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Similar story and game plan here but with 1 year price target of $25 - 30 as big capital realizes it's time to reallocate capital back to the biotech sector.
I have a hunch that as the $AVXL story unfolds in 2022, with trial starts and more confirmatory publications, $AVXL will catch the attention of market participants and lead the sector.
Donate some of that cash to "Reverse Rett" in the UK, I did.
I'm so sick of building short duration bond ladders after 3 decades in the equity and option world, I'd rather donate my cash at this stage in my life.
$UNRV's communications have been compliant.
The industry as a whole sucks, which makes $UNRV suck even more.
The revenue from asset sales has been realized, and the real work of running a dispensary business has yet to be proven. Maybe a leaner company using contract operational support might help, but could be pissing in the wind waiting for the inevitable collapse.
Also, I doubt $UNRV has been able to grow operating revenues in this environment and hence why the recent registration of stock.
Here in my neck of the woods, those with access to capital and operational expertise have been continuing their "roll up" strategies as small companies struggle with lower demand and sales.
https://www.westword.com/marijuana/colorado-marijuana-sales-reach-new-lows-2022-13622122
California news:
https://www.nbcnews.com/news/us-news/-brink-collapse-california-pot-businesses-call-tax-overhaul-rcna12175
https://www.rollingstone.com/culture/culture-features/california-weed-cannabis-crisis-emerald-triangle-1302545/
FDA this, FDA that... frankly I rooting for the Australian TGA to steal the thunder from the FDA.
Explaining why CGI anchored RSBQ-AUC is better than total RSBQ change has definitely been a PR fail, but gives those of us who understand the methods more time to validate our position sizes.
Side note: this is the longest I have ever held a biotech and through the most clinical stages. The science "story" simply fascinates me.
Not sure if it's St. Patrick's day Irish Coffee or the confirmatory PR and conference call... but I'm getting that bullish feeling back.
Hmmmm... but is dose dependency really something of concern to discover in a rare disease population like Rett once a safe effective dose is found?
On the PDD front, I was wondering if 2-73 could also be a possible adjunct therapy to counter the drawbacks of Levodopa off-periods.
"In Part III for motor function, ranging from speech to hand movements, posture to gait, 30 out of 34 items showed score gains (88.23%), while five out of seven items (71.42%) improved in MDS-UPDRS Part IV scores for motor complications like dyskinesia (uncontrolled movement) and levodopa treatment “off” periods."
“ANAVEX 2-73 (blarcamesine) demonstrated dose-dependent efficacy for both motor impairment (MDS-UPDRS) and cognition … which correlated with SIGMAR1 mRNA as a pharmacodynamic biomarker, respectively,” said Christopher Missling, PhD, president & CEO of Anavex.
The lack of dose effect is disappointing, but it's not the end of the world and the company's credibility by not making such claims is good to see. And see what they do claim shows dose dependency.
Thankfully 2-73 has clinical efficacy in addition to a biomarker response. ;)
Establishing SIGMAR1 mRNA expression as an accepted biomarker in and of itself was a goal.
Establishing mRNA as a biomarker for one disease is helpful. It will still have to be established as a relevant biomarker for each additional disease
In the most simplistic terms:
"we've run the numbers and if this magic S1R thingy works it's worth a freaking bundle!"
...to continue the thought, this will also add value the development and growth of a rare disease franchise with all indications initiated at phase 2/3.
Indeed, we really haven't delved deep into the gut brain microbiome connection yet.
Capital is still flowing OUT of the biotech sector.
Fast forward to when this cyclical factor reverses and we will see $AVXL leading the index.
Understanding that sector weakness is not company weakness will be the lesson for 2022.
Quality robust trials require agreed upon biomarkers of response in order to be pivotal.
The recent data adds to the evidence that SIGMAR1 mRNA expression will be an accepted biomarker by various regulatory agencies such as the FDA or Australia's TGA in the forthcoming multiple indication trials.
Not being caught up in the daily social media drivel allows me focus on the strategic importance of the recent data presentation. Which is the establishment of trial parameters that will be accepted as pivotal. This is a critical part of successful trial design. That step is complete.
Once the foundation of trial design has been laid, the initiation of further trials will be relatively fast.
Indeed "patience and perspective" while the successful trials continue.
Trial evidence continues to mount that mRNA biomarkers are directly correlated to positive outcomes and will continue to be a primary biomarker for all indications.
Since $AVXL has presented evidence of pharmacodynamic-biomarker outcome measures such as mRNA to MDS-UPDRS scores, I would expect further trial initiation to be started post haste.
Expect new lows all week....
Was $CYDY one of his pump and dumps? $CYDY wasn't listed in this article.
https://www.securitieslawyer101.com/2021/steven-gallagher-arrested-and-charged-with-securities-fraud-for-using-his-twitter-account-to-operate-a-pump-and-dump-scheme/
$CYDY hires multiple firms for stock promotion so if so he's one of many.
How about a CNBC "American Greed" episode?
