Going Green
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I appreciate this note — good to keep in mind — but I wonder if, given the current climate, we could replace this with another post. Not sure which Mod stickied it but there were a few fantastic posts over the last 24hours on the potential of both the IV & Inhaled trials, Javitt in Israel, and so on.
No disrespect but I just think there’s a better “fit” up there for now, IMO. I also don’t believe that Dr. Javitt spoke in such as way as to manipulate the SP.
Thanks all & have a great day!
$RLFTF
As Dr Javitt said, this peptide was formed through “evolution” or “God” depending on your perspective. They’re rollin’ it out commercially and this could save many lives!!!
Morning Wuhnners !!!
GM Curt ! Yessir ;) — you should see what the “eye-opener” looks like! LOL. Sombre day friends .... perhaps a day of celebration for those without a shred of moral fibre...
... but let’s leave the politics out if it and see RLFTF get the attention it deserves!
Good Luck & Have Fun !! ;)
Nice! Humility, be yourself, be kind. Grounding principles that are necessary in tempering our emotions..........the only thing we can really control, and at times the most difficult thing to control...
A pleasure to watch. Now I am getting philosophical. Ha!
Enjoy your evening! Starting to look forward to these videos now— and the first one I watched was the shirtless one FYI!!! And I kept comin’ back. Rock on brother.
$RLFTF
That’s right. Only one I was apart of was ANAC. If my memory serves, they were QB and went to Nasdaq, ran up to $60 or thereabouts and got bought at over $90 by Pfizer, $5bln valuation.... I had it at $9 in 2010 or 2011.... going back a bit ... it dumped hard and might have even lost Nasdaq status for a bit ... can’t remember if it restructured to maintain compliance.
https://www.pfizer.com/news/press-release/press-release-detail/pfizer_to_acquire_anacor
I think we could see it here Curt D. Could happen from QB for sure.... I think it’ll fetch a better valuation on the Nasdaq.... wouldn’t mind seeing it up around $5bln and get bought for $10bln .... At $1.2bln we’re still a little baby !!!
Also we gotta remember all the EU stuff they’re doing , and Israel ... and not just the US rollout.
Anywhooooo .... my .02 !!! Time for a vodka-valium-spritzer-super-smoker cocktail ;)
$RLFTF
I love how folks talk about the “huge outstanding share count” as if it makes a difference on something like this. I forget but ANAC might’ve even restructured to maintain compliance before uplist. Anyway .... it was either gonna be Allergan or Anacor for Pfizer .... Allergan had a $160billion price tag.
Covid treatment going through trials &
Just a reminder that I need to learn to behave myself. LOL
Don’t— inside joke — lol! I am editing the message Ha!
Ah sorry confused you with the video dude... ah all these aliases ... hard to keep track sometimes
Yeah damn that’s also a good point too ! Lol. My last post touched on what you were saying there .... such a weird time here that the “usual way of doing things” is being sped right up multiple gears, or being mixed in with necessary workarounds ... I really don’t know for sure!
That makes absolute sense. I am also not a pharma / trial expert here... but I remember Javitt mentioning that as well. That’s the whole point of the “randomized double blind” thing — patients AND the Doc / company / whatever aren’t aware of which are in the Placebo or Experimental group.
But that’s not to say that the ones “monitoring” —in the know— won’t see observe positive results in the experimental group and say “Hey, we have X % of improvement on this this and this for Patient 33-102 (random numbers), without serious side effects.... Placebo group is declining, let’s get them on this NOW.”
When lives are in the mix, in this unique situation, this crazy year 2020, I believe it’s quite unethical to sit and watch folks die.
(I like your post & Trading Is Fun’s post too — great value in your chats fellas — thanks a lot).
Still a green day and a greeeeeeeeeen(k)night!!!! ;)
$RLFTF
It would really be incredible... I know a handful of us have seen it and been apart of that sort of scenario before! Keep seeing vaccine delays etc.... I am very interested in the INHALED trial as well — and that’s going to be available to a larger population.
Very very interested in inhaled medicines.... speaking of that... time to start my evening! ;)
Enjoy & best wishes to you all!
Couple nice buys there by someone ;)
That was a nice pr.... damn
Without question!
Excellent post. You got it! I also realized that they only were looking for 120 to begin with... drew “within their 144 patient pool” (I wonder if some folks died before getting assigned too... he wouldn’t say that in an interview!). As you say here — treatment was also considered “safe” and “may be effective” after the “Safety/Futility test” which happened after just 30 patients were enrolled !!
