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Hey M$, I was on the Youtube link. That's what was sent by email that day.
When signing up for the live event it asked for questions. So, in-between things I was doing, I thought about questions I'd love to know pertaining to the upcoming trials- clarity on some info from the pr's, their schedules, how many cohorts they'd be using in part 1, and some clarity on part 2, if they'd be using EEG, aMRI, or other testing during this phase or in phase 2 to show brain activity, re-connectivity and possible regenerative-type events.
With bringing togther these two brilliant people I was really excited for a deep dive. My expectations were too high for this, is all.
After the last Q&A live talk with just Chris, was really excited for the same to come with Drs. Nutt and Strassman live. With the questions section as part of the sign-up, I thought that's more of what was going to happen.
Oh well. For the 80k+ views/viewers, it was a good intro to a brief background on them, their work with DMT and the fact there will be a trial. Guessing most people already knew much of what was discussed, but we can really see the draw of Drs. Nutt and Strassman, so that's good for Algernon, especially once on Nasdaq.
Seriously, 10 minutes? When I registered, I asked three questions about the upcoming trial that should have taken at least 10 minutes for them to answer in and of themselves. I sure hope they went on to have a private recording that she's going to release some other time. Doon..
M$, you're welcome. Sounds like we both posted your question. Glad it was answered, and that you had the time to attend.
Okay, thanks for posting the questions. Hopefully, you can make it. If not, then I'll try to get the questions answered along with an update on their uplisting status.
Definitely post your questions. I, or someone here, should be able to get them asked and hopefully answered. Once I saw there was going to be a Q and a, I figured you would not be letting that opportunity pass.
This just in from Bloomberg News.
Now, go back and look at the valuations posted here and compare them to what Bloomberg notes for stroke as a whole and see what you come up with for a likelihood on Nasdaq uplisting and valuation potential.
https://www.bnnbloomberg.ca/can-we-treat-strokes-with-alternative-medicine-1.1690130
M$, thanks for the info. That seems pretty close to what is posted in the pdf for Nasdaq uplisting, except, being able to qualify for special circumstances at $2/share is interesting. Nasdaq seems to have built in "flexibility" to do what they want as they go.
For Algernon, that seems a good thing.
The two things I wondered about most from the start was the market cap and the value of the public float, and the share price of $3 or higher for the past 90 consecutive days.
Now, starting with the share price, if Nasdaq looks at the stock at 168+M shares in total and only a price of $.05+ over the last 90 days, then I see no way they could get approved. However, if Nasdaq looks retroactively at 168M at $.05, being the same as 1.68M shares being traded at $5.00+, then, I could see where Nasdaq would say they've been respectively trading at more than $5 the entire year.
If A (168M at $.05) = B (1.68 at $5), then, by "Substitution Property of Equality," this takes the part out of the equation that asks, "how do they qualify at $.05/share?"
However, they still need (needed?) a $50M market cap and/or a $15M public float valuation, depending on through which of the 3 routes they will qualify.
I say (needed), because a high enough valuation is what I suspect CM was thinking the private valuator would discover for them all along. He's stated his position on their value many times.
I, and others, have also posted researched findings on this topic, but what will be an initial offering at this stage?
Based on the current pipeline and news of successful meetings for near-future trials, we'll soon find out what Nasdaq thinks of Algernon's value.
Glta
https://www.mathplanet.com/education/algebra-1/how-to-solve-linear-equations/properties-of-equalities#:~:text=This%20is%20called%20the%20substitution,for%20b%20in%20any%20expression.
Well, check another box off the news list.
Australia IPF/Chronic cough to reach final enrollment by end of Dec, with Q2 final read out.
https://finance.yahoo.com/news/algernon-pharmaceuticals-projects-full-enrollment-120000186.html
According to the 6 week timeline in that document about uplisting and qualifications, I mentioned a while back, tomorrow, Dec. 2nd, is that 6 week date. So, could today's dip be like many other days when the stock hits lows to get people to fold their hands so management and friends can pick up shares cheap? Could be, could not be.
Could tomorrow be the day for Nasdaq announcements? Maybe, maybe next week.
Namah, good to see you posting right now.
Almost as reliable 'probability indicator' as any, Namah's written voice only comes up on these boards when people are trying to run the price lower before something smacks his words in the face and it goes the other way.
We now have an additonal C-suite member, who can be added to the BoD and who will help them qualify for the missing committees they need/needed to create for Nasdaq compliance, irregardless of what companies he/they may have worked for in the past.
Think they've gone 5 for 5 or 6 for 6 on news releases or talking points these past 6 weeks.
