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It is not all conspiracy and evil machinations - human shortcomings like ego and defensiveness as well as plain stupidity and incompetence work just as well yet with less planning effort...
Look here - this is from STAT NEWS' "The Readout":
What does it take to get Covid treatments past the FDA?
Midway through Novartis’ 90-minute-long earnings call yesterday, CEO Vas Narasimhan casually made some news: The company’s treatment for Covid-19, currently awaiting FDA authorization, might need more data to convince regulators.
That sent shares of Molecular Partners, the company that invented Novartis’ treatment, down nearly 20%. Within hours, the company issued a statement of its own, confirming Narasimhan’s account and adding that Novartis is working with the FDA on the design of a Phase 3 study that might address the agency’s outstanding questions.
The news could signal a shift in the FDA’s standards when it comes to new Covid-19 treatments. Novartis and Molecular Partners were widely expected to win an emergency authorization based on Phase 2 data showing that their treatment significantly reduced patients’ viral load and the rate of hospitalization. If the FDA is now demanding data for larger trials to justify authorization, it could scramble the timelines of a host of companies moving toward the market with therapies of their own.
I have liked HUMANIGEN for a long time but Cytokines are NOT the real reason behind the devastating damage patients can suffer from COVID19. It is symptom of cell death etc. just as shortness of breath etc. is a symptom of the virus targeting those very cells producing surfuctant necessary for transporting the gas exchange between lungs and bloodstream!
Treating for cytokine reduction does help on the surface (which is why docs love steroids and cortisone) but is like putting a bandaid on a flickering alarm for low oil on your car's dashboard to fix the oil leak...
AVIPTADIL fixes the root cause for the whole infectious process right were the virus docks on
Hi Elk! Have you seen this report on the progress of AMARIN with their drug VASCEPA for COVID19 patients?
Some pretty impressive results backed by Harvard Medical school:
https://www.uspharmacist.com/article/icosapent-ethyl-linked-to-decreased-inflammation-and-improved-covid19-symptoms
There are these other therapies out there based on icosapent ethyl ester (which is a molecule derived from Omega3 fatty acid) which has shown astounding efficacy in reducing strokes , heart attacks and diabetes related inflammation etc. and is now being tested by KAISER PERMANENTE for it's effects on COVID on some 15.000 CVD patients that are already receiving VASCEPA for their cardiological condition
By the time RELIEF is moving on this, the new standard of care replacing REMDESIVIR may well be VASCEPA even so AVIPTADIL is way ahead up to now...
I have been pondering wether there might be a way for a (yet to be formed)share- /stake-holder group to reach out to Dr. Javitt and try to engage him in a direct conversation with civility yet forthright?
Any ideas?
Ahoi Capt'n! Did you consider asking about including any questions on the progress of VASCEPA for COVID19 treatment options?
I am sorry if that was already discussed here, but I just got back and have no ability to read up on the last thousands of entries here..
I wish that COVID could be impressed on their mindset as a priority issue and not on the backburner as they do need to move on this in a timely fashion.
https://www.uspharmacist.com/article/icosapent-ethyl-linked-to-decreased-inflammation-and-improved-covid19-symptoms
There are other therapies out there based on human hormones that have astounding efficacy and are already included by Dr. Fauci in direct comparative trials with REMDESIVIR under auspices of the NIH:
https://www.nih.gov/news-events/news-releases/clinical-trial-therapeutics-severely-ill-hospitalized-covid-19-patients-begins#.YIGCIeEERSU.twitter
By the time AMRN is moving on this , the new drug AVIPTADIL // ZYESAMI by RLFTF might already be standard of care replacing REMDESIVIR...
As much as I feel sympathy for your loss (and everybody else's including my own) I wonder wether you adressed your concern and feelings directly to Dr. Javitt? His mail adress is on the website and /or LinkedIn
If he is not a total fake I feel that your sincerity might elicit a response.
Voicing it here helps to vent the traumatic disappointment but right here we are just howling at the moon (or worse just at a flickering street light)..
Let me know if you do get a response from the good doctor
Re:misleading article + false statements.
this was just forwarded to my phone.
