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Question from another MB about progression from Phase 2b to phase 3...
"
How is it possible to move to phase 3 without a phase 2b data readout?"
Hmmm, then why a PR at 90+% saying the recent review had a Unanimous Green Light to continue the Trial. The 2b? Really, Maybe, Why, JMO. The COVID Trial was always billed as a 2b moving directly to Phase 3 when Data proves the first part. I said it May be interpreted by AGN to think Forward. Maybe ducks need to be in rows for some deal. We're herding the last cats here in the Phase 2 with a Unanimous Green Light from the most recent DSMC (3rd?) Review...GLTA...
From the 13th or 14th of Oct, also couldnt find the Solo Trout Dr JJ
presentation.
Thought I bought the bottom @$.52, went to $.58 and right back here. Sold those @ .537 Thursday and will wait until we see the effects of this latest news...LOL...
I wrote the last weeks about the RLF plan to stop this Trial at 102 patients and then effectively sit waiting for an FDA answer, while few patients were dosed/treated/saved. Suggesting why not finish the Whole Trial as all other companies are doing, I was soundly rejected. I used the word, overconfident referring to this belief. The FDA has told us to finish the Trial and now these Trials are affected, both have slid with later Data reads as an effect...
https://relieftherapeutics.com/neurorx-and-relief-therapeutics-announce-data-monitoring-committee-determination-to-continue-phase-2-3-trial-of-rlf-100-for-critical-covid-19/
Wow, thanks. Also in a Dr JJ interview recently at the news of COVID Trial continuation.
Thought I saw more info on the NRX IPO PR from Sole Trout(?) (cant find it). Doesn't matter much as they have Enrolled since, should be full by now...GLTA...
https://relieftherapeutics.com/neurorx-and-relief-therapeutics-announce-data-monitoring-committee-determination-to-continue-phase-2-3-trial-of-rlf-100-for-critical-covid-19/
Even sorrier for those where new methods aren't developed yet. Your sad loss. I'm Blessed, so far...
The link you posted didnt work but I did find info that Some Trials have just SOC arm. My wrong.
Many Trials Do have a placebo arm including Aviptadil IV. Good initial data is fine but a completed Trial seems very important to the FDA, IMO.
The updated Trial now wants 160 as before 144? This conflicts with such positive reports from RLF and agrees with NRX recent update.?.
I do agree that with the stress and effort an Infusion Trial is for the patient already, that faking someone out with a Placebo is cruel, (but needed?) especially at the terminal level.
I think it means that there has been continued presentations to the DSMB and their Unanimous opinions at the reviews are to continue.
No additional patients needed in Phase 2 for a consensus from the DSMB.
This May also signal for AGN to progress or even accelerate with the plans for the part Phase 3 of this Trial...IMHO...
Please show one where a Placebo arm is not part of a Trial.
The trials I was involved with, during st4 cancers, all had placebos and that is informed to patients before signing on as a participant. EVEN WHEN TERMINAL patients are involved that is the Goal, to distinguish life from Death Results and get progressive supporting Data.
Yes, it's a tough-shit sandwich that participants in TERMINAL level Clinical Trials are given Placebos. Take that bite and chance or Don't participate and probably get SOC for that disease.
Cancer deaths have dropped due to some m*mab drugs using the immunotherapy path instead of Chemotherapy and combinations after surgery/Rad...JMHO...
. That's Enrollment...GLTA...done
The important phrase I see is...
"the external Data and Safety Monitoring Board (“DSMB”) has once again unanimously approved the continuation of the Company’s multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for the treatment of COVID-19."
"AGAIN UNANIMOUSLY APPROVED"
Every real Trial has blind placebo arms. All companies NEED to complete Trials as Planned for FDA. Less is less, more is better.
Inhaler should be prioritized as this is the Golden ticket, IMO. In this "spare time" the IV Trial should be Completed, IMO.
Companies are cautious of claims until proven...
https://www.cnn.com/2020/10/30/health/covid-19-vaccine-predictions-pharmaceutical-companies/index.html
Side by side compare link...
https://clinicaltrials.gov/ct2/history/NCT04360096?A=1&B=3&C=Side-by-Side#StudyPageTop
So True because After all that effort, raised money and gathered expertise we are stuck with a Remdesivir* as the best SOC treatment and talk of a mab or antibodies for vaccines. UNPROVEN. All with limited successes for patients.