If that is the timeline they are on, which the reverse split was right on the 4 week date and could be an indicator, then we'll find out soon enough about Nasdaq; although, there was a holiday in there. So, maybe next Monday?
Peace to all.
M$, personally, I very much appreciate today's latest DD posts! I was with family and just got home to read through the last 10 board posts or so, and was happy to see all that comparative info come through. And, was about to do the math for averaging them out when I saw your last post; fantastic stuff. Thank you.
For myself, this is not a prediction, though I think I broadly mentioned this once before, with the pipleine as we know and the timeline being what should likely play out, I see a great chance at this being in a $250-350M cap range by mid-Summer. Too many factors to consider at the moment, and haven't done the cost/treatment breakdown of CC and rSCLC like I did with DMT, yet that $1B market cap with start of two Ph2 trials on DMT and CC, and a Ph1 rSCLC seems possible, based on a quick review of the info you shared.
For Algernon, from memory, CC could be near the same value as DMT, though with more competition in the space. (That competition reaching a billion in market value in Ph2, as you've posted here in the past.). SCLC affects about 30k people (US) each year. Unfortunately, it's a sh!t show and nearly all will recur in 12-18 months, most within 3 months. From past research, Topotecan costs around $36/mg. There are 5 days of treatment for at least 4 rounds. It'll depend on what amount of Ifenprodil is given with the topotecan to really forecast any value. I'm sure it can be closely equated from Dr. North's work. Since most patients pass within 3 weeks of secondary treatment, it should be very easy to see positive trends and make positive impacts should the real world data play out like the Dr. North studies. (Perhaps GSK would like to partner on this trial?)
This being said, I do feel there's a strong chance we will be closer to 3 million shares oustanding by the end of first quarter should all pre-IND outcomes go as well as the rSCLC and they move forward simultaneouslyon them all, but really am hopeful for partnerships instead.
Glta
Happy Thanksgiving, Happy New Year and GLTA.
For those who haven't seen the new video, here you go. Chris is looking quite giddy. Hope it's contagious for all very soon.
All pre-IND news prior to NASDAQ uplisting should be out for the month. Maybe a PR on finishing the part 3 pre-clincical with Hammersmith in early December, then an application update for Ph1 in later December after uplisting. Think January-March gets real interesting with probable trial info besides Ph1 DMT, ie.- CC Ph2, SCLC Ph1, pre-IND pancreatic cancer; not in particular order.
Until next year...health and peace to you and your loved ones.
Hey M$, I should clarify, you and I are professing for the same goal... keeping the float the same while raising the value of that float.
I haven't specifically talked about the float and keeping the number of shares the same, but that is what it's all been about.
To be clear, Nasdaq is fantastic! Excited for the direction and wanted it a long time ago. It appears to me they are doing this at this time to raise money to start moving forward on multiple trials all at the same time, or at least over the next half year. Understanding the research, the nearly 100% probable trial success of a Ph1, the short duration it would take along with it's inherent value for the company, I just believed there was a way to move forward with DMT with the funds they have, to be able to land a large Pharma partner going into Ph2, increase their company valuation to low/mid 9 figures, $1.50-$2 by June/July and then, if they wished to uplist, do a 5 or 10 to 1 reverse, going into Ph2 DMT, announce a start of Ph2 CC, have final results of AUS IPF (not as big a deal), and then start into cancer.
In the end none of this matters. They can still hold off on the other trials and attain the same achievements and valuation on Nasdaq, only it will have to be a $150-200+ stock price to equal the $1.5-2 at the current 167M shares.
Now, I have $1.2B - $13+B, as the outer ranges of valuation based on the combined US/EU stroke potential, with $4-7B being highly probable with successful Ph3 trials. What does a Ph1 company value out at? How about a Ph2? What about a company that was just told by the MHRA to look at DMT in Ph2a as an acute stroke TREATMENT, not just prophylactically after the acute phase?
Now what if you knew tPA currently costs the hospitals $6430 to purchase a 100mg vial. That they run a 90mg max dose over one hour. That with 1.405M stroke patients yearly, 610k EU and 795K US, the potential of tPA, the only other adjacent drug for stroke, is $7.227B. They of course can only treat up to 80% (1.124M) of stroke patients, while Algernon has a high potential chance of treating 100% of pateints, since in sub-hallucinagenic doses heart rate and blood pressure are not elevated; that's $9.034B for a single treatment per patient.
What if they do a treatment every 2-3 days, like Chris said in his interview with Dr. Strassman? My guess is it'll be a 1/10th dose treatment, since 3nM solution also demonstrated clinically significant growth, or a shorter 30nM treatment time to make it more cost acceptable to hospitals and insurance companies. Who knows? I believe a $4-7k/5-8k total treatment cost for an acute Stroke treatment is a value range.