Swiss pharma firm Relief, U.S. partner fight after hopes dented for COVID-19 drug
ZURICH, April 19 (Reuters) - A Swiss company whose market capitalization rose at one time to more than 1.5 billion Swiss francs ($1.6 billion) on hopes an old drug it owned would succeed against COVID-19 is embroiled in a dispute with its U.S. partner, it said in a statement.
Relief Therapeutics' market cap has fallen about 70% from a high in the third quarter of 2020, as the company's aviptadil, a 50-year-old medicine, failed to win U.S. emergency approval and in February demonstrated no survival benefit at 28 days in a U.S. clinical trial of people with COVID-19 respiratory failure.
Relief said on Monday that its U.S. partner, NeuroRx, and it are fighting over issues including sharing of trial data, invoices totaling about $4 million that NeuroRx contends Relief must pay, funding for clinical trials, the allocation of potential profits, and other issues.
"Relief intends to continue its efforts to resolve amicably the pending disputes with NeuroRx over the Collaboration Agreement," Relief said in a statement. "However, if such disputes are not resolved amicably, Relief intends to take all necessary actions to enforce its rights under the Collaboration Agreement."
Separately, a Securities and Exchange Commission filing on Friday by a special acquisition corporation that in December announced a merger with NeuroRx contends Relief had "reimbursed NeuroRx for approximately $10.6 million of expenses, but has not paid approximately $4 million in invoiced costs associated" with the aviptadil clinical trial.
"These circumstances may lead to a dispute with Relief Therapeutics regarding what share of profits Relief Therapeutics should be entitled to receive," according to the SEC filing by Big Rock Partners Acquisition Corp.
($1 = 0.9206 Swiss francs)
(Editing by Simon Cameron-Moore) ((J.Miller@thomsonreuters.com; +41 58 306 7734; Reuters Messaging: j.miller.thomsonreuters.com@reuters.net))
No idea! Busy... @IonStock seems to know
Thx Ion! Please do and also provide Vanille et.al. with the correct details who to write to! I am busy at the clinic...
Great idea! Have you reached out to Dr.Javitt as his email is on their website ?
If so would you kindly share the content of your letter with all of us?
@Vanilla all other regulars here, since you do seem to have the time to be here continuously I request all of you to please take a minute or two to write to this clown (Editing by Simon Cameron-Moore) and/or CC the editor in chief of YahooFinance that this report is factually wrong and materially damaging to shareholders as the trial produced overwhelmingly positive results meeting all endpoints and demonstrated amongst other targets a significant shortened Length of Stay and also survival benefits!
They do have the journalistic duty and liabiliy to correct a badly researched article citing outdated data and additionally making false statements regarding the EUA!
Thank You All in Advance
Ain't dat da truth, Elk! However most everybody lacks the training to understand that a pathological narcissist is NOT vain per se but only for show as in truth he is rather desperate that people will see right through his pretense of grandeur and recognize him for the miserable failure he is in his own perception
(which usually thoroughly programmed, beaten into and ingrained by cold and violent parents before the age of 6)
Thus a pathological narcissist is driven by the all consuming obsessive need to be in the centre of attention so he does not have to feel this terror inside. This imperative need is so overarching all other biological and psychological needs that to this end he is even willing to make himself a fool and act self destructive as long as he remains in the centre of attention for a just a little longer. Neurophysiologically the hormonal mechanism in play is just like a substance addict that needs that next shot.
This complete recklessness towards one's own reputation, even survival if it can be traded in for a little more attention is what makes pathological narcissist so unpredictable and dangerous.
For simplicity's sake I will copy another poster on the EARS board
LINK Oracle Member Level Tuesday, 04/13/21 09:53:21 AM
Re: None 0
Post #
671
of 671
COVID News AM-301 helps to reduce growth in infectious titer in ongoing SARS-CoV-2 infection
In parallel with the outcomes from the allergy studies, Altamira Medica obtained first data from testing AM-301 after the start of infection of human nasal epithelium cells with SARS-CoV-2. In a previous study in the same type of assay, AM-301 had been shown to be highly effective in reducing the infectious viral titer when daily treatment was started right before inoculation of the cells, i.e. in a preventative fashion. In the new experiment, daily treatment with AM-301 started 24 or 30 hours post inoculation. Saline- and vehicle-treated and untreated cell cultures served as controls.
