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Having the 'safety' history of Bucillamine certainly helps with the FDA, but it just doesn't address the efficacy question. So that's the gamble IMO.
I don't know what to think about the final outcome here. It's a crap shoot IMO. I just know that the FDA does not care about what the CEOs think or feel. They only care about the study primary endpoint.
Well, at the moment this is looking like a falling knife.
Chart-wise, this has been a falling knife since 10/28/22. In cases like this support levels only have meaning to "Day Traders" who are trading who are picking off small profits (short or long) on a 5 minute chart. This non-revenue penny stock is driven by news only. The gamble is whether or not the new marketing initiatives being rolled out this month will have a positive impact on sales. What will get this PPS going is for a PR announcing a new, real deal with a major customer. The MACD and moving averages cannot predict that news.
It's PPS southern drift occurring with the lack of positive news. Investors get impatient. And there is also tax loss selling pressure. Those fundamental forces ignore what a chart looks like. They don't care about moving averages, MACD, and so on. It's simply southern drift until a catalyst comes along (news) to provide pps support. It doesn't take sophisticated technical analysis to see this coming.
Without good news on revenues we'll eventually see .50 Technical Analysis is irrelevant without revenues or some form of catalyst.
I'm not getting my hopes up for 'substance', but we'll see. Thanks
Maybe Arthur read my post. Let's hope so.
Good question.
Gov... so far this is similar to what happened to another foreign biotech that we all know. A Swiss biotech. Silence and non-progress with the FDA causes southern pps drift. Everything is hanging on whether the trial has success with the primary endpoint. Nothing else matters. Not safety, nor what scientists say. The FDA will only look at the endpoint and whether the trial met it. So the design of the endpoint is KEY. Did they overshoot and set the bar too high? IMO we most likely will not know until the spring/summer of 2023, and there will be more southern drift between now and then. This is painful for the longs who hung in there believing. I've seen this happen with many small bitotechs over and over since the pandemic began. JMHO
In light of the SEC investigation, it is wise of Arthur to obtain his lawyers approval before speaking or communicating to shareholders. He doesn't want to go from the frying pan into the fire.
That should have been 100th (not 10th). iHUB won't let me edit/fix the post though.
I'm perplexed at HOW is he paying his bills! Selling shares at 1/100th of a penny won't get you very far. And the small volume being traded doesn't support that hypothesis anyhow.
If he had issued PR communications a little more regularly showing the investment community that there still is s heart beat, then maybe he would have been able to sell a few shares here and there for 100x today's share price. Perplexing!
I'm still slightly bullish though (at these prices).
At least they are communicating with their shareholders. That's a step in the right direction!!!
At this rate RVVTF will be in company with RLFTF. None of it surprises me though. The FDA moves slow on tiny foreign penny stock biotechs. Only BF gets their full attention due to the huge PDUF $$ that gets fed to the FDA. .
If the new, upcoming marketing/advertising campaign generates potential customer interest, then December could be an exciting trading month for both swing traders and longs.
My guess is Arthur tried to say too much in the draft PR and the lawyers reeled him in on that.
Well, IMO law firms typically are not IR experts. Matter of fact, they often get in the way of CEO's trying to engage their investors. So, if Arthur is taking IR (in addition to legal) advice from his attorney...that is a very bad mistake. The attorney will always tell their clients to NEVER speak unless they have to. I have lots of attorneys in my family tree, but they never follow their own advice. They all talk toooo much themselves (advising of course).
His lawyer may have asked him to make some major changes to the PR.
Until Arthur issues that PR with some details, everything is speculation.
Won't have to wait for 6 months of earnings if over the next couple of months their marketing efforts prove newsworthy. All they need is to strike one or two major deals, and investors will forecast out the earnings.
