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I think these delays work to JJ's benefit. He'll be able to salvage a great deal on his own behalf. However, if it goes to court and the judge rules against him personally, he will pay dearly. JJ won't let it go to court though I'm sure.
JK, my question is ....does the 90 day clause imply that the June 8, 2022 hearing date is now pushed out? They still list that date under "Appearances" though.
Yes, this was posted on 4/1/22 under "Show eFiled Documents" at this link. You have to do a "Party Search" first on "Relief Therapeutics". Great to show some progress.
https://iapps.courts.state.ny.us/webcivil/FCASSearch
They have to dilute to pay the salaries/bills, so at this rate I suspect we'll see an R/S sometime this fall.
DollarSquad..looks like you blew that call. They uplisted to the NASDAQ just 2 months after you made that comment. It is what it is.
Just waiting for the FDA established June 5, 2022 PDUFA!
JK, I agree. Also, here is Dr Joey's read on the inhaler trial failure for severe COVID.
Joey Johnson
Author
Samantha Buffong Scheurich Excellent question! This is what Relief Therapeutics' intentions were. However, NRXP wanted to go for severe and critical patients. If you notice NRXP's other trials for inhaled form are also scheduled for severe/critical, but the ones for Centurion and Dr. Leuppi (the two inhale trials for Relief Therapeutics) are both for prevention of ARDS or to treat earlier symptoms of COVID-19. So there seems to be a conflict of understanding and interest between Relief and NRXP regarding at what stage the inhaled form should be applied.
PB, I've always felt that this CEO cares more about shrooms than the covid therapeutic. There's never been a sense of urgency with him on this. How does that saying go...."slow you blow, snooze you lose".
changes.. that's pretty amazing that the NY Times actually took action off of your letter! Nice Job!
ReviveThomas.. It's just my opinion, but I provided an estimated overall time line a few months. Based on this new estimate from RVVTF today, and my painful experiences with bitotech and EUA, my new projection is:
- July 1, 2022. Enrollment complete.
- Sep 1, 2022. Finish trial from new enrollments.
- Dec 1, 2022. Collect, organize, study, raw data. Package & sub EUA.
- Mar 1, 2023. FDA reviews and makes a decision on EUA.
This assumes there are no snags (ex: FDA request more data, hence trial is extended, pandemic formally over, etc.)
Unfortunately, this timelines will put downward pressure on the PPS while investors patiently wait. The FDA processes are always slow and painful for investors, unless it is BP. JMHO
I have not studied all of Tim's forum posts over the past 60 days or so.
Has Tim indicated YET where the $$$ will come from to finance the FDA trial? When I asked him that question on the forum over the winter he refused to provide a definitive answer.
Sure, if you are a long term investor, and you have not yet used up all of your powder to enter. However, there is risk of this swinging/dipping sub-penny as investors wait for more news over the coming months. Those types of price swings are meaningless for those with 'nerves of steel'. Unless Tim executes an R/S this summer/fall or in 2023 to raise $$. Everyone must make the risk/reward tradeoff themselves. JMHO
Todays PR is NOT a fluff PR.
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The Board of Directors has selected Biorasi as the contract research organization (CRO) to run its Pivotal FDA Registration Clinical Trial assessing efficacy of its JadiCell™ Adult Stem Cell Product in patients with advanced COVID-19.
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This is important news!! TSOI is getting the ball rolling by contracting with Biorasi.
Having said that, there is a very long and hard road to hoe here. The phase 3 trial could take 3-12 months to run, and another 3 months to compile and format the raw data before submitting an EUA application. Then another 3-6 months for the FDA to get around to reviewing the application and making a decision. IMO, most likely the COVID pandemic will be over by then. However, there are many other uses for JadiCell. This is a long term investment.
Of concern to ME is.... where will the $$$ come from to pay for this FDA trial? The O/S and float is already grossly too high which makes it ripe for a devastating R/S. Yes, I know....Tim swears that he will never do an R/S 'on his watch'. Do we trust his word on that? I don't. I would never trust any CEO's word of any penny stock. I will be watching carefully at where the $$ funding is coming from. If Tim pulls in a 3rd party investor to finance the FDA trial, that will make me very happy as a long term investor.