In control cultures, SARS-CoV-2 replicated efficiently over four days, resulting in a rapid increase in viral titer (as measured by the Median Tissue Culture Infectious Dose, TCID50, in Vero cells). Daily treatment with AM-301 resulted in a statistically significant deceleration of the viral titer growth compared to controls (p-value <0.01, linear mixed-effects model). At Day 4 of the experiment, viral titers were 73.7 to 94.5% lower compared to controls.
https://www.otcmarkets.com/stock/EARS/news/story?e&id=1862250
That is what they say as a first level argument to get expedited CE clearance for EU distribution BUT they are already in discussion with the FDA for therapeutic labelling.
However it does not matter how you label it if protects 95% efficacy against infection by Sars2-CoV
Read up on their presentation. Pretty impressive slides!
That's because Operation Warp Speed was made up by former Big Pharma Execs whose main qualification for receiving public office and federal authority was the amount of their contribution to Team Trump.
Look at the gangsta that was installed as Post Master General trying to destroy the US Postal Service as he is heavily invested in private competitors..
For REMDESIVIR the EUA came after 24 hrs of deliberation only - in spite of proven clinical uselessness and established deadly side effects..
Look at my previous posts..
Gumpy, this is easily outdone by another swiss biopharma company AURIS MEDICAL (EARS) that today released clinical data and will start selling nasal sprays by June 21 :
https://finance.yahoo.com/news/auris-medical-announces-positive-preclinical-114500006.html
Look at the J&J halt today and this disturbing trend:
SARS-CoV-2 spike E484K mutation reduces antibody neutralisation
https://www.sciencedirect.com/science/article/pii/S2666524721000689
Also since we spoke about the toxicity of REMDESIVIR:
https://www.medscape.com/viewarticle/933623
@jasbg & @marjac, @north and all legal experts:
could Thero be held personal liable for refusing the Rule 60 motion?
Any ideas what caps an executive personal liability insurance might have?
Of course this only flies if Marjac & Team win the case which would already make us good again.
Butthat would be the icing on the cake!
According to Dr. Haseltine this is a misconception:
https://omny.fm/shows/seattles-morning-news-with-dave-ross/dr-william-haseltine-on-the-effectiveness-of-a-cov
This board should be jubiliant yet markets don't seem to like it that a wild card is being played:
https://seekingalpha.com/pr/18267807-amarin-announces-ceo-succession-plan
Have you finally informed the IR-department about your concerns?
Actually that legal conflict is why XRP is exploding right now and could hopefully serve as a blueprint of what will happen for us here once yours and HK and Marjac's efforts come to fruition!
At least in the pre-trial discovery conferences the law team for Ripple is winning against the SEC.
At least getting into Relief Therapeutics before EUA and NDA should work out to be like buying AMRN below 1$... unfortunately I did that also after having first bought at 18$ hoping for Buy Out then already...
Obviously I have the ability to find outstanding issues but bad timing overall in entering a position
That is what I am afraid of now that you have found it and caused my hopes to go up.. Maybe HK has a way around it . Hospital pharmacies - at least in Europe - can cut a lot of red tape..
Thank you for the reminder! Will you keep it on watch for those results and remind me of it as I do not have the capacity to stay on top of such developments due to frequent and longer absence from the net?
Hindukush, I would love that more than you can imagine, except that I could not even phase out VASCEPA as it is still not available in Europe. As I live right in the Swiss-France-Germany-tri-border area I have been waiting with growing anxiety for it's final approval as I am battling severe, shockingly progredient neuropathic inflammation and demyelination due to a massive lead poisoning.
The neuroprotective and regenerative effects of VASCEPA that are so far anecdotal at most but convincingly authentic have been one of my sources of hope...