We are SO good. Thanks for flagging all these additional points. Certainly deserves a sticky ! :) $RLFTF
Thanks man. Reaching back to old PRs ... I see we do have some boxes checked already .... really should see this stuff updated on the Trial website itself. Based on this, the language here is very important ... “within the 144 patient sample” — does not mean they NEED 144.... Originally they were looking for 120. Now I believe at patient 102 we have hit that “trigger point” where they have a suitable number of participants, as Dr. Javitt said in the interview “you’re kind of the first ones to know, we just got patient 102.... so we will have data on this in 28 days..” (BEDSHITTING in market ensues). Lol. Anyway... here are the references. I have been thinking that, sadly, because this is an “end-of-life” / “last-resort” treatment, participants have likely died as well, so they’ve perhaps had some shuffling with these numbers too?? I mean, maybe they have had folks sign up and then just die before they can even randomly assign them? That’s certainly a quantifiable consideration, I think, and something Dr. Javitt would not say on an interview.... But I do believe his words and RLFTF press have alluded to this. That is just another thing I am considering because of the uniqueness of this whole “situation”....
Ok here’s the stuff I was reading last night. I don’t think my light medicinal valium-vodka-gin-smash cocktail got me too off kilter, but please add thoughts & feedback bro! I know you have been following longer than me and are still bullish regardless of the interim action. Thanks for reading!
Re: 30 patient “safety check”
“This first interim analysis was focused on verifying the apparent safety of the drug in the first 30 patients and the feasibility of the study to reach its endpoint. The committee determined that the study appeared capable of reaching a statistically significant endpoint within its 144 patient sample size and voted for the study to continue until its next scheduled evaluation in four weeks.”
https://www.otcmarkets.com/stock/RLFTF/news/story?e&id=1645880
Prior to that —- they “aimed” for 120 patients for this trial: “
The multicenter randomized placebo-controlled trial aims to enroll 120 patients with COVID-19 who have Acute Respiratory Distress and require intensive care with mechanical ventilation. Patients will be randomized to intravenous (IV) RLF-100 plus maximal intensive care or placebo plus maximal intensive care. The primary endpoints will be mortality and index of respiratory distress. The secondary endpoint will include levels of TNFa and multi-system organ failure free days. For more details on the clinical trial, go to the government’s website: www.clinicaltrials.gov (NCT04311697).”
https://www.globenewswire.com/fr/news-release/2020/06/01/2041739/0/en/Relief-Therapeutics-and-NeuroRx-Announce-Enrollment-of-First-Patients-with-RLF-100-in-Phase-2b-3-Clinical-Trial-in-Patients-with-COVID-19-Associated-Acute-Respiratory-Distress.html
You said it haha. Man... $200K orders been blowing through left right and centre.... gorgeous PR yesterday.... A doctor speaks a bit more “low key” because (IMO) shit is gonna be happening here FAST... and then the dumpening!!! Lol. Ah well to each their own ! ...
“What’s the future of mankind? How should I know I got left beeeehindd!!!!!”
$RLFTF
100% my thinking... DSMB can adjudicate ... this is not “new” and is safe so why shouldn’t it be fast-tracked with Dr. Javitt’s pedigree, and why do we need more patients if the original target was 120 and now they have been OKAY’d at 102!!! Something tells me that we see interim results in near order because of this:
“Intervention Model Description:
Multicenter trial, initially conducted at a single center with a safety/futility assessment following enrolment of 30 patients.”
Have we seen that yet??? Says the page was last updated August 31st 2020. Because DSMB calls the shots here, we are going to get an interim update soon which says “safe and showing <insert qualifier here> (some? Significant?) efficacy for ARDS from COVID-19 in patients on ventilators.
IMO
Except I think there is a lot of confusion on what constitutes the “real medical community / experts, etc” —- but don’t wanna go there lol. GL !!! Love our Vets !!!
Good post & good luck to you!
In my opinion ANYTHING can happen from now to then and the aim for the study was 120 originally ... DSMB can “modify” depending on several factors outline there... “background of testing agent” is one of those reasons... As Dr. J said, this is NOT a “new peptide” but of course it’s the first time this medicine is being used for this purpose... He has the medical lingo to explain that better than me...
I see this frenzied COVID rush ..... very urgent... President fast-tracking vaccine and treatments .... Wants to get stuff in and approved before election. Being that this has plenty of evidence for being “safe” and some evidence for futility (yes more data needed, and here’s the “28 day talk” that effed with the SP)... I simply still see this moving quickly, given the situation and for the reasons I listed there... This thing isn’t new under the sun. Shows some efficacy, safe, meets EUA criteria....
As Mr. J Belfort mentioned in here.... The path seems to be toward a BUYOUT. Even NeuroRx....Dr. Javitt’s first company was bought... Don’t you guys think Pfizer, J&J, Moderna, whomever, have eyes on these things??? This is about the biggest no-brainer, imo.... Vaccine will be great BUT this sounds like a safe treatment that might need to be coupled with the vaccine for many of the reasons Dr. Yo mentioned yesterday.
