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Djazz 19 augustus 2021 10:54

2

Gisteren verscheen ook nog dit artikel over de mogelijkheden en kansen voor Zyesami:
lastfuturist.com/zyesami-is-safe-and-...

Zyesami Is Safe and with Declining Vaccine Efficacy We Are Going to Need It
August 18, 2021Michael Spencer

With Israeli data showing reduced vaccine efficacy that starts to accelerate after 6 months, the U.S. is scrambling to get ready to give its citizens booster shots earlier than anticipated. U.S. agencies are preparing to offer booster shots to all eligible Americans beginning the week of Sept. 20. In Australia that’s when adults will be lining up for their first vaccine shot.

With over 1,000 deaths a day again in America, things are getting serious for hospitalizations on the rise, even among children. The vaccines aren’t looking that great over time.

NRx Pharmaceuticals released rather empty PR that we already knew today, that Zyesami is safe, in an NIH sponsored report that tracked 140 patients in an ACTIV-3 critical care study, where no new safety concerns were raised by the independent data safety monitoring board. Relief ticker $RLFTF (OTC) and ticker $NRXP await an EUA for this promising lung saving treatment that could reduce Delta variant mortality rates where Delta is seen with a higher viral load as slightly more dangerous.

This is also because as the pandemic drags on, ICU nurses and hospital staff are getting PTSD and having to leave the profession at scale, meaning in 2022 some hospital systems will be more likely to crash. Deaths have mounted in recent days in Russia, Indonesia, Iran, Brazil, South Africa — I mean all across the world as even mRNA vaccinated people can transmit the Delta variant, and reduced efficacy of the double vaccinated after 6 months means a significant rise in hospitalizations among them who are 65+, as Israel has shown.

Zyesami could be one of the best treatments globally for Covid-19 in 2022 and 2023, especially if Delta mutates to become more dangerous (as is perhaps 15% likely).

So, to repeat, Zyesami is being tested in the ACTIV-3 Critical Care Phase 3 study sponsored by the National Institutes of Health. The study’s Data Safety Monitoring Board found no new safety concerns in the trial and recommended continued enrollment. From Relief Therapeutics we already knew Zyesami was perfectly safe so it’s puzzling why the PR news stoked a short-lived 30% rally in the stock of $NRXP that, like $OCGN, has a meme-rally army of watchers.

The true beneficiary of all of this, however, is Relief, a small biotech company in Switzerland, ticker $RLFTF. They have the majority of global rights and half of the North American profits on the Zyesami patent. The partnership between the two firms has been fraught with challenges and added expenses due to conflicts. Needless to say, NRx Pharmaceuticals wouldn’t be fighting if Zyesami was nothing.

Relief has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for RLF-100 (aviptadil), an inhaled formulation in development for the treatment of sarcoidosis. RLF-100 is a synthetic form of vasoactive intestinal peptide. In open label exploratory clinical experience in sarcoidosis patients, RLF-100 has been shown to be well tolerated and safe, and to produce favorable immunoregulatory effects in the lungs that have been associated with symptom relief in a significant proportion of the patients. The commercial name is Zyesami.

Orphan Drug Designation is granted for products that are intended to treat life-threatening or chronically debilitating conditions affecting less than 200,000 patients in the U.S. and no more than five in 10,000 persons in the European Union.

One of the major problems for Delta in 2022 in the U.S. is both its impact on children and that around 10% of cases become long-Covid, a debilitating condition that requires disability benefits for months and in some cases permanently. With the high transmission and lax masking guidelines by the CDC, the situation is more dire in the U.S. than it appears. Cases of children being hospitalized have gone up around 300% in just a few weeks. The U.S. will likely reach some kind of herd blunting effect of Delta some time in September 2021 (like the UK), where cases go down suddenly, not to be mistaken with herd immunity which is now very unlikely for the Delta variant since breakthrough cases are so common due to higher viral loads.

This all suggests a treatment like Zyesami for serious hospitalizations becomes more valuable at scale, globally. As vaccines are no longer the silver bullet, treatments become more important. $NRXP as a stock is very volatile, going from $10 to $30 and wildly moving like a meme stock. However based on future earnings potential, ticker $RLFTF is a much more serious long-term winner since the stock is only at a price point of around $0.21.

All of this suggests that Zyesami, once seen as a dark horse potential treatment, is getting more mainstream acceptance. ZYESAMI™ is administered as a daily 12 hour intravenous infusion over three days, typically in the ICU or as a preventative measure. This is all because ZYESAMI™ (aviptadil) is a proprietary, synthetic version of Vasoactive Intestinal Peptide or VIP, which is made naturally in the human body and appears to have lung-protective, anti-viral and anti-inflammatory effects.

