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Opinion,
It seems that the COVID-19 Ifenprodil Clinical Trial has some steep targets and outcomes as Primary and Secondary outcomes. I have seen some COVID stock drug Trials with the simplest descriptions and apparently much easier targets.
Dr. Williams seems to have expected strong results with the higher targets he set. Seems like he actually expects Results as compared to some. Was it a mistake to set Ifenprodil high goals OR will serious considerations be given by the DSMB and FDA for Actual significant results?
Ifenprodil CT with actual Real world designated targets"
https://clinicaltrials.gov/ct2/show/NCT04382924?term=Ifenprodil&cond=COVID&draw=2&rank=1
Another Trial
" Primary Outcome Measures :
Efficacy: Frequency of hospitalization or death [ Time Frame: From time of first dose through Day 28 following randomization ]
Proportion of patients meeting a composite endpoint of hospitalization or death
Secondary Outcome Measures :
Safety: Changes in adverse events from baseline to end of study [ Time Frame: From time of first dose through Day 28 following randomization ]
Number of adverse events
WTF?
...GLTA...
Yes by whatever brand name, RLF shareholders own the Patents to RLF-100...
"Zyesami"
"Relief also holds a patent issued in the United States and various other countries covering potential formulations of RLF-100TM"
late night lurking...GLTA...
Does this mean they have a reorg plan or that they have been denied because of the THC laws?
1-12-21
Copy of Order Granting The United States Trustee's Motion To Dismiss Chapter 11 Cases. IT IS ORDERED that the above-captioned cases of UC Colorado Corporation, Case No 20-12689 JGR, and United Cannabis Corporation, Case No. 20-12692 JGR, are hereby dismissed.
I accept I we / the company is stuck with the current continued Bet/investments in the Data release. In spite of the problems we experienced. the Data will be what counts and direct where we head now. The last Private Placement was to prioritize and further the COVID Trial. That is still the main direction and issue.
The 'science' has not changed or been proven un-effective in Humans. No Magic bullets. Several long term and short term COVID treatments are needed. Ifenprodil could be one, IMHFO...GLTA...
The only stuff moving to the front of the line has had BP $ doing it. Do youall see anything with strong results. I dont. It was a gamble to set a 15 day WHO score Primary goal, IMO, but Nothing has achieved that level of success yet. Combinations of Drugs are having some limited success. Ifenprodil was intended as a Cocktail ingredient as seen from discussions way back. But that is/was not the Trial specs even as Dr Wiliams is hopeful for those possible results now.
I quote some here posting info and saying "invest in the Science", has that changed.?. I dont see that has changed either, just that it didnt 'blow the doors off' interim results thru WHO scores. A > one tick WHO score improvement is still the bar to be crossed, short term. Long term.
Some drugs have extreme treatment courses and costs compared to our pill, which will be cheap and possibly as effective, especially over the 28 day Secondary Outcome targets.
At the SK Trial, Novotech dropped our ball resulting in A real blow to possible quick Data.
Isnt IPF a direct result for some from COVID. Come on Novotech there's plenty of COVID related IPF/CC patients. Novotech did Run the COVID Trial comparatively well under extreme conditions, IMO.
The 'science' has not changed, IMO. Studies are being presented with confirming data. Plans for the 'company' need to be made to continue the 'repurposed drug' model. They feel a Phase 3 Trial is indicated for Ifenprodil.
I believe CM and Dr MW expected stronger Interim results, we all did. They run the company and want Successes as much as any Investors do. We can invest in other stocks while This is Their life/business and I believe they will be as competent as possible...GLTA...
NRXP, as the current Deal, hinges on the RLF-100. Everything does.
Shareholders of RLF FLOAT hold basically the only public interest of the MAIN thing. RLF-100.
Shareholders paid for R+D and Trials while NRX claimed managing the process.
THEY WILL WANT TO MAKE A BIG SPLASH ON NASDAQ as data is released. NO Strings...