But, of course, you'll have to figure out if you're comparing apples to apples or oranges.
Is Algernon only infuisng a few milligrams of DMT or hundreds of milligrams.
I know you think no one knows the possible valuation potential of DMT, and I believe Chris Moreau knows, soon the Nasdaq valuation specialist will know, and that based on the many nuggets of information gleaned from their PRs and interviews, that a high probability value assessment can be done. We only have possibilities and probabilities to work with and not all the insight they have, but it's still quite a bit from which to engineer a probable value and range, if they're successful.
Since you believe people here don't do DD, I will share enough info to get people started down the direction I took, should they be interested.
Well, how many milligrams might Algernon be infusing over the course of their 6 hour treatment?
You'd have to figure out the molecular weight of DMT, of knowing how many mg are in one mole, and then calculate for milligrams in a 30 nanoMolar solution of DMT. (0.0056481 mg = 30nM of DMT, is the answer I come up with.)
Then you'll have to figure out the infusion rate the medical team will be using, mg/kg/?.
Are they running 0.0056481mg as a specific total for each person in 6 hours, are they infusing that per hour, or maybe even per minute?
This is the most difficult answer to come up with, and the most important for all subsequent calculations, since they do not tell us the infusion rate. I spent dozens of hours delving into studies, talking with research scientists and medical personell to varify my solution.
For easy math, let's use a 100kg (220lb) person. Is 0.0056481mg X 100kg person = 0.56481 mg, the total they will be running in 6 hours?!? What if they ran it each hour for 6 hours; 3.3886mg? Or, per minute; 203.3316mg?
30nM may not be so small, after all.?
There are enough past human studies, by Dr. Strassman and others, and current studies, by Yale and University Hopsital, Switzerland, etc... to give you a pretty good answer.
Then, what is the average weight of a stroke victim? Most studies are done in BMI classifications? So, convert BMI into kg. Using the average height of a male and female is helpful to get a figure.
Based on stroke meta-data, my math shows about 95% of patients fall within a range of 56-110kg. You'll have do some more math to come up with an average where 50% are above and below a number, but as a hint, averaging the above two numbers is a bit high.
We already know how many pateints there are in the EU and US.
Figuring out price comparisons, hospital reimbursement costs, etc...for appropriate drug pricing or total treatment cost range is next.
Or, there's enough above to apply to calculations and come up with a range.
If someone wants to figure out the value of the UK, the EU or the US, individually, those numbers are out there.
There are a number of other factors about Algernon's trials, their findings and successes, the market... but to me Ph2 is where those answers lay and the excitement factors around a new possible stroke treatment would play well for stock price mid-next year.
We'll see if they hold off on those other trials until later, or even use the cash on hand to initiate those trials and land a partner for DMT or CC before a PP.
-----
Some links, like the first one for reimbursement rate...may not come through so just copy and paste the name into a browser.
Reimbursement Rate for Clot-Busting Drug Does Not Match Price Increase
https://www.hmpgloballearningnetwork.com/site/pophealth/content/jj-prices-ketamine-depression-treatment-590-885-two-doses
https://www.ncbi.nlm.nih.gov/books/NBK482376/
https://pubchem.ncbi.nlm.nih.gov/compound/N_N-Dimethyltryptamine#section=Chemical-and-Physical-Properties
https://hextobinary.com/unit/molarconc/from/molar/to/nmolar
https://clinicaltrials.gov/ct2/show/record/NCT04711915?view=record
https://clinicaltrials.gov/ct2/show/NCT04353024#studydesign
A Model for the Application of Target-Controlled Intravenous Infusion for a Prolonged Immersive DMT Psychedelic Experience
A Model for the Application of Target-Controlled Intravenous Infusion for a Prolonged Immersive DMT Psychedelic Experience
https://jamanetwork.com/journals/jamapsychiatry/article-abstract/496494
https://www.frontiersin.org/articles/10.3389/fphar.2016.00211/full#B54
https://scholar.google.com/scholar_lookup?author=E.+Gouzoulis-Mayfrank&author=K.+Heekeren&author=A.+Neukirch&author=M.+Stoll&author=C.+Stock&author=M.+Obradovic+&publication_year=2005&title=Psychological+effects+of+(S)-ketamine+and+N,N-dimethyltryptamine+(DMT)%3A+a+double-blind,+cross-over+study+in+healthy+volunteers&journal=Pharmacopsychiatry&volume=38&pages=301-311#d=gs_qabs&u=%23p%3DgLlYBw97jC8J
https://analyticalsciencejournals.onlinelibrary.wiley.com/doi/full/10.1002/dta.422
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4294078/?report=reader
PsyCap Recap: 3 Key Takeaways from Algernon Pharma at PsyCap
PsyCap Recap: 3 Key Takeaways from Algernon Pharma at PsyCap
The team at Algernon Pharmaceuticals is investigating the neurogenesis properties of microdosing DMT through an IV infusion in the treatment of ischemic stroke.
