Romans 12:19
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Thanks, yeah I have to look things up I have no idea.. ;)
According to this Dr it's been FDA and Big Gov. blocking therapeutics all along..
https://www.newswise.com/coronavirus/dr-pierre-kory-president-of-the-flccc-alliance-testifies-before-senate-committee-on-homeland-security-and-governmental-affairs-looking-into-early-outpatient-covid-19-treatment#.YI8OMf7Q2U4.twitter
?? Blackacre ?? ..I was just defining your code from a search..
"Just 12(b)6 the FUD noise"
no, I saw the post looked it up and posted it.. I think may be time to stop posting here.. wayyy to touchy here...
Just 12(b)6 the FUD noise
Rule 12(b)(6), permitting a motion to dismiss for failure of the complaint to state a claim on which relief can be granted, is substantially the same as the old demurrer for failure of a pleading to state a cause of action.
..not interested.
Greed is NOT Good !! ..a few days ago Dr J posted that the info on the last patient wasn't in yet.. (But I'm guessing they can tell the direction from the info they have) From October I was always hoping for a FDA approval based on the positive data.. some believe they want the Vac's to be taken before letting out Therapeutics.. I don't know but this all seems to be a strange madness in light of the Hippocratic oath. I've quit the debate in my mind to save it.. now I just copy and paste. IMO
related - Updates (replies) https://www.facebook.com/101285508473396/posts/198502252085054/?d=n
$RLFTF (related) Opinion post: Bream Medical, LLC April 28 at 1:26 AM
An open letter to FDA commissioner Dr. Janet Woodcock.
If you agree, I ask you to share it to your page. We will only make a difference with sheer numbers!
Dr. Woodcock,
While most of this happened under the prior administration and Dr. Hahn’s leadership, it is worth noting the FDA’s record on Emergency Use Authorization.
Therapeutics that have received EUA:
1) remdesivir - ACTT-1, the trial sponsored by Gilead and the NIAID, changed its endpoint essentially from ordinal scale improvement to time to discharge.
This trial remains the only trial that showed any benefit for remdesivir.
In fact, the WHO has gone so far as to recommend against its use, which is the correct decision based on the literature.
This is based on studies out of Hubei (which were available at the time EUA was given in pre-print) and the SOLIDARITY trials.
The Chinese study nor SOLIDARITY found any benefit to using remdesivir. SIMPLE - severe trial showed no benefit from 5 days of remdesivir versus 10.
Clearly, the studies are all negative except the one backed by the Gilead and the NIAID with a changed, clinically insignificant endpoint.
Not to mention, remdesivir’s relatively high rate of adverse effects.
Why are we still using remdesivir when the data is clear it doesn’t work?
What has happened to first do no harm?
2) baricitinib - ACTT-2 expounded upon ACTT-1’s non-patient-oriented outcome by showing a decreased time to discharge by 1 additional day with baricitinib.
Two wrongs don’t make a right.
3) hydroxychloroquine- the data here was so poor that the FDA rescinded the EUA. This is not surprising as the study used for this EUA was of very poor quality and ultimately was retracted, I believe, as it arrived at its conclusion that HCQ is beneficial only by excluding the 6 deaths in the HCQ group.
If I read the study and knew this, how does it get by the FDA?
4) convalescent plasma - admittedly, I supported this EUA on “safe and may be effective” grounds. Further study showed that plasma isn’t useful. However, it should be noted that even the initial evidence was shaky as there was not even one placebo-controlled trial for comparison.
5) bamlanivimab - BLAZE-1 earned an EUA for for this drug based on a phase 2 interim analysis showing decreased viral load at only one dose (2800mg) and a reported decrease in ER visits/hospitalizations.
Turns out, none of those conclusions were found to hold merit in the phase 3 trial - except in the polyclonal antibody cocktail - which wasn’t even in the original phase 2 portion of BLAZE-1 (or at least not that I could find). Now, it’s rarely used - even recommended against in some states - due to variants.
I reviewed this study and saw this coming in November (see Bream Medical FB Live in November the Battle of the MABs: leronlimab v bamlanivimab). If I could see this, how did the FDA not?
6) polyclonal antibodies - the only EUA that actually looks legitimate and is backed by solid data (especially Regeneron’s cocktail).
