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Yeah you’re right. Gotta temper my enthusiasm a wee bit ;).... Haha! Let’s see ze data!!!
Absolutely no idea but I am sure Javitt will bring us up to speed a bit, insofar as he is able. I’m looking forward to it!
That’d be something !!! I see they have a $1.6bln annual budget so they better be putting it to good use !!!
Yeah that’s actually a good question ... wonder how many EAPs ... hmmm ... Javitt did say it’s the most exciting thing he’s ever been involved in... probably lots! Ha! (No I am not laughing at “emergencies,” but just my own silly lingo....) ;)
You’re right — and here’s the video. Dr. Javitt mentions that, unfortunately, “patients die before they can receive the medication.”
There have been LOTS of requests for it by the sounds of things, and I agree they must have more data from patients who were treated under the EAP.
So..... the EUA will be incredible and super necessary because then NeuroRX doesn’t have to work with EACH hospital individually, get the patient the treatment, etc (and meanwhile some DIE.... very sad).
EUA on RLF-100 / Aviptadil just in the “critical care stage” alone will save many many lives.
As Dr. Javitt says here, it will then just be a matter of the hospital calling the pharmacy and requesting the medication.
Video here:
Meat should be RLF “meat” according to this — but I’ll check out the link once I get home, as I saw you posted that — I think it’s a typo / misdirected link or whatever....
But yeah the suicide / bipolar trial stuff from Neuro is cool too!
Just going off this statement here. Sounds to me like Javitt will speak (confidently!) on RLF tomorrow:
Dr. Javitt will cover the latest news for RLF-100™, which is in clinical development for the treatment of respiratory failure related to COVID-19, as well as the other pipeline programs. The presentation will be webcast live and is available for replay. Click here to access the webcast: https://www.webcaster4.com/Webcast/Page/2408/38140
Nice post ! Love the blue ! :) Yes I am so eager to hear more tomorrow!! On the road today unfortunately so had to blast out my msgs and take off !!
Enjoy folks! Have fun & keep’er lighthearted !! :)
$RLFTF
OCT 15th Dr. Javitt Webcast & NEWS $RLFTF
LINK to Webcast here:
RADNOR, PA / ACCESSWIRE / October 14, 2020 / NeuroRx, Inc., a clinical-stage pharmaceutical company developing small molecules for unmet medical needs, announced today that Chairman and CEO Jonathan C. Javitt, M.D., M.P.H., will present a company overview at 9 a.m. EDT on Thursday, Oct. 15, at the Fall Private Company Showcase hosted by Solebury Trout, BMO and Davis Polk.
“Dr. Javitt will cover the latest news for RLF-100™, which is in clinical development for the treatment of respiratory failure related to COVID-19, as well as the other pipeline programs. The presentation will be webcast live and is available for replay. Click here to access the webcast: https://www.webcaster4.com/Webcast/Page/2408/38140”
From Oct 14th news:
https://www.biospace.com/article/releases/neurorx-s-dr-jonathan-javitt-to-present-company-overview-at-2020-solebury-trout-private-company-showcase/
October 13th PR Announcing Top-Line Data:
Overall, 81% of RLF-100™-treated patients survived beyond 60 days, compared to 17% of control patients. Patients treated with RLF-100™ demonstrated a 9-fold increased probability of survival and recovery from respiratory failure, with a high degree of statistical significance. Statistical analysis was performed by Prof. Phil Lavin, FASA, FRAPS of the Boston Biostatistical Research Foundation.
"We are encouraged by these initial results in highly comorbid patients with COVID-19 respiratory failure, and we are pleased that the majority of these patients have returned safely to their families. We look forward to the upcoming results from the randomized, double-blind, prospective trial in less severely comorbid patients for confirmation of these results," said Jihad Georges Youssef, MD, section chief of General Academic Pulmonary Medicine at the Houston Methodist Hospital, who serves as the study's principal investigator at Houston Methodist and also serves as national co-chair for the ongoing randomized controlled trial.
"The patients included in this study are representative of those who are too ill to be included in the clinical trials of any known treatment for COVID-19," said Dr. Jonathan Javitt, CEO and Chairman of NeuroRx, Inc. "We are grateful to Dr. Youssef and to the Houston Methodist Hospital for having the courage to treat and study patients at this level of risk. The results suggest that there may be substantial hope to mitigate the attack of the coronavirus on the delicate cells that line the lung with a natural peptide that has been protecting the lung's lining since humans first walked the earth. While the number of patients treated at Houston Methodist is modest, the initial results in our nationwide expanded access program suggest similarly encouraging survival with RLF-100™. We continue to closely monitor treatment with RLT-100TM in other hospitals."
