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FDA guidelines for Meetings... I think NRX/RLF is an A or C meeting.?. Immediate means these timelines...
https://www.fda.gov/media/72253/download
Point #1, obvious
#2, reinterated
#3, yes results < 70 days
#4, yes scrap it/failure
#5, Not true, unless it's BP nothing is approved
#6, pandemic, A + NZ isolated
#7, IDK
#8 It was cheep and is currently a failure
#9, CM needs cards to play, BTH?NASH?
#10, Yes MY POINT, ENDPOINTS that IFENPRODIL can POSSIBLY ACHIEVE
#11, Why did Dr Nutt mention NDMA antagonist, why is 40MG of Ifenprodil NOT better than 20 mg dose?
#12, it was cheep in SK but not enough cases then Au/NZ/SK closed to reduce COVID spread successfully
Kinda looks like you mostly agree after adding your minor subplots.
Drop the AU Ifenprodil CT as incomplete due to ****/COVID and POSSIBLY PLAN a couple GOOD ACHIEVABLE Endpoints for a Phase 3.
GET A PARTNER fror Phase 3! POSSIBLE...
OUR Current scientists at AP should be able to look at the New Ifenprodil Stroke reports and see if there are relationships with how DMT may work. The Psyk/psylocibin could use a fresh angle.
My grandson's Lab puppy just pissed on the carpet, Fun talk...GLTA...
The time lines you posted for EOP2 meetings from the FDA Guidelines suggest that a meeting and results should be within the 70 days AP set. They must have decided to give the longest time frame so we wont expect Fast replies.
Many companies dont discuss up-coming FDA meetings or applications from what I have read.
Of course I hope for the surprise of an Earlier date and results. Under promise and over deliver would be a nice change.
Lung X-rays?
AP needs to drop the current IPF/CC Trial/failure and somehow combine all those efforts toward Endpoints of a Phase 3 CT for Ifenprodil that may be achievable. Maybe CM can then find a Partner.
...GLTA...
Some 'Exciting Hype' of an Ifenprodil/DMT micro-dose combo for their Stroke "Research", even.?.
Fkn calculate a dosage and write a procedure/Thesis, then try it on the Fkn mice. Then patent it. JMHFO...
It seems Dr Nutt is saying that there has been a problem with NDMA drugs in the past when used for treating stroke? or. Specific answer to the Ifenprodil stroke treatment news? Possible eyes on it at the least?
Smaller 20mg doses of Ifenprodil worked better than the 40mg arm.
There are few Magic cures for Anything. Certainly COVID proves that. Many small things added cumulatively, ah yes the 'Cocktail' approach, have shown the Best successes. Strokes too?...
...GLTA...
Thanks Keva and Shell'
https://pubmed.ncbi.nlm.nih.gov/33713028/
Dr.Nutt;
"A number of drugs that were being researched for stroke that ended up causing hallucinations were abandoned for this reason including NMDA receptor antagonists."
AND;
GEM is a Major financier for Both RLF and NRX.
Opinions.
GEM MAY not want their company's in court about RLF-100 / Zyemini.
RLF-100 + ACER + AdVita + NRX-101... Nice Pharma combo...IMO...
Aviptadil Formulation Patent is the CROWN JEWEL...
Will BRPA accept NRX not having Aviptadil Patent?
Does the QUIET suggest more May be Happening behind CLOSED DOORS? S4 share conversions?
... GLTA...
The Bigger News for RLFTF is the active 'Recruiting' in Turkey, adding sites too.
NRX just got the Georgian's to be able to use the current IV EAP. Check the Trial #s. Don't get me wrong, It's Great News that NRX is pushing OUR DRUG into use ANYWHERE.
IMO, GEM wants some Coordinated ACTIONs, ASAP.
I posted the criteria for FDA 'meetings' and it is not casual or because JJ wants one. JJ needs to follow the rules. ASAP would be nice...GLTA...
https://clinicaltrials.gov/ct2/show/NCT04453839?term=aviptadil&draw=2&ra
https://clinicaltrials.gov/ct2/history/NCT04844580?A=2&B=3&C=Side-by-Side#StudyPageTop
Looks like GEM wants NRLA, IMO.
