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Dosing completed with Sarcopenia cohorts in the blinded study of MYMD-1 drug. FDA's Safety Committee will be reviewing the results of the blinded study. The results will be shared with MYMD once completed and, the company would then post the results from the study. The results from the study could be very significant and could begin to propel MYMD stock higher based on the new drug's effect with patients. The study results should be posted in a few weeks ... very much looking forward to them and the effect on MYMD's share price.
MYMD submitted details for a NDA (new drug application) to the FDA. MYMD is awaiting a response from the FDA on the details before submitting their proposal for their NDA. The thought is that the FDA should respond by July to MYMD re: the NDA details. I was expecting an announcement earlier, by the end of May but, there was none. So I called the company to inquire. The above communication was what I was told and was sharing. I believe the steps MYMD and Chris Chapman are taking on the new NDA drug study could produce a monumental response. Let us not forget all the significant fiduciaries that got involved in MYMD last year and ended up driving the MYMD share price above $5 and $6 a share.
I am a big believer in MYMD !!!!!
Potential news still pushing the stock higher 11 days later after my last post ... already cleared it's inverted 50dma ... head upwards to overtake it's inverted 200dma, currently sitting at $2.27 ... MYMD Relative Strength continuing to move UP robustly inn pursuit at 62.21.
Could Anavex be applying for Accelerated Approval for it's 2b/3 AD study and FDA Approval of for it's drug, Blarcamesine?
ZIM stock is performing great ... relative strength improving ... it's chart is healthier, as it's 50DMA has now cleared it's 200DMA. Is this portending that it's quarterly report will be above expectations? And, will ZIM be paying a dividend? Investors need to make a good decision. Me? I've been a buyer of ZIM in the $18 & $17 area. Good Luck !!!
In After Hours saw the stock trade UP to $1.94 ... UP 15% from Friday's closing price on excellent volume and cleared it's inverted 50 DMA. "Upcoming highlights include a planned filing of an investigational New Drug application (IND) with the FDA by the end of the month, with recruitment, enrollment, and dosing commencing next quarter." This potential news may have pushed the stock UP today.
JP Morgan analyst viewed the ZIM chart tis past December and recommended that all their customers that they "BUY" the shares insisting that the stock had bottomed in the $16 - $17 level. He was the ONLY analyst that got it correct. ZIM would go up to the $24-ish level going into it's higher than expected dividend of $6.40.
Stock selling off after dividend was paid. JP Morgan analyst retreats to "Neutral" rating on the stock. Stock goes back to $16 - $17 level. Me ... I was a buyer, all it that area. Shipping rates having "nomalized" non-pandemic year of 2923 but, the word out on the street was ZIM's net income & dividend would re-surface in the 2nd half of 2023. Couple that the ZIM chart is getting healthier and it's Relative Strength improving, and a Seeking Alpha analyst commenting that a ZIM dividend could surprise !!! Stock up nicely yesterday. ZIM does take care of it's customers and it's shareholders ... and does have a habit of exceeding it's estimates .............
Currently in Phase ! ... Phase 2 commencing in July ... dosing trials with cohorts almost complete ... the FDA's Safety Committee monitoring the patients on the new drug has already noted that there were no toxicity issues with the drug thus far. Company evaluating which dose is the most effective.
Blackrock, State Street, and The Vantage Group already own at least 5.5 million shares of Anavex's common stock shares.
Significant move in Anavex stock is upcoming after a 5+% move yesterday. In afterhours yesterday some 406 shares traded, closing at 8.38, up another .31 from it's regular trade close of 8.07. Check Out our chart's MACD as a prelude to Anavex's Friday trading activity leading in Anavex's 8 A.M. presentation at the 22nd Needham Healthcare Conference prior to the stock market opening on Monday morning. Anyone negative on the timing of everything? Being punished by short sellers to an oversold position with a Relative Strength in the 20's prior to yesterday's performance. Will be very, very interesting to see where Anavex's stock performs next week?
All the best to Anavex shareholders, Anavex, and the patients and their families that need Anavex's safe drugs, which can only help !!!
Very positive PDD news from Anavex and blarcamesine in their Phase 2 48 - week study. "Drug holiday" caused by Covid.
Swedish Alzheimers Conference due to take place very soon. Anavex is not one of the presenters ....but does get favorably mentioned.
A analyst advised the ZIM CEO on a conference call that they could better use the money that went for dividends to buy back sZIM shares of stock. The CEO listened, then said, "Yes, we could" but hesitated and, then responded to the analyst. "Our shareholders depend on us and, we like our shareholders. Our dividends will continue.