Raghuram (Ram) Selvaraju, Chairman of the Board of Relief commented: "The encouraging EAP topline data give us continued motivation to remain focused on the rapid clinical development of RLF-100™. We look forward to topline results from our randomized, placebo-controlled study this quarter. We remain dedicated to our goal of providing therapeutic relief to critical COVID-19 patients as quickly as possible."
Scientific findings of the analysis have been submitted for peer review.
https://www.otcmarkets.com/stock/RLFTF/news/NeuroRx-and-Relief-announce-topline-efficacy-data-from-patients-treated-with-RLF-100-aviptadil-under-the-US-FDA-Expanded?id=276663
Good morning! Thank you for keeping the pool clean here re: political discussion etc. It’s essential we of course not violate the TOS and stay on topic.
That said, I am going to throw together a quick post including the link to tomorrow’s Webcast with Dr. Javitt. Could you kindly have that post stickied and perhaps keep this one “on-the-ready” in case we drift into political nonsense going into October 22nd... ;)
Will send you the post #. Thanks in advance!
Thanks for the shout out eh buddy ;) hahaha
Thank you for taking the time to consider my thoughts and post a stellar reply. I agree and wanted to add that “flair” ... “Speculation... but...”
I think you pointed out some great facts there ... Also back in that last Dr. Yo interview when Dr. Yo asked that question on “uplisting” (a question I thought was out-of-the-blue and a bit absurd to be honest).... I liked that Javitt answered and distanced NeuroRx from Relief in saying “oh you mean for Relief? Not sure what they are doing ... we are privately held.”
Dr. Javitt has been very careful with his language... gave us the good the bad & the ugly, and now it appears we might (MIGHT) have a positive development on the US side with Neuro where Dr. Javitt can speak more candidly on the data THEY have submitted to the FDA.
That’s JMHO, spitballing off what you have said here. It IS curious that this is coming from NeuroRX and not another avenue... ONE Week after they submitted data to FDA..... It would make sense for EUA to drop during a US business day since this is happening through Neuro... And yes they’d certainly have to halt the Swiss!
I can’t see it being delivered during Swiss trading hours with RLFTF being halted, since this is NeuroRx’s “baby” in the USA. Thanks for the food for thought Uncle Gee Gee!
I can assure you I am absolutely not excited based on this possibly “baseless” dot connecting... But I don’t think it’s baseless and actually, now that I think about, I am pretty excited ;) Ha!
$RLFTF
Agreed. And looking at the NeuroRx team and where they come from ... JJ, Pfizer, Eli Lilly ....
Just for those thinking that there is some sort of “direct competition” between big pharma & Neuro or RLF .... we are an “appendage” of sorts...
“NeuroRx draws upon more than 100 years of collective drug development experience and is led by former senior executives of Johnson & Johnson, Eli Lilly, Pfizer, and AstraZeneca, PPD. In addition to its work on RLF-100, NeuroRx has been awarded Breakthrough Therapy Designation and a Special Protocol Agreement to develop NRX-101 for the treatment of suicidal bipolar depression and is currently in Phase 3 trials. Its Board of Directors and Advisors includes Hon. Sherry Glied, former Assistant Secretary, U.S. Dept. of Health and Human Services; Mr. Chaim Hurvitz, former President of the Teva International Group; Lt. Gen. HR McMaster, the 23rd National Security Advisor; Wayne Pines, former Associate Commissioner of the U.S. Food and Drug Administration; Judge Abraham Sofaer; and Daniel Troy, former Chief Counsel, U.S. Food and Drug Administration.”
$RLFTF
I was just gonna say!! Damn! 150!!! All these people saying “we don’t have enough data bla bla ... participants... 2.5bln shares... waaaah!!!”
Right here, as you aptly pointed out!! We gotta be SO close.
“Since July 2020, more than 150 patients with Critical COVID-19 and Respiratory Failure have been treated with RLF-100™ under FDA-approved protocols.”
$RLFTF
Speculation but... EUA drop & Javitt discusses this tomorrow during the interview? Would seem timely to me.