So, what we have are a litany of failures - that were largely predictable - based on poor studies for medications that are geared only toward mild-moderate illness - all of which are backed by “Big Pharma.”
Why hasn’t the FDA emergency use authorized a single therapeutic for severe-critical?
What is certain is that the data behind leronlimab, tocilizumab, aviptadil, and lenzilumab, while imperfect, is eons better in quality than the data backing up any of the EUAs provided for therapeutics excepting polyclonal antibodies.
As proven above, most of the drugs that received an EUA were based on highly flawed studies that any medical student would recognize, but somehow this all escapes the FDA?
And why has severe-critical remained completely neglected when multiple drugs meet the “safe but may be effective” criteria?
If leronlimab, tociiizumab, aviptadil, or lenzilumab were made by Gilead, Pfizer, Lily, or other “Big Pharma,” are we having this discussion?
Dr. Woodcock, I think you owe the public an explanation.
As of today, 573,000+ Americans have died without access to a therapeutic targeting severe/critical COVID-19 while a myriad of EUAs were given out based on shaky data for mild-moderate illness in drugs that failed to provide benefit in severe/critical populations.
That’s 573,000+ patients and families who had no hope - a handful of whom I cared for in their final days as these patients poured into Emergency Departments.
Dr. Woodcock, my final request is simple.
I ask you to watch this video:
..it's an interesting thread on yh-0 , not mine.. just putting some positive things here .. balance ;)
$RLFTF (related) thread on Yh-0 by Glunker
I did my own statistical analysis of the data provided in the Previous SSRN Peer Review report. Z-test of Proportions on the various values provided in Table 4 - Day 60 Mortality by Site of Care.
I notice that they never showed a statistic for the total number of Aviptadil vs Placebo patients and deaths across both Tertiary and Regional hospitals (Aviptadil 136 patients, 46 deaths [35.1%] / Placebo 65 patients, 37 deaths [56.9%]).
I ran the statistic for this and got a P-value of 0.00181. However, there is a difference in the actual totals shown in the Placebo Deaths column for Tertiary (23 vs 30 [true sum]) with asterisks noting it.
If you put the seeming 'incorrect' sum value of 23 in the results, the percent deaths is the reported value of 46.2%, and the P-value comes out to be 0.067...just off the mark of 0.05...so it wasn't reported as significant.
7 patients were pulled from the placebo death column for the tertiary hospitals as indicated by an asterisk note in the table.
The result with asterisks are not explicitly discussed in the document other than one sentence with the asterisk that said "However, a significant treatment * site interaction, opposite in sign with site of care was observed and, therefore, Wilks test was used to confirm changes in -2 log likelihood."
I am thinking that "a significant treatment site interaction" was probably death due to nosocomial infection, etc. If so, then all this does is establish even more credibility of the team by not allowing this to skew data in their favor.
Either way, if true counts are played, Aviptadil has a REALLY significant affect on probability of death (Avip=35.1% vs Placebo=56.9% at P<0.00181)...HUGE as we already know.
Just wanted everyone to feel comfortable with the 60 day results. Our team did not embellish...in reality they were extremely conservative in the reporting of their results.
$MSTO .. Get your motor runnin'
Head out on the highway
Lookin' for adventure... brick by brick.. brick by brick..
Penny, that was a copy of a yh-0 post.. not mine.. there were a couple points I liked and was running low on sleep.. ;)
-- RE: 600,000 shares is a lot of skin in the game. I'm at 150,000.
$RLFTF DD (opinion) Post by DanG on Yh-0
Hi fellow longs:
Time for one of my rare posts. I hope it helps.
1. There is no reason to worry based on the stock price. Volume is generally low and the ups and downs we are seeing are not atypical for a bio stock in the absense of concrete news.
2. All of the information we have about the trial results is positive. FDA approval generally takes months for an EUA and the company needs to have all its ducks in a row. DR. J is one of the most experienced people in the world at this and if that does not bring you confidence you really should sell.
3. The trial with Remdesivir is a huge deal for this stock as all past results suggest the results will favor Aviptadil.
4. We don't yet know if the inhaled version of Aviptadil will be effective. That is really the biggest unknown impacting the potential value of the company.