"All development costs under the agreement are paid by Relief, providing NeuroRx with non dilutive development capital through drug approval"
Zyesami"
Relief also holds a patent issued in the United States and various other countries covering potential formulations of RLF-100TM"
NRXP will need to settle the ownership of RLF-100 for their deal. IMO Lawsuits question NRXP deal for High price and not having 100% control of RLF-100...
There should be No free ride for Dr JJ/NRX, IMO. No one will buy that company with just their PTSD drug, The 'PEARL' is RLF-100 and VIP Patents . Good Data makes everyone HAPPY. ALL IMO...GLTA...
"
Almost 2M fatal cases of COVID and 40M 'not recovered or recovering' world wide.
The slow rollout of Vaccinations here in My USA is sad to see with currently less efforts or coordination's than we would hope for.
Sadly there will be continued needs for Treatments for Hospitalized patients and afterwards.
I hope the data shows positive results for 15 day Secondary Outcomes as is being mentioned by the company's PRs.
I'm especially interested in the the 28 day reviews with hope for long term Lung healing effects as the disease wanes...GLTA...
Great news Today for NRX/RLF and their RLF-100.
The SPAc NRX will be using IS not having good news for them though. It will add influence to NRX side to expedite this merge.
I Still think a solution to Patent Rights for RLF-100 will need to be settled. BRPA has 'investigations going on delaying things. The Value and "JEWEL" of that deal is still RLF-100. (by any Brand name).
Rewrite the Deal to include RLF. Makes little sense for both NRX and RLF to go to the Nasdaq, IMO. Consolidate ownership, Logistics, production, Sales.
https://www.marketscreener.com/quote/stock/BIG-ROCK-PARTNERS-ACQUISI-38908842/news/BIG-ROCK-PARTNERS-ACQUISITION-Notice-of-Delisting-or-Failure-to-Satisfy-a-Continued-Listing-Rule-o-32167858/
News of investigations of the Deal with NRX and now delisting.?. WTF.
https://www.marketscreener.com/quote/stock/BIG-ROCK-PARTNERS-ACQUISI-38908842/news/BIG-ROCK-PARTNERS-ACQUISITION-Notice-of-Delisting-or-Failure-to-Satisfy-a-Continued-Listing-Rule-o-32167858/
RLF-100 will show Good Data when the results are shown. We know the trending from the 102 data. Highly probably the Best Severe COVID-19 Treatment. With the added wide spectrum of RLF-100 uses the Patents present.
A possible R/S Reasoning at this point will possibly be Joining the Merger with BRPA and NRX.
RLF-100 will be the ""JEWEL"" if there is good Data. NRX does not own the Patent rights to RLF-100, WE do. NRX-101 isn't worth the deal alone and BRPA has 'investigating suits' now due to questions of their deal value for NRX.
The math right now is easy @.5 and 1 for 20 R/S. RLF shareholders will own 130M - $10 shares out of about 225M shares of ?NRLXP? in the end.*.
(WAG numbers)
GEM and insiders control any Vote @ RLF and GEM can consolidate their investments. They hold the BALL, we are just on the Ride, IMHFO.
""NRLXP"" will hit The Market right as "SUCCESSFUL" Data from the current RLF/NRX Clinical Trial is released.
The US and WORLD COVID-19 issues continue to worsen and Vaccines will need time for sufficient inoculations at a 70% + target.
A R/S for US WILL BE A GOOD THING.
IMO, IF there is enough "Enthusiasm and PUMP" due to Very Good Data AND the companies HAVE been working Logistics/Sales AND there is Increased Demand, it may be needed to increase the OS with a Forward split, say 2++ for 1...
Possibly pretty good #$ as soon as April, possibly. These kinds of possibilities are why I play...IMHFO...GLTA...
* 600M shares from Dec @ 1/20 is 30M to NRX/BRPA.
