Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Acer wins FDA OK for Olpruva to treat urea cycle disorders
Dec. 23, 2022 2:30 PM ETAcer Therapeutics Inc. (ACER), RLFTF, RLFTYBy: Dulan Lokuwithana, SA News Editor
Headquarters of US Food and Drug Administration (FDA)
Grandbrothers/iStock Editorial via Getty Images
The U.S. Food and Drug Administration (FDA) has greenlighted Olpruva, being developed by Acer Therapeutics (NASDAQ:ACER) and Swiss biotech Relief Therapeutics (OTCQB:RLFTF) (OTCQB:RLFTY) as a treatment for patients with urea cycle disorders (UCD).
The oral treatment, also known as sodium phenylbutyrate, will therefore be indicated in the U.S. as an adjunctive therapy to the standard of care for chronic management of adults and children with UCDs.
UCDs are a genetically-driven group of diseases that impact the urea cycle, leading to excess accumulation of blood ammonia, which can result in lethargy, coma, multi-organ failure, seizures, and psychiatric symptoms.
In June 2022, the FDA rejected the therapy citing the need for an adequate review of Acer's (ACER) third-party contract manufacturer for the drug, then known as ACER-001.
However, the following month, FDA accepted the company's resubmitted New Drug Application for ACER-001, issuing Jan. 15, 2023, as the target action date.
In August, Acer (ACER) and Relief (OTCQB:RLFTF) announced the European orphan medicinal product designation for ACER-001 as a treatment for the rare metabolic disorder Maple Syrup Urine Disease.
That will never happen. The SEC does not have the resources to go after little fries like QNTA. Their motto with little penny stocks is.... 'Buyer Beware'. 99% of the time, that's as far as they go with it. And the CEO's of tiny sub-penny stocks know it, so they play the odds and almost always win. All we can do is diversity, and use stops for protection.
This is encouraging.....RLFTF will receive profits from this drug if it is approved.
https://industrytrend.net/2022/acer-acer-therapeutics-acer-001-to-be-approved-by-fda/
Yes, take profits to recapture one's initial investment, then hold on to the rest for the ride into the unknown. That's another great 'exit' strategy. Often traders do not have an exit strategy up front. It's critical to have one, otherwise .... later, emotions start influencing the trading behavior. The key is to have rules and the discipline to trade by them (with little emotion). JMHO
Yes, and when / if the longs are sitting in a situation where this pps pops to a buck or two from optimism, pump and hype, then they will have to make the tough decisions!!
Hold on for more paper profits while the analysts keeping pumping/forecasting that the price will go higher (FOMO), OR start cashing out before the final FDA results are in.
Those types of situations really put the emotions and nerves to the ultimate test.
Conventional wisdom suggests that when such a large pps pop occurs, 50% of the chips should be taken off the table (take profits), then let the rest of the chips run where they may. That's how I play the game now.
nosbir.. I purchased a penny stock for 9 cents MANY years ago (CDIK). Within 90 days it went to $4 while on the verge of FDA approval!! I foolishly held as analysts predicted $8. I then watched it fall to a nickel over a period of several months. My lessons learned? Not to be greedy, and have the wisdom and courage to take profits.
Well, it looks like the case between RLFTF and NRX is over. I'm assuming that now the IP and trial data will be handed over to RLTF. But Dr JJ is not yet off the hook!
https://investorshub.advfn.com/uimage/uploads/2022/12/19/ixjytRLFTF_Case_Update.jpg
I emailed the company with that question twice over the past several weeks ago, and nobody replied. It's a simple question, and they are avoiding it. It seems like it would be pretty easy to thwart the security by putting a thin coat of just about anything transparent on your finger tips. This question is also not addressed anywhere in any of their sales literature. Security is a very important issue here, and they are not being transparent about it.
rick....what makes you so sure that revive won't plunge as well if the rejects their EUA. One needs a reality check here. As least for relief they have a broader pipeline of drugs as a backup.
Giovanni...I had to go look that up.
https://www.urbandictionary.com/define.php?term=poly-tick
Giovanni.. so the FDA is grossly understaffed. Then why in the world is the administration sending 55 Billion dollars to Africa in aid over the next 3 years. A large chunk of that should first go to the FDA to help them get life saving drugs out to human beings.
Giov.. I've posted many times that I feel that FDA needs congressional oversight. Without that there will be corruption with officials 'on the take'. And those PDUFA fees are very lucrative, and they waive a carrot in front of FDA decision makers. There is too much of a cloud of secrecy with the FDA. More transparence is needed.
