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In a letter to NIAID Director Anthony Fauci and FDA Commissioner Robert Califf, Sen. Ron Johnson (R-Wis.) demanded to know why public health officials ignored three Emergency Use Authorization (EUA) requests from the drug manufacturer, NRx Pharmaceuticals, and refused to review data on ZYESAMI’s efficacy against COVID. The letter, co-authored by Sen. Ted Cruz (R-Texas) and Reps.
The Republicans are requesting answers to the following questions to better understand the FDA’s decisions regarding an EUA for ZYESAMI:
1. Please provide a timeline of FDA and NIAID actions to review ZYESAMI as an
emergency treatment for COVID-19.
2. Please provide documentation of any communications between FDA or NIAID and
physicians or hospitals that are utilizing ZYESAMI under Right to Try.
3. Has the FDA ever accepted the data of ongoing clinical trials when issuing an EUA for a
treatment for COVID-19? If so, please provide the treatment and its EUA.
4. Please explain why the FDA refuses to review ZYESAMI data until completion of a
clinical trial.
5. For COVID patients that received remdesivir and steroids but did not recover, what is the
FDA and NIAID’s current treatment recommendation?
They have asked for a response from the FDA and NIAID no later than 5:00 p.m. on March 17.
In a letter to NIAID Director Anthony Fauci and FDA Commissioner Robert Califf, Sen. Ron Johnson (R-Wis.) demanded to know why public health officials ignored three Emergency Use Authorization (EUA) requests from the drug manufacturer, NRx Pharmaceuticals, and refused to review data on ZYESAMI’s efficacy against COVID. The letter, co-authored by Sen. Ted Cruz (R-Texas) and Reps. Andy Biggs (R-Ariz.) and Chip Roy (R-Fla.), cited a physician who treated more than 20 patients who were suffering respiratory failure from COVID-19, and received ZYESAMI as authorized under Right to Try.
Full article...
https://amgreatness.com/2022/03/09/in-letter-to-fda-and-niaid-ron-johnson-demands-to-know-why-promising-late-stage-covid-drug-was-never-approved/
pegs1
JJ probably felt that the current EUA application has some weaknesses, and rather than WAIT for potential rejection....include the BTD to improve the odds of success. That's my guess.
I feel that the bigger story for RLFTF (over the short-term), and one that has higher odds for success, is the June 5, 2022 PDUFA event. With full FDA approval for ACER-001 (to treat Urea Cycle Disorders), that paves the way for new revenues for RLFTF. We could see a pps boost if all goes well with that initiative.
https://www.acertx.com/2021/10/06/acer-therapeutics-and-relief-therapeutics-announce-fda-acceptance-for-filing-of-new-drug-application-for-acer-001-to-treat-urea-cycle-disorders/
I don't know. I'm hopeful that this week we'll get an update.
JJ stepping down...... so I wonder how this impacts the law suit?
https://ir.nrxpharma.com/news-events/press-releases/detail/120/nrx-pharmaceuticals-announces-leadership-transition
Until Tim finds a partner we will continue to see dilution to pay the bills. I fear that if he is flat bought out, the new owner will r/s on day 1. So let's hope he doesn't sell the company. He needs funds via a partner to keep this motor running.
I think if Tim had secured phase 3 funding via a partner that he would have PR'd that.
A2Z, I'm also looking at TSOI as a long-term play (not swing or otherwise). I normally do not do that with a high O/S penny stock. However, Tim has gone 'on record' stating that a R/S will never occur 'on his watch'. Of course it would be impossible to hold him to that, but nevertheless, his position on that is something of value (until further notice).
A2Z, I tend to agree with you. Last fall there was a lot of optimism regarding initiation of EUA phase 3 clinical trials. Then radio silence from management. IMO I believe the delays are related to lack of $$ to pay for everything that the FDA expects to successfully carry out a clinical trial. Tim even commented on the high $$ of FDA trials on his forum a few months ago. The pps is too low to generate adequate funds. Not to mention the fact that the O/S is already in the stratosphere. So, Tim is not being transparent with the SH regarding the delays with the EUA trials.
So, we need an official PR to update the SH on the progress with phase 3 trials. After all, he started this conversation last year.
Up 75% today. Nice
skiluc. Thanks for the succinct summary. And we can assume that QNTA will take until April 15 because they are operating on a lean/mean staff to help contain expenses.
They have a pattern/history of exploiting the SEC extensions. Lots of legit companies on the OTC do that. They just have a lean staff. No concern IMO.
Jedi...that's great that Mikaelian is replying to your inquiries!! Thanks for share! It's important that they communicate with the SH considering all of the challenges that they are up against. A simple AK that the name change, ticker change, and the Mexico venture are all still WIP would suffice.
It wouldn't be an issue so much with me if they had 'not' inserted that R/S clause in their financial statements last fall. So we know that it has/is clearly been on their minds.
skiluc.. until the low O/S and float situation dramatically changes, it's the one fundamental element of QNTA that presents hope and huge potential!
