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Drop the P...NRLA... "The show's about to start"...GLTA...
Maybe an effort for New sites should be made in Central EU or India or Brazil. Phone calls should be made at least to possibly recruit Investigator Physicians, IMO. Many speak English.
Even in the USA, Outpatient 'NO CARE' is most common until Critical issues occur and then Hospitalization is needed.
Many countries do not 'Test' until symptoms are seen.
A few hundred M vaccine doses so far around the world with the usual suspects glomming most. 130 countries have received NONE. 7.5B population!
Will there be Rna effects/mutations?
Maybe as bad as Remdeathsevere? COVID-19 from Gilead's Wuhan China Virologic Institute SARS research.
Karma?
Gung Ho for Buc - Thiols. Yea. Let's go. Sadly the COVID is steadily increasing World wide. An inexpensive Over the Counter drug with easy wide distribution is needed.
https://www.worldometers.info/coronavirus/
New* VP of Research and Operations...Hmmmmm. We may see changes some here have talked about. IMHFO.
I thought the current data and implications with AGN's limited successes could have been promoted into a possible partnership for Phase 3. A least taking the time to try. Attitude and Presentation are So important for salesmen or Management...
Remdeath and others barely show limited success (with High Safety issues) and yet the CTs that ALL the BigP have had has taken most of the patients trying to show SOME significance. IS there significance or just Masks/SD/SOC effects? Sadly for all infected, all BigP drugs are also with limited results so far. But they HAVE suppressed competition well. No SILVER Bullets.
Glomming most of the World's vaccines here in the USA with 130 countries getting NONE.?. Will the Viruses be tweaked thru Rna mutations? karma? Shots every 6 months?
AGN did well to complete this first Phase. IMO. Yes, Data should be Reviewed and as much data as possible collected / presented (Xrays). Can we see a PowerPoint and some Graphs. Something MORE than a 'finger wave'!
A strong effort to highlight the benefits of Ifenprodil, FROM MANAGEMTNT, is needed by shareholders. Glum moping and unprepared blow-offs of KEY questions wont help the PPS. Statements like 'WE WILL WORK HARD TOWARDS OUR GOALS' are needed. Not 'oh well', 'I dont think we can do that' and 'BS technicality Duhs'. IMHFO.
Opinions that are possible excuses should be kept buried and NOT be the main topics left for message-Boards and investors to consider.
ICU time Maters, Fibrosis Maters and EVERY EFFORT should be made to Highlight successes and correlate them and SHOW Progress. It's THERE...JMHFO...GLTA...
*Dud
Sour Grapes are free with the Ripple Wine for BTH Long-Hal-ers.
A stronger presentation from the CEO with possibilities and plans would have been nice. Something like a comparison with what Rem received EUA for, maybe.
The Nail is the 40mg question, IPF plan?, new VP introduction with answers that most of us could do better with, no carrot of even 3rd world partnerships for Phase 3.
682 patients was the CT full enrollment target for both Phase2b and 3 combined. Maybe Amg gets the New* to answer to that.
AGN continues to pull de-feet from possible success.
A lot is in the (prepared?) presentation. IMO this sucked and held little hope for investor's future...GLTA...
COVID critical Hospitalization cases are increasing fast. Possibly wave 4.
Quite CAN mean they are doing something. Retrieving lung X-rays. Data. FDA.
CJM and crew hopefully are organizing the data to clear the SNAFUs and THEN preparing to discuss their Data with the FDA for advice of a Phase 3 Primary Endpoint or an EUA targeting 'time in ICU'. Maybe sell that.
AGN didn't have the Knock-out because there is probably none anyway. I posted the Rem data a while ago and it wasn't a knockout either. Worse IMO with serious Safety issues being seen...
We all made speculative investment in this Hope for an effective part of the still Mysterious Solution for the Enigma COVID Has brought to the World...GLTA...
Yes, me too. How do they say 'time in ICU' was 4 vs 9 days and not have WHO or NEWS score changes?