Institutional Inflows and Outflows
Several large investors have recently modified their holdings of the business. Vanguard Group Inc. increased its position in shares of Acer Therapeutics by 55.5% during the first quarter. Vanguard Group Inc. now owns 278,215 shares of the biopharmaceutical company’s stock worth $807,000 after purchasing an additional 99,335 shares in the last quarter. Renaissance Technologies LLC raised its position in shares of Acer Therapeutics by 216.8% during the 2nd quarter. Renaissance Technologies LLC now owns 69,700 shares of the biopharmaceutical company’s stock worth $88,000 after purchasing an additional 47,700 shares during the last quarter. Finally, Copperwynd Financial LLC acquired a new stake in Acer Therapeutics in the 2nd quarter valued at about $29,000. Hedge funds and other institutional investors own 9.76% of the company’s stock.
https://reporter.am/2022/11/22/acer-therapeutics-nasdaqacer-shares-cross-below-200-day-moving-average-of-1-54.html
trip..with the FDA they have to dot their I's and cross their T's. One mistake or miscommunication and they lose 6 months with the FDA. And they have to try and anticipate to read the FDA's mind. Example: a stock (ACER) had a PDUFA date of June 5, 2022 for final FDA approval of their drug. Then in May (1 month prior) the FDA requests to inspect their manufacturing facility. ACER was totally unprepared for the unannounced inspection, so they had to request a new PDFA date, which the FDA set the new date for January 2023..... even though ACER quickly had the site ready for inspect within 30 days. Murphy's Law!
It will be summer 2023 before the dust starts to settle on this. They get the ball rolling mid-December when they submit the paperwork. JMHO
Thanks for sharing Mountain.
gov.. In general I agree with you. However, since the FDA is requesting 'more information, it's been my experience that that can add on another 6 months very easily. The FDA process (in both directions) is usually a very, very time consuming process.
I'm no longer looking at this as a swing trade. This recent news could result in setting a new lower support line before she starts to swing again.
JMHO
rick.. and the jury is still out on this drug. I suggest to not count one's chickens until they are hatched.
At least their O/S and float are not ridiculous (yet), as it is with RLFTF. So I don't see an R/S over the near term.
Per OTC Markets (a little dated)
O/S: 320,008,751
Float: 315,580,417
Go ahead and beat up on me, but as I've posted several times, IMIO this will follow the same path (roughly speaking) as the other small Swiss biotech RLFTF. We won't get an answer on this drug until deep into 2023. It's unfortunate, but the FDA takes their time with small, foreign biotechs. Asking for more data is the norm. Big Pharm has the edge. Is there corruption at the FDA? You tell me.
I'm just looking for a heart beat at this juncture. Anything above that will be icing on the cake. GLTA
Thus far this has been a falling knife! A new fresh PR demonstrating progress on the sales front might help offer a little technical price support. Silence will only result in more price erosion.
It would be very helpful if the new Director of Commercial Development (Marius Karoy) PR'd an outline of his new overall marketing strategy....of course without disclosing any I.P. or trade secrets.
The company has a very well designed web site. However we are essentially playing a waiting game as the company embarks on strategies to generate sales/revenues.
JMHO
Mountain...nicely done! eom
The mechanisms surrounding the 'data' need to be explained and yes, that includes a certain level of persuasion. I also don't think that it is a laughing matter. It's serious business when dealing with peoples lives.
Ecomike... I have no doubt that Bucci is safe! The challenge is to convince the FDA that they met their primary end points. Time will tell. I've seen so many disappointments in the past two years that I won't even try and speculate the outcome. GLTA
Obtuse, I haven't seen that, but i did watch the undercover video of the FDA by ProjectVeritas. I've posted many times over the past two years that there should be a congressional oversight committee overseeing the actions/behavior and decisions made by the FDA. There is too much incentive for corrupt behavior, and it all starts with the FDA receiving lucrative kickback fees (from Big Pharma) via the PDUFA. Because of these issues/risks, I now am no longer a long-term investor in any small biotech. Swing Trading ONLY. The cards are stacked against the little guy IMO.
Here is the undercover link. Just scroll down a coupe pages to access the video.
https://www.projectveritas.com/news/fda-executive-officer-exposes-close-ties-between-agency-and-pharmaceutical/
Giov..yes, Pax apparently has a rebound issue. The latest I'm hearing is the 5 day dose is too short, so they are looking to expand that. I haven't rebounded yet, but it's too early to tell.
The devil is always in the details. Reading carefully is the hallmark of a good decision making. 98% of the biotechs never claimed 100%. The other 2% were scams. Lots of scams out there who want your investment $. Be careful.
Never!! You omitted the rest of the story. Click your link and read the full sentence...
Vaccine was 100% effective in preventing severe disease as defined by the U.S. Centers for Disease Control and Prevention and 95.3% effective in preventing severe disease as defined by the U.S. Food and Drug Administration
Lots of FA traders have condos too. Maybe more.