Herd immunity is impossible
Breakthrough cases are common
Children and Long-Covid complicate the Delta situation in 2022
Booster shots are needed 6 months after 2nd dose
New treatments such as Zyesami will arrive for ICU cases

The Israel data really do show a bleak forward indicator for America’s Covid-19 situation. The Delta variant and what it might mutate into really is being underestimated by an economic recovery that’s begging for the virus to go away, rather than being careful with moderate State guidance. The U.S. appears very content to let Delta sweep the country yet again, leading to a needless loss of life, even as other countries take stricter lockdown and mass testing measures. Canada is ahead in terms of both vaccination rates and vaccination passport systems. China employs mass testing while Australia is doing full-on lockdowns. America seems more concerned with its economy and the financial impact of policies than solid health measures and safety precautions.

In Israel after 6 months vaccine efficacy against hospitalizations is drastically reduced and this is frankly a nightmare scenario for global control of the pandemic. This makes an EUA for Zyesami in the next few weeks or months much more likely, as the FDA has no choice but to take a closer look at newer treatments, as vaccines aren’t everything and herd immunity is not within sight.

MisterBlues 20 augustus 2021 10:28

2

Op basis van het PR beleid van NRXP en de nieuwe kapitaalronde, een private plaatsing, stel ik vast dat het idd nog een tijd gaat duren eer ZYESAMI™ (aviptadil) op de markt komt en dat NRXP er alles aan gaat doen om Relief te kunnen negeren.

Beleggers van NRXP komen op de korte termijn ook bedrogen uit na de koersexplosie van afgelopen 18 aug naar ca. 18 dollar :

RADNOR, Pa., Aug. 19, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NRx) (Nasdaq: NRXP) (or the "Company"), a Delaware corporation, today announced that it has entered into definitive agreements with investors to purchase 2,727,273 shares of common stock in a private placement. The Company will also issue to the investors unregistered preferred investment options (the "investment options") to purchase up to an aggregate of 2,727,273 shares of common stock. The purchase price for one share of common stock and one investment option to purchase one share of common stock is $11.00. The investment options have an exercise price of $12.00 per share, will be immediately exercisable, and will have a term equal to three years following the date of issuance.

DeZwarteRidder 23 augustus 2021 14:45

0

$15 treatment gets COVID patients off ventilators in under a week - study
Fenofibrate could dramatically shorten the treatment time for severe COVID patients.
By MAAYAN JAFFE-HOFFMAN AUGUST 23, 2021 14:34

Hebrew University Professor Yaakov Nahmias
(photo credit: DANIEL HANOCH)
Fourteen out of 15 severe COVID-19 patients who were treated in an investigator-initiated interventional open-label clinical study of the drug TriCor (fenofibrate) didn’t require oxygen support within a week of treatment and were released from the hospital, according to the results of a new Hebrew University study.
Fenofibrate is an FDA-approved oral medication. The results were on Research Square and are currently under peer review.
Specifically, the team that was led by HU’s Prof. Yaakov Nahmias carried out the study at Israel’s Barzilai Medical Center in coordination with the hospital’s head of the Infectious Disease Unit, Prof. Shlomo Maayan, and with support from Abbott Laboratories.
The 15 treated patients all had pneumonia and required oxygen support. They were also older with multiple comorbidities, ranging from diabetes and obesity to high blood pressure.
In addition to standard of care, the patients were given 145 mg/day of fenofibrate for 10 days.
“The results were dramatic,” Nahmias told The Jerusalem Post. “Progressive inflammation markers, which are the hallmark of deteriorative COVID-19, dropped within 48 hours of treatment. Moreover, 14 of the 15 severe patients didn’t require oxygen support within a week of treatment." The 15th patient was off oxygen within 10 days.
Lung cells infected with coronavirus (credit: YAAKOV NAHMIAS)Lung cells infected with coronavirus (credit: YAAKOV NAHMIAS)
When looking at the data on other similar severe patients, less than 30% of them on average are removed from oxygen support in a week. In other words, fenofibrate could dramatically shorten the treatment time for severe COVID patients.
“We know these kinds of patients deteriorate really fast, develop a cytokine storm in five to seven days and that it can take weeks to treat them and for them to get better,” Nahmias said. “We gave these patients fenofibrate and the study shows inflammation dropped incredibly fast. They did not seem to develop a cytokine storm at all.”