Still here some, too. Celebration was quelled by another confusing (at best) PR and no positive follow up / hype by AGN. I hope amg doesn't get CJM's head, then what. Will it mater?...GLTA...
Inept or NRLA...
Got bad vibes a couple days ago too. Would have liked to have 'time to ICU' in the Interim data in Dec. It was a 15 day data point.?.
'Then I spotted the p=0.0315 (Yay!!), then they crushed my flickering hopes'. Always a snafu.
Long ride since Dr Frost, I should have listened to me. -5/7...GLTA...
AMG posted that GSH '71 tune and it was significant to deployed soldiers back then and Good to listen to again Now. BLM...
"Once the full data set has been obtained, Relief will reach out to European regulators to present the outcomes of the Phase 2b/3 clinical trial. A European Phase 2b/3 clinical trial is planned to be initiated later this year".
https://finance.yahoo.com/news/relief-confirms-release-60-day-052000337.html
Pretty weak PR...Why not claim application for EU approvals. A COVID Trial in the EU does not make much sense with Trials of Inhaler and IV formulations tested against COVID already.
Makes more sense for a Lung Long-hauler's treatment Clinical Trial of some sort, ASAP.
Vaccine passports are a good idea. IMO.
Masks work. Do you get a Flu shot?
Our Soldiers have always had 'shot records' for deployments.
Personal responsibility To All and For All outweighs irresponsible actions of claimed personal freedoms. Geeze...
Safety over personal irresponsibility? Masks? Background checks make sense.?.
Personal Freedoms? No Mask super-spreaders, Drunk drivers and insane folks/criminals* with Guns giving these all a Bad Rep! Jail terms longer for a Joint than Armed Robbery?
How do you think most Police and Emergency responders feel?
Try to go to South Korea or Japan or Vietnam or Hawaii or most EU countries or come to the USA mainland without proof of testing right now. Got time for a quarantine?
A stamped shot record was needed before deployments for Many decades both going and coming home. Ha, walked thru a line of pneumatic type injections, LOL. Hurry up and wait in line for That.
Why not stamped passports for ALL Air Travel now.?.
*Armed criminals do Measure 11 time. Yes, many guns on the black-market, have not fixed that.
In the RLF - NRX 50-50% / 80-20% deal the manufacturing and logistics were RLF's responsibilities and running the CTs/FDA, sales and marketing were primarily with NRX. Right?
Splitting markets of course too. Now the world market is looking larger.
IMO, the EUA(s) will be successful pretty FAST for RLF-100*. thru NRX efforts, as that is needed for their NRXP deal.
GEM has financed BOTH paths. They UNDERSTAND MEDIA and liquidity, that's their 'thing'.!.
The FDA does not have many successful Phase 3 COVID Trial EUA Applications to consider. ONLY ONE I THINK.
...GLTA...
*whatever BRAND name for a formulation of Patented RLF-100...
There is a wide range of data in these 'Live' info charts.
There are also maps for showing how different countries test and when. Kind of relates to where the Viruses are getting worse...link...
https://www.worldometers.info/coronavirus/
RLF has the 'rights' already to sell to the rest of the world, where the increases are, AT THE 80% - 20% rate.
The US or Israel may buy some RLF-100 in one of OUR Patented Formulations thru NRX AT THE 50%-50% rate.
Because the USA is purchasing and providing vaccinations to All citizens there is going to be less for the rest of the World but some positive results here and other countries using vaccines.
Masks and improvements in testing/tracing have helped in the US and Israel. Many countries do NOT Test until there are symptoms.
80% effective with herd immunity of 70%+ vaccinated?
This report on the IV Trial may be the main reasons for an EUA but their other running COVID EAP Trial has also been collecting Data. I would guess they will submit something as supplemental info to any EUA from the FDA under NRX.
Ahhh, WHAT will RLF do now???
Our news has just been seen so far by folks like us with direct interest or medical folks following it already. JMHOs...GLTA...
USA has done well with COVID decreases but the world is not. US now #3 after brazil and India. Critical Hospitalizations are increasing fast...
It's still all about RLF-100...NRXP...NRLA???