5. My guess is the conflict between Relief and NeiroRx is being driven behind the scenes by BRPA. I am not terribly worried about itbut share the perspective that it is not helping the current share price.
6. I have 600,000 shares and have no intention of selling
In fact I have steadily added shares since I first bought in August of 2020. Would buy more now if I could, although I don't suggest others do so. This is a high risk investment, as are most bio stocks.
That's a Fact Jack !!!
Relief owns the Intellectual Property relating to Aviptadil and has a written contract with NRX. NRX is not some other random "other company", they are our hired contractor with whom we have entered into a profit sharing agreement with. They are not a competitor and well aware of who is in charge at the end of the day. If you disregard the "noise" about some imaginary feud or about naming trademarks or whatever the FUD purveyors spread on any given day, the drug and trials have all produced amazing results and positive news. More results will be coming since the last was entitled "...#1" Nothing to worry about IMO, just waiting.
Best,
JB
I'm not worried.. the contracts and GEM are overseeing these things.. IMO
$RLFTF DD by Bert-Jan Yh-0: NEW locations added:
https://clinicaltrials.gov/ct2/history/NCT04843761?A=4&B=5&C=merged#StudyPageTop
Georgia.. mhh 80-85% cut for Relief.. Thanks :)
$RLFTF (related) NeuroRX on LinkedIN
"The Republic of Georgia's Minister of Health today initiated an expanded access program to treat critically ill patients with COVID-19 respiratory failure with ZYESAMI. NeuroRx was invited to extend its industry partnership with the Republic of Georgia under the auspices of the Richard Lugar Institute for Public Health Research and the National Security Health Policy Center of the Potomac Institute for Policy Studies, in light of the company's partnership with the U.S. NIH. As the world confronts ongoing waves of infection and new variants, NeuroRx is anxious to share ZYESAMI, a proven, lifesaving therapeutic, with critically ill COVID-19 patients in Georgia, the Caucasus region and beyond. Learn more about the partnership: LINK IN REPLY"
$RLFTF (related talk) Interesting talk, with Dr. Samuel Brown talking about the ACTIV 3B trial with Aviptadil and Remdesivir
https://www.abc4.com/coronavirus/intermountain-researchers-part-of-study-aiming-to-help-patients-with-severe-covid-19/
$LWLG Lightwave Logic to Host One-On-One Meetings at the Oppenheimer 6th Annual Emerging Growth Conference
ENGLEWOOD, Colo., April. 28, 2021 -- Lightwave Logic, Inc. (OTCQX: LWLG), a technology platform company leveraging its proprietary electro-optic polymers to transmit data at higher speeds with less power, today announced that management will attend the Oppenheimer 6th Annual Emerging Growth Conference taking place virtually May 11-12, 2021.
Lightwave Logic management, led by Dr. Michael Lebby, Chief Executive Officer, will host one-on-one meetings with institutional investors throughout the duration of the event.
Conference participation is by invitation only and registration is mandatory. For more information on the conference or to schedule a one-on-one meeting with management, please contact Lightwave Logic Investor Relations or your Oppenheimer representative.
About Lightwave Logic, Inc.
Lightwave Logic, Inc. (OTCQX: LWLG) is developing a platform leveraging its proprietary engineered electro-optic (EO) polymers to transmit data at higher speeds with less power. The Company's high-activity and high-stability organic polymers allow Lightwave Logic to create next-generation photonic EO devices, which convert data from electrical signals into optical signals, for applications in data communications and telecommunications markets. For more information, please visit the Company's website at www.lightwavelogic.com.
Safe Harbor Statement
The information posted in this release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by use of the words "may," "will," "should," "plans," "explores," "expects," "anticipates," "continue," "estimate," "project," "intend," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, lack of available funding; general economic and business conditions; competition from third parties; intellectual property rights of third parties; regulatory constraints; changes in technology and methods of marketing; delays in completing various engineering and manufacturing programs; changes in customer order patterns; changes in product mix; success in technological advances and delivering technological innovations; shortages in components; production delays due to performance quality issues with outsourced components; those events and factors described by us in Item 1.A "Risk Factors" in our most recent Form 10-K; other risks to which our Company is subject; other factors beyond the Company's control.