I don't think $CYDY has enough filler for a 10 episode Netflix special unless the series went into the explosion of the shady world of toxic financing and the pump and dump dynamic of social media and MEME stock gamblers.
So true, $CYDY is a textbook example of a stock selling scheme, but still par for the course on the OTC. But it's the unprecedented actions by the FDA that totally add to the drama and makes it eligible for a CNBC "American Greed" episode.
I've seen many stock promotion schemes in multiple industries, but $CYDY is the first I've see make such bold claims in violation of FDA rules that multiple government agencies are investigating.
Was there any competence in anything at $CYDY?
The FDA investigator had doubts about Amarex data collection flaws from the get go?
So suing for the data is just another smoke and mirrors show?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167908923
Obviously the company knows their shares are worth no more than $0.30 per the terms of the latest unregistered stock offering.
So even if $CYDY gets the data from Amarex the data may be faulty? Was $CYDY an failure immediately due to a bad CRO?
"5. Data from different trials is mixed up. The FDA reviewer suggests Amarex has faulty data collection."
"6. Patient discrepancy is noted by the FDA reviewer as he again calls into question Amarex collection methods.
In particular one patient is reported deceased. But one month later this same patient is complaining about a right arm abscess."
Was there any competence at all in anything at $CYDY?
More biz for the bookrunners to churn the price down to $0.30
I noticed the patents put up as collateral too. The jig is up on this scheme.
This is the first time that I know if that CYDY has put patents up as collateral:
$CYDY filing alerts are always so entertaining!
The $CYDY share selling scheme continues on. But apparently HIV is going to be cured completely via stem cells. No need for leronliamab.
$CYDY's financial arrangements keep getting crazy and crazier!
https://www.sec.gov/ix?doc=/Archives/edgar/data/0001175680/000119312522045570/d141577d8k.htm
The toxic dilution with deep discounted shares continues.
The exercise price of the 4-Good Warrants is $0.30 per share. The payment obligations of the Company to the Indemnitors under the Backstop Agreement bear interest at 10% per annum and are secured by substantially all of the patents of the Company.
Under the Backstop Agreement, on or before the 120th day following the date of issuance of the 4-Good Warrants, the Company will use commercially reasonable efforts to file a Registration Statement on Form S-3 with the Securities and Exchange Commission (the “SEC”) that is intended to register for resale the shares underlying the 4-Good Warrants.
secured by substantially all of the patents of the Company.
Indeed, or $IBBQ the newest to add $AVXL.
Regarding the biotech indexes and $AVXL, the magnitudes are different but the tick directions correlate.
There are very few similarities between $CYDY and $AVXL except for the fact $AVXL was once OTC.
The similarities are that both AVXL and CYDY have an outstanding drug candidate. But Leronlimab is light years more valuable.
It will be interesting to see if the trip to $0.30 be a slow churn down, a death spiral, or a mix. Regardless it's going lower.
Smart biotech do "know what they own", but also know holding for long term should be based on positive trial data and good management, not blind faith and luck.
The GLTA (Good luck) signatures are too funny. Luck and hope are not valid investment strategies.
Now what if the FDA accepts SIGMAR1 mRNA expression as an approvable biomarker?
It would make approvals for multiple indications much faster and easier to get the drug to market.
What about an accelerated approval after the FDA accepts certain biomarkers? And if so what would those biomarkers be? and is this consistent across all possible indications?
Mayomobile thoughts?
Of course 2-73's efficacy is the real approving factor, just looking for more ideas in a post Aduhelm FDA.
It's the integration of the OLE data with the blinded trial data that will create a robust argument for accelerated approval and/or design of future trials.
Fill me in on this part of the scheme. What exactly was transferred?
The right to the intellectual property of leronlimab?
Correct and why I keep reiterating $CYDY common stock is worthless.
I was once a frontline broker, before telebroker and online trading, and I was always amazed at clients who ignored the required disclaimers I would read them before I sent down the trade ticket.
Yep..old school "paper tickets"...
Once the toxic lenders add another board member the most logical is Chapter 11 with a capital restructure handing over the new equity to the lenders and old common will be cancelled.
When the company has virtually no cash, no means of raising cash and ~$100 mil in debt they can't pay that is the recipe for bankruptcy. Samsung will be owed $35 mil the end of January. The company couldn't post the $6.5 mil bond to get their clinical trial data back to be able to START preparing the clinical portion of the BLA. Can't pay the Vulture debt and the vulture is converting the maximum each month to get their cash back. SEC won't allow the company to do a significant secondary with all the shareholder approved stock.
By any definition, these are the conditions for bankruptcy -- protection from creditors -- Chapter 7 or 11.
"real longs" haven't thrown in the towel and toxic lenders know it. That is precisely why they are modifying the debt via retermed partitions. Why partition for more stock? because the "real longs" will hold the bag in the end and the $CYDY cow is still giving milk.
"real longs" are learning a stock market lesson the hard way.
It's not over and this script for an episode of CNBC's "American Greed" is still writing itself.