two options.
(.... but I'm quiet: it's not Pfizer !)
Pfizer guarantees the amount of vaccine only, they are the largest company in the world to do that ... but they do it very well !
I may have expressed it wrong, but I'll be happy to explain it again:
With the following reason, FDA does not issue an EUA anyway.
When the vaccination rate in the USA reduces the number of seriously ill patients, a point in time has been reached certainly when there is no longer EMERGENCY !
.... and without an emergency there is no EUA ! It's as simple as that !
Relief then does not need an approval furthermore that takes many months or even years! Do you really think Relief will wait that long?
Very well ! If you think so it's your opinion !
Time will tell !!!
If the FDA is thinking it depends on them whether a company will succeed in getting a drug approved, or will only be successful after it was bought by a large company first, then FDA will lose in case of Relief Therapeutics Holding. Then FDA is mistaken enormously !
Please take notice of post # 38330 (Quotation in excerpts):
@J-B
I think my ID says all !
I'm long since 2008 and never sold a share.
Today I'm siting on a boatload of escrows, hoping for a good end.
....and everybody knows, that this was a big fraud ! Nothing else !
Any questions ?
-------------------------------------------------------------------
.... but I was lucky ! With todays COOP-shares I earned a lot !
.... and my ESCROWS are still valid
Even before I read your post I had this thoughts. Now I am convinced of it.
A former FDA commissioner can say that only!
You're right, but do you think BigPharma thinks that too? Right now it is better not to let people an alternative to vaccination. BigPharma only allows approval when the market is saturated.
It's up to BigPharma, not the FDA !!!