<$.30 a share now so 10 rs to 1 makes 320M @<$3.00. 1 NRLA for 3 shares RLF then makes <$10, the deal price for NRXP.
Their S4 discussed BRPA share exchange but i Guess they BRPA will get 50M shares + the 50M (+100M) for NRX to become NRXP and then the RLF 100M = 300M as NRLA @ $10+-. NRXP wont happen without RLF-100 (100% Patent control and RLF-100 EUA), IMO.
The Crown JEWEL IS THE RLF-100 PATENT, IMO.
GEM wants a success story for their Investments, certainly NOT bickering stupidity that may decrease Values, IMO. They probably don't want to fund competitions in Logistics, manufacturing and possibly sales areas, IMO. They MAY want a Big Splash and liquidity, IMO. ASAP, IMO.
EOP2 / EOP3 meetings with the FDA should be getting set for review of RLF-100/Aviptadil/Zyemini, IMO. Brand Name does NOT MATTER, IMO. The Clinical Trial DRUG is RLF-100, given Intravenously, IMO.
Inhaler results will come after RLF-100 EUA and as NRLA happens, That's My LONG Bet. I dont see NO Box...GLTA...
Yes, maybe, but with the rest of the World headed toward 1M NEW cases a day, FAST, there is not even HOPE for vaccinations.
The Spoiled US citizen with No Mask yelling 'MY Rights' yet refusing vaccinations...*...!
Ignoring the WHO efforts to spread Vaccinations around the world by a NEED criteria was over ridden by Trump/Biden for America First. The MATH and HERD Immunity does not work unless COVID is attacked on All Levels and in ALL countries. IMO. Unless a country is run like China, no tourists, no travel, Wuhan VI/Gilead. IMO.
The World needs a simple Treatment, The Logistics of Most Vaccines will not be possible in many areas.
*US Army ret, I get to call it as I see it in the USA...
The NRXP IPO article in this old post said NRX does not pay for RLF-100 ZYE-sami development, it was Their claim right in the prospectus. I posted several articles during that time questioning why we paid. Now they want additional payments. Check out the Sole trout linkand JJs actual words. Two sides of HIS mouth for sure..?.
STOP FIGHTING NRX/RLF and get WORKING TOGETHER.
https://moneymidnight.com/2020/10/relief-therapeutics-otcrlftf-neurorx-to-list-on-nyse-via-merger/
ALSO...
https://www.msn.com/en-us/news/world/as-pandemic-surges-anew-global-envy-and-anger-over-u-s-vaccine-abundance/ar-BB1fZRNk?ocid=msedgdhp
America first , for vaccines? Is our greed / fear / wealth causing the real problems to come?
https://www.msn.com/en-us/news/world/as-pandemic-surges-anew-global-envy-and-anger-over-u-s-vaccine-abundance/ar-BB1fZRNk?ocid=msedgdhp
Looks like it is 'full steam ahead' for an EMA Inhaler and IV application of RLF-100. AdVita makes better sense now. Also the deal with ACER. EU/EMA . RLFTF...GLTA..
GENEVA, SWITZERLAND and GUNDELFINGEN, GERMANY / ACCESSWIRE / January 20, 2021 / RELIEF THERA
Amongst the AdVita assets being acquired in this transaction, Relief will gain further pending intellectual property rights that may cover RLF-100TM inhaled formulation specifications and the potential application of inhaled Aviptadil in the treatment of Acute Respiratory Distress Syndrome (ARDS) and Checkpoint Inhibitor-induced Pneumonitis (CIP).
"AdVita's intellectual property around inhaled formulations of Aviptadil and its team's expertise with Aviptadil will be invaluable as we move forward with the development of the inhaled formulation of RLF-100(TM) for the treatment of COVID-19-related ARDS, as well as other potential lung disease indications, such as pulmonary Sarcoidosis and Chronic Beryllium Disease," said Jack Weinstein, CFO and Treasurer of Relief. "We look forward to initiating the development of inhaled RLF-100(TM) in Europe within the coming months for COVID-19 patients using inhaled Aviptadil. Furthermore, we plan to re-start a clinical development program for RLF-100TM in pulmonary Sarcoidosis later this year."