Open eyes to a company's possible future can make OTC gambles more palatable. So far this is a 4 bit bet. This is not a Big Pharma.
Some see possible plans with possible strong relative near term Rewards. Risks are +/- 4 bits a share. Kind of Fun being a possible part of a SEVERE COVID-19 Treatment that actually appears to work and may hit the NASDAQ. JMHO.
Maybe a HACIX, HACAX, HABDX combo with less stress.
...GLTA...
20 was not my number, but @$10.00 X 160M post split. @$10 is the same #$ for the NRXP deal? 50M/60M NRX + ?BRPA will leave a reasonable OS that can be Jacked.. If the tide raises enough, Data very good - $50 NRLXP pps, maybe a forward 3/1 in the near future.?.
The Pump can be turned ON here. IF...JMHWAG..GLTA...
I hope that is the plan. Leaks are notorious.
A RS makes sense in my crystal ball though, as a way to give those new shares into the NRXP value and then RS. Cant forget Management CoC/Bonuses/incentives. Along with obvious REAL Management and Logistics benefits..
It also suggests the whole deal has great potential to hit the Nasdaq as Data will be released. I think the Market will buy it.
OR Before? They pretty much know the future data from the 102 numbers and may not want RLF too high for the deal, ornot. IDKS...JMHO...GLTA...
The change in % of GEM ownership needs to take into account the about 20% new shares.
I cant see both NRXP and RLF heading to the Nasdaq separately. I think many of the new shares will be given into the NRXP entity when RLF is rolled in. That makes the math of a whole entity relationship concerning an NRRLFXP deal.
BRPA wants 100% control of RLF-100 as the Deal. The JEWEL is RLF-100, not the NRX PTSD drug. BRPA is a shell/SPAC.
GEM has invested in NRX too. Consolidate ownerships and logistics/production/ sales. Insiders/GEM still have controlling power, RLF common shareholders are along for the ride.?.
...JMHO...GLTA...
Lets all hope for successful Buc Interim Data which will allow internal funding for the Psych side.
I remembered this article and think it is still relevant...GLTA...
https://www.vox.com/2020-presidential-election/2020/11/4/21548800/election-results-marijuana-legalization-drug-decriminalization-new-jersey-arizona-oregon-montana
Dr JJ and NRXP cant steal RLF-100 for themselves, RLF has the patent.
From NRX/RLF PR about Trial enrollment complete 12-30
Currently, Relief is concentrating its efforts on developing new treatments for respiratory disease indications. Its lead drug candidate RLF-100TM (aviptadil) is being investigated in two placebo-controlled U.S. phase 2b/3 clinical trials in respiratory deficiency due to COVID-19. Relief also holds a patent issued in the United States and various other countries covering potential formulations of RLF-100TM.
Wow, I sold too early.
BRPA and NRX do not have the patents. IMO they will have to deal with that and RLF shareholders including GEM. There are several law suits against NRX with implications of the High price paid and yet not controlling the RLF-100 rights. Will folks invest in the BRPA/NRX deal with just their PTSD drug? I think the jewel is the VIP RLF-100...GLTA...
From the NRXP press release;
"" Relief also holds a patent issued in the United States and various other countries covering potential formulations of RLF-100TM"
It appears to me AGN intends to apply for an EUA due to success with 'time to intubation and coming off intubation" Secondary Endpoints. Of course there are 'Ifs" right now.
Also they cant discuss their progress about possible partnerships or of any plan for an additional PP which we all hope will be minimal.
Sure many/all of us wanted knock down interim data but I have not seen this from Any Pharma, big or small like AGN. NO 'cures' or treatments that truly outpace SOC that I see.
The continued statements about treating patient's ventilator needs seems a huge positive. Being included as part of treatment 'cocktails' has always been the Goal for Ifenprodil.
I feel the CEO will be making the 'rounds' showing the 'trends' seen and is trying to jam a foot in some doors.