Re: uplisting, all Dr. J said is that investors need to continue to have interest in the stock... He didn’t say it needs to “sky rocket.” Yes we NEED funding from GEM (which we got, all topped up, great) and we NEED so many shareholders on record for Nasdaq, plus $4 a share. I am reading between the lines and I think this is looking very good. I can see a couple different ways of hitting $4 with a buyout coming after we are up on the Nas....
IMO as always!!
$RLFTF
My strategy is dump old bags and put it into this LOL
Damn right yer not ! Smarter than the average bear I’d say !! ;)..... Nice pics..... “Heeeeeere we go!” Lol!
I know the money is here to eat them up lol so I agree IMO !!
Hey thanks :) At least that’s how I’m seeing things.....Grabbed some more this morning,
Mr. 42 doesn’t really want to let them go it looks like. Dangerous manoeuvre....
Nice trades man. Yup RLFTF has something for everybody. Lots of us want something we can leave sit too haha. I just usually post too much anyway.... ;) Go $RLFTF
Good morning $RLFTF
Beauty
Yes EXACTLY. “It will be hard for them to say No.” ... He was, as he said, “very clear” that this is, as it stands NOW, a final option for those near death. People are requesting it too, and it’s too late because of the IBR approval thing... red tape.
No way this thing doesn’t get approved. I reviewed a lot of info this evening... this ain’t his first rodeo... This is a medication showing efficacy in Europe that they haven’t used readily in the US. He’s not gonna come in hot and heavy and saying “possibly a treatment for pulmonary damage related to X Y and Z.” Keep it focused on Covid.... EUA... that’s the way in. After that.... holy crap, sky is the limit. Second half of the vid he gives us all the “maybes,” which are even based on real studies in Europe & Israel..... So we KNOW the EUA is as good as a done deal as it gets...
Thanks for your “insider perspective” from the front line! I don’t have a medical background so I love gleaning what I can from you guys .... Thanks for your work & for sharing your knowledge!
DD Post & Some Thoughts on Today:
Looking at this link to the Clinical Trial in question on the interview .... https://clinicaltrials.gov/ct2/show/NCT04311697
Am I missing something here? I see “estimated enrolment” to be 144 but according to the above (or below), it is tested for “safety / futility” after 30 patients are enrolled.
ALSO the June 01 PR from RLFTF said they were “aiming for 120 patients”:
“The multicenter randomized placebo-controlled trial aims to enroll 120 patients with COVID-19 who have Acute Respiratory Distress and require intensive care with mechanical ventilation. Patients will be randomized to intravenous (IV) RLF-100 plus maximal intensive care or placebo plus maximal intensive care.”
SO, to me, this sounds like NeuroRX is on-track and they have checked that “Safety” box, but he is NOT going to say “boom it’s safe” when the entire study hasn’t been completed yet and now patient 102 has come along so therefore it is NOW up to the Data & Safety Monitoring Board to report interim data — and from the looks of their website they can change things on a dime with these trials. Javitt said 28 days and I know that’s why everybody’s butt-hurt.... And he gave us the “BAD” and the “UGLY” first....but given what I am reading here from DSMB, timelines can change quickly depending on their assessment of the trial:
“The primary responsibilities of the DSMB are to 1) periodically review and evaluate the accumulated study data for participant safety, study conduct and progress, and, when appropriate, efficacy, and 2) make recommendations to NIDCR concerning the continuation, modification, or termination of the trial. The DSMB considers study-specific data as well as relevant background knowledge about the disease, test agent, or patient population under study.”
Now THAT is interesting, because there already exists a LOT of background data on the “test agent.”
From the Trial Notes - Background Info:
“Five phase 2 trials of aviptadil have been conducted under European regulatory authority. Numerous healthy volunteer studies have shown that i.v. infusion of Aviptadil is well tolerated with few adverse effects including alterations in blood pressure, heart rate, or ECG. In addition to published studies of human use, Aviptadil has been used on a compounded basis in certain ICUs for many years in the belief that it preserves life and restores function in pulmonary hypertension, ARDS, and Acute Lung Injury (ALI).
In this study, patients who are hospitalized for Critical COVID-19 infection with respiratory failure will be randomly allocated to Aviptadil administered by intravenous infusion in addition to maximal intensive care vs. maximal intensive care alone. Primary endpoints will be improvement in blood oxygenation and mortality.”
So, reading between the lines....