:
Dorian Bevec, Ph.D., CSO of AdVita, commented: "We are excited to combine our specific expertise in inhaled formulations of Aviptadil with Relief's comprehensive scientific catalog of the compound and its uses in respiratory diseases."
Interesting nugget besides the COVID CT...
". Altogether, our results suggest ifenprodil improves long-term neurologic deficits through antagonizing glutamate-induced excitotoxicity."
Ifenprodil Improves Long-Term Neurologic Deficits Through Antagonizing Glutamate-Induced Excitotoxicity After Experimental Subarachnoid Hemorrhage
PMID 33713028; Translational stroke research 2021 Mar; ?(?):
Name matches: glun1 ifenprodil
Maybe Stroke research? Maybe additive for micro-dose DMT?
The 'Show' starts soon. I hope. We still need a PR for the Final Data. Something BIG would be nice. Maybe I missed it/ ALL OF THEM.
An NRX announcement of USFDA filing and a meeting date will be a good start.
RLF should be in a process with AdVita / Swissmedica to NOW FINALLY file some applications at EMA as the data is available.
At least they stopped the bleeding from the 'self inflicted' bs with the 'leak'. It would be Great if the RLF-100 Inhaler version/(60 day)formulation Trials in Europe gets attention before NRX's 1 year shelf life stuff. An unneeded costly delay add-on, IMO...GLTA...
https://www.fda.gov/media/72253/download
I dont see the info/results from the new data posted to this MB on any other Official media. Must be a leak, but it stopped the major bleeding, for a while and helped rlf.SW. It seems that RLFTF would acknowledge receipt of Data and MAYBE expedite EMA processes.
NRX should be making their applications for their review as a Type A (appeal) or Type B for EOP2/3 because it apparently is 4 week wait. After data submissions. I guess IND and NDA are different than EUA??
Looks like we / some investors only saw it. TIME TO MAKE MANY PRS!!!IMHFO!!!
Butt,,, it also seems that RLF/NRX "Management" teams are more involved in the recent pissing match, so far.
RLF SHOULD have this Data NOW.
Dumped some and bought some back.
BUUTTT, I certainly DO NOT UNDERSTAND THESE CRAZY company's Managements REMARKABLY DUMB?PUBLIC?HINDSIGHTED?CONTRAIRIAN?STUPID?UNCOOTH?UNPLANNED?REACTIVE not PROACTIVE paths and actions.
NRX/P surely knew the data was IMMINENT, so why the Tree-shake Pissing match.
At least we KNOW the Data is confirmed and WE CAN HOPE it is being expedited...
Plagiarized link...
https://www.fda.gov/media/72253/download
Wow, JJ is Still pissing in the SOUP bowl. Brilliant to have these issues made PUBLIC. I guess he must feel Good about this Public pissing match. SURE BUILDS CONFIDENCE WITH INVESTORS.
MAYBE a few SKYPE Calls "IN PRIVATE"? Maybe a "Special Meeting", "IN PRIVATE" like in December? Maybe they'll pass around more Bonuses for ALL with what's left of GEM's/OUR MONEY.
USFDA imminent? Data WITHHELD from EMA and SA Regulatory Agencies...BRILLIANT...
GEM, CONTROL these PREMADONNA INFANTS... Buy back at $.10? WTF...
POSSIBLY FUBAR. Maybe $500M NRXP deal and more than 1/2 the MC of RLF lost. A hope for reasonable cooperation for BUSINESS success PISSED on for relatively minor disagreements now BLOWN UP into a PUBLIC Sh*t sandwich we must all eat.
This all wont just Blow - Over, it appears to be headed for a Court. Fkn Great!
60 day shelf life was fine but NRX wanted THEIR slice +++++. DR JJ FAILED at handling the IV Trial (30 + 102 Interim un-blinding, delays and resulting Costs etc) and is NOW holding that Data and the EAP Data hostage.