Frankly and utterly amazing, that in all the decades that I've owning and traded stocks that I know of ... ONLY ZIM chose to share percentages of it's net income with it's shareholders. When I shared this information with friends they screamed back at me, "Every company should be doing this !!!!!!!!!! "
Recognize that ZIM is unique ... and, consider yourself fortunate.
Anavex chart-wise is a WoW !!! ... an inverted 50dma at 10.25 and the inverted 200dma at 10.33 with pretty strong volume today suspect other investors/BIG Investors became enthused as a possible positive plan for significant Anavex stock appreciation potentially transpiring ... Relative Strength only 41.80 can afford a good push to prevail.
What makes you believe Jun wasn't aware of Anavex and blarcamesine in the first place ... since has been conferring with the FDA re: it's studies throughout? I have to believe Jun was well aware of the situation and, now with Biogen getting accelerated for a drug that has the potential to cause brains to bleed and, a Medicare & Medicaid, likely to not approve a dangerous drug that can kill ... I suspect Jun may already knew which company and their drug should really have the accelerated approval path, don't you?
I did call Anavex in the wake of what was occurring today and affecting their stock. The Spokesperson that I spoke with felt that some might believe that their company might be invested in SVB. The answer was Anavex is not. The Spokesperson also reasoned "that cash is tight right now", the Federal Reserve is working to control inflation and raising interest rates ... some investors or, potential investors are waiting on the sidelines waiting to see what happens. The company is very excited that Dr. Jin is on board. "Imagine if he was here 2 years ago?", was a question offered by the Spokesperson. I responded that "That would have been a WoW, WoW, WoW !!! and now it's just a WoW !" The Spokeperson didn't disagree and, laughed at my response comment.
CPI & PPI next week & Federal Reserve to decide whether to increase rates by 25 or 50 basis points.
Currenly AVXL stock is sitting on it's 50dma inverted chart. Poised to move through ... Relative Strength back above 50 !!! The inverted 200dma line is currently at 10.33.
Aqueduct
Maybe ... you thought you did in terms of "the facts". Me? I called the company after reading the report study telling the Anavex spokesperson that "I considered the study and the significance of it big, big, big" and, he agreed with my opinion. I did ask if anything had been submitted to the FDA yet or, did the FDA inquire, since material is usually shared? The spokesperson could not comment, and I understood.
Not what was posted.
A 14 week/ 3 1/2 month Phase 3 study on Parkinson's disease and Parkinson's disease dementia (PDD). Results were extremely significant vs. the placebo group of patients in all 4 categories being assessed. As the medical doctor.PhD pointed out in as the investigator researching the study pointed out that no new therapy approvals for PD & PDD by the FDA in more than 20 years Anavex's Blarcamesine was the drug utilized in this study. The investigational doctor recommended that the Phase 3 PD and PDD study be considered for approval along with with Anavex drug 2 - 73/Blarcamesine
Me too liked your dreams ... believed in mine (dreams) too and my racehorse. The racetrack clockers got distracted watching another horse and were late in trying to record my horse's workout and improvised what it was ... 5F in 1:03 3/5's. Me? I looked at my stopwatch, did not say a thing and walked away. What did the horse workout in? 59 3/5 and just had me shaking my head the rest of the day. The horse made his 1st career start 3 1/2 weeks later. It was ridiculous ... my horse went off at 85 - 1 in the 11 horse field. The 4/5 favorite stumbled at the start and threw his jockey. My horse was 4th at the top of the stretch, stayed on the rail and blew by the leader when he drifted out in the stretch. Saw that Clocker the next morning when getting coffee for the barn. He said to me, "Was that you yesterday?" Me? I just smiled and nodded, while leaving.
As for Anavex, I believe the FDA will approve their Phase 3 Parkinson's disease study and Parkinson's dementia drug blarcamesine for treatment very, very soon ... which had very, very significant results for patients treated vs. the placebo ... another winner of a bet .........
Short-sellers in Anavex stock at risk ... BlackRock, Inc, State Street, and The Vanguard Group now own together in excess of 16.6 million shares of Anavex common stock, or roughly 25% of the common shares that exist. ANY ... positive news relating to Anavex Life Sciences, medical journal articles, study news and, more large investment purchases of Anavex stock could have the Anavex short-sellers scurrying faster to cover their short positions as quickly as possible to cover ... ANY ... positive news our company has the potential to become the sounding bell and, the springboard for ALL Anavex shareholders stock appreciation ... both, near-term and, long term.
