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There is absolutely not a revenue requirement to uplist from the OTC to NYSE American. There are 5 initial listing standard categories, and only one category which requires revenues (Standard 1).
https://www.nyse.com/publicdocs/nyse/listing/NYSE_American_Initial_Listing_Standards.pdf
Exactly right. They meet many of the initial listing standards of the NYSE American right now. More $ is not a requirement based on their current market cap, at a stock price of $3 per share. Or, if CYDY has a stockholders equity of over $4 million only, they can uplist at $2/per share. That probably requires a raise of $4-10 million only at the current stockholders equity.
Facts are in short supply sometimes, but bwolfy2002 has posted the link to the NYSE so all can see it with their own eyes.
Is there a misunderstanding of the term "immunomodulation"?
As of June 28, 2019, CYDY had 8 U.S. patents for PRO 140 (Leronlimab) and 12 U.S. patent applications related to "HIV-1, GvHD, immunomodulation and cancer treatments." We don't know how many provisional patents they have filed as placeholders to cover emerging treatment rationales.
Considering Covid-19 graced the world's presence no earlier than the second half of 2019, certainly you wouldn't expect any company to have filed a patent on treatment of Covid-19 prior to its existence?
The research on this board has confirmed: A. A patent assigned to CYDY for the composition of matter of Leronlimab; B. Numerous patents describing methods of use, including immunomodulation; C. An active patent filing and prosecution regime at CytoDyn, which no doubt will have applied for method of use patents on Leronlimab for coronaviruses such as Covid-19.
I'm sure it is known that even without any patents, a company that ushers a treatment through the FDA protocol receives exclusivity for a number of years.
A - Always
B - Be
C - Closing
Case Closed.
The point is that the key statements in your post were incorrect. Insiders were not selling shares.
I agree that the sell-off at the time came from the word of the placement leaking.
No, you are reading the filing incorrectly. This is the recording of the $25,000,000 placement through Cowen from August 7! Old news.
Won't be long before the international conference at the beginning of September. Hoping for the announcement of EU sales of the Genesis soon after.
Seems like some new customer wins should be soon, or have happened but not yet announced, based on their demonstration to field testing schedule.
Wrap Technologies Demonstrates BolaWrap 100 to the International Community
This didn't get picked up by a lot of sites, but worth reading.
25 reps from 10 countries saw the BolaWrap and the company is ramping up international deployments.
https://www.accesswire.com/533496/Wrap-Technologies-Demonstrates-BolaWrap-100-to-the-International-Community
New Article: A Policing Tool to Rival the Taser
https://seekingalpha.com/article/4233598-wrap-technologies-introduces-policing-tool-will-rival-taser?v=1547653006&comments=show
WRTC just announced that Coral Gables Florida Police Department has signed on to acquire the BolaWrap for its officers. Initially special teams, and eventually the 200 officer force. More to come soon I think.
Los Angeles PD (over 2,000 sworn officers) is in Field Testing right now!
WRTC is coming along very well. 500 requests for demonstrations, and many large departments in testing phase right now. I think we'll see a bunch of police departments signing up in the next few months.
Insiders own over 50% and the public float is under $6 million shares. This will move quickly.
There is a black box warning, however they have additional language that is not contained in Celebrex labeling stating that by lowering blood pressure, it lowers the risk of heart attack and stroke.
Since Conseni lowers BP, Kitov believes that a partner can market this benefit of Consensi, since the FDA has approved the drug based on its proven BP lowering effects.
Not a bad entry point here, now that KTOV has FDA approval in hand and deals in China and South Korea. Actually, a great entry point.
Particularly intriguing to me is the wording of KTOV's May 11 China deal release:
"This is the second commercialization agreement for Consensi™ in Asia, further confirming its global sales potential. Kitov continues to work diligently towards finalizing additional commercialization agreements in the U.S. and in other territories.”
"Finalizing" indicates an advanced state of negotiation.
Now, Kitov has money to commence trials for NT219, while continuing negotiations from a position of strength, as EM stated.