Flippers will come and go and they will milk the stock price swings over the next couple of years. Traders will make AND lose $$ day trading and swing trading this stock. And we will often hear them cast their opinions here as they come and go. That is power for the course, and goes without saying. As they say, if you can't stand the heat (or don't like to cook), then one should get out of the kitchen.
JMHO
I think that the attorneys have pretty much put a 'gag order' on management until the SEC investigation is behind them.
Complements of Dr Joey. Aviptadil is mentioned in the 1st paragraph under "4 Discussion" (near the end).
https://jlb.onlinelibrary.wiley.com/doi/10.1002/JLB.5COVA1121-626R?fbclid=IwAR14bTF2T03kftjFa-K39e1wswg0aCV1DA7G1ajN_N3cwDEpHioO-L8zCZY
My previous post implies that the FDA did not yet comply with the March 17 Congress deadline.
Important excerpt from recent Form 20-F filing:
As of June 30, 2021, we had cash and cash equivalents of approximately CHF 18 million, following the payment of CHF 21.5 million in cash to the shareholders of APR at the closing of that acquisition. As of March 11, 2022, we have cash and cash equivalents of approximately CHF 36.5 million.
Based on current financial current projections and available cash, we expect that we have sufficient resources to fund operations through the first half of 2023, assuming timely approval of ACER-001. We also expect that with a successful launch of ACER-001 and the potential expansion of our Golike franchise into the United States, we could reach operating cash flow-positive operations during 2024. This could also be positively affected if we are successful in obtaining an approval to market RLF-100. There can be no assurance whether our estimates will be accurate or whether we will ever achieve cash flow-positive operations.
A new post from Mopar (a vested attorney)....
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Mediation is a set event that has a starting point and ending point where a mediator is paid per hour for his/her services. However settlement negotiations only require the two parties to talk at any time. It’s my opinion, Mediation was over the day it was scheduled however I believe they are in settlement discussion amongst themselves currently and it’s ongoing. I also believe they have outlined a course of events that each side must perform to continue settlement talks. I believe the removing of JJ was one of those requirements.
I believe NRXP understands that they are liable for JJ’s past action. I believe their lawyers advised them that their motions to dismiss/strike would not survive. The retirement/consultation contract with JJ was purposefully thought out by legal counsel to cure any future liability claims so I don’t think they are waiting on June to negotiate as that indicates they know the facts/law is against them thus the moves were made.
Whether JJ stays a defendant has no affect on any settlement agreement. It only matters if there is no settlement. The issue has a bearing on the scope of the discovery and damages if there is a trial.
*This is not legal advice nor financial advice just opinions/notes to myself. For entertainment purposes only
The failure of Sentinox will only make the success of RLF-100 all that more profound!!
Airlines Recovering from COVID....
https://www.cnbc.com/2022/03/15/airlines-raise-revenue-outlook-as-travel-demand-jumps-fuel-costs-jump.html
change...a little current event...
CatchTheCleanUpSet — Today at 9:40 PM
So I noticed that Ted Cruz hasn’t posted anything about the letter to Fauci/Califf on his Twitter account (4.7 M followers). However, Biggs (385K), Roy (91K), and Johnson (328K) have posted on their Twitter accounts. I just messaged Ted Cruz to say thanks for his efforts, and politely asked him to post something about the letter on his Twitter feed. It would help if everyone else did the same: https://www.cruz.senate.gov/contact/write-ted
I just obtained the letter that was sent out. Formatting may be a little goofy, so you will need to reformat and customize it as it being sent by you. I had to recopy/paste in a couple of the links.
