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Panton... right. Efficacy of the drug (ACER-001) is not the question. Somebody was sleeping at the wheel because the FDA requested to inspect the manufacturing plant and ACER was totally unprepared for that inspection request. Hence.... the delay. ACER believes that they will have the plant ready for FDA inspection within a month or two.
But IMO this shows a level of incompetence (both RLFTF and ACER) that is very disappointing. Considering all of the negative news related to aviptadil (NIH trial, law suit, etc), I would think that management would have pulled out all of the stops to make sure they were ready by the June PDUFA date. Let's hope they have their ducks in a row for the FDA inspection. Both RLFTF and ACER "NEED" this ACER-001 win!!!!
There is speculation that the NIH study design and execution was not suitable for aviptadil and COVID-19. RLFTF is waiting for NIH to release all of the raw data so that they can figure out what went wrong so that they can determine 'next steps' for aviptadil in Europe and ROR. It looks like median failed with NRX, so it looks like they will be going to court.
I think at this point EUA for aviptadil is dead. NDA approval for some other application could well be in the cards though, but that won't happen anytime soon.
IMO RLFTF needs to obtain all of the raw data from NIH, and then move forward with aviptadil in the ROW without any reliance on the FDA. ACER-001 needs to get approval to help with the revenue flow.
There is still the Swiss inhaler study which will soon be releasing their results which could influence RLFTF's next steps with aviptadil. JMHO
panton...what does this have to do with RLFTF?
Jedi.. Excellent Post !!!
JK..I sure hope that ACER-001 FDA approval occurs before the forced 1 for 150 ADR conversion. The cards just don't seem to fall right for RLFTF shareholders.
2,000,000 shares were purchased at .0005 at 12:03 PM
2,000,000 shares were then sold at .0005 at 12:04 PM
Totaling 4 million shares traded in over a period of 2 minutes.
A fool with his money?
There is no need to panic and dump shares at this juncture. What's the point. One can sell shares anytime 'this year' and it still is a tax write-off for 2022. IMO best to hold and hope for a lucky draw.
Ditto!
I think what we are seeing here with QNTA is more about insider incompetence with following SEC reporting requirements, than we are with mgmt defrauding shareholders. This is not a shell. They have a product. What they lack is expertise in following formal SEC regulations. The question is.... "can they fix this". IMO they need to hire an expert to turn things around. I know I'm singing to the choir, but it's always wise to have a diversification strategy with trading with pink sheet stocks. I learned my lesson with that a long, long time ago.
Yes, that is a great strategy for separating out the relevant information from the irrelevant, or the constructive from the destructive. In some cases, it is the only solution.
Once (if) QNTA puts the SEC investigation behind them, we will most likely see the PPS rise out of sub-pennyland. So for those willing to take a little risk, patience is a virtue. A scorched earth policy is not in the best interest of incumbent SH.
JK...we could use another PR from RLFTF outlining what their 'next steps' (strategy) is once they obtain the NIH trial data.
JK... I wonder how many $$ Fauci personally has invested in Paxlovid. Call me Cynical.
If they were trying to sell the company then it would behoove them to seek the highest price possible.
I have lawyers in my family tree. It is what it is. They don't want you talking or saying anything related to the case for fear it will jeopardize your case. I suspect that due to the investigation a lot of the CEO's initiatives are placed on 'hold' so that he can focus on his rebuttal to the SEC. That's what I would be doing. Time will tell all. But we all would like this investigation to get behind them ....no matter the outcome.
Any good lawyer would tell their defendant to 'zip it up' while an investigation is on-going. Maybe we'll learn more as we get closer to the 2 week deadline.
In addition, the SEC has a terrible track record with bringing justice to the OTC. The OTC is a graveyard of littered fraudulent pennystock scams that eventually die under their own weight --- with absolutely no help from the SEC. IMO the SEC chose to pick on QNTA to make a political point. It has nothing to do with justice. It's a waste of tax payer money when there are much bigger fish to fry.
Folks that judge before seeing all of the evidence would make very poor jury members. Innocent until proven guilty. That's the law of the land.
I say..... let them have their day in court. Innocent until proven guilty. The SEC occasionally must prove their net worth, so they go after the little guy who has little resources to defend themselves.
Over the years I've seen many, many other penny stocks that have clearly defrauded the investors by pumping and dumping followed by an R/S. They then repeat the cycle (R/S, pump and dump). Yet the SEC seldom ever goes after those fraudulent schemes. Sometimes the SEC investigations are political in nature.