Millstone
Holy sh*t you are right! A moment ago consensi.com redirected to the Kitov Pharma homepage!
GSK + Kitov!!!!
Congratulations to all! This is a great day for believers, and there are many milestones ahead!
Millstone
Always enjoy reading your analysis Mycroft. Thanks for highlighting the science.
My opinion is that A2-73 is not a cure for Alz., but it will help some very much. It might be a huge help in Epilepsy and Parkinsons. It will reduce symptoms in Retts. Will the girls with Retts be able to speak finally? I cross my fingers!
A2-73 will, at the very least, provide benefits to Alz. patients in the area of mood and sleep. Which is huge on its own.
Millstone
Interestingly, MS was mentioned in today's press release as a target for Anavex's molecules:
"The Neurotoxicity Research publication provides further insight on the mechanism of three Anavex sigma-1 receptor (S1R) agonists, ANAVEX®2-73, ANAVEX®1-41, and ANAVEX®3-71, which are all being studied in neurodegenerative diseases including Alzheimer’s disease (AD), Parkinson’s disease (PD) and multiple sclerosis (MS)."
So, only removed from the slide in the deck, not removed from the pipeline.
Hmmmm.
Very good link regarding the Zuckerberg investment fund. Here's some more info about Iconiq:
https://www.forbes.com/sites/briansolomon/2014/12/01/the-spider-of-silicon-valley-inside-zuck-friends-secret-billionaire-fund/#6110ec0f4765
I reviewed the recent SEC filings for CDXC and Iconiq did indeed just invest $6,999,999.70 of the most recent raise.
Looking good.
Rett Syndrome Clinical Trial -
Thought this will be interesting to track, since Dextromethorphan is also a S1 agonist and acts on the NMDA receptor:
https://clinicaltrials.gov/ct2/show/NCT01520363?term=rett&draw=1&rank=27
This trial is apparently completed but does not have published results yet.
A previous DM trial was halted because there was no placebo arm, though results indicated an increase in social interaction among the Rett kids using the Screen for Social Interaction (SSI). Here are the results of the previous trial: https://clinicaltrials.gov/ct2/show/results/NCT00593957?term=rett&draw=1&rank=20§=X01256#all
Obviously, DM is not A2-73 - completely different molecules and different activity. I have not yet found pre-clinicals on DM in a Rett model, but that might be useful to see if there were positive results in pre-clinicals.
Anavex's n=32 trial was Alz patients with "mild to moderate" Alzheimers. The trial inclusion criteria was an "MMSE score of 16-28 inclusive."
Interesting. It seems that aducanumab can reduce amyloid plaque levels more with a larger dosage over time. However, the reduction in amyloid plaque does not result in a similar dose proportional increase in MMSE. I think we've seen this before with other amyloid reduction gambits. Hard to get excited with these results from Biogen. I think the next step in the amyloid reduction approach is giving these mabs to pre-alz patients as a prophylactic, yet the side effects will be a hard pill to swallow, since the amyloid / dementia connection is debated now as much as the chicken/egg debate.
edit: per blu's post, it appears that the patients in this long aducanumab trial ARE already pre-alz or mild-alz. So, even less supportive of these amyloid reduction mabs.
That appears correct kevindenver.
BIIB's results appear to have a random relationship between dose and MMSE:
4.83 points in the 3 mg/kg treatment group
8.97 points in the 6 mg/kg treatment group
4.10 points in the 10 mg/kg treatment group
The biggest benefit was seen at 10 mg, however the worst performance was seen at 6 mg, and the second best performance at 3 mg.
They are being responsible and not hyping timelines. Good for them. In the meantime, their K-302 should be approved in short order and ready for partnering and upfront $.
The Anavex website sports a new look for November.
They've gone purple for Alzheimer's.
Lot's of attention to Alzheimer's. Makes me wonder what is in store for CTAD and November as a whole.