As of now I have to make do with plasmapheresis and a european company that I used to advise licenced to produce highly concentrated extracts from medical mushrooms.
https://gluckspilze.com/Medicinal-mushrooms
That seems to be the most beneficial therapeutic up to now and their pharmaceutical purity is beyond any comparison as they control everything from spores to bottling right in Austria whilst chinese mushrooms e.g. are basically repositories of heavy metalls and insecticides as mushrooms accumulate all toxic substances in their reach....
Also I would not know how to order the QUALITAS algae product from the USA or Israel.
I have gone through imports of high grade and highly purified OMEGA3 products in the past and had to pay up to 300 US$ in import taxes for every package and app,ly first for special permits as US nutritional and nutraceutical products are mostly not legal in Europe. I gave those up long tim e ago as it did nothing but give me burps... and been hounding for alternatives since..
So I was hoping as a licensed physician (and working in hospital I presume) you could request your clinic pharmacist to research how to get this algae EPA product and then maybe we find a way how o ship it to Europe
Ouch, that must have hurt, Louie! I am still a digital alien so have not even managed to get a wallet activated, but did own XRP as a derivative with 50 % margin all the way from 0.4$ in a CFD-account. As AMRN tanked I had to sell it to cover the margin call for my shares.. now that it is above 2$ I wish I had rather kept XRP and sold AMRN... I could buy em back now and still be profitable from that moment's valuations .
I suppose I was just to enamored from all the scientific data and too certain the investing world would all agree...
What I hear from some pros in the ICO environment is that TRON (TRX-USD) and IOTA are the next best bets...
If (?!?!) AMRN goes back over 8$ at least I will be all over these cryptos to hedge against future surprises.. and also some very promising bio-pharmas like XXII, EARS, NWBO and most of all RLFTF.
Hi Iryokabu,this is a valuable find as it adresses the growing numbers of vegetarian and vegan patients that are ethically challenged by using VASCEPA as it is derived from killing millions of sentient beings..
As it looks at first sight ALMEGA from Qualitas Health seems a superior product:
https://www.qualitas-health.com/almega-pl
Are you aware if this is available for retail customers?Cannot see a landing page for direct orders.
Great Captain! Looking forward to it
Glad to hear that your investments have worked out for you and your family, North! Unfortunately I was to concentrated on AMRN which after thousands of hours of research worked out well (after a decade of waiting at least) until Du doomed us.
I am just now starting to branch out but lack the time and energy to do that much DD ever again... which is why I hoped you could share your original reasoning to get invested in such a subpenny stock in the first place
Appreciate that encouragement, Marjac!
And Triratna (or 3 Jewels) is actually my given name, not a handle.
When I first joined this community I did not even know that I could post myself and if I had known I certainly would not have had any intention to actively participate) so it did seem natural to use this abbrevation.
I am a big fan of Last Kingdom as well. It is historically correct most of the time and it rivals Vikings in authenticity of characters
BTW:
did you think of turning off all electronic devices for acouple of days?
Sometimes this brings forth major insight, just like spending a night in the open in pouring rain shapes character!
In my internship I had to deal with a lot of soldiers on R&R from Nam suffering from post traumatic stress syndrome even so that word was not en vogue then. A great many of those had their most terrifying moments sitting in trenches in the dark whilst tropical rains poured down and they were endlessly waiting for contact...
Hindukush, you are a poet on top of all other achievements!
Your kind response made my day as it sums up my life's endeavours!
This is the true meaning of the word "Religion" which translates from the roman language as"Binding back to the Origin
There is no way to Truth.
Truth is the Way
satyameva jayate
...
yatra tat satyasya parama nidhanam
Thank you for your heartfelt response. I admire your dedication and humbleness. I am glad you do have contingency plans .
I appreciate all of your statements and find it reassuring that you will not get into biased discussions but stir yourself away from all distractions to stay on purpose.ever
As for your "oath of allegiance" I was aware of the depth of your commitment and sincerity right from the start without you ever having had to point it out. I just knew it "in my bones" which is why I had hoped to join your team but due to medical challenges was just not free to do.
So I am glad to have you as our champion to right the wrong and protect the disenfranchised !