RodgerRodger 25 augustus 2021 10:31

0

zzzzzz

MisterBlues 26 augustus 2021 10:39

0

“Game-changing” antibody cocktail prevents COVID-19 in the chronically ill

By Rich Haridy
August 22, 2021

The injectable antibody therapy was found to reduce risk of symptomatic COVID-19 by 77 percent

A new monoclonal antibody treatment has been found to protect chronically ill adults from developing COVID-19. The Phase 3 trial results suggest the novel antibody cocktail, delivered by intramuscular injection, could offer up to 12 months protection.

Antibodies are like our immune system’s front-line soldiers. They constantly circulate around the body, on the hunt for whatever specific pathogen they have been trained to target.

In early 2020 researchers at Vanderbilt University Medical Center homed in on a handful of particularly potent antibodies, isolated from some of the earliest detected COVID-19 patients. The antibodies were subsequently licensed by pharma company AstraZeneca and turned into monoclonal antibody treatments designed to prevent symptomatic COVID-19 infections.

The new treatment has been dubbed AZD7442 and the latest clinical trial results announced by AstraZeneca indicate it could play an important role in helping protect the most vulnerable from severe COVID-19.

newatlas.com/health-wellbeing/astraze...

[verwijderd] 26 augustus 2021 12:51

0

NRx Pharmaceuticals to Work with
Cardinal Health to Ensure Efficient
Distribution of Potential Therapies
- Agreement Represents Path to Market for ZYESAMI™, as Time to
Treatment is Crucial for Patients
- Cardinal Health Third Party Logistics Services to Provide Logistical
and Distribution Support for ZYESAMI™ (aviptadil) Upon Potential FDA
Approval
- Cardinal Health Specialty Pharmaceutical Distribution to Serve as the
Exclusive Distributor to Ensure Access to ZYESAMI™ (aviptadil) Upon
Potential FDA Approval
RADNOR, Pa., Aug. 26, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NRx) (Nasdaq:
NRXP) announced today it has signed an agreement with Cardinal Health to provide third
party logistics and distribution of ZYESAMI™ upon the potential Emergency Use
Authorization (EUA) approval by the US Food and Drug Administration (FDA). In May, NRx
submitted an application for EUA to the FDA for ZYESAMI™ (aviptadil) for patients suffering
from Critical COVID-19 with respiratory failure.

DeZwarteRidder 26 augustus 2021 13:07

0

quote:
Gerardke schreef op 26 augustus 2021 12:51:
NRx Pharmaceuticals to Work with
Cardinal Health to Ensure Efficient
Distribution of Potential Therapies
- Agreement Represents Path to Market for ZYESAMI™, as Time to
Treatment is Crucial for Patients
- Cardinal Health Third Party Logistics Services to Provide Logistical
and Distribution Support for ZYESAMI™ (aviptadil) Upon Potential FDA
Approval
- Cardinal Health Specialty Pharmaceutical Distribution to Serve as the
Exclusive Distributor to Ensure Access to ZYESAMI™ (aviptadil) Upon
Potential FDA Approval
RADNOR, Pa., Aug. 26, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NRx) (Nasdaq:
NRXP) announced today it has signed an agreement with Cardinal Health to provide third
party logistics and distribution of ZYESAMI™ upon the potential Emergency Use
Authorization (EUA) approval by the US Food and Drug Administration (FDA). In May, NRx
submitted an application for EUA to the FDA for ZYESAMI™ (aviptadil) for patients suffering
from Critical COVID-19 with respiratory failure.

De naam Relief is totaal verdwenen uit de berichten van NRX.

Leglesslegolegolas 27 augustus 2021 13:47

4

quote:
DeZwarteRidder schreef op 26 augustus 2021 13:07:
[...]
De naam Relief is totaal verdwenen uit de berichten van NRX.

Jouw geloofwaardigheid is al maanden weg vent :)

[verwijderd] 28 augustus 2021 06:54

0

www.precisionvaccinations.com/vaccine...

DeZwarteRidder 28 augustus 2021 08:43

0

quote:
Leglesslegolegolas schreef op 27 augustus 2021 13:47:
[...]Jouw geloofwaardigheid is al maanden weg vent :)

En toch blijft de koers maar dalen................

Hoe zou dat komen.......???