N,N-dimethyltryptamine compound found in the hallucinogenic tea ayahuasca, regulates adult neurogenesis in vitro and in vivo - Translational Psychiatry
N,N-dimethyltryptamine compound found in the hallucinogenic tea ayahuasca, regulates adult neurogenesis in vitro and in vivo - Translational Psychiatry
Translational Psychiatry - <ArticleTitle Language="En" xml:lang="en">N,N-dimethyltryptamine compound found in the hallucinogenic tea ayahuasca,...
https://www-hopkinsmedicine-org.cdn.ampproject.org/v/s/www.hopkinsmedicine.org/health/conditions-and-diseases/stroke/stroke-recovery-timeline?amp_js_v=a6&_gsa=1&=true&usqp=mq331AQKKAFQArABIIACAw%3D%3D#aoh=16358596270547&referrer=https%3A%2F%2Fwww.google.com&_tf=From%20%251%24s&share=https%3A%2F%2Fwww.hopkinsmedicine.org%2Fhealth%2Fconditions-and-diseases%2Fstroke%2Fstroke-recovery-timeline
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4361809/#!po=8.72093
https://www.sciencedirect.com/science/article/abs/pii/S1388245703002633
https://www.cdc.gov/healthyweight/assessing/bmi/adult_bmi/english_bmi_calculator/bmi_calculator.html
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5451428/#:~:text=Baseline%20characteristics,-There%20were%206508&text=The%20mean%20age%20of%20those,517%20(10.8%25)%20were%20obese.
As they have demonstrated quite well over the past month, they had, and still have every intention of fu@%ing over their common shareholders at every opportunity until the up list is complete, or until they are told to go back to the drawing board and come back when they have built more value.
On Oct, 24th, I shared a list of the 5 probable catalysts between then and Dec 2nd (the date Nasdaq was most likely to give their final decision). I did that work for my own DD, but because of the Nasdaq PR, I shared it to show there are near-term value building events on the horizon and to call managment into question publicly as to why they're doing this now.
Currently, 3 events have come to light- DMT pre-clinical data on part 2, MHRA positive feedback, and we know they received news to go back to the drawing board on DMT in the US next year, so they have had their pre-ind on DMT.
We still have pre-INDs on sclc and cc to hear about. If they plan to move forward with them next year then news should be coming very soon.
We still have 100% trial enrollment in CC/IPF AUS/NZ to hear about. High probability to hear about that very shortly, also, considering Australia actually opened up borders to two countries and intra-country on November 1, earlier than the Nov 5th they originally stated. That's 19 days now Algernon's had to enroll and on-board the remaining waitlist, which should have made 22 patients, at last count.
Even that list was only a partial list of the potential short to mid-term catalysts, 0-6 months. And that should have had a good impact on company and share value by year's end.
As well as the list of 5 catalysts, I mentioned the probability of early Q1 for starting to see patients in Ph1. Moreau has confirmed the start of Ph1 in early January. It only takes 2 weeks to gain approval for their Ph1 trial. Big catalyst!
Before my most recent research I expected their trial to be complete by June 1st. Ph2 start by July/ August. In actuality, depending on the number of people in the Ph1 Healthy Volunteer trial, they could complete the volunteer portion of their trial in just weeks and move out final data within mere months. CM keeps talking about how easy this Ph1 trial will be and how they are not concerned about safety, at all, so they are looking squarely onto Ph2 with pure excitement and knowing success to come.
For example, One such recent DMT, Healthy Volunteer, trial with 30 participants, completed their participant portion in 15 days and had trial completion in 3 ¹/2 months. Unless there are delays to the start or it's much larger than 30 people, I now fully expect Algernon's DMT trial with data release to be completed by May 1st. How's that for a huge catalyst for which Nasdaq isn't needed prior?
If they have $3.5M CA, then why the hurry to push Nasdaq? They have all the funds necessary to complete their Ph1, get data, build tremendous value and gain partnership into Ph2 without and prior to uplisting.
THERE IS SO MUCH VALUE TO BE BUILT WITH WHAT YOU'VE ALREADY STARTED. WHAT IS YOUR FU@%ING HURRY TO START ALL OF THESE OTHER TRIALS, CHRIS?