It's government. Just like the FDA approving COVID vaccines with very little testing (NO long term testing), yet they almost never approve a COVID therapeutic. Why does the FDA do that? Because they receive very lucrative "User Fees" based on drug sales. So they have a corrupt incentive to approve drugs from big pharm like Pfizer over the little guy. It's government which can be very disfunctional. JMHO of course.
pegs1, due to the NIH trial failure, I have assumed that NRXP has abandoned EUA for aviptadil. They have PR'd that they are focused now on their other drug. However, there are other ongoing studies (ex: Swiss inhaler trial) that could prove promising. However, IMO that study is too underpowered to pursue anything with the FDA. But the inhaler version of aviptadil could have some viable applications for RLFTF downstream.
We know that RLFTF is waiting to get their hands on the NIH trial 'data'. So we'll have to wait and see what RLFTF thinks about that data.
I feel that obtaining FDA approval for ACER-001 is the next significant milestone for both RLFTF and ACER. That should give both PPS's a small lift. They need to get past the FDA "inspection" milestone first. What a blunder that was!
What is an SEC Wells Notice?
A "Wells Notice" is a letter sent by a securities regulator to a prospective respondent, notifying him of the substance of charges that the regulator intends to bring against the respondent, and affording the respondent with the opportunity to submit a written statement to the ultimate decision maker.
How do you respond to a Wells Notice?
After getting a Wells Notice, the recipient has a chance to respond. Usually, this response, called a Wells Submission, has to be returned to the SEC within two weeks. The Wells Submission may be written or oral. Wells Notice recipients don't always respond.
QNTA's Position:
We contend that we have not committed any wrongdoing or the violations referred to in the Notice. We cannot predict whether the Commission will follow the recommendations of the staff and file suit against us. If any enforcement proceeding is instituted by the Commission, we will defend the action.
So, this is encouraging......
Acer Therapeutics has hit a regulatory speed bump on its quest to advance a taste-masked alternative to existing urea cycle disorder (UCD) meds like Buphenyl. Still, the company and its production partner should be able to sort things out “relatively quickly,” Acer’s chief executive said.
https://www.fiercepharma.com/manufacturing/fda-rebuffs-acer-and-reliefs-urea-cycle-disorder-prospect-over-pending-contract
Well this is somewhat encouraging.....
https://www.fiercepharma.com/manufacturing/fda-rebuffs-acer-and-reliefs-urea-cycle-disorder-prospect-over-pending-contract
Obtained from the discord board. It looks like either NRXP complies with RLFTF requests, or RLFTF will see them in court soon. IMO that should be a good thing for us assuming NRXP never intended to comply anyhow.
"We feel it incumbent upon us to notify the Court now that unless there is a significant breakthrough within the next two weeks in the parties' efforts to resolve their dispute amicably, Relief likely will be requesting that the Court not renew the stay but instead let it expire on its terms."
Documents 33 and 34 ......
https://iapps.courts.state.ny.us/nyscef/DocumentList?docketId=8No7H4GMUa0k7Z7qeEGRrg==&display=all&courtType=New%20York%20County%20Supreme%20Court&resultsPageNum=1
I've read somewhere that since the NIH is affiliated with the US Government, that they are subject to the FOIA. So from what I understand, they MUST eventually disclose ALL of the data and processes behind the data.
RLFTF management has requested the 'data' from the NIH study. My guess is that that will take a couple of months or so. Until the data is assessed by an expert, we just don't know all of the specifics of the trial (IMO). There's been a lot of speculation that the trial was improperly designed which was a formula for failure.
We do know that Dr JJ study was targeted for late stage patients, so possibly NIH tried to mirror that for validation purposes.
India clearly has seen benefit from their study, hence their issuance of EUA. So there is clearly some sort of mismatch between the trials. The devil is in the details. You have probably already seen this report on outcome of the India study. https://acrobat.adobe.com/link/review?uri=urn%3Aaaid%3Ascds%3AUS%3A91aa11ad-10cc-3179-8838-1a6d8b949439&fbclid=IwAR005OpIYAc0QcsmmB78gNm4EDk46WeImEX4sgtJ3xE5RUr4sSShD7ZiiJA&fs=e&s=cl#pageNum=1
RLFTF is now at the Level II stage of the ADR process. Sometime over the summer/fall they should reach Level III, and in/around that time RLFTF plans on uplisting to the NASDAQ. See their PRs on this which are posted on their web site. There is false information being circulated that RLFTF is in financial trouble. Per company guidance and their financial statements, they have enough cash to get through YEND 2023, and they have access to new funding if required. The ticker is in excellent standing with the OTCQB, and the ADR process to uplist to the NASDAQ is going according to plan.