Investor Relations Contact:
Greg Falesnik or Luke Zimmerman
MZ Group - MZ North America
949-385-6449
LWLG@mzgroup.us
www.mzgroup.us
$RLFTF DD by HANS on Yh-0: RLF-100 (Aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP) has been granted Fast Track Designation by the US FDA for the treatment of Critical COVID-19 with Respiratory Failure.
We describe the clinical course of the first patient treated with this investigational medication in an open label manner -- a 54 year old patient suffering antibody-mediated rejection of his double lung transplant who contracted COVID-19 with respiratory failure refractory to all currently available therapies.
He received three infusions of RLF-100 under an FDA-approved emergency use IND. Within 24 hours of the third infusion, substantial improvement in oxygen saturation and radiographic improvement in characteristic COVID-19 pneumonitis was noted.
He was discharged from intensive care at that point and returned home at 1 week on room air.
Replies
Mt:
And no EUA / NDA. This world is crazy.
---
HANS
Our talented team of scientists, determined to do their part to contribute to the fight against the worst healthcare disaster in 100 years, had a brilliant idea to repurpose a legacy compound, RLF-100TM (aviptadil), a recombinant form of a naturally occurring peptide found in the lung - Vasoactive Intestinal Peptide (VIP) - to protect the lung from injury due to COVID-19.
Taking advantage of the extraordinary measures implemented in the U.S. to speed up clinical research for COVID-19 therapeutics, Relief partnered with NeuroRx Inc., a U.S. based biotech that excels at innovative novel therapeutic development for rapid deployment.
Ten weeks from concept to clinic, we began our journey to providing this potentially life-saving drug to critical COVID-19 patients.
$RLFTF (related-opinion) Clinically proven COVID therapeutic https://www.lockhaven.com/opinion/letters-to-the-editor/2021/04/clinically-proven-covid-therapeutic/
$RLFTF (related) DD by fabio on Yh-0 - NeuroRX interview: Min. 42: https://www.podomatic.com/podcasts/technation/episodes/2021-04-27T12_47_49-07_00
$MSTO Brick by Brick.. sleeper
;) ..just copies of good DD.. though my post limit is kicking in.. will post copies of interesting link/posts here as they come as I do on tw--t'er.
.. I hear ya.. hope EUA will put us all in a better perception overall.
tryn2 / E111k, I don't know of one at this point.. most of these are coming from the yH-0 brd, I watch several boards but went on a spree here today.. ;)
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elllk Re: mc67 post# 3896
Many seem to not know what is happening in India.
..so true.. a few other places are also all about finding grave space.. with all the variants .. are we really at the beginning of this?
$RLFTF (related) Sevy Yh-0: We are now over 5 weeks out, first patient treated w/inhaled Zyesami.
Clinical trial NCT04360096.
NeuroRx Announces Dosing of First Patient with ZYESAMI™ in P2/3 Clinical Study for the Treatment of Moderate and Severe COVID-19 (AVICOVID-2)
3-19-21
$RLFTF DD by Fabio on yh-0: Update Turkey Trial: Recruitment has begun.
Sam: The two sites in Ankara were already recruiting. Now, Istanbul followed. Great.
https://clinicaltrials.gov/ct2/history/NCT04844580?A=2&B=3&C=merged#StudyPageTop
tryn2 / n3n :) YW, $RLFTF DD (opinion) by Rich B: Well, the pandemic, in general, is looked upon with the attitude that we are “nearing the end”.
The vaccines have given this false impression, and it is the common spoken word.
In my opinion, this is ridiculous.
Case counts are higher today than ever.
A high percentage of people are refusing the vaccines.
The vaccines’ length of efficacy is entirely unknown.
SARS-CoV-2 has mutated with variants, as viruses do, from the start, and is likely a long term, if not permanent, issue.
I initially viewed investing in Relief or NeuroRx as a short term play.
Now, I believe the opposite is true. When COPD is talked about in conjunction with RLF-100 (and ARDS in general), this has become a long term investment with a great amount of future potential.
Patience will be rewarded.
$RLFTF Zyesami DD (opinion) by Sparks Yh-0: Dr Fauci
Congratulations to anyone who made it here when they heard Dr. Fauci talk about the NIH trial involving Zyesami.
Just a quick rundown on the complicated family that this therapeutic belongs to:
First Zyesami is a US-based trade name for Aviptadil, a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP) - there are many others - RLF-100 being one that Relief Therapeutics uses for outside the US.