The company needs to dilute to pay the bills, and doing so with the pps in subpenny land can quickly trash out the O/S and float.
Therefore, the company does need to make (and communicate) more progress on the sales fronts (ex: Mexico) as well as the FDA trial front. They need a higher pps to dampen the adverse impact of diluting to pay the bills.
I too have played down the importance of the SEC investigation. It's the radio silence and their lack of IR response to my inquiries that has been raising the flag.
When you emailed the company, did you use the IR email address?
I'd check out Dragon Lady's post. She elaborated a bit more on the topic. Her post is that the top of this stack.
Skiluc... During the fall of 2021 (Q-3 QNTA 10-Q filing) they reported that they are being investigated by the SEC. After that announcement, it wasn't long before QNTA fell into 'radio silence'. It's been downhill on the pps ever since. I am just speculating that their lawyers have instructed them to stay under the radar until the SEC investigation is complete. I sure hope that I'm wrong on that. QNTA claims that they have not broken any laws, and are confident that the company will prevail.
I emailed QNTA Investors Relations 2+ weeks ago asking if they are still pursuing a name change and a ticker change. I received NO response. In the past (on several occasions in 2021) they were very quick to response to my inquiries. Here is an email that I received from IR on November 15, 2021...
---------------
Hello XXXXX,
Thank you for reaching out. Yes, the paperwork has already been filed with FINRA and we are still waiting on them.
We always appreciate your support!
Thank you,
Pauline R
My thinking is that the ongoing law suit may be responsible for the delay in name and ticker change. Possibly they are in some trouble with that suit. After all, for a while there last year they were pulling out all of the stops to make the SH happy. Then 'radio silence'. Just speculating.
Hopefully the posters here are keeping a look out for a resurrection of the R/S in the financials.
I wonder if "Dragon Lady" has cashed out?
I emailed the I.R. dpt at QNTA a little over 10 days ago ask them if there is still a plan to change the ticker symbol and have a name change. They never replied.
For those that are a little technically/legally savvy (I am not), here is some good food for thought on how to potentially 'predict' the outcome and/or progress of the upcoming mediation. Mopar is a seasoned, practicing attorney:
Mopar — Today at 11:02 AM
I hope the Mediator is successful tomorrow. I will be watching the docket filings on Thursday (24th) to see whether another continuance of the briefing/hearing date is filed or if the reply brief is simply filed along with having the hearing proceed as scheduled on Friday (25th). If another request for continuation is filed then that indicates that either an agreement has been made or they are making meaningful progress toward a settlement and need more time to reduce it to a writing and/or work out some details. If the JJ/NRXP reply brief is filed and the hearing proceed as scheduled then it indicates there is no agreement or no meaningful progress toward a settlement occurred on 2/22/22. This has been past normal experience in mediation but nothing about this litigation has been normal . However a settlement can occur at any point during litigation so it’s not just limited to the small window of mediation. I would love to see them use the 2/25/22 hearing date to read an agreement into the Court Record on the date. In my opinion, there hasn’t been enough Chess pieces captured to pressure the parties to settle until after discovery has been completed but anything is possible. I’m just thinking out loud. Good luck to us all!
https://iapps.courts.state.ny.us/nyscef/DocumentList?docketId=pgGwqeBmpZCRBLxrnghRIA==&display=all
Shouldn't JJ have reported out on the outcome of the inhaler trial that was scheduled for completion on Dec 31, 2021??? The recruitment status still reflects "recruiting". If they are still recruiting, then why hasn't the end date been pushed out?
https://clinicaltrials.gov/ct2/show/NCT04360096
pegs... I want to make sure that I have not misled you. I picked up the video link from Joey Johnsons FB page. Someone posted the FOX News video there which links to a youtube video. I did not personally witness it happening on TV, however this video led me to believe that Hannity did air it on TV. You tell me. Here is the link. Hannity kicks of the discussion talking about new yearly jabs, then leads into the undercover videos.
pegs.. I'm not sure if you know about it, but Sean Hannity ran the story today!! on Fox TV. He played back parts of the videos, and called it 'bombshell' news.
Mopar on discord (attorney) description of typical mediation format. I wish I were a fly on the wall next Tuesday (2/22/22)!!
-------------------------
MOPAR.....
My guess is that the defense lawyers were initially paid for mediation only and are still trying to get money out of JJ. They kicked the can down the road until after mediation. If mediation fails then the defense lawyers will want to get paid to litigate the case to an end. Remember an answer to the petition has not been filed yet as that’s when the attorneys are obligated to stay in the case. I would love to be in the room when the mediator brings over the initial offer from JJ. I’m sure it’s going to ridiculous and cause laughter. Lol
Mediation typical format: 1.) initial meeting of all the lawyers and litigants in one room with the mediator and there is a reading of the petition and what relief is being sought by both parties; 2.) then the parties with their respective lawyers are put in separate rooms; 3.) mediator goes to defendant to see what are they offering in respect to the demands of the plaintiff; 4.) mediator takes defendants’ offer to the plaintiffs and ask if acceptable or give a counter offer; 5.) this continues back and forth until there is a settlement or it’s determined the parties are too far apart to compromise in which case mediation ends; 6.) if there is an agreement then the mediator reduces the settlement to written form, it’s signed by both parties and notarized; 7.) the notarized written settlement is read into the record in Court and reduced to an enforceable Judgment that’s signed by the Judge after verbal acknowledgment of the agreement/signatures is done in open court by both parties in front of the Judge.