Per the OTC Markets web site:
https://www.otcmarkets.com/stock/RLFTF/overview
OTCQB Member Since 08/2020
OTCQB
Verified Profile IconVerified Profile 01/2022
Dr Joey just recently released a new, very informative video (which someone else posted here today). Dr Joey drills down on RLFTF using fundamental analysis, and he projects out the future revenue streams from its various subsidiaries. RLFTF has a broad and deep pipeline, and the absence of Aviptadil to serve COVID-based ARDS has always been insignificant. In contrast, non-COVID ARDS applications for Aviptadil are more promising, and RAM has always been pursuing those avenues of revenue longer term.
The video does a fine job of breaking down key fundamental data related to projected future revenue streams (among other metrics). Here is the link again to his new video on fundamental analysis of RLFTF. You will need to first rewind it to the beginning because it was saved 1/3 into the 35 min video. It's a great video!
Most everyone was expecting the denial of BTD based on the NIH trial results. The market is also expecting the latest EUA to be denied as well. The broader drug pipeline of RLFTF (including ACER-001) is what is holding up the stock price IMO.
On October 8, 2021 Dr Joey posted this........
3. Add ACER deal - this is going to happen! Next June, ACER-001 has a 90% chance of approval rating right now. It has been accepted (big deal and 2month process alone from submission to announcement of official acceptance). It is going in under section b (505) meaning it's applying for an ALREADY APPROVED DRUG with modifications to it (that do not affect its effectiveness). In other words, the drug is already approved as safe, effective, beneficial for the conditions for which they are submitting the application. The bar is very low here for these types of drugs under section b (505). You only have to prove by bioequivalence. Basically, the hard part is over. In layman's terms, ACER put a hard candy shell on the outside of the same nasty drug that patients have been refusing and spitting out for years because of the taste. They hard part to get this ACER-001 drug approved was just proving that once the pill passes the palate and into the stomach, and the hard candy shell dissolves, does the drug amount available to be delivered equal the same amount of available drug as did the original nasty stuff once it made it to the same stage of digestion. Also, does their manufacturing processes to make the drug yield pure bioequivalent substance of the same sanitary quality as the original already approved drug. Obviously, they are past out of this. Now they will meet to discuss marketing and aftermarketing observation methods for the drug before user fees are applied (for which they won't have to pay these either because MSUD has already received ODD status! That means a $2.9mil amt that stays in the pocket!).
I emailed ACER IR for a status update on the PFUDA date. Doubt they will respond. If they do I'll post.
Ok, up front I must state that I have been long and a believer in RVVTF and Bucillamine. Some of you probably remember me posting frequently here in 2020 and early in 2021. I stepped back to take a pause for several reasons which I will not bore you with here. I just have one question for anyone. But i do I apologize up front for not reading every ihub post and every RVV PR over the past 1.5 years.
But one of my concerns was that when RVV started the Phase 3 FDA trials, they at that time had not have 1 single patient who was saved from COVID using Bucillamine. As of TODAY, does RVV have at least 1 single covid patient that had their life saved from Bucillamine ? It's a simple question.
Thanks
No skull and crossbones. There is too much misinformation floating around. RLFTF has enough cash on-hand too get them through YEND 2023. And if the ACER-001 drug is approved by the FDA today or Monday, that will provide RLFTF with an important infusion of revenues.
I predict that by Labor Day 2022 RLFTF will be trading on the NASDAQ via the ADR process that is currently WIP.
Everyone should do their own DD and not rely on others. June, July and August 2022 will be exciting months for RLFTF.
Once QNTA has the SEC investigation behind them, the PPS should be out of sub-penny land. The CEO recently implied that the investigation may be nearing completion.
Tim has private funding and when the time is right he will disclose who they are.
Monk... I use TradeStation platform. They have a tool called "Time & Sales". It displays REAL TIME every transaction that is executed. Green for price uptick, and red for price downtick. It's a pretty useful tool since it displays the ACTUAL trades, rather than just the limit orders in the queues which can be faked/manipulated by MMs. Just because you see a limit order on Level 2, doesn't mean that the limit order will ever get executed. But I don't trade on the Swiss, so I can only see RLFTF on the OTC.
MB1972....thank you. You explained it better than I could.
Monk...I look at more from a 'trend' perspective. So if the trend is 'red' (selling) that is not good. I noticed that RLFTF closed 'up', so we should be good. No neg micro-trend.
monk. I was wondering if the 30M shares traded as a sell order, or a buy order. Obviously we would prefer if the order was a buy order (rather than a dump).
Was that a buy or sell trade?