Its lead drug candidate RLF-100™ (aviptadil) is being investigated in two placebo-controlled U.S. phase 2b/3 clinical trials in respiratory failure due to COVID-19. Relief also holds a patent issued in the United States and various other countries covering potential formulations of RLF-100™.
We look forward to working with the National Institutes of Health, the Department of Defense, the FDA, and regulators around the world to bring this treatment to patients as quickly as possible."
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).
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.
We look forward to working with the National Institutes of Health, the Department of Defense, the FDA, and regulators around the world to bring this treatment to patients as quickly as possible."
AND!!!
Dry powder RLF-100 AND Inhaler Trials...TFF...
“We are excited that ZYESAMI has demonstrated a highly significant reduction in time to hospital discharge for seriously ill COVID-19 patients treated with High Flow Nasal Oxygen, along with an increased likelihood of recovery and excellent safety,” said Jonathan C. Javitt, M.D., M.P.H., CEO of NeuroRx. “Although our current production methods yield a drug that is sufficiently stable for emergency use, a long-term, shelf-stable formulation will be needed for ongoing use of ZYESAMI, once the pandemic subsides. The thin-film freezing technology holds great promise in potentially making this available to patients with other stages of COVID-19 with an inhaled form of ZYESAMI.”
https://finance.yahoo.com/news/relief-reports-neurorx-announced-feasibility-062500174.html
My youngest brother and his wife too. A pregnant niece too. All told to go home and use normal flu treatments. Certainly none of the Rems etc, not sick enough to be hospitalized Trials. Brother's wife had 'long-hauler' lung issues. Something for this group needed.
Buc IS the 'Outpatient' treatment that will help keep mild-moderate patients out of the Hospitals. Thiols...GLTA...
Buc is for mild-moderate symptoms and the Trial is for outpatient. The vast majority of COVID patients never are admitted to the Hospitals and Dont get the fancy Drugs. Link>
https://clinicaltrials.gov/ct2/show/NCT04504734?term=Bucillamine&draw=2&rank=2
NRX/RLF are targeting the sickest patients with the EAP using ""ZYESAMI"" . I notice that all Refs for RLF-100 are now changed to ZYESAMI as of 3-19.
As said before, there are more Patients treated in the EAP CT than the Main 'less critical' Patient's IV CT.
Gathering ALL Available Data for Aviptadil / RLF-100 / ZYESAMI for inclusion in a FDA presentation and Application(s) makes basic sense. The CTs NEW DATA Supports the Application(s) for an EUA, IMO. If they can pull together (Interim) Data from the UC / St. Jude Inhaler study, GREAT.
Target Groups, of course. Both Short and Long term Data Results, Duh.
https://clinicaltrials.gov/ct2/history/NCT04453839?A=5&B=6&C=Side-by-Side#StudyPageTop
...NRLA...
GEM and Insider's stock prices are the same as Ours. They have the BALL and want this all to succeed as much as we do...GLTA...
20X to 1000X+ of AGN MC, what's the point? Why not GILD and PFE too.?. 1 year Chart?
I've been here since BTH and BLO FAIMS, kind of transformed to >NASH>AGN IPF/CC Australia Trial. That's before COVID and SK..
I was an old investor when my 'are you diversified' pick was T C MO OI BA. Also kept my GOOG from ONT theft and L3 shares from IMSC theft. GNLB/GLNC. Shoulda kept my Clne. What's my point?... GLTA...
'Cherry picking' patients too sick to qualify for the normal CT? We have heard of strong results with those patients.
Rem / Lilly pulled data from combining CTs for their EUAs. Weak data with Safety issues at that...GLTA...
$10k each for 100 + x-rays plus independent evaluation of the combined data as a group and made into a presentation quality report. Probably. AGN has been pretty good with our money and more successful at completing the COVID trial as any I that have seen. I agree with CM/Smoki, data asap and supplementary data to expound on possible successful WHO scores.