People easy Testing for COVID. They want a pill or inhaler or ? with a fair cost with HIGH success rates for an early defense and treatment. The world has failed to show anything more effective than a Mask. SOC delivered by the world's Dedicated Dr.s and Nurses has been responsible for saving many at their great Risks. An opening for Something is begging for entrants...GLTA...
Rem=Gilead / Wuhan Virologic Inst developed BatSoup
Possibly still time for RLF to set up some video interview/PR/etc for Friday but probably not. So Monday is first chance again at some Market news.
Lots of things for Management to review and then to plan a real announcement through several mediums. Too many fluffs/repeats and people get tired.
Finishing up the CT was a great plan, IMO, no matter how confident some feel partial results will make any FDA stuff more difficult.
Thanks for your technical's and other DD work here. I use it.
Of course there is that initial phase, splitting profits with NRX/? and then some kind of Royalties* will probably be next. All good and especially with low production costs. Just wish they would be more careful about what is said publicly and if it is necessary. $.
The Inhaler is what's needed at least as much as the IV, IMO. They didnt talk about storage or trained nurses/Drs, why some crazy stuff about low production cost #'$? duh...GLTA...
*./?... That's also the 'rub' I have about the NRX/? and exactly where RLF fits into it/ is part of/ partnered with/ (reverse)merged with/ can we Vote, does it matter what we would Vote anyway?...GLTY.
I'm confused, here it talks about "pennies a dose" while discussions of $5k+, for a COVID IV course of 3 infusions, was said by Dr JJ.
AHH, the "buy Breathtech's (AGN) shelfed Breathalyzer IP" and develop medical/COVID uses for a Breath tester. Wow what a great Idea...Any Pot breath tester will need to deal with a COVID world anyway. Why has there not been a PR about developed safe use for this already?
2.6B X $.81 =$2.1B
* X $8.10 =$21B
* X $81.00 =$210B??? Really?
GEM has been selling just like the rest of the insiders and so many that bought the < $.15s. JMHFO...
Total volume @ 5M a day, Just pennies so far and waiting for what happens with the NRX/NYSE Big Pharma/ RLF consolidation...GLTA...
Through the info gathered from Clinical Trials it seems this new wrinkle of different affects for Vip-1 and VIP2. Pha* still has a strong pipeline for PAH, another serious result of COVID. Repair of arterial issues is barely secondary to the Lung issues which happen earlier in the infection's path. A patient has to lIVE long enough to start working at the other resulting problems.
A message stated that the need to progress past long Trials would result in a much higher Death count, MANY more. These Drugs, in the process of completing their 2b Trials, seem to have shown very important and impressive result, Survival thru positive affects on the breathing mechanism. The FIRST step toward any healing, IMO.
Delaying/limiting access to a few patients thru continued Trials for more proof that these Drugs are safe and effective, is where things are now.
The FDA took the political path of authorizing Rem with it's meager positive affects. OK, done. Next...
The Record - World wide increases in infections proves that this illness is NOT just "going away" and has NOT been 'conquered". Actual Biggie Pharmas will NOT accept false or misleading claims for their antibodies or Vaccines or treatments etc until researched enough to quell the questions of these NEW drugs' SAFETY, at the least. "Cure" is a Big word in COVID with many levels just as is a 'Cure" claim for Cancers.
There comes a time in many things that simple and safe, with actual adequate / superior results proven thru accepted DATA in an accepted setting, 2b Clinical Trials should be enough. Political pressure or the lack of political support or a prolonged path for Patients should not result in More Deaths due to FDA questionable delays or priorities...JMHFO...GLTA...
Their expectations for COVID were not met but other things are being done there with VIP.
Out some there @3.35 this am and bought here @.52. Bottom.?... We'll see how well this VIP works for COVID and Lung issues with expected good DATA soon from apparently full enrollment in the IV / (EUA?) Trials.
"Expanded Access intermediate size population" is that designation NOW which was "Expanded Access personal use" ('EUA') before the Oct 22 CT.gov update.
Also combining this makes the PR totals match better. We'll see if that is significant.?.
Then IPO with nrx to NYSE for Phase 3.?...GLTA...
Important info. This seems to just be targeting a small population and is not an overall EUA. Important distinction for sure. Shows that $$$ and political influence must be involved to raise THIS medication above so many others.