(even so, admittedly, I am aware that we are complaining from a high ground to begin with... grieving about lost 6 or 7-digit investments implies that one had the means to afford such an amount to begin with..)
p.s.:
Ratna means "precious jewel", not rodent
Thank you for you ongoing education charts and presentations! However there is only one(1) picture that can be opened yet you mentioned 9 slides?
Hi Marzan, how could "things get ugly for Judge Du quickly" if she decides to can the motion ?
She is a Judge for life....
Are there any remedies left after this?
Thank you Marjac & Team for your relentless defence of your fellow shareholders. Just out of pure self interest let me request from you that you do take a day or two off to spent with family and friends and/or go out all alone into nature without a timetable to replenish yourself!
If you have done that would you adress my personal pet concern (with all due prejudice that your online posts are certainly monitored by Hikma counsel) which is wether a victory in your motion 60 (if the court recognizes that it has been defrauded) would open the door to civil damages litigation?
If a case of fraud would be established by Judge Du's decision would this establish Hikmas strategy to be a criminal act ?
Thus could it be that this would constitute "tortious / wrongful / malicious interference" against shareholders interests in the company?
Would that allow for a class action suit being brought against Hikma seeking redress for losses resulting from their criminal interference with bad intent?
I for one basically lost my retirement already depleted by punishing medical expenses capped by my insurer...
I am sure others on this board would show even larger losses to constitute for a class
Dear Hindukush, first of all Thank You for your (and Marjac & Crew) ongoing and tireless efforts on behalf of us All!
Then as you might have guessed from my infrequent appearance here that due to health challenges I am unable to spearhead such an effort no matter how successful it may be turn out to be.
I have been appointed as chairman and spokesperson for an AdHoc shareholder committee in one of the great CH11 cases after the subprime crises as I grew up bi-lingual and was thus able to represent shareholders from various continents. Since this was a huge and protracted re-organization of a major insurer spanning years and years I gathered quite some experience in voicing and defending shareholder interest against predatory BoD practices alas I could only serve as an advisor with a limited timeline.
The will to do this has to come from all those being vocal here and present daily.
One thing clearly stands out from memory :
it is imperative to have legal counsel that is partisan to the cause and not just satisfied by doing what is necessary.
Since we have unusually engaged and passionate legal experts on this board the first step could be done quite simply.
With warm regards
Ratna
Look,Vanilla, as long as GEM (which is no devious but common protocol procedure for each and every fund and institutional investor) gets paid stock loan&borrowing fees they do not have a vested interest to bring up the share price until the full data and EUA have shifted the tides..
Currently the annualized interest rate is at 5.7% and was as high as 6.5% on Jan.1st and is being paid on a daily base EOD.
There is a fully functional exchange named as SLB that does nothing else but broker shares to be borrowed between holders and shorters..
As log as GEM is in it for the money I don't expect this to change even so you are invested because of humanitarian reasons only, ain't it?
Contrary to you they earn money while they wait
But then there is no need to be wailing about the share price..
p.s.:
there is no substance to any ideations that GEM wants to keep the shareprice down to orchestrate a Buy Out. It would not serve their self interest to build this investment up for 8 years and sell it all for 2$ when the can keep it and earn 3,4,5 or eve 10$
Elk,we are being gifted with a billion $ promotional campaign compliments of NHI and FDA with this direct comaprison of AVIPTADIL vs. REMDESIVIR as I pointed out earlier:
When I first read the news of the international clincial study of the direct comparison of AVIPTADIL with REMDESIVIR it gave me goose bumps all over as I recognized the tremendous significance that will catapult AVIPTADIL into the TOP TEN of COVID19 meds as soon as the trial will officially be announced by the NIH!
( Even so it also pushes the timeline for massive gains in shareprice back for another 4-6 more months...)
(see below: II.a.:)
As REMDESIVIR is without proven statistical significance EXCEPT highly toxic - even deadly - side effects it’s use is basically nothing more than a Hail Mary application signaling total capitulation by emergency room and intensive care docs because they have NOTHING else as a therapeutic intervention on hand with patients dying on ventilation and ECMO!!