Short-sellers in Anavex stock at risk ... BlackRock, Inc, State Street, and The Vanguard Group now own together in excess of 16.6 million shares of Anavex common stock, or roughly 25% of the common shares that exist. ANY ... positive news relating to Anavex Life Sciences, medical journal articles, study news and, more large investment purchases of Anavex stock could have the Anavex short-sellers scurrying faster to cover their short positions as quickly as possible to cover ... ANY ... positive news our company has the potential to become the sounding bell and, the springboard for ALL Anavex shareholders stock appreciation ... both, near-term and, long term.
Our FDA has been grasping at straws ... any straws because it's been desperate to find a drug or, a process that works. Unfortunately, in over 38 years concerning any drug company that focused exclusively on the plaque or, the tau has been unsuccessful. This includes the 2 Biogen drugs. The first one, Aduhelm never, ever should have been approved by the FDA. In over 6 years of Biogen testing it, the drug repeatedly kept failing it's testing to costing Biogen $6 - 7 Billion. The drug caused the patients brains to bleed and patients to die.
Biogen's 2nd drug with Elsai has the same focus and the results are pretty much the same with brain bleeds and AD patients again dying. Their approach does not work !!! They are treating a symptom of the disease but, not the disease itself, which many, many areas and our FDA does not understand ... and it's killing AD patients. This treatment does not work
Anavex has a solution with it's drug blarcamesine. Hopefully, an article gets published in a medical journal and Anavex meets with this FDA to discuss approval ... accelerated approval as soon as possible because lives and families will benefit and depend on this approach !!!
Several big pharmas are interested in partnering with Anavex on their drugs. No decision/s reached yet. Anavex is awaiting the publication in the medical journal as to prepare for both ... the partnering which will likely involve shared expense between the 2 companies ... and, setting the stage for the meeting with our FDA.
In over 38 years Big Pharmas or, biotech companies that focused exclusively on the plaque/tau none have been successful in their treatment of the disease of AD. Even our FDA in desperation to find a meaningful approach to this catastrophic disease approved 2 Biogen drugs that do little to alleviate the significant issues of the disease ... plus their drugs are very expensive, must be given I.V. and must be done by medical personnel ... adding more expense for the treatment .... and the treatment can cause the patient's brain to bleed, which could result in the patient's death. Summed up, just more failures with this dangerous approach.
Am awaiting the approval of Anavex's blarcamesine drug/2 - 73, a safe drug, a pill taken by mouth, that has demonstrated significant results with neuro-degenerative and neuro-developmental diseases affecting the CNS.
I guess investors forgot BlackRock,Inc bought 5.5 million shares of Anavex Life Sciences common stock for a reason that they believed it was a very, very, very good investment for their customers. Maybe other investors might now become a bit more savvy? After all BlackRock,Inc. is a fiduciary whose current value in it's stock positions exceeds $8.6 Trillion Dollars ... that figure IS NOT A TYPO ............
Very interesting that during the CC that foreign countries drug regulators could be focusing on Anavex and possible approval of Anavex drugs and, Anavec very aware of this ... and the possibility that our FDA would need to play catch-up ... especially, with our desperate FDA approving a new Alzheimers drug causing that causes brains to bleed and patients to die.
Anyone else interested or curious the BlackRock, Inc. owns or controls slightly more than 5% of Anavex common stock as of the SEC filing on Tuesday, January 31st 2023? I am suspecting that timing-wise those shares could produce large gains ... very, very interesting!
Yes, Yes, and Yes ... awaiting a medical journal article prompted by Anavex and, a meeting with our FDA for approval Anavex's studies re: Rett's Syndrome, Parkinson's Dementia and, Alzheimers Disease along with approval of their drug Blarcamesine.
Please read the latest Seeking Alpha article on Anavex's Blarcamesine/ 2-73. I expect our stock today will get a good deal of positive attention today ... unlike yesterday. Read the article, I don't believe you will be disappointed unless you are a short-seller.
I sincerely hope you bought Anavex shares cheaply yesterday like moi. Why? Blarcamesine likely approved by our FDA in 2023 ... and, it could be by Accelerated Approval. Please read the Seeking Alpha article posted yesterday:
https://seekingalpha.com/article/4573554-approval-for-anavex-blarcamesine-looks-inevitable