A 2021 plan will include additional efforts to bring other repurposed Drugs forward. Of course.
"If the data is positive, the Company will consult with the U.S. FDA on an Emergency Use Authorization (EUA)."
The Company will also evaluate all aspects of conducting a Phase 3 trial, which will be required regardless of whether or not the Company receives an EUA.
The Company advises that it is not making any express or implied claims that Ifenprodil has the ability to eliminate, cure or contain COVID-19 (or the SARS-2 Coronavirus) "AT THIS TIME". "AT THIS TIME"
The longer than expected Data processing may indicate very thourough reviews of the Secondary Endpoint targets including 28 day + results...GLTA...
Yea and to think Dr JJ hung the bill on RLF and left with His company and a bright contract for NRX. Problem is the lawsuits for the payoff being too high and NRX doesnt own 100% RLF-100 (by whatever name). People aren't interested with a ptsd drug...IMHFO...Its full 100% of RLF-100. Not a flashy new name. Patents anyone.?.
" Relief also holds a patent issued in the United States and various other countries covering potential formulations of RLF-100TM"
From the proxy. The only NRX / BRPA / RLF news is more lawyers so I wont paste that.
Zyesami
"All development costs under the agreement are paid by Relief, providing NeuroRx with non dilutive development capital through drug approval"
50/50 US Israel and 80/20 world revenue split wont fly and more delays puts this ALL farther behind. Time and covid vaccine results and lawsuits...
A deal needs to include RLF shareholders AND 100% of RLF-100 and VIP.
...JMHFO...
5 covid -19 patients in investigator led trial?WT*?
RLF/NRX has the EAP from 200 patients and a Phase 2/3 Trial with 195 patient results due.
World wide cases up to 732K new cases again. 86M total.
How about a PR like 'last patient completes Trials'. Or Something ASAP.
http://www.globenewswire.com/news-release/2020/10/01/2101992/0/en/Enlivex-Reports-Positive-Allocetra-Trial-Results-in-COVID-19-Patients-in-Severe-Critical-Condition.html
Thanks AMG
Excellent thoughts and strong DD to support it, IMO Lt. I see the effort in your DD and will be looking forward to more.
My limited DD agrees. The 210 data will be good but I feel the real successes for BUC will show even better in the longer term results. The relative low OS allows for good prospects ahead. Relative low dilution to run a Phase 3 CT, Remarkable...GLTY Sir...
The Rogue Warrior sometimes used 'cur' but you earn a 'sir', IMHFO. LOL ...GLTA...
The 102 was the data used for the now delayed EUA and when the DSMC said to continue to 165 for full completed data.?. There were plenty of discussions here. I kept prompting to continue and finish the CT, asap. S@$.53 in Nov,B@.42/S@.41 just before/at CT update and now B@.31 after reconsiderations. IDKS. Increased my holdings though, Data will tell whether it mattered...
The point I make is reasoning for going to 195. Data will be presented for the Phase 2/3 CT, nothing about data being limited to Phase 2.?.
...GLTA...
Expanding the original 150 patients to 165 is probably due to covering drop out patients that don't complete the infusions but were enrolled. Maybe even penalty for the early 102 un-blinding. But.
I read the move to 196 as needed to power the new Endpoint targets. It also shows those sites providing patients and their Doctors have seen success. Doctors would not continue to enroll further patients if there were adverse effects.
As they said getting this all done as a small Pharma was a significant achievement.
The Trials are Done and it appears these patients were enough to call this a Phase 2/3 Trial. Both Phase's data seems to be expected thru the 28 day stage for all and 60 day evaluations for many. The data must be significant to run a Phase 3 CT with this few patients and the DSMB approvals.
Strong possibility of an EUA, IMHFO...GLTA...
A shame she had to compete against Bloomberg's money with no DNC support. I donated to her campaign.
A sadder shame to insult her service. She is a Veteran.