Obviously it was Team Orange with it's cozy interdependent relationship with campaign donors from GILEAD and it's intimate closed doors hugging sessions with their lobbyists that led to the application for EUA being granted for REMDESIVIR in just ONE (1!) day without clinical data to support it!
Talking 'bout armlength negotiations....
(see below: I.:)
What this really means for me is that Janet Woodcock and the other professionals at the FDA had had enough of the cronies of Trump being pushed ahead of them and being allowed to do damage for personal profits ( just like that Postmaster trying to dismantle the Postal Service even so he holds shares big time in direct competitors of the USPS).
Since it would come across really bad to call "Foul" and raise accusations of corrupt dealings within the agency it is easier and far more effective to directly compare REMDESIVIR with AVIPTADIL and it's already proven superior efficacy :
(see below:II.b.)
.
It is going to blow REMDESIVIR with it's potentially lethal long term side effects right out of the water without raising a direct accusation.
The results will fall back on the feet of those responsible for this reckless EUA simply due to power of gravity
Our problem is that timelapse until this space debris is pulled back to earth and the pubication of the results...
The outstanding positive is that this trial will take place in 8 countries across 3 continents thus basically broadcasting the results to ALL the doctors around the world using REMDESIVIR out of desperation!
In the long run this means that we will have a billion dollar marketing campaign for free because every practicing emergency and intensive care doctor will be informed about the failure of REMDESIVIR at once !
I presume this will be one of the most watched clinical trials world wide!
(And not only by doctors desperate for an effective therapeutic but also M&A specialists
What I am fairly shocked with is the share price decline instead of a break out?!?!
I cannot comprehend how people have missed this game changing news?
With this overwhelming developments we ought to be up above 1,00 SFr respectively 1,1US$ already...
Maybe it is the updated valuation report that RLF management commissioned …
we don't need a Short hitpiece as long as management employs these bashers!
Question is :
how to survive this long with our investment whilst NASDAQ hitting All Time Highs all the time...
Best Regards to All!
References:
I.:
Remdesivir starts 2 Phase 3 Clinical Trials on 26/2/20
Remdesivir Results 29/4/20
FDA Emergency Use Authorization 1/ 5/20
Results Of 2483 consecutive admissions, 342 individuals received remdesivir, 184 of whom also received corticosteroids and 158 of whom received remdesivir alone. For these 342 patients, the median age was 60 years (interquartile range, 46-69 years), 189 (55.3%) were men, and 276 (80.7%) self-identified as non-White race/ethnicity.
Remdesivir recipients had a shorter time to clinical improvement than matched controls without remdesivir treatment (median, 5.0 days [interquartile range, 4.0-8.0 days] vs 7.0 days [interquartile range, 4.0-10.0 days]; adjusted hazard ratio, 1.47 [95% CI, 1.22-1.79]).
The addition of corticosteroids to remdesivir was not associated with a reduced hazard of death at 28 days (adjusted hazard ratio, 1.94; 95% CI, 0.67-5.57).
II.a.:
https://www.prnewswire.com/news-releases/neurorx-announces-zyesami-aviptadil-has-been-selected-for-inclusion-in-nih-sponsored-global-clinical-trial-to-include-aviptadil-and-remdesivir-301262506.html
Hi North,I recall that I read with great interest your post #331079 about TSOI. Now I noticed that the share price has dropped significantly from the high you mentioned in March while interesting new data is published including peptides formed in the brain chemistry of gambling addicts..
I wonder what sort of neuronal and / or biochemical changes in their brains long term AMARIN shareholders would present?
Anyway what is your assessment wether the shareprice has reached an investible retracement level or are better levels yet to come?
https://finance.yahoo.com/news/therapeutic-solutions-international-demonstrates-potent-130000047.html
https://finance.yahoo.com/news/therapeutic-solutions-international-demonstrates-potent-130000047.html
it is right in the reference, Vanilla!
You should know that PR by heart as it laid it out in detail - trial is just recruiting .. once it gets underway it scheduled for 90days duration and then it might take a month or more for data analysis..