-------------------
I’m a ________ that has done an extremely extensive amount of research on a Covid therapeutic called Zysami (aka Aviptadil). The bottom line is that the drug works against Covid for the critically ill where no other drug is proving to be effective. The data has proven it stops cytokine storm (correlated to saving lives!), immediately improves blood oxygen levels (it heals the lungs and saves lives!), decreases hospital/ICU time (median 10 days), and ultimately decreases mortality (it saves lives!). Several leading statistical consultants and regulatory law firms have assessed multiple Zyesami drug trials (including a Phase 3 clinical trial: placebo controlled randomized) and believe that Zyesami has proven that it meets the legal standard for Emergency Use Authorization (EUA) to be “safe and may be effective” as mandated by Congress. However, the FDA has been dragging their feet on reviewing the EUA applications, and has denied an EUA twice over the last year. The thrid EUA application (filed 1/4/22) is currently under review still. Senators Ted Cruz and Ron Johnson along with Congress Members Andy Biggs and Chip Roy have recently written a letter to address this issue. The letter was addressed to Robert M. Califf, M.D. (Commissioner U.S. Food and Drug Administration), Anthony S. Fauci, M.D. (Director National Institute of Allergy and Infectious Diseases), The Honorable Xavier Becerra (U.S. Department of Health and Human Services), and Acting Director Lawrence A. Tabak, D.D.S., Ph.D. (U.S. National Institute of Health) which can be seen here:
https://www.ronjohnson.senate.gov/services/files/437F18E0-4C3D-4376-B535-629B040E3BC2
The data shows that this drug saves lives. Yesterday ~1500 Americans died from Covid. Please look into this to help save the lives of your constituents. “We The People” need your help. Please make savings lives a bipartisan goal and join the senators/congressmen listed above in running this to ground. You could help get visibility that this drug will have a profound impact on fighting Covid. Thanks, _ PS. As one example of the drug saving a patient under the “Right to Try” Act, please see this article about Dr. Elgozy MD who was on his death bed from Covid and scheduled for a double lung transplant. He took Zyesami and improved so quickly he called it a miracle and he wrote an Op-Ed to his local newspaper: https://wsvn.com/news/local/miami-dade/miami-beach-doctor-recovering-from-covid-19-after-taking-new-drug/
Here’s his Op-Ed: https://miamicourant.com/stories/617928153-op-ed-the-emergency-use-law-should-be-used-for-emergencies-like-now
WSVN 7News | Miami News, Weather, Sports | Fort Lauderdale
Rubén Rosario
https://wsvn.com/news/local/miami-dade/miami-beach-doctor-recovering-from-covid-19-after-taking-new-drug/
MIAMI BEACH, FLA. (WSVN) - A South Florida doctor who was in critical condition after he contracted COVID-19 is making a remarkable recovery, and he...
Miami Courant
https://miamicourant.com/stories/617928153-op-ed-the-emergency-use-law-should-be-used-for-emergencies-like-now
Imagine you have a loved one hospitalized in intensive care facing death from Covid-19. All approved therapeutics were tried. Time has run out and you have been told to prepare for the worst. Your doctor advises there is one last drug to try, a natural protein that has been safely used in early trials and shown signs of effectiveness in rescuing...
changes... you may find this post helpful. Here is his follow-up post today. He is "On a Mission" !!!
CatchTheCleanUpSet — Today at 4:35 PM
I just sent out the same letter I wrote to Bernie and Trump. That makes 57 senators, house reps, governors so far. If anybody wants the letter to use as a template to edit and make their to send out to their elected officials, newspapers, etc, please let me know. Here’s the contacts link to Bernie and Trump:
https://www.45office.com/info/share-your-thoughts
https://www.sanders.senate.gov/contact/
posted by an assertive poster on discord....
I just got a phone call from the Congressman Bill Posey’s Chief of Staff in regards to the letter I sent out yesterday to 55 governors, senators, reps.
He said he read my letter and the letter from Ron/Ted/Andy/Chip and that they agree with it. He said they will send out a letter of their own saying that they’d like to sign the Ron/Ted letter. He also said Bill Posey has worked with Ron/Ted before on similar issues and would’ve signed this letter originally if they had known about it. He also mentioned that the more people that sign that letter will help put pressure to get an answer. How cool is that? Everyone should reach out to their elected officials.
As long as QNTA can stay out of trouble with the SEC, and they don't destroy what is now a very sweet float and O/S, then I'm willing to HOLD this for 2-5 years to give it chance. After all, anything involving the FDA takes time. And technically, QANTA does NOT need the FDA to succeed.
My biggest issue with Fauci is that he lied to the public about the efficacy of masks against COVID. He told the nation that masks don't work, when he knew in fact they did. He did not want the common layman (us) buying masks and thus creating a shortage for hospital staff. So, he lied to the public to serve a hidden agenda. He should have told the truth, and asked the public to be conservative with their purchases of the masks.
If he lied to us about that, then what else has he lied to us about??