There are more long-term 'user fees $$' (billions) for the FDA with annual Pfizer vaccine shots than there is with a potential covid cure like Aviptadil. Money talks. Congress should get involved to put a stop to this FDA corruption.
This looks like a stall tactic. JJ is seeking the extension until after the Feb 22 median date. What' he up to? This request was posted today. I don't know the significance of it though.
Kent A. Yalowitz
+1 212.836.8344 Direct
Kent.Yalowitz@arnoldporter.com
Arnold & Porter Kaye Scholer LLP
250 West 55th Street | New York, NY 10019-9710 | www.arnoldporter.com
February 15, 2022
VIA NYSCEF
Hon. Jennifer G. Schecter, J.S.C.
60 Centre Street, Room 228
New York, NY 10007
Re: Relief Therapeutics Holding AG v. Javitt, No. 655857/2021
Letter Request for Extension of Time to Respond to Plaintiffs’
Omnibus Opposition Memorandum
Dear Justice Schecter:
We write on behalf of Defendants in the above-referenced action to request an
extension of time to reply to Plaintiffs’ omnibus opposition memorandum, currently
returnable in Room 130 on February 18, 2022. Specifically, Defendants seek a one week
extension of their deadline to respond from February 17 to February 24. Accordingly,
Defendants also seek a one week extension of the return date from February 18 to
February 25.
Plaintiffs consent to this request.
Respectfully,
/s/ Kent A. Yalowitz
Kent A. Yalowitz
cc: All NYSCEF Counsel
FILED: NEW YORK COUNTY CLERK 02/16/2022 02:31 PM INDEX NO. 655857/2021
NYSCEF DOC. NO. 95 RECEIVED NYSCEF: 02/16/2022
1 of 1
JJ will create a fluff PR out of nothing.
pegs, it's my understanding that mediation begins on Feb 22, and the judge will make key decisions on Feb 18 regarding how mediation procedures will proceed which includes decisions on motions that were filed by the parties. So we wait and see how things unfold.
Pegs.. my only concern is that the WIN you speak of won't occur until after ADR Conversion. We need a major win before ADR Conversion IMO. And no one has the crystal ball as to when ADR conversion will occur.
pegs1... Bob just posted GREAT news for aviptadil!! See his post.
Joe, the attorney who posted that message is also of the opinion that we should be in very good hands with the designated judge (Schecter, Hon. Jennifer G). He posted several hearing outcomes of hers that demonstrated that she is no fool, and she can be tough with the law. So that should bode well for RLFTF.
Joe, That's an interesting question. But I do think that NeuroRx, Inc. existed when the CA was signed...it was just not a public corporation.
The prevailing thought is that JJ will have a lot of questions to answer due to ALL of his communications being revealed via formal, legal 'discovery'.
An attorney's perspective on the upcoming 2/22/22 mediation.
----------- posted on 2/9/22
I agree that meaningful mediation does not look hopeful. There are two rulings I anticipate against NRXP that will cause movement; 1) an order maintaining personal jurisdiction over JJ and 2) an order granting access to all financial records, formulation records, clinical trials data and FDA applications submitted along with all FDA response communications to Relief through discovery. These rulings will put Relief’s lawyers in a position to shoot fish in a barrel for the remainder of litigation. JJ wants to be personally excluded from the lawsuit before the mediation on 2/22 to decide on his play for mediation by assessing his personal risk. If those financial records contains what I believe they do and the court denies the motion to dismiss then things will start to move. Mediation is a formality that most courts require you to atleast attempt before moving forward with litigation. Due to overloaded dockets and case loads especially due to post-Covid backlogs , courts use this tool to encourage settlement whenever possible to lighten case loads. The ruling from the hearing on 2/18 will be very important to start the dominoes to fall!
I only factor in uplisting if there is other 'significant' news occurring at the same time as the R/S. To put a floor under the new higher pps, a catalyst is required. Otherwise there is almost always 'southerly drift' in the pps as mgmt dilutes to raise capital. There are exceptions of course, but few and far between IMO.
The R/S is almost never a good thing with a penny stock flirting with sub-penny (as this stock). Next phase will be dilution to raise capital by the insiders, hence pushing the PPS down and down. That's how they operate in penny land. It is what it is. The SEC turns a blind eye. I got in at .06 and out at .10, I only tracked this penny because I suspected that the R/S was in the cards.