Try thinking instead of emoting.
Outrage rarely changes acts.. unfortunately or I'd be all over the place..
p.s.:
did you write and hear back from these nice girls at the IR department?
When I first read the news of the international clincial study of the direct comparison of AVIPTADIL with REMDESIVIR it gave me goose bumps all over as I recognized the tremendous significance that will catapult AVIPTADIL into the TOP TEN of COVID19 meds as soon as the trial will officially be announced by the NIH!
( Even so it also pushes the timeline for massive gains in shareprice back for another 4-6 more months...)
(see below: II.a.:)
As REMDESIVIR is without proven statistical significance EXCEPT highly toxic - even deadly - side effects it’s use is basically nothing more than a Hail Mary application signaling total capitulation by emergency room and intensive care docs because they have NOTHING else as a therapeutic intervention on hand with patients dying on ventilation and ECMO!!
Obviously it was Team Orange with it's cozy interdependent relationship with campaign donors from GILEAD and it's intimate closed doors hugging sessions with their lobbyists that led to the application for EUA being granted for REMDESIVIR in just ONE (1!) day without clinical data to support it!
Talking 'bout armlength negotiations....
(see below: I.:)
What this really means for me is that Janet Woodcock and the other professionals at the FDA had had enough of the cronies of Trump being pushed ahead of them and being allowed to do damage for personal profits ( just like that Postmaster trying to dismantle the Postal Service even so he holds shares big time in direct competitors of the USPS).
Since it would come across really bad to call "Foul" and raise accusations of corrupt dealings within the agency it is easier and far more effective to directly compare REMDESIVIR with AVIPTADIL and it's already proven superior efficacy :
(see below:II.b.)
.
It is going to blow REMDESIVIR with it's potentially lethal long term side effects right out of the water without raising a direct accusation.
The results will fall back on the feet of those responsible for this reckless EUA simply due to power of gravity
Our problem is that timelapse until this space debris is pulled back to earth and the pubication of the results...
The outstanding positive is that this trial will take place in 8 countries across 3 continents thus basically broadcasting the results to ALL the doctors around the world using REMDESIVIR out of desperation!
In the long run this means that we will have a billion dollar marketing campaign for free because every practicing emergency and intensive care doctor will be informed about the failure of REMDESIVIR at once !
I presume this will be one of the most watched clinical trials world wide!
(And not only by doctors desperate for an effective therapeutic but also M&A specialists
What I am fairly shocked with is the share price decline instead of a break out?!?!
I cannot comprehend how people have missed this game changing news?
With this overwhelming developments we ought to be up above 1,00 SFr respectively 1,1US$ already...
Maybe it is the updated valuation report that RLF management commissioned …
we don't need a Short hitpiece as long as management employs these bashers!
Question is :
how to survive this long with our investment whilst NASDAQ hitting All Time Highs all the time...
Best Regards to All!
References:
I.:
Remdesivir starts 2 Phase 3 Clinical Trials on 26/2/20
Remdesivir Results 29/4/20
FDA Emergency Use Authorization 1/ 5/20
Results Of 2483 consecutive admissions, 342 individuals received remdesivir, 184 of whom also received corticosteroids and 158 of whom received remdesivir alone. For these 342 patients, the median age was 60 years (interquartile range, 46-69 years), 189 (55.3%) were men, and 276 (80.7%) self-identified as non-White race/ethnicity.
Remdesivir recipients had a shorter time to clinical improvement than matched controls without remdesivir treatment (median, 5.0 days [interquartile range, 4.0-8.0 days] vs 7.0 days [interquartile range, 4.0-10.0 days]; adjusted hazard ratio, 1.47 [95% CI, 1.22-1.79]).
The addition of corticosteroids to remdesivir was not associated with a reduced hazard of death at 28 days (adjusted hazard ratio, 1.94; 95% CI, 0.67-5.57).