I feel the delay in IPF/CC is partially the result of the attention the COVID Trial has taken.* Two (+) lung specific CTs with overlapping results is how Gilead/Rem pushed through their limited results for EUA, and lots of cash to dominate a large portion of available Trial sites. I posted their CT results and asked experts here to discuss the results/ P-values / safety. Obviously AGN does not have those resources.
OAN, US COVID cases have dropped but World cases are increasing back to over 500k average again.
Besides BOTH South Korea and Australia were being leaders in suppressing COVID and those countries ability's to Isolate their populations certainly helped them. Just too few patients. Yes 20 patients, but X $25k would have sapped the COVID effort.
The WHO scores for COVID may reflect similar results as the IPF/CC Trial, IMO
" Primary Outcome Measures :
A ≥50% reduction in the average number of coughs per hour over 24 hours comparing baseline to treatment period using an ambulatory cough monitor [ Time Frame: Baseline and week 12 (≥11 weeks of treatment) ]
No worsening of force vital capacity (FVC) in either mL or % predicted [ Time Frame: Baseline and week 12 (≥11 weeks of treatment) ]
YES these longer term data points and treatments would be GREAT info. But, $$.
...GLTA...
I had proposed that this EAP data may be combined with the CT data when the EUA applications are made. I didnt find any reasons why it could not be included as supplemental data. Sound reasonable, Probable, wrong?
Well we're part of the ETF...Old news though...
https://finance.yahoo.com/news/horizons-psychedelic-stock-index-etf-153349524.html
RLF-100 has been used through the EAP program by hundreds of patients too sick to qualify for most other treatments/Trials. 'Word' is that there are strong results. That Data Has been collected already so future use under COVID EAP programs shouldn't be an issue, at least for RLF-100 and their acquired data.
I believe NRX/RLF are working to present a combination of the data from their EAP program and the COVID Trial results in application(s) for EUA. The EUA and a path for FDA approval for several indications are in the works. I hope...
Go NRLA...GLTA...
9-24-20, yes with only 51 total patients at that time it was too early for this application. But the World was on Fire and they Tried.
NOW with several hundred treated through the EAP program AND met secondary endpoints in the COVID Phase2/3 Trial AND now having much more general Data supporting the Lung healing results for NRX/RLF/RLF-100 in the IV form.
I think this current EUA should have a much stronger application.
The UC/St jude Inhaler Trial should have filled fast and could have Interim results and supplemental data to the IV form of RLF-100.
'Relief Therapeutics and NeuroRx have applied to the FDA for an Emergency Use Authorization (EUA) for RLF-100 (aviptadil) for the treatment of critical COVID-19 patients with respiratory failure.
Aviptadil is a synthetic form of a natural peptide that blocks replication of the SARS-CoV-2 coronavirus in human lung cells and immune cells. "The agency previously granted Aviptadil an Orphan Drug designation for treatment of acute respiratory distress syndrome".
""The EUA application was based on a study of 51 patients"", in which those treated with Aviptadil demonstrated a three-fold increase in survival, recovery from respiratory failure and improvement in other clinical measures compared to those receiving the standard of care.
"""The emergency use request targets the same critically ill population that the FDA allowed to receive the drug under an expanded access protocol."""!!!"
https://www.fdanews.com/articles/199199-relief-therapeutics-and-neurorx-seek-eua-for-covid-19-treatment
Drop the P and GO NRLA...GLTA...
Aviptadil IV and Inhaler
USD MSU D(sodium phenylbutyrate)
Emetine
ASIB and PTSD
I think this is an Lincoln Capital pipe and supports ACER.
https://ih.advfn.com/stock-market/NASDAQ/acer-therapeutics-ACER/stock-news/84570552/prospectus-filed-pursuant-to-rule-424b3-424b3#D656020D424B3_HTM_TX656020_5
I seen some posts inferring RLF/NRX are picking sub groups of patients, well look at what Merck is doing with their Drug.
https://www.clinicaltrialsarena.com/comment/ridgeback-mercks-molnupiravir-for-covid-19-has-moa-administration-advantages-but-phase-iia-faces-execution-obstacles-may-have-value-gaps/
BTW, NP-120 (Ifenprodil) Outperforms Merck’s Phase 3 Drug MK-7264 (Gefapixant) in an Acute Cough Study by 110%
IMO, any EUA application will include the Strong data from the EAP.