$RLFTF
$MYCO/ $MYCOF NEWS Doesn’t appear “toxic” to me. Debt settlement news for shares at .23 which won’t trade for 4 months.... AND non-dilutive capital raise from FreeMind:
FREE MIND CONSULTING
https://www.freemindconsultants.com
“The FreeMind Group is the premier international consulting firm specializing in assisting life science organizations secure non-dilutive funding from US federal agencies and private foundations.”
TODAY’s PRESS:
https://www.otcmarkets.com/stock/MYCOF/news/story?e&id=1713954
“The Company further announces that its board of directors has approved the settlement of a principal amount of $847,500.00 in debt for services rendered through the issuance of common shares (the "Debt Settlement"). Pursuant to the Debt Settlement, the Company issued 3,684,783 common shares of the Company (the "Shares") at a deemed price of $0.23 per Share to a creditor of the Company. All securities issued will be subject to a statutory hold period which will expire on the date that is four months and one day from the date of issuance.”
Hey that’s cool! A young chip off the ol’ Javitt wood ;), advancing his own means to an end, one which we can only hypothesize...... Good for him!
I’ll likely be dead before I bank on that but will take my $RLFTF cents to multi dollars meantime :)
Good find !
Same guano pile ;)
Amen. Good riddance. OK USA— goodnight! Are we going to run this thing tomorrow on Suisse Cheese momentum or let them prop it up and sell it all the way down again?? ;)
I’m CANADIAN so I’m like a hybrid here ... I don’t drink your fine selection of bourbons, but enjoy a beer outside my Igloo now and again.... ;) maybe some Great Lakes brews and buffalo wings....
Good evening all. Keep’er light & have fun.... privilege to play the game....
$RLFTF !!!!!
Gk
Yeah what has changed since then? Only positive developments. Lol. Goodnight friend :) $RLFTF
Uncle Gee Gee ! Wow that’s a heck of a nice post to cap off the day I’d say. Thanks ! $RLFTF
Ahh we love a bit of “ribbing” here on RLFTF ;) .... I been through a bit myself .... We’re all on the same team ! Keep rockin’ and rollin’ folks :)
“Pps drop after top line data” — look at the tape and see all those who loaded below the 50DMA on the daily.... .556.... of course we open at .59-.60 after seeing Swiss at .54CHF... and they’re going to sell it down. That’s not unhealthy....
Buy today, maybe we open at .70 tomorrow. Let’s see it.
$RLFTF
Many people don’t realize the EUA is (what I am calling) “the easiest entry” for a drug traditionally used for ED, Erectile Dysfunction, into the “COVID19 Treatment world”.....
Look at REGN and LLY and the “politics” involved, spearheading very bold moves and putting them under the heat lamp....
$RLFTF .... This is NOT Dr. Javitt’s first rodeo. I think in the interview he made this especially clear for a reason... “we are very clear that all other treatment options should be exhausted FIRST....our EUA is for critical patients, last option.”
It is because of this that the EUA for RLF-100/Aviptadil IV is a “safe play” in my opinion ..... And once they’re in the door, as I believe they are, the “snowball” effect can happen.... Inhaler trials, all this, can go very quickly in my estimation once the drug is deemed SAFE and is showing some efficacy.
Today showed us that is the case beyond a shadow of a doubt IMO!!
$RLFTF
Crazy because they applied 1 week later than RLFTF for EUA .... Looks like we are seeing FDA cull through these and focus on SCIENCE.
Who’d’a thunk it?!?
$RLFTF
WOW.... That’s huge. Big nod to Therapeutics!!! $RLFTF is the one everybody should be looking at.
“Funny part is, anyone who bought pre split in the past 2 years is actually sitting much prettier than they were prior.”
Exactly this! IMO. I was trying to say that in my first kinda garbage incoherent late-night post here lol....
Was just telling a friend the other day about the possibility of making $$$ post split on some of these ... RCHA(D) was one example I recall....
Lots of folks should be lookin’ good here long as they keep the tap shut off, as you’ve said here.
Anyway - great post. Go $GOIGD
Sounds ... awesome.. an awesome sound to me ;)
Sounds like an anxiety med or sleeping pill, doesn’t it?.... “Take this and go away....” .... Typical! Doesn’t hold a candle to Aviptadil though.