II.a.:
https://www.prnewswire.com/news-releases/neurorx-announces-zyesami-aviptadil-has-been-selected-for-inclusion-in-nih-sponsored-global-clinical-trial-to-include-aviptadil-and-remdesivir-301262506.html
NeuroRx Announces :
Zyesami™ (Aviptadil) Has Been Selected for Inclusion in NIH-Sponsored Global Clinical Trial to Compare Aviptadil and Remdesivir
NEWS PROVIDED BY
NeuroRx
Apr 06, 2021, 01:01 ET
RADNOR, Pa., April 6, 2021 /PRNewswire/ --
NeuroRx, Inc. reports today that Aviptadil, to be supplied by NeuroRx, has been identified by the National Institutes of Health (NIH) as one of two drugs selected for inclusion in a phase III multicenter clinical trial that will include the United States and multiple foreign countries. Aviptadil is being developed by NeuroRx as ZYESAMI™ in collaboration with Relief Therapeutics Holding, AG (SIX: RLF,OTCQB: RLFTF).
The trial, designated as TESICO (Therapeutics for Severely Ill Inpatients with COVID-19), is funded by the US Government COVID-19 Therapeutics Response and sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). The TESICO protocol has been reviewed and approved as a phase III trial by the US Food and Drug Administration and will randomly allocate 640 participants to Aviptadil, Remdesivir, the combination of both drugs and placebo.
Remdesivir is currently marketed as Veklury© by Gilead Sciences (Nasdaq: GILD). The primary endpoint of the trial will be participant recovery from respiratory failure over 90 days. Additional information will be supplied by the NIH when the trial randomizes its first patients.
II.b.:
NeuroRx Announces on March 29th,2021 ZYESAMI™ (aviptadil, RLF-100) Met the Primary Endpoint of Its Phase 2b/3 Clinical Trial and Also Demonstrated a Meaningful Benefit in Survival from Critical COVID-19
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RADNOR, Pa., March 29, 2021 /PRNewswire/ — NeuroRx, Inc. today reports 60-day results of the Phase 2b/3 trial of intravenously-administered ZYESAMI™ (aviptadil acetate) for the treatment of respiratory failure in critically-ill patients with COVID-19, which is being developed in collaboration with Relief Therapeutics Holding AG (SIX:RLF,OTCQB:RLFTF).
Across all patients and sites, ZYESAMI™ met the primary endpoint for successful recovery from respiratory failure at days 28 (P = .014) and 60 (P = .013) and also demonstrated a meaningful benefit in survival (P = < .001) after controlling for ventilation status and treatment site.
In addition to the robust overall significance across all 196 treated patients at all 10 clinical sites, the prespecified analysis of recovery from respiratory failure is clinically and statistically significant in the 127 patients treated by High Flow Nasal Cannula (HFNC) (P = .02), compared to those treated with mechanical or non-invasive ventilation at tertiary care hospitals. In this group, ZYESAMI™ patients had a 71% chance of successful recovery by day 28 vs. 48% in the placebo group (P = .017) and a 75% rate of successful recovery by day 60 vs. 55% in the placebo group (P = .036). Eighty-four percent (84%) of HFNC patients treated at tertiary medical centers with ZYESAMI™ survived to day 60 compared with 60% of those treated with placebo (P = .007).
To the company’s knowledge, ZYESAMI™ is the first COVID-19 therapeutic to demonstrate advantages in both survival and recovery from critical COVID-19 in a randomized, double-blind multicenter trial. On the basis of these findings, NeuroRx plans to apply immediately to the United States Food and Drug Administration (“FDA”) for Emergency Use Authorization (EUA) and to subsequently submit a New Drug Application (NDA).
Recovery from respiratory failure (without relapse) with discharge from acute care and survival through the observation period was the prespecified primary endpoint specified by FDA for the study, originally intended to be assessed at 28 days and then extended to 60 days based on recently-published FDA guidance. The above analysis includes all 196 participants who were randomized and treated in the placebo-controlled, double-blind clinical trial (www.clinicaltrials.gov NCT04311697) conducted at 10 US hospitals. Treatment with ZYESAMI™ or placebo was in addition to standard of care treatment that included steroids, convalescent plasma, antiviral therapy, anticoagulants, and various anti-cytokine drugs.