Obviously full 60 day data may be important and will be reviewed. NRX will apparently be thorough this time so we should NOT see another fiasco like the interim data reaction/PRs.
RLF is waiting for NRX to collect all the relevant info and completing the processing. A coordinated effort probably is being made towards any FDA filings. I hope "THEY" are planning for a long term success and consolidation as a NASDAQ stock(s).
The current 80%/20% areas around the world are where the Virus is now increasing. The USA is controlling things better now and also in other 50/50% areas. More incentive for strong efforts from NRX to plan successful FDA application. ie, NRXP...
NRLA, RLFA may be in the works separately but I've posted what I think of GEM's investments in NRX/RLF/RLF-100...GLTA...
One of My points was their taking the Time for all date's Interim data reviews of the 210. There are pre 14 day, 28 day, 42 day and 60 day patient reviews. The main Trial is only set for 28 days. The remaining two later review dates per patient must have some meaning. Obviously to see longer term results. 210 interim data is to set dosages for the rest of the Trial and to pass first DSMB reviews. MF said they would also apply for EUA if/when data reviews at 210, 400, 600. Lots of new sites to expedite enrollments. Reliable data collection, DUH...
COVID is slowing (temp?) and Long Haulers are the large future market along with other lung diseases. 'Some' investor(s) have helped recover the PPS. Thiols -Lungs - Buc. JMHFO...GLTA...
It seems that data through 4 weeks from starting a patient dosing will initially be what this CT is set for, 28 days.
The 'study' then has 6 week and 8 week data collection that may be 'significant'. Are these results somehow to be included in the Trial records ? Maybe at least be a part of any FDA applications?
IMO, they are Smart putting some longer term data results as important.
Long-haulers and latent damage to the Lungs.?. Certainly a relevant issue....GLTA...
"Following completion of the treatment course, follow up assessments will be performed by a study nurse 14, 28, 42, and 60 days following the end of treatment."
"Up to 1000 patients will be enrolled in this study. Patients will participate in the study approximately 45 days".
https://clinicaltrials.gov/ct2/show/NCT04504
Don't you think that RLF-100 data from the EAP patients that were too sick to enter the official COVID Trials will be coordinated into any results presented for an EUA? Will it matter and be helpful?
Rem's data was worse than CNDY. The W.H.O. is against the use of Rem, *quin and *zone, I posted the links.
Old news that Thiols help heal Lung damage. Long-haulers may benifit for the use of Buc too. Just a repost but interesting, IMO...GLTA...
"It is becoming increasingly clear that certain types of pulmonary injury may be closely related to oxidant-antioxidant imbalance in the lung, resulting from the production of reactive oxygen species within the lung during endogenous metabolism and xenobiotic insult. We have investigated the role of glutathione in pneumoprotection from such reactive species and, in particular, methods of manipulating the resident antioxidant capacity of lung glutathione. One such approach has been the use of the thiol-containing drug N-acetylcysteine. We have shown that N-acetylcysteine is able to both support intracellular glutathione biosynthesis and act as a 'scavenger' of reactive electrophilic species through the chemical reactivity of its thiol group. N-acetylcysteine reduces hydrogen peroxide to water, with the commensurate formation of N-acetylcysteine disulphide both when the peroxide was supplied directly or generated enzymatically. This basal reduction of hydrogen peroxide by N-acetylcysteine was greatly enhanced by the inclusion of catalytic amounts of the selenium-containing heterocycle, Ebselen, in the incubations. Thus, Ebselen mimics the activity of glutathione peroxidase but, unlike the enzyme, is able to use N-acetylcysteine as a co-substrate. Thus, the combination of N-acetylcysteine and Ebselen may provide a useful therapeutic tool in conditions of pulmonary toxicity associated with oxidant insult.'
https://pubmed.ncbi.nlm.nih.gov/3318962/
Single large Buyer? Buyers? Not the PSYK funds yet.