BTW, 'Don sTumped' and his ilk are Not 'Senator Bob Dole' Republicans... Ask General Mattis...
I guess youall might be missing the bubble. TSLA @ 1350 P/E, etc?
Companies with actual significance will be where to be, not the over pumped Markets bought up wastefully with our Trillions to Wall Street. Some say we can't afford to give back 1 month of Taxes to folks. I've averaged >$2k taxes for 40+ years.
Who is flying/partying and even harvesting as in the past? Capital preservation anyone, Masks.?.
Pfizer vaccine results in Israel? New COVID mutations. Time to shift from the US Gov buying new Subs, MRVs and last years stock failures and focus on realities. Support the Troops that will have 'Boots on the Ground' and who will be frontline actors along with NURSES and Doctors( the new Veterans). INFRASTRUCTURE.!. Vaccines and TREATMENTS that actually help and a National Plan. My USA is the Worst failure in a World of troubled Humans. Time for Change, I Pray...
An Old Corporal's answers may contain controversial Truths and we tend to speak realities to 'butterbars wearing Stars'.
...God, please help as possible. BUT. Less populations and pollution of 'His/Her' world may be the plan? Last rant on this board, I sort of promise...GLTA...
I see some folks are now out picking 'liberty caps' in the same fields as way back when I did it in the '70's+.
Thanks kmack for info and I'm sure glad I listened. Have not posted because I worried about the 'stigma'. Apparently not nowadays.
Really invested in the 'Buc' science, but know personally about the benefits of shrooms. A friend would give me some during cancer, which helped spirit and possibly health...GLTA...
Quick RS justification;
NRXP deal price is $10 for calculations in their deal. RLF has 3.2B OS and 1.3B float, so GEM and insiders could already have made plans and agreements at the 'extraordinary' BoD meeting . NRx/BRPA BoD - RLF Management complicity.
After good top line news RLF goes to $1(+) then a 1 for 10 RS will be 300M shares, with 60M could go to BRPA.
NRXP could then give 1 NRXP share for 10 RLF even if the pps is different. (but hopefully higher, 2x-4X). It's about shares.
NRRLXP will combine management and commercialize asap. Everything is sub contracted, nothing 'inhouse'.
This provides another double + in Feb when full data and possibly EUA are announced. Nasdaq runs NRRLXP to X? next year...
Any other thoughts on the possible RLF future...GLTA...
Really? Nothing to do about taxes and EOY and Most are having a good time and not expecting anything till after the NewYear. I threw some more on the piles for a few ventures today. Always good to watch and listen to opinions.
Fr*zen Fl*me likes this, but I'm out over there for awhile (maybe):) ;)Blue flames have a lower carbon rating than Electric. Line losses ect, like taxes... Yes Hornitos and lime.
Not worried about anomalies at this point IMHFO, the Data is either Good or not...GLTA...
I kept 50k of my highest priced shares from over the years. Tax loss like evtn and esph the last years. All had proprietary stuff and were early entrants to their fields. Great ideas, badly implemented although they all had great markets. Main problems were thinking they had it made with arrogant greedy management that took pay before success. Then laws/competition/dilution/ realities changed.
I currently have as good a 'cure' for covid as there is with similar issues. Another one with good leadership I respect.
Google's first takeover and then l3's ETD line were forced buyouts to shareholders also due to mismanagement.
" We Don't run the companies and can just Buy - Hold - Sell the stock. Hopefully with fore sight, Hind sight is usually less desirable."
Quote is from 'Retailextortion', a totally untrusting 80's ID and the first 'trader' I remember. Should have learned better from his example. Glad I had some winners along the way....GLTA...Elsewhere...God Bless...
Bought some already today at a few places as I had planned for these dates because of taxes, my broker must love this stupid stuff.
Thought I was wrong, glad that seldom happens, LOL. That's a Corporal thingee... Learned the value of a 'stop' recently again, about overconfidence, about possible capital preservation, etc ...LOL...