This Does leave open treatments for the sicker patients over 40kg, which is most.
I feel other EUAs may be approved very soon for many specific indications and circumstances. A Wave? Actions are in process from so many paths to contribute to the COVID fight. Many paths with remedies for the prevention, attacking the symptoms, comfort and for help healing from the damage after surviving this disease, worldwide, for some time to come still...GLTA...
This morning's info from the Trial's Oct 22 FDA update and NRX updating enrollment is new and important.
Good to see continued enrollment too from the NRX PR/new consent form data...
A randomized placebo-controlled trial of Aviptadil is underway that has enrolled more
than 130 patients. In that trial, no drug-related serious adverse effects were seen and
an independent data safety board determined that the trial should continue with a clear
possibility that a difference between RLF-100 and placebo will be seen.
Cant see if this is from the 102. July IRB date but new info and forms?
My point it is easier to see changes side by side.
Individual patient changed to expanded population!
Additional VIP info
Consent form
Look at them side by side not merged...Consent form and new info...
https://clinicaltrials.gov/ct2/history/NCT04453839?A=1&B=4&C=Side-by-Side#StudyPageTop
LS5 is asking for answers to specific poster statements that I'm reading now, too. There has been implications by posters here of inside help at the FDA, etc, and connections to shorten normal Paths and required Clinical Trial DATA.
Maybe skip back to the Question of what RLF gets for all it DOES (funds development of RLF100)(VIP manufacturing)(+$40M on the books) in this deal Dr JJ promotes for NRX and the unnamed NYSE pharma IPO/rev merge, backed by up to $150M from GEM. Is the RLF/NRX 'Profit' share plan changed?
Could the reason Dr Swain was hired to the AGN Med Advisory Board possibly be to help Dr Williams "crunch the numbers" for reporting the current Ifenprodil - COVID Clinical Trial DATA to the FDA? Maybe write applications? New Presentations to who/for what???...GLTA...
Great reminder for me that this is a Swiss company and a private Israel one making a move on the NYSE. They can configure things almost 'free' from worry on their side and then 'reverse merge' THRU an IPO with a existing NYSE ticker... following those rules.
My earlier post of what we get was way rough numbers and meant to ask what we get. If?
RLF has $40M cash on their boots to bring to a deal plus Aviptadil ++. Still crickets from Trials even with probably good DD on that by some here looking into everything.
I give credit to AGN/You for calling out the devil. Seems to have no concern for the investments, just cullet shares to eek miniscule results at all other's detriments. Stupid sad, pissing in the soup bowls everyone must share and that the public Smells.
BUT Data Results, after full enrollment and last patient dosed in the COVID Trial, are what matters now, IMO...GLTA...
So, my crystal ball... $5 min for up-list.
{RS 10 for 1 for RLF = 258M OS} same MC. GEM will invest $150M total into new NRX side of the new venture. Just 30M shares @ $5,?, + what value is put on NRX, 200M new shares.?. Then the NYSE BPharma gets the drug and logistics,?+? piece of the pie resharing the 'Profits" among the three/two. Total 560M OS @ $5.?. BUT...
What value will be actually placed on RLF / Us in this deal.?. Double value, more, much more?...GLTA...
HMMM, quick path changes, this is 9-27 $$ Raise. Then NRX partnering. Now, NRX to merge with NYSE 'pharma'. GEM to invest $150M.?.RLF $ to develop REL100.
Dr JJ says Trials going forward but what about current words of enrollments for the 3 Trials seen here and financed...GLTA...
"The available cash on the balance sheet of the Company, after receipt of the funds, will be approximately CHF 48,000,000 and will be used primarily to fund the ongoing Fast Track FDA trial of RLF-100 (IV) in COVID-19 acute respiratory distress syndrome (NCT04311697) and the RLF-100 (inhaled) trial for the treatment of non-acute lung injury in COVID-19 (NCT04360096) as well as to run a phase 3 study in Europe."
https://finance.yahoo.com/news/relief-announces-capital-increase-final-053000789.html
" Covid-19 SamiAir development paid for by Relief Thera". Still don't understand this unless RLF shares are rolled into this new entity.?.
RLF has partnered with NRX to share Revs. Money was raised for Trials and production/distribution/logistics. (400M shares for $30M)?
Should also continue to listen to 20.00 to 25.00+ on your facebook link. CEO Talks about Big Pharma interests and Dr Williams presentations.