They will have money if they strike an investment deal. I don't feel that their products are attractive enough (from an ROI perspective) to persuade Big Pharm to invest in them. They have nothing that is FDA approved, so Big Pharm would need to see monster ROI before they would finance that operation. JMHO.
Yes, but nice for swing trading.
I would also be concerned that any buyout would also entail a massive (undesirable) R/S in order to make the financial statements more attractive. No, I'm willing to be patient.
It does sound like Arthur is in negotiations with a possible investor(s), so they don't want to jeopardize those negotiations. I think it makes sense to let the negotiations with the multiple options they are seeking .....work their course. Patience is sometimes a virtual.
Well, thus far revive has been exhibiting the same downward trajectory as relief. The only thing revive has going for is its lower float, but that may not last long because they need to pay the their high salaries and bonuses.
That's not how the FDA works.
relief is not over. They'll be on the NASDAQ by spring per the ADR process.
No, I stopped swing trading this after the price collapsed. Silence is the killer with tiny biotechs looking to capitalize on covid.
What PR lie?
So you are not aware of material event that specifically hurt KNDI?
Over the years I've successfully swing traded KNDI quite a bit. But over the 12 months I haven't been working it. I'm thinking about working it again though. They appear to have some momentum on sales growth.
mick.... so what is your read as to why KNDI has been in a nose dive over the past 30 days? Thanks
ACER is on another run again (up 45%). If the the Jan 15 PDUFA is a success, that means some nice future revenues for both ACER and RLFTF !
ACER is on another run again (up 45%). If the the Jan 15 PDUFA is a success, that means some nice future revenues for RLFTF !
panton...nice profit deal recap!
Bernardino gives ACER shares a Buy rating, and his $12 price target implies a hefty upside of 664% for the coming year. (To watch Bernardino’s track record, click here)
Turning now to the rest of the Street, other analysts are on the same page. With 3 Buys and no Holds or Sells, the word on the Street is that ACER is a Strong Buy. The stock has a $9.67 average price target and a share price of $1.57, for a one-year upside potential of ~516%
ACER is on a 'run'. Remember.
PDUFA date is January 15, 2023.
Good PR out on this.
https://finance.yahoo.com/news/2-biotech-stocks-under-10-023527396.html
ACER is on a 'run'. Remember....RLFTF receives a chunk of the profits from the sale of ACER-001.
PDUFA date is January 15, 2023.
Good PR out on this.
https://finance.yahoo.com/news/2-biotech-stocks-under-10-023527396.html
What prevents someone from putting a thin film of vaseline (or some clear, non-porous lotion) on one's finger before applying it to the detector? I asked the company via email 3 weeks ago and they never responded. Has this question been raised here before?
Joe, it's my understanding that the R/S only impacts you if you own ADRs. I never bought any, nor have I converted my RLFTF OTC shares to ADRs. I'm still waiting for RLFTF to 'force' me to convert my OTC shares to ADRs.
What's not clear to me is what impact will the ADR R/S have on the price of RLFTF. I suspect none. But I could be wrong. This whole ADR initiative is weird stuff that RAM is doing, and he doesn't communicate the mechanics of his intent to the SH. Other than his goal is to eventually convert all RLFTF shares to ADRs. I'm holding my breath on that one.
Hopefully someone else here who is 'in the know' on the ADRs can post on this topic.
Volume Profile is pretty good for that. Requires a bit of training to use though.
Very Interesting!
What about the warnings regarding taking too much zinc dosage? I think I read to take it just once a week (not daily).
The paperwork that came with my Paxlovid provided a longggg list of ailments that would qualify someone for the drug.
You mention Zinc and D-3. What about Vit C?
Naught. prior to catching covid, I did have four jabs though (the latter two being the booster shots). I don't know for certain, but those jabs may very well have contributed to how quickly I recovered after taking those little pills.
Naught, yes, I was told to take 2 pills a day for 5 days ...starting immediately. I had no side effects. It worked great for me.
The doctor also asked me - 'when' did I start having covid symptoms. I told him they started the day before. So he was making sure that I wasn't on day 3, 4, 5.... You may want to check with your doctor on what rules he/she is following on that pill. I think if you are under 50 (or 60) they won't give it to you because it is operating under EUA (not fully tested long term). Unless you are at risk (dabetes, etc.) It's always good to have a plan of attack before you catch covid.
mypennys..btw, apparently the way that little pill (paxlovid) works is it stops the virus from replicating itself. It doesn't kill the covid virus, it just halts its duplication thus giving the body's immune system a chance to go after it. That's why if you wait too long (more than 3 days after symptoms) then it is usually too late for it to help that much. That's my understanding. It doesn't kill the virus, it just prevents it from reproducing itself.