[verwijderd] 28 augustus 2021 23:56

0

Volgens mij komt dat door shorters en omdat er geen "snelle" goedkeuring komt voor medicijnen.
Humanigen , jouw tip van voirge week doet het trouwens niet veel beter .
Relief heeft het bericht ook niet gedeeld , omdat die ook wel weten dat dit een herhaling was van "oud nieuws"'.
Fda is zeker niet gehaast , en zolang ze spuiten kunnen zetten gaan die voor , van zodra er goede medicijnen komen gaan er nog veel meer afhaken , en ze hebben dat wellicht afgewogen ..
Hoop dat dit onzin is ..
Ondertussen zijn er wel al 37 locaties waar ze deelnemen aan Activ 3 , tel hierbij dan nog de Zwitserse en Georgische .. kan moeilijk geloven dat het echt niet werkt en dat ze ermee blijven doorgaan ,
maar kan niets bewijzen , het is voor iedereen koffiedik kijken , ik blijf het positief bekijken , en bewijzen van het omgekeerde heb ik van jou ook nog NOOIT gekregen..

DeZwarteRidder 29 augustus 2021 10:11

0

quote:
Gerardke schreef op 28 augustus 2021 23:56:
Volgens mij komt dat door shorters en omdat er geen "snelle" goedkeuring komt voor medicijnen.
Humanigen , jouw tip van voirge week doet het trouwens niet veel beter .
Relief heeft het bericht ook niet gedeeld , omdat die ook wel weten dat dit een herhaling was van "oud nieuws"'.
Fda is zeker niet gehaast , en zolang ze spuiten kunnen zetten gaan die voor , van zodra er goede medicijnen komen gaan er nog veel meer afhaken , en ze hebben dat wellicht afgewogen ..
Hoop dat dit onzin is ..
Ondertussen zijn er wel al 37 locaties waar ze deelnemen aan Activ 3 , tel hierbij dan nog de Zwitserse en Georgische .. kan moeilijk geloven dat het echt niet werkt en dat ze ermee blijven doorgaan ,
maar kan niets bewijzen , het is voor iedereen koffiedik kijken , ik blijf het positief bekijken , en bewijzen van het omgekeerde heb ik van jou ook nog NOOIT gekregen..

Je bevestigt wat ik al vele malen gezegd heb: Relief heeft hier vrijwel niks mee te maken en krijgt geen rooie cent van NRX.

Relief wordt een doodloper.

[verwijderd] 29 augustus 2021 16:02

1

quote:
DeZwarteRidder schreef op 29 augustus 2021 10:11:
[...]

Je bevestigt wat ik al vele malen gezegd heb: Relief heeft hier vrijwel niks mee te maken en krijgt geen rooie cent van NRX.

Relief wordt een doodloper.

Ik bevestig niets wat jij zegt . Relief krijgt van Nrx wat is afgesproken.
Jouw commentaar bevestigt enkel dat je veel zegt zonder iets te staven..
Waarom zou Relief niet krijgen wat afgesproken is ?

DeZwarteRidder 29 augustus 2021 16:36

0

quote:
Gerardke schreef op 29 augustus 2021 16:02:
[...]Ik bevestig niets wat jij zegt . Relief krijgt van Nrx wat is afgesproken.
Jouw commentaar bevestigt enkel dat je veel zegt zonder iets te staven..
Waarom zou Relief niet krijgen wat afgesproken is ?

Een en ander is duidelijk geworden uit vele berichten op dit forum.

Leglesslegolegolas 29 augustus 2021 18:54

1

quote:
DeZwarteRidder schreef op 29 augustus 2021 16:36:
[...]

Een en ander is duidelijk geworden uit vele berichten op dit forum.

Waaronder het feit dat jij 0 aandelen van beiden bedrijven hebt en dat je op een zondagmorgen hier komt posten. Zoek een vrouw, koop een kitten, ga sporten of vissen ofzo kerel ;)

[verwijderd] 29 augustus 2021 23:45

1

quote:
DeZwarteRidder schreef op 29 augustus 2021 16:36:
[...]

Een en ander is duidelijk geworden uit vele berichten op dit forum.

Dus weer niets ...veel bla bla maar geen boem boem ;-)
sorry , maar ik geloof niet veel zonder data of verslagen dus Humanigen is ook rejected want die hebben hun aanvraag 3 dagen vroeger gedaan , dat was nochtans jouw tip ..

Dit bericht van Jonathan C. Javitt, gelezen ?
www.linkedin.com/posts/jonathanjavitt...
www.precisionvaccinations.com/vaccine...