EVERYONE will LOSE NOW, YOU STUPID MORONS.
IT WAS TIME TO WORK TOGETHER FOR THE SUCCESS OF BOTH RLF + NRX. Where's the USFDA APPLICATION, JJ??!??
NRXP? RFLA? NRLA? POSSIBLY COULD HAVE BEEN WORTH $BILLION$.
Shooting themselves in the Foot.?. NOT. They HAVE SHOT OFF EACHOTHER'S BALLS and WE ARE the COLATERAL DAMAGE...GLTA, somewhere else...
RLAA or NRLA?
EMA - Swiss / Turkey CTs.
GEM has much more invested in RLF than NRX... The Phones are busy tonight, IMO.
What is NRXP without a patent for the Trial Drug RLF-100? Starting over.?. 60 day /1 year shelf life, it's 2021. Big deal is no IV or sub-zero needed.
Give Dr JJ/NRX 60-40% in the US as he has failed to produce the EUA and Fkt up the 30/102 interim un-blinding. AFTER full data is provided. BFD. The ROW is the Market now...GLTA...
NRX/Dr JJ seem to have messed up the IV CT timelines thru early interim data(un-blinding) and then did not have sufficient power to pass the FDA EUA. This then required to increase the total enrollments to 196, also delaying everything. Data for the CT Trial is still not fully transferred to Relief. That seems a good argument for Relief not paying for those costs, IMO.
The data publicly released so far, 'meets all endpoints' and ALL data from the EAP patients (which NRX was Not running) is Relief's, IMO.
The new Swiss efforts and Turkey CT will move Fast, IMO. EMA asap, IMO...GLTA...
They have an extension until May...GLTA...
"to extend the date by which Big Rock has to consummate its initial business combination from April 23, 2021 to May 24, 2021"
https://ih.advfn.com/stock-market/NASDAQ/big-rock-partners-acquis-BRPA/stock-news/84779834/additional-proxy-soliciting-materials-definitive-d
NRXP;
NeuroRx established a commercial development partnership with Relief Therapeutics Holding AG (SWX:RLF, OTCQB:RLFTF) ("Relief") in March 2020 for global commercialization of aviptadil which has been the subject of previous press releases.
More time for NRXP.
The 'Jewel' is still RLF-100. Dispite the retorect from NRX the partnership is Relief 80-20% throughout the WORLD and 50-50% US/I/Ca for commercialization of RLF-100.
New Swiss and Turkey Inhaler Trials for Aviptadil by RLF are super significant, IMO.
NRX better get MOVING FAST or their deal passes away.
More time for NRXP.
The 'Jewel' is still RLF-100. Dispite the retorect from NRX the partnership is Relief 80-20% throughout the WORLD and 50-50% US/I/Ca for commercialization of RLF-100.
New Swiss and Turkey Inhaler Trials for Aviptadil by RLF are super significant, IMO.
NRX better get MOVING FAST or their deal passes away.
"to extend the date by which Big Rock has to consummate its initial business combination from April 23, 2021 to May 24, 2021"
https://ih.advfn.com/stock-market/NASDAQ/big-rock-partners-acquis-BRPA/stock-news/84779834/additional-proxy-soliciting-materials-definitive-d
NRXP;
NeuroRx established a commercial development partnership with Relief Therapeutics Holding AG (SWX:RLF, OTCQB:RLFTF) ("Relief") in March 2020 for global commercialization of aviptadil which has been the subject of previous press releases.
https://finance.yahoo.com/news/big-rock-partners-acquisition-corp-131500357.html
LOL, the vaccine issues will take some time to work out. Then possibly yearly like the flu-shots?
My point was that European countries may choose to do what THEY want and it is a common sentiment there. Past respect for my Country and Dr falsei/FDA has declined recently Their words...
Most importantly is the Swiss inhaler Trial and a possible path to EMA, IMO...GLTA...
BTW:
https://en.wikipedia.org/wiki/Netherlands
Yes it does, my dumb old eyes and I and the F in rvvtF. Seems strange. Always read everything, I did many times and still missed that.