Many here suspected some issue with the 50% deal/NRX/JJ babble. The theoretical science may be proved correct. My guess here is still an RS to roll into NRXRLP...GLTY...
The NRX stuff by JJ has worried me for some time. I planed to buy back today but this reaction and PR will make me cautious... Diversified COVID stock portfolio is what I am again aiming at...Good reentry for U2.?...Like the science...
" Obviously the CT Trial update doesn't seem as disastrous as my first impressions and actions.
1.25B float with 3.2B OS. Yes, I'm an ant in this crowd and I'm still watching what JJ and GEM do. Last thing this needs is CT difficulties.
My other qualifier was 'with good data'...GLTA..." yesterday" I still think the data will be good...
I did this am. This is still my COVID treatment favorite in spite of the bth>nash/AGN ride we're still on to get here.
I hope to see another Dr Williams repurposed drug in 2021. CKD - nash might prove relevant due to the damages caused by Rem, IMO...GLTA...
Maybe you missed the "IMO, my bet, my guess, maybe I'm wrong" qualifiers. It's a discussion board.
Strange to update a CT literally days(weeks?) before top line data. JJ did go with NRX(P). Continued enrollments to 196 right after CEO on CNBC.
I was gung-ho yesterday and bought early again @ today's open. Thought I was smart to wait for taxloss sales. No lies or pumps/bashes. No continuous 'cure' posts. We are/were all awaiting data asap. Now delayed?
Just pontificating. Still think RS and NRXP will be involved somehow. Obviously the CT Trial update doesn't seem as disastrous as my first impressions and actions.
1.25B float with 3.2B OS. Yes, I'm a piss-ant in this crowd and I'm still watching what JJ and GEM do. Last thing this needs is CT difficulties.
My other qualifier was 'with good data'...GLTA...
I see today's update to the IV Trial. Extended to 196 patients, extended for 28 day and 60 day data AND RLf is not a sponsor anymore. NRX with JJ now is. How can they do that? Will initial data be RLf and long term NRX? When will it be released? RLF paid for everything thru dilution.
Sorry, IDKS, out and will take a small loss to be safe, maybe I'm wrong but look at the 'side by side'...
https://clinicaltrials.gov/ct2/history/NCT04311697?A=1&B=17&C=Side-by-Side#StudyPageTop
R/S with the right news will be a good thing IMO. Too many shares otherwise and $30+ tag (depending on the ratio, 2.6+B OS) will blend easy for a future NRRXP. LOL. RLF-100 and Inhaler is what it's all about, right? RLFTF = $1+ after good data. That's my bet/opinion. Then.?. IDKS..
BRPA had comments about NRX not owning 100% of RLF-100.
It's up to GEM as they already have the votes to do whatever. Consolidate, Combine management (CoC for all), logistics Efforts, listing, Phase 3 funding.?.
or
Things stay as they are and with good data we're all still happy...?...
People didnt believe that CLNE would quad+ either. I didnt... HOPE for good data. I might buy more here...GLTA...
Yes, January will have the data readout. I bought back in at this range today. The tax selling may be around a couple more days, IMO. THEN...
My guess is a R/S and announcement in this Jan 2021 time frame to roll into the NRPX entity. They have to clean up this issue, IMO. With good data all will be WELL rewarded for the risks...GLTA...
That's DDPo sentiment from Yahoo. Things are progressing pretty much in this Sole Trout IPO deal just as JJ said.
Maybe a 1 for 30 and then roll into this deal after Data in January @ 50% of NRXP OS with a 300% overall from here, JMO...GLTA...
I've been writing about where NRX will merge and take RLF-100 and Dr J then leave the bills back there. SoleTrout did just what they/JJ said so far.
DDpolice on Y also nailed it a couple days ago with excellent figurn #'s. NRXP / RLF PR after new year and successful Trial Data to settle everyone's issues there and here, JMHFO...GLTA...