Djazz 30 augustus 2021 15:52

0

Hopla -> NRx Pharmaceuticals Announces New Finding from ZYESAMI™ (aviptadil) Phase 2b/3 Clinical Trial Demonstrating Clinically Significant Relief from Respiratory Distress in Critical COVID-19

finance.yahoo.com/news/nrx-pharmaceut...

- NRx Has Provided Updated Data to US Food and Drug Administration (FDA) in Support of Emergency Use Authorization Request for ZYESAMI™ (aviptadil)

- NRx to Submit Breakthrough Therapy Designation to FDA for ZYESAMI™ for the Treatment of Respiratory Failure in Patients with Critical COVID-19

RADNOR, Pa., Aug. 30, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NRx) (Nasdaq: NRXP) announced an additional finding in its phase 2b/3 clinical trial investigating ZYESAMI™ (aviptadil) for the treatment of patients with acute Respiratory Failure due to Critical COVID-19. Previously announced results have focused on survival and recovery from respiratory failure at 60 days, and ZYESAMI's apparent role in preventing rise in the inflammatory cytokine IL-6, known as "Cytokine Storm."l

NRx's new analysis shows that patients treated with ZYESAMI demonstrated improvement in blood oxygen, indicative of improved lung function, within a day of starting treatment. The average difference in Respiratory Distress Ratio between those treated with aviptadil and placebo was both clinically meaningful and statistically significant. Moreover, the difference is comparable to that reported a year ago from an open label study at Houston Methodist Hospital by Dr. J Georges Yousef.

"With the conclusion of the analysis of primary and secondary endpoints, we are able to focus on prespecified endpoints that confirm mechanism of action," said Prof Jonathan Javitt, MD, MPH, Chairman and CEO of NRx. "COVID-19 attacks the cells that line the lung in a manner that prevents them from transmitting oxygen to the body. It is this respiratory failure that starts the lethal process of COVID," This latest analysis provides confirmatory evidence that aviptadil improves the lung's ability to transmit oxygen within a day of initiating treatment. The benefit was seen across all patients, all baseline severities, and all types of hospitals. We believe this new finding illustrates ZYESAMI's mechanism of action in a placebo-controlled trial and supports our application for Breakthrough Therapy Designation to the FDA."

Prior data regarding reduced respiratory distress were reported by Dr. J. Georges Youssef, Head of Academic Pulmonary Medicine at Houston Methodist Hospital one year ago. Dr. Youssef and colleagues reported the results in 21 patients treated with ZYESAMI, compared to 24 patients who received best-available standard of care.

This latest analysis also supports NRx's application for Breakthrough Therapy Designation (BTD) to the FDA for ZYESAMI. BTD is a process designed to expedite the development and review of medicines intended to treat a serious condition and is supported by preliminary clinical evidence showing the drug may demonstrate substantial improvement over available therapies on a clinically significant endpoint(s). www.fda.gov/patients/fast-track-break...

Djazz 30 augustus 2021 15:53

0

quote:
Djazz schreef op 18 augustus 2021 19:27:
Aandelen 50/50 in NRXP en RLF: tweetrapsraket (als 'm afgaat) in mijn gokafdeling van de portefeuille. De andere is LWLG, bij deze een gratis tip: wel meer een langeafstandsraket.

Jullie hebben toch LWLG gekocht!!!????

DeZwarteRidder 30 augustus 2021 15:58

0

quote:
Gerardke schreef op 29 augustus 2021 23:45:
[...]
Dus weer niets ...veel bla bla maar geen boem boem ;-)
sorry , maar ik geloof niet veel zonder data of verslagen dus Humanigen is ook rejected want die hebben hun aanvraag 3 dagen vroeger gedaan , dat was nochtans jouw tip ..
Dit bericht van Jonathan C. Javitt, gelezen ?
www.linkedin.com/posts/jonathanjavitt...
www.precisionvaccinations.com/vaccine...

Ik heb nooit Humanigen 'getipt'.

[verwijderd] 30 augustus 2021 17:22

0

quote:
DeZwarteRidder schreef op 30 augustus 2021 15:58:
[...]

Ik heb nooit Humanigen 'getipt'.

DeZwarteRidder 6 augustus 2021 14:31

Humanigen wacht op goedkeuring FDA
Humanigen (HGEN) op $16

Wie van een beetje avontuur houdt kan met het aandeel Humanigen mikken op een goedkeuring van de FDA. We geven rond uit toe dat het speculatief is. Verkopen doet u bij teleurstelling, maar ook bij de eerste euforie. Dit aandeel is geen kernbelegging, maar interessant is het zeker.

....yeps...

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