It's interesting that at one time over a year ago he talked about Zyesami on national TV, then.... radar silence.
IMO Zyesami has been snuffed out because the ONGOING purchase of vaccines (yearly) will generate more "FDA User Fees" for Pfizer and Moderna than a one time fix eith Zyesami. So Fauci and the FDA felt the pressure from Big Pharm. Money talks! This is not rocket science. Congress needs to get involved.
On the other hand, this may provide the NEW FDA commissioner (Robert Califf) an opportunity to put a feather in his hat.
QNTA has most likely been advised by their lawyers to NOT issue any statements related to the ongoing investigation. Hence, I'm not reading much into to their silence related to the investigation.
However, I don't see why they cannot issue a PR updating the SH on their marketing progress with DR and Mexico, and well as their FDA trial efforts.
I agree. I suspect the same.
I emailed their IR with that question several weeks ago (twice) and they never replied back.
Copy of the March 3, 2022 Letter from Congress to the FDA & Fauci regarding Zyesami:
https://www.ronjohnson.senate.gov/services/files/437F18E0-4C3D-4376-B535-629B040E3BC2
JT, I'm not interested so much in the letter itself, as I am when/if the FDA replies to it. That's a big IF though. Let's see if Congress has any weight with the FDA.
JT..haven't you read the letter from Senator Johnson to the FDA and Fauci. Here is a repost.......
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.
[color=red][/color]
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/
changes..yes, it looks like the poster left off the 2nd half of Dr Joey's post.
So, things could get very interesting between the March 17 GOP letter deadline for the FDA, the June 5 PDUFA date, and the June 8 trial date. Then we have the BTD and EAU applications, and the mediation efforts all occurring somewhere in the middle.
Update from Dr Joey on FB....
Good Morning Everyone,
Just a quick update from Washington, these next two weeks are going to be HUGE regarding aviptadil. The Repubs are mounting a full attack on NIAID division of NIH and demanding answers from Dr. Fauci specifically about our drug! They will be giving him a deadline to respond regarding why ZYESAMI has not already been approved. Deadline is most likely set for the next two weeks.
They are also considering not signing for any more COVID funding to be approved until we get answers about this. I'll keep y'all informed about the developments. For added background, This was part of the reason the Dems had to remove the request for additional COVID (vaccine) funding from the recent Ukraine financial aid bill that just got approved.The Rebubs want an update on more COVID therapeutics first! They are telling Fauci it is time to stop focusing on vaccines now and approve more therapeutics... and trust me, they are using ZYESAMI as their flagship example of one that is ready for approval but has been ignored by both Dr Califf ( FDA) and by Fauci (NIAID).
Don't give up yet! Nothing has changed! We have (most likely) been held back by certain individuals with certain ulterior motives. But I don't want to speak to that as facts just yet. It's under investigation. But, it will all come to light soon though! We are on the precipice of something HUGE! Ted Cruz, Ron Johnson, Chip Roy, Gov. DeSantis, Rand Paul and many others are getting involved! We're pushing this thing like I said would happen in March.
Some of yall may remember from the Discords that I offered for anyone who wanted to (or who was able to), they could come with me this month to push something like this. If this gets approved from this push, I would like to ask this aviptadil community to please sign a virtual letter of thanks that I write to all applicable parties involved. I will personally deliver it to them and take pictures for us. God bless! And good luck ?? with your investments!
Changes_iv.... great summarization!!
Joe, that attorney has $250K in RLFTF, so he has a lot of skin in the game. So, he is closely watching events as they unfold. I am invested in both RLFTF and NRXP, which some traders refer to as potentially excessive correlation. Although my skin in NRXP is minimal.
Per the discord site...
The hearing date for both motions has been set for June 8,2022 at 11am from information I received. My thoughts are that given the length of the delay on the hearing date, coupled with the news of JJ’s retirement from the ceo position, I believe the parties are giving themselves time to continue settlement negotiations and gather/process information. People like JJ who have had success being a certain way don’t usually just suddenly stop their behavior so again to not be a Debbie Downer I’m being cautiously optimistic with an inside smile on my face until I see a judgement signed by the Judge. Just my opinion. Hopefully by June, we will see a lot of great things happening with everything in our pipeline all at once.