Most new cases in smaller countries so I hope the new Site locations will fill recruitments ASAP...GLTA...
https://www.worldometers.info/coronavirus/
I disagree VF. GEM will want a Big splash on Nas. We (shareholders, GEM, NRX, RLF)are riding in their boat / Votes.
1 for 10 then ther is 320M RLF and 1 for 1 to join @ $10. (3X from here) NRLA. NRX 150M, 26M for Acer and 320M for RLF.
VIP PATENTS ARE THE "JEWEL"!!!..
500M shares Outstanding and probably way less than half in the float. IPO @ $10 with these PTSD-urinary-VIP++ paths...JMHO...NRLA...GLTA...
or RLFA which I like much less. IMO something happens before Data release...
Will the current moderators update the INTRO.?. Some posters (me2) struggle to find important links in the past posts of the steady info / DD seen here. We may see many new Visitor and a sharp/updated MB INTRO would be nice...IMO...
We need a Volunteer...
There was this poster that took the time and effort to continue as a moderator during the BTH to AGN transformation and helped make the current INTRO. The current INTRO to this Board is OK YET only reflects AGN before COVID and DMT. Some strong literary/computer skills and good knowledge of AGN's prospects and business model Would be nice. Of course I have the default poster in mind.
A new MB visitor and hopeful investor may want easy background DD of the company* and the stated future plans and some possibilities. Gathering pertinent info is hard work. My default choice does that. Maybe we can ADD some BIG things SOON too...GLTA...
"Unleash the 60 day, and then start to clarify how NeuroRX, Gem, Blackrock, TFF Pharmaceuticals, and Acer provide a cohesive synergy with Relief."
I think there is much discussion and bargaining internally about your statement. IMO, the money guys want their share and a future for their long time investments in NRX/RLF...GLTA...
1 for 10 will do fine. I agree with Who as it being part of a whole deal. GEM doesn't want to wait, they are cooking something and want to make a splash ASAP, WITH a Future....RFLA...NRLA...ASAP...GLTA...JMHO...LOL...
The WHO does not support use of some competition's drugs anymore.?.
“The panel considers that this drug is no longer a research priority and that resources should be used to evaluate other more promising drugs to prevent COVID-19,” the WHO said in a statement....
About time, wasted hospital patients lives and other possible treatment research...IMO
https://www.msn.com/en-us/health/medical/world-health-organization-advises-against-using-hydroxychloroquine-as-covid-19-treatment/ar-BB1eajPZ?ocid=msedgdhp
https://www.who.int/news-room/feature-stories/detail/who-recommends-against-the-use-of-remdesivir-in-covid-19-patients
Wow, seems there is at least one convert to this theory...RLFA;NRAX.JMHO...GLTA...
COVID testing policies probably effect the number of known cases. Even in the USA where tests are openly available the number tested has dropped significantly. Many countries only test when symptoms are seen or at the hospital stages.
Dr. fauci says vaccines are the answer but distribution is slow even in more advanced countries and many countries have almost no vaccine AND little testing..?. The dip in cases is going back up almost everywhere.?. Herd Immunity is not even close. Residual effects will be around for a long time.
With the reported LOS and time ventilation shown in the COVID Trial and ALL the accumulated data from EAP it seems that a RLF-100 EUA may encompass longer term benefits too from 60 day data.
https://ourworldindata.org/grapher/exports/covid-19-testing-policy.png?v=193
https://www.worldometers.info/coronavirus/covid-19-testing/
The WHO now has added o-quin to Rem as showing no benefit and some risks...
https://www.msn.com/en-us/health/medical/world-health-organization-advises-against-using-hydroxychloroquine-as-covid-19-treatment/ar-BB1eajPZ?ocid=msedgdhp
https://www.who.int/news-room/feature-stories/detail/who-recommends-against-the-use-of-remdesivir-in-covid-19-patients
With the 500M warrants (exercised in Dec) GEM now owns twice as much as the 23% they had in Sept...We are riding in their boat.
RLFA;NRLA. JMHFO...GLTA...