Anavex website
Today's news is superb. If you look at the trials of NT-219 in conjunction with Gemcitabine (Gemzar) on page 25 of KITOV's June 2017 presentation, it shows the effectiveness of the combo to counter the acquired tumor resistance to Gemcitabine.
It is nothing short of amazing. Granted this is a human tumor implanted in a mouse, so not yet all human, but the effectiveness, if confirmed in human trials, would be a game changer.
Millstone
Anybody terribly surprised that this post is misleading and incorrect regarding Dr. Fadrian's University? He posted a link to the "University's Centre for Distance Learning". This is the actual link to the University proper: http://www.oauife.edu.ng/
"The Obafemi Awolowo University is a comprehensive public institution established in 1962 as The University of Ife. The University is situated on a vast expanse of land totaling 11,861 hectares in Ile-Ife, Osun State, southwest of Nigeria."
AND, it is the University of Ife, not the "University of Life".
Ile-Ife is a region
"The University comprises the central campus, the student residential area, the staff quarters and a Teaching and Research Farm. The central campus comprises the academic, administrative units and service centers while the student residential area is made up of 10 undergraduate hostels and a postgraduate hall of residence.
In the 1970’s and the early 1980’s, the University attained a foremost position among universities in Africa, with a vibrant academic and social atmosphere and a high international reputation. Today, the University celebrates a rich tradition of excellence having produced, from among its staff, a Nobel Laureate and four National Merit Award winners."
And another thing, while on the subject of Nigeria. I think it is highly offensive to accuse somebody who spent 24 years at the FDA of bribery and corruption for simply having been born in Nigeria. A pattern of aspersions against the man based on racial animus? The Baltimore pharmacy that he has a connection to was called sketchy or shady when referring to the neighborhood, too. Anyway, research must be meticulous or it could even be libelous, too!
Millstone
I agree for the most part that the movement in AVXL has largely been in lockstep with the whole biotech sector. I have a number of bios, and they've almost all done the same thing.
Not hard to comprehend the desire on the part of pharmaceutical companies to find a compound that can protect OPCs and accelerate their maturation to OLs.
What you have provided is evidence that this is a shared pursuit, and that there are compounds that can protect OPCs in the presence of "the synergistic inflammatory cytokines, tumor necrosis factor a and interferon-?".
What is not elucidated is:
1. Is A2-73 better, more capable of protecting OPCs, OLs and Neuro cells?
2. Do these compounds that have been listed actually accelerate the maturation of OPCs into OLs? Or do they just protect OPCs to allow for them to mature in due course?
3. How do these compounds handle protection of OPCs, OLs, and Neuro in the presence of other bad actors against such cells in addition to inflammation, such as apoptosis, excitotoxicity, reactive oxygen species (ROS)? That is what the Lisak study tested. Find me THAT study, or don't, but be sure that you are accurate in your comparisons or you will be at risk of...not being accurate.
Excerpt from abstract: "Cell cultures containing >90% OL, OPC or Neu were prepared from neonatal rats and were incubated with staurosporine (apoptosis), glutamate (excitotoxicity), H2O2 (reactive oxygen species; ROS), quinolinic acid (inflammation) or additional medium (control) with or without DM or ANAVEX2-73 (provided by ANAVEXTM Life Sciences Corp, under the SIGMACEPTOR (R) program)."
Certainly Biogen thought it promising enough to test A2-73, as did the Parker Webber Chair in Neurology, Wayne State University/DMC Foundation (independently). Not to mention these are follow-up, confirmatory studies. They've been looking at A2-73 repeatedly. Maybe there's something to this?
Millstone
The purchases are according to an SEC sanctioned trading plan, through which purchases, even while in the possession of material non-public information, are completely legal. That is the main purpose of a trading plan. It is generally constructed to be at arms length, with a preset timing/share amount.