Relief Therapeutics is a public company based in Switzerland (RLF on the Swiss Six, RLFTF on the OTC) and owns the patent for aviptadil formulations - they partnered early on with NeuroRX (US based, not currently public but planning to go public through a 'combination' with Big Rock Partners (BRPA, BRPAW, BRPAR, BRPAU) some time in May) to have a US based partner to take it through clinical trials. NeuroRX and Relief have a collaboration agreement where NeuroRX is responsible for the US, Canada, and Israel and Relief is responsible for rest of world - they split the profits in all cases.
NeuroRX's main responsibility has been to guide Zyesami through the necessary trials to get FDA approval starting with an EUA due to the covid pandemic. Since the FDA is very stringent on drug approvals, they wanted to start trials in the US and get approval here first before looking at pushing this out to other countries globally since many of these countries rely on the US FDA for drug approval. They started with an EAP last fall and had some very encouraging results. Dr. Javitt applied for an EUA last fall based on the EAP data that the FDA found encouraging but since it wasn't attached to a blinded/placebo based trial, they said to finish that and come back with those results. It seems that Dr. Javitt applied knowing it would initially not meet trial criteria but would put it on the radar for the FDA keeping them in contact and making it easier once the results from the blinded trial were out.
This double blinded study for an intravenous version of Zyesami finished up recently and we learned that it met all of its primary and secondary endpoints when they shared top-line data. There is a paper out now for peer review - you can find links on this board if you dig a bit or someone could post some links in the reply to this message if you are so inclined. The data is in the final stages of being consolidated and it is either about to be given to the FDA. Zyesami was given a fast-track for FDA approval so the time needed for approval should be shortened.
Beyond EUA which is emergency use authorization, Relief and partners have started additional studies with various groups like NIH, I-spy, etc. for both intravenous and inhaled versions of aviptadil as in order to get full drug approval (NDA) you have to have multiple studies and a good safety database to get full drug approval. On a side note, most people seem to think that the intravenous results will get us the EUA since it was targeting the most critical patients when everyone else was going after moderate to severe, and in the door, but that the inhaled version is the holy grail for this drug for many different lung-related indications way beyond covid.
In the meantime, Relief has partnered with Acer Therapeutics (ACER) to start building a pipeline of drugs beyond Zyesami for some very strange drugs for rare conditions, and they have also been busy ensuring they hold all the patents for aviptadil-related formulations by essentially acquiring all the shares of Advita Life Sciences as they have been working on inhaled formulations of aviptadil as well.
LIke in all dysfunctional families, once that first trial was done and all the endpoints were met and this thing became real, Relief and NeuroRX have been squabbling a bit over money but these are smart people that will get this worked out.
This is my interpretation to give you a quick overview, but if you look at the Relief Therapeutics and NeuroRX websites, you can find all of this info in their press releases.
$RLFTF Dr Fauci from transcript: And then, finally, there’s a clinical trial of therapeutics for severely ill individuals. It’s randomized. It’s blinded. It’s placebo control. And it’s going to study Zyesami which is a synthetic version of a vasoactive peptide and remdesivir alone and in combination against a placebo
So, as you can see there are a number of things going on right now in the area of therapeutics. And as we go along the weeks, months to come we’ll be updating you on not only the clinical trials but any important results that have come
Dr. Javitt made 4 comments on LinkedIn yesterday afternoon to clear things up.
https://twitter.com/KarenKEL111777/status/1385934392388952070/photo/3
$RLFTF Bert-Jan Yh0 All sites are now recruiting, let's go!
https://clinicaltrials.gov/ct2/history/NCT04843761?A=3&B=4&C=merged#StudyPageTop
$RLFTF Dr. Anthony Fauci Confirms ZYESAMI Phase 3 Trial with Remdesivir at Press Briefing by White House COVID-19 Response Team
PRNewswire April 26, 2021
https://amp.benzinga.com/amp/content/20791635
$RLFTF DD awareness by Dustin over a site move on the 23rd:
Updated Friday, ..we're on the front page now.
https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-therapeutics-tracker
$RLFTF (related) DD by Rian Yh-0: Did we already know about research in UK?
https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=203190