My family/friends from Holland write about common opinions in EU. They are Pissed at the USA for glomming most of the vaccines, about the Rem Gilead disaster / FDA incompetence's / Dr.falseFausi and Trump's America first...We have distanced ourselves from our Allies, WORLD WIDE. They dont like us much anymore as for a country and it's policies and do not respect even out judgements ie FDA. They remind me regularly how the USA is #1 in COVID.
Switzerland is running a Clinical Trial of Aviptadil thru our Ad-vita. There apparently are patients being dosed / recruited. The Swiss are renowned for their Medical opinions. EMA is the Big Deal Now, IMHO.
...GLTA... Anything RLF-100 in the USA/FDA is NRX dependent. Including their NRXP deal
Thanks C504 for posting this...
"Translation of the AdVita PR:
14 April 2021
AdVita Lifescience AG is sponsoring a Phase II study in Switzerland entitled:
"Inhaled Aviptadil for the prevention of COVID-19 related Acute Respiratory Distress Syndrome (ARDS) - a randomized, double-blind, placebo controlled, multi center trial."
Swissmedic and the relevant ethics committee have approved the protocol for implementation in several Swiss test centres.
The study medication was produced by a Swiss company and the first patients can be included."!!!
As in , First Patient Dosing/recruitment...
I say Rem is a disaster and product of Wuhan virologic Institute. It abused the Trial process by taking up patients around the world and has show low benefits and severe safety issues. Buc is much better and Thiols will be beneficial for many other diseases. JMHO. Vaccines will take very long to be spread around the world, maybe never...
Rem and other drugs used patients from around the world. Buc can do the same...JMHO...
Let's hope we are pleasantly surprised...GLTA...
COVID will be around the world long after Buc is approved. A few countries are vaccinating, many countries don't test until after symptoms, many countries have had NO vaccines, Idiot delays for JJ will hurt the world. Thiols will help...JMHFO...
NRX is supposed to submit the USFDA EUA application for Aviptadil/Zeysimi, right? I think that RLF may go thru Swiss/ EU/ EMA. Thats what I got from go's post. Trials in Switzerland with sites approved. Turkey?
The USA may meet their vaccine 70% goal towards 'herd immunity' by summer (!?!) but the chances for the rest of the world are dim for vaccines.
India has stopped exporting their AZ vaccine for use in there.
The DSMB passed the 210 and said to continue the Phase 3 CT. Requested updates.
Why not stronger recruiting of Patients in Canada? Maybe Central European Hospitals?
Incentives?
ChangesIv +, There are requirements in the NRXP deal that should put incentives at NRX to MOVE FAST.
G, I agree on the Europe/EMA path for RLF-100. I posted that the EMA has new guidance for their 'accelerated assessment' program. The US FDA credibility has been damaged thru Rem etc. IMO.
The disease is in their/Relief's back yard and Turkey is having Big issues with COVID.
I think RLF NOW has the 'bit between THEIR teeth' and IS Leading this. IMO.
My Prayers for their health and RLF-100 success...
Interesting data / Map of countries vaccinations and many that dont or have none available...GLTA...
https://www.nytimes.com/interactive/2021/world/covid-vaccinations-tracker.html
Vaccination tracker...GLTA...
https://www.nytimes.com/interactive/2021/world/covid-vaccinations-tracker.html
Even NRX can see that Israel had only 89 new cases and the US is only 70k out of a recent World daily average of 700K+, rapidly increasing now. 50/50% vs 80-20%, BTW.
The US COVID decrease was this winter, which was before Any Vaccines, but the Virus is increasing now mainly in tropic/warmer areas around the world. 130 countries have NO vaccines and many others have just a trickle. Many countries dont 'test' until symptoms are present.
I have read recent info about the bat virus possibly being less virulent in cold weather and that it may be more active in warmer areas/times. I guess we will see...
I doubt RLF is 'doing nothing' and your interpretation of past quotes is yours. GEM has alot invested in RLF-100/JJ RLF/NRX and the NRXP deal depends on FDA EUA. Profits will be world wide and not US/Israel right now. Certainly less incentive for the FDA to do alot while the EMA and Switzerland is close to an epicenter south of the Alps.