$RLFTF
Some people are SO far behind on this one.... Amazing. I thought I was “new” but then I see I’m not THAT new .... ;)
$RLFTF
Nephron is gonna roll this out pronto — they’re massive. Neuro & RLF working with them and one nod from the FDA & the treatment will be available to millions.
https://www.prnewswire.com/news-releases/neurorx-and-relief-therapeutics-establish-supply-and-distribution-agreements-for-rlf-100-aviptadil-301140389.html
Nephron Pharma
https://markets.businessinsider.com/news/stocks/nephron-pharmaceuticals-corporation-announces-historic-expansion-in-lexington-county-1029384581
Excellent post. Thank you Nelskof. Also I am seeing vaccine trials being stalled on top of it all.... Window wide open for Therapeutics! RLFTF miles ahead of others.
Yeah I saw that there too — very cool — and mouth attachments etc... Could be that Aviptadil is administered as such, through these atomizers!
Re: the Inhaler & Nephron Pharma
Speculative post here, also shared on Twitter lol, but Tiggeriffic shared something interesting that maybe deserves to be looked at again in consideration with the Inhaled version of RLF ....
Could Nephron’s “Atomizer” perhaps be the method of delivery here for “long-haulers” with symptoms if efficacy is shown there? Curiously named “E-100”..... Not saying it’s by any means ready to go but just doing some dot connecting here, since Nephron is supposed to be rolling out the inhaled version as per PR linked below??
https://www.nephronpharm.com/products/ez-breathe-atomizer
“The development partners, NeuroRx and Relief, are leading US and EU commercialization plans, respectively. They have now contracted with Nephron Pharmaceuticals, Inc. to manufacture commercial supplies of RLF-100™, in order to ensure that adequate drug inventory will be immediately available, should the clinical trials demonstrate safety and efficacy.”
Taken from Sept. 30 PR:
https://www.prnewswire.com/news-releases/neurorx-and-relief-therapeutics-establish-supply-and-distribution-agreements-for-rlf-100-aviptadil-301140389.html
Yeah and then we also have random 400K orders that come in ... And that’s the scary thing for flippers, IMO .... business as usual and then we see these frenzied buys which are jaw-dropping .... That’s the writing on the wall right there so far as I am concerned! Follow the $$$
Have a great day everybody!
$RLFTF
Nice data! I am a big fan of data... EUA in the bag by the looks of it ... Nevermind big Pharma $$$ etc, RLFTF had that EUA submitted before REGN and LLY ....
Even if the Prez is good to go for this debate, testing negative, etc., his treatment cocktail can’t help the folks RLFTF IV & Inhaler therapeutic targets!!!
Stellar results for those with damn near both feet in the grave...
$RLFTF
Hey nice catch - thanks
They did that. Out with the old. Now they have a company coming into the shell with $650mln revs from last year ??
So something that is worth billions of dollar is being injected into a shell with a $6million market cap and under 7 million floating shares.
Notes: looks like all those converts at .25 don’t mature until well into 2021 and “they” don’t appear to be converting & selling ....
Looks to me like they’ll let interest accrue for as long as possible, then blow out what they want when the stock is at say $2.00 ... which would still be just ~$27mln market cap with today’s OS ......
Given the mammoth acquisition here I’d say all these numbers I mentioned are pretty small potatoes, quite conservative.
This first acq sounds like it will create a snowball effect:
“PTGI will be the first acquisition in TransWorld Holdings newly formed TMT division, and will have an immediate mandate to grow the TMT division through M&A transactions. Along with TransWorld's recent and pending acquisitions, including GetCharged, Inc. TransWorld's global strategy is to offer infrastructure, electrification, and communication services in cities around the world.”
Immediate mandate to grow the TMT division through M&A Transactions.
Damn I love that part.
$GOIGD
Amazing isn’t it. Lol.
Wow ! That’s scary! Thanks for sharing your story there.... what a Christmas!
Yeah it is just a strange way of wording what we already know. Checking out the definition of the Expanded Access Protocol.... “Expectant mothers” would fit under condition to gain access to an investigational medical product. The other article (Oct. 9) says “broadened use protocol,” but they are just talking about EAP:
“Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable ...Apr 27, 2020
https://www.fda.gov/news-events/public-health-focus/expanded-access
“The U.S. Food as well as Drug Administration (FDA) has actually given RELIEF THERAPEUTICS Holding AG as well as its U.S. companion NeuroRX, Inc. Broadened Access Protocol for therapy of Respiratory Failure in COVID-19 with RLF-100 (Aviptadil), an artificial kind of Vasoactive Intestinal Peptide (VIP). This activity makes the therapy readily available to people that have actually worn down common treatments as well as are not qualified for the existing Phase 2/3 scientific test of RLF-100 because of confounding clinical problems as well as particularly makes the therapy readily available to expectant ladies.”