I don't believe that is correct either. The purpose of the plan is for people that are often in possession of material non-public information (officers/directors) to avoid the appearance of acting on said information, by setting up a stock purchase plan that is either administered by a third-party and/or automatic (set amounts, prices, or dates). Having to suspend automatic purchases would be contrary to the purpose of the 10B5-1 plan. Some people recommend not beginning purchases immediately after setting up the plan to avoid the appearance of impropriety, but I have not heard of stopping purchases prior to material news after the plan is up and running.
Reminder of the tantalizing potential of TyrNovo's NT219:
""Based on the pre-clinical results generated to date, we are receiving solid preliminary interest from potential strategic partners for NT219, which presents a novel, first-in-class mechanism of action in the oncology field."
A quote in KTOV's press release of October 6, 2017.
Kitov now OWNS 97% of TyrNovo. NT219 is made for a BIG partner since it converts ineffective (patented) chemo drugs to effective in many types of cancer thus far in the lab.
Millstone
Meant to say Elysium is "proving" to have acted in bad faith.
Thanks for the insight.
Seems like Chromadex will have a solid case for patent infringement. Up to this point they probably didn't want to rock the boat imagining that Elysium would back down. Instead Elysium has gone for the IPR nuclear option. Chromadex at this point might have to file for patent infringement since Elysium is providing to be acting with bad faith
Sure seems like a deliberate miscast of the facts on the part of Elysium's legal team. I'd have to think that it was the lawyers that came up with this defense since it is so out of the norm (i.e., crazy) and appears like grasping at straws.
It does seem that, since per the Agreement Elysium's use of the trademark(s) is entirely optional and does not have any bearing on the royalty, the argument that there is a royalty directly tied to the use of the trademark(s) is completely obliterated. Further, any lawyer making the argument would have had to have read through the Agreement and: (i) deliberately overlooked the multiple references to "may" rather than "shall" or "must"; (ii) as you mentioned in your post on your website, disregarded that a patent is a legal monopoly, and has the express intention of giving the patent author the right to profit (or not) from their invention. Even if the trademark were required on the packaging (not unusual or unwarranted), it does not further restrict any party more than the patent itself (as a legal monopoly).
Are Rule 11 Sanctions rare?
Terrific analysis Milarepa! You nailed it. Elysium is playing a dangerous game. If they are getting Niagen from another source, I imagine it can only be:
1. A third-party with a supply agreement with Chromadex;
2. A third-party that is mixing the stuff up on their own.
Evidence points to #2, since the chemical signature was different according to Chromadex's analysis of the contents of Elysium's latest bottles.
So, Elysium would be infringing BIG TIME, and knowingly.
Elysium's claim about the License Agreement is so poor it is maddening. As you point out, there is no requirement that Elysium even USE the trademarks. Elysium is simply purposefully misinterpreting the title of the Agreement itself, and not reading any of the contents of the document. What a farce!
Millstone
Thanks for your thoughts, based on personal experience. I do believe that A2-73 should see approval as well going by symptomatic improvement alone.
Maybe by analyzing our gut microbia we'll find a correlation?
There are quite a few of us here napkin. I do think I have tempered my expectations as the data has come in. Though ANY reversal in Alzheimers progression is a MASSIVE victory! Now, finding the magic correlations.
Investor2014 - That slide represents a study of P3a amplitude from 2007 in different patients.
It seems that Anavex believes that they have a compound that works in some patients with Alzheimers Disease. They have many reports of symptom alleviations (insomnia, gait, mood, etc.) and a dose/response alignment. They have a small group of strong responders, and are still (as far as we know) looking for the magic correlation, though they do have some clues that will enable a better Phase II/III patient selection.
The MOA is what intrigues me (restoration of cellular homeostasis) and certain measurement improvements that correspond (p300 data). We could be looking at an approach which targets VERY early intervention, and one which requires long treatment before the beneficial effects are truly seen.
I cannot help but think that the Rett trial and Parkinsons trial could be great successes based on symptom alleviation alone. As has been stated many times, at the basic cellular level (endoplasmic reticulum, mitochondria) murine biology is the same as human. Our S1R, acting on such systems, might do for humans what it has shown to do in preclinical models. At the very least.
Millstone