My mistake to reply to argue VF post, my comments are to the MB as this post mainly is. Thanks for your consistent opinions. Do you bet with your posting sentiment. Alot of effort here...GLTA...
Is it possible that RLF.SW makes an end run around NRX and applied for EMA accelerated assessment for RLF-100.?.
The disease is increasing most in Central Europe.
Relief is a Swiss company while NRX is US/Israel based and may be applying for FDA EUA for RLF-100. 50%-50% revenue split.
The EAP and Phase 2b/3 data have been received by RLF. Their AO is the rest of the World. IMO it would be their responsibility to do any applications and sales in those Areas of Operation.. 80%-20% revenue split...GLTA...
A little history reading of Remdeathisnear... Maybe the EMA will consider Aviptadil, a drug from Swiss company RLF.SW, with the new 'accelerated application' paths now in play. The Virus is exploding in that region.
It appears the USFDA is bought by BP. Just like MOST Trial sites were taken/bought by BP / Rem-etc (after expedited EUA) , basically delaying and even preventing OTHER possible treatments from access to patients. Rem's use is Criminal given it's ineffectiveness and Dangerous Side Effects, IMHFO. Open Travel is spreading the Virus World Wide and RNA tweaking Vaccines and treatment/mabs/virs are causing Variants now. How many are sick from their treatments?...GLTA....
https://www.newsweek.com/humans-not-animals-likely-took-covid-virus-wuhan-contrary-chinas-claims-1578861
https://www.independent.co.uk/news/world/asia/coronavirus-china-hospital-wuhan-virus-beijing-latest-a9314201.html
https://www.kgw.com/article/news/verify/verify-what-is-remdesivir-and-who-has-the-patent/507-ae00b396-a731-487c-8951-c15ec8668505
http://www.sciencepublishinggroup.com/journal/paperinfo?journalid=252&doi=10.11648/j.ajim.20200806.18
Hmmm, updated EMA Pre authorization and accelerated assessment procedural advice...3-25-2021.
... RLF.SW...GLTA...
https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance
'Relief Therapeutics, a penny stock trading under RLFTF is a small Swiss biotech that owns the rights to synthetic vasoactive intestinal peptide (VIP). The substance is also known by the trademarked names, aviptadil, RLF-100 and Zyesami. VIP is a peptide.'
"OWNS the RIGHTS to RLF-100/VIP/*brand name."
It is GOOD to see mention of the 'other' CT.
'EAP CLINICAL TRIAL RESULTS:
Relief Therapeutics has enrolled more than 200 patients in their compassionate use (EAP) program. These patients were patients who were too sick for the Phase 3 trial. Patients who had multiple comorbidities such as: lung transplant patients, patients with lung cancer, patients who were immunocompromised or had evidence of severe, multisystem organ dysfunction.
Initial data from a 102 patient sample size showed a 72% rate of survival with aviptadil + SOC vs 27% SOC. Although full results of the EAP 200+ patients have not been reported to date, it is reasonable to assume that results will continue to show the same, favorable outcome.'
...GLTA...
Isn't that what the Stock Market is about.?.
Wait for the confirming news and get the milk-toast gains... Speculating in an investment carries greater Risks and Rewards. Rational-analyzation? ...GLTA...
Everyone gets skunked sometimes, fishing/poker/stocks/health. Sometimes there's success...Enjoy the bowl and bottle talking about those in the Game. Maybe some 'Shrooms' will also help...GLTA...
Well we all know about the possible deal of NRXP.
RLF still owns the Patent for RLF-100 formulations.
GEM has enough control thru debt of NRX and a huge amount of RLF stock.
Dr JJ appears to be the 'Star' and the only active voice for VIP/RLF-100/Aviptadil /Z*.
They all almost HAVE to WORK TOGETHER Now...
Bring on ACER and make ARLF. Then merge NRXP for a NRLA. ASAP. Of course, IMO.
But it could happen and makes sense and is in the best interest of NRXP now with the USA controlling COVID and the rest of the world Not...GLTA...