Implies? posible Very positive data for EUA, yes (if). Solid intellectual property filings. Possible drug sales (if) partnerships (if)... I hope for the initial business plan of selling the 'Rights' @ 2b success, of course.
Streetwise was 10-08-2020.
Thanks to those that 'corrected' me. I make mistakes, those that dont make mistakes are probably not doing anything. This is an OPINION FORUM, I just attempt to add mine. My DD/Opinions usually provide links for anyone to check out. Please post others.
I dont do PMs, so keep those comments / incoherent rants public if they are important to this MB or Stock. LMAO...
Well, I'm a Veteran and a veteran of the Bth>nash>Agn metamorphosis. LOL.
IMO, there is Trial data due presently and Private Placement investors are at about this PPs. Nice low OS count. Ifenprodil will have a relatively low costs to patients. Strong Science of the NDMA / COVID path exists.
Some long time investors have posted that they have bought more recently. Be glad to have you aboard. Your strong opinions elsewhere would be valued here too, IMO. The video I just posted has good guests and info...GLTA...
The CEO was asked about EUA and responded that they would consider all options. The Safety / futility reviews have long past, so at least that is good. Some have calculated full enrollment and dosing should be announced. The CEO also said that they release market updates with a 'Halt'...GLTA...
https://www.streetwisereports.com/article/2020/10/08/streetsmart-live-presents-algernon-pharmaceuticals-inc.html
Yes, apparently. My questions exactly, plus a couple. Raised $30+M for?...GLTY, Sir...
I am somewhat fearful about the Administration's talk of giving the first doses of the New Vaccines to many of the healthcare workers. Long term testing hasn't been done and some unknown issue could arise and then it would be in that critical population.
Drugs with long proven safety records are better than rushed 'leading edge' solutions not fully tested, IMO...GLTA...
Nice. Does the motor run to recharge or is it a 'plug in' recharge?
" Or, with a fully charged battery, the Re-Leaf could power the average UK household for roughly six days."
I realize my limitations as I am just an investor attempting to put up links and comments to stimulate conversations so I can learn too. Glad to have you back with your accepted knowledge to refine stuff. Good to hear you're healthy, I / we were worried.
I said, I 'hope' Dr Williams has some comments. Another 'popular' drug in similar Phase 2b Trials has had their leaders give semi-supported guidance from an uncompleted Phase 2b Trial and I didn't want that. I thought it might be common to give a general "we have confidence in the current Trial Data" kind of thing 'AFTER' last patient is enrolled/dosed. I agree REAL DATA is found on the CT.Gov site, all else is opinions from ('dudes') or unsubstantiated questionable hype/bash.
Thanks for also confirming that a Phase 2b Trial with success moves to a Real Life Phase 3 for statistical significance.
Maybe the 'Rights'(?) might be sold to a Biggie Pharma or maybe a partnership, using them to continue with further Trials and for marketing/production after a COMPLETED Phase 2b CT has significant enough Data.?.
AGN doesn't carry the 'big stick' to push things thru like a Big Pharma might do and can more easily afford.
Your opinions, evaluations and inputs were missed and appreciated...GLTA...
So, even though Trials have been funded with Raised monies specific to that goal, stopping these Trials before completion and waiting for possible FDA action is a good idea.?. We all should just wait for the magic to unfold. No one else will be treated with RLF100 until we get EUA.?. All raised funds are going to set up partnerships and subs? Nothing for Trials?
100+ companies are following FDA Trial paths to Prove efficacy. Dr JJ knows better because he has friends inside?
Come on...Why NOT continue treating patients, why not continue increasing the Data pool? Some companies are Completing successful Trials going to real life Phase 3. RLF doesnt need that kind of Trials' confirmation , even though shareholders have been diluted specifically again to provide for it.
Looks from recent the presentation that some form of IPO with a rolled in of RLF is a likely scenario. We can hope. I hope for an overall $5 + B return for RLF shareholders right away if this happens (selling shares) and/or the chance to wait for production/logistics/sales to bring in possibly larger revenues. (holding the new entity's shares).
All now depends on the FDA and IF the strategy Dr JJ has chosen is successful...JMHOs...you asked...
The $30B to $45B represents the MC @ 2.5B OS. ($13 to $18 pps) Follow the thread with those estimates by others.