They don’t need 144 by the sounds of it. DSMB gave them the OK after 102. Also, Dr. Javitt was very clear in saying that this is NeuroRX’s trial on a medication that has been used for a long time... Later he mentions Relief Therapeutics, etc, but I frankly don’t see any issue with him sharing that timeline & the fact that they have 102 participants.... NeuroRX is privately held, so he has not said anything here that puts RLFTF in violation with Securities Laws. Shareholders dumped when he said things like “we have not applied for expanded applications,” bla bla.... because Traders were thinking “Ha he is gonna say this shit works on influenza, makes my dick hard, and ALSO cures covid, study done, ready to roll.” YEAH RIGHT. He clearly BELIEVES in other applications but STEP ONE here after Expanded Access is to get the EUA ..... Dr. Javitt is not going to push a bunch of extras in NOW when there is dire need to get this stuff to patients through Pharmacies! Second half of the video is awesome because it’s like he KNOWS there is efficacy here, and he has a rolling list of publications (top 1% in the world), so he’s got
But anyway, that’s my .02. Also I would advise watching this page here, since it was last updated end of August, it would make sense to have an update here any time? Amid the “covid frenzy,” it would not surprise me to see an interim update “soon” on here, after a nod from DSMB:
https://clinicaltrials.gov/ct2/show/NCT04311697?term=NCT04311697&draw=2&rank=1
To me, the News today coupled with this page = money in the bank.
“Approval of a Drug can only be achieved if the drug is shown to be safe and effective....”
“The standard for Emergency Use is different .... it has to be SAFE and MAY be effective.” ... “We clearly have evidence this drug may be effective.”
Study Type :
Interventional (Clinical Trial)
Estimated Enrollment :
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Multicenter trial, initially conducted at a single center with a safety/futility assessment following enrollment of 30 patients
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Randomized, placebo-controlled trial with identical drug and placebo infusion bags
Primary Purpose:
Treatment
Official Title:
Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure
Actual Study Start Date :
May 15, 2020
Estimated Primary Completion Date :
August 2020
Estimated Study Completion Date :
September 2020
TLDR(?) - Too Lazy Didn’t Read —
DSMB likely assessed the trial’s preliminary data ALREADY and said 102 patients was sufficient. June PR said the study aimed for 120. Clinical Trial NCT04311697 said “estimated 144 patients.” [U]Dr. Javitt did NOT incriminate himself or say anything damning here in speaking about his PRIVATE company’s Clinical Trial. 28 days is an “earmark” that can change swiftly —both North or South, let’s keep in mind — based on such things as the background of testing agent, population in study, etc. IMO speaking of violation of Securities Laws is egregious here, given that NeuroRX is private & is advancing RLF-100 in a new application... original aim was 120 patients. Let’s not make a mountain out of a mole hill.
Thanks for reading all the verbiage ;) ..... I always keep a pot o’ gold kickin’ around for the monkey market bedshitting, so let’s see what we get tomorrow ;) .... imo :)
$RLFTF
Nice summary ! Well-said
I like the way you’re thinkin’.... rewatching video... I don’t see anything damning here. Javitt says a LOT without saying it directly.... Start of the interview wasn’t as rigorous as the second half.... Traders backed off as Javitt began with some “storm warnings” and I simply think some folks got spooked....downward momentum continued.
Second half has several allusions to the sizeable market ESPECIALLY for the inhaled product...
I’ll take .40s if you guys wanna put it there though ! ;)
Great video, excellent analogies there... Love your humour man. Haha. Really a pleasure to watch, especially with a shirt on LOL ;) (JK sorta kinda!). Everybody watch this with your vodka-valium cocktails and walk yourselves back from the edge....
This year has brought TRANSPARENCY to the forefront of OTC stocks — I got some old “greys” that are totally defunct.... Just small “battle scars” now and reminders of what to stay away from, especially in THIS climate...
Not too many “keepers” but when you get one and you know it, you wanna hang onto it.
I’ll be buying more in the morning. Enjoy your evening everyone!
(PS — you should have your wife do the next video ;) waa waa wee waa ... ;) Ha ! )
GO $RLFTF !!!!!
HoooAH! Let’s do it LTT.
Insiders Acquired 28million shares here.... 4 Form 4s posted After Hours so far:
1
https://www.sec.gov/Archives/edgar/data/1557376/000168316820003313/xslF345X03/ownership.xml
2
https://www.sec.gov/Archives/edgar/data/1207638/000168316820003314/xslF345X03/ownership.xml
3
https://www.sec.gov/Archives/edgar/data/1207638/000168316820003314/xslF345X03/ownership.xml
4
https://www.sec.gov/Archives/edgar/data/1557376/000168316820003315/xslF345X03/ownership.xml
So many Form 4s hitting here bro:
BPSR ... 4 after hours so far ... here is one ...
https://www.sec.gov/Archives/edgar/data/1557376/000168316820003313/xslF345X03/ownership.xml
Hey that’s a great one! I always listen to that in my head.... LOL... gotta put the tunes on tonight!!
Let’s get up toward .50 here !!