Since I posted Oct. 24th, I have spent weeks deciphering and building a valuation of Algernon based on their 30nM DMT solution alone. As I stated before, I do not understand why anyone thinks the value of 30nM is small, IT IS NOT!
I had originally done this work for myself, but after they continued allowing the company and value to spiral, and did not respond privately to enquiry, I decided to put together a very lengthy breakdown of the potential DMT value and it's range. This, of course, was also to help show why this is still the wrong time for Nasdaq, and that reverse splits aren't needed to build share price in order to uplist in the near futute.
Ironically, I was finishing up that post the morning they went public about their reverse split, which I should have realized they might do since that was the '4 week date' of when all final paperwork needed to go back to Nasdaq in response to any issues brought to their attention.
Anyway, more than anything else, this post is to air my disdain for what they have done and how they have treated their shareholders. For, unless shareholders plan to do something about this legally, then the informatiom I have is no longer pertinent at this time.
Good luck to all. I'll share the DMT breakdown once they share the Nasdaq outcome, or once we hit a penny, whichever comes first.
Until then, don't pick up the soap, Kal's pirates are watching.
Now we wait. Over the next two weeks Nasdaq will look over their final submissions and the independent valuation will be complete.
Some good news for current and future DMT researchers in the US.
https://www.marijuanamoment.net/dea-boosts-psilocybin-mdma-and-dmt-production-levels-again-in-final-quotas-for-2021/
I only have time for a very quick reply right now, and will try to reply in more detail later.
What we know right now, based on what they've released, is that this is one infusion lasting 6 hours. That does not mean that it will be cheap, though I have no idea what will be the actual cost of purchase.
We don't know anything about how they will conduct their clinical trial, other than it will be used concurrently with cimt. Most hospitals try to get a patient their first rehab therapies within 24 to 48 hours upon arrival. Be able to complete an infusion within six hours, seems to me this could quite possibly be added and completed within the first 24 hours of admittance. The average latient is in the hospital for 5-7 days.
There are several studies that show a number of mechanisms working in conjunction through stimulation of DMT infusion that would produce the neuronal outgrowth, some of these mechanisms would appear to be very beneficial to helping reduce the overall damage and increase the potential healing of the brain after a stroke or traumatic brain injury, so having such a strong effect in a short timespan is great, though this is not it's initial intended use, beyond neuronal growth and faster physical recovery, though the mechanisms of action being fonished in part 3 of pre-clinical may warrant it being used as soon as possible after stroke due to how it works.
I'll be very interested to find out how they're going to run their Phase 2 trial and whether or not they will use additional infusions either prior to or during cimt. Traditional cimt, from my research, has a patient constrained for up to 6 hours per day for two weeks, but most are using modified cimt protocols.
Out phase 1 in humans will allow more potential earlier use based on saftey.
Anyone have any luck in reaching out to the company regarding answers on this latest news?
Agreed.
And, I agree with you whole-heartedly, that CM should be doing Q&As. I expected at least two, just as he does with every PR lately, and yet, not a one. Highly disappointing to own as many shares and potentially be watching them all go up in smoke. Just as I was finally excited for the next 6 months to play out, this is perplexing to say the least.
Sorry, yes, you're right that link was only about the CTA process, which states that for a type A trial, there is a 14 day processing time, and for class B and C there is a 30 day time, but 14 days if the trial is Ph1 using healthy volunteers.
Unclear, but since it's DMT and not an already approved drug it's probably a class C, but won't matter much as they should still get approved in 14 days for healthy volunteers.
I don't seem to have the link to the scientific advice outline. From memory, it stated that the company submits an application with as much specifics as possible, and precise questions, provides a set of dates that work for the company and the MHRA will choose a date. From there, the company submits its full packet, with any presentations, 15 days prior to the meeting date. After the meeting the MHRA will present, within 30 days, in writing, all answers to the company's questions. From there, I deduced a minimum of 46 days- 1 for submission, 15 days packet before the meeting and 30 days for a written answer follow up. Perhaps, this can all get done in 30 days, but I felt pretty safe in using 60 days as for my calculations.
Oh, of course, now I find it. And, actually it turns out those are 15 and 30 working days.
Here, Gives the MHRA scientific advice meeting outline
https://www.gov.uk/guidance/medicines-get-scientific-advice-from-mhra
First off, let me say, I do not understand why they're doing this right now, nor do I understand how they're going to get around needing to have a $3 minimum share price being traded for 90 consecutive days before they can be approved. That is what is stated as one of the requirements bullet pointed below the Capital Markets grid. The only thing I can even fathom is that there will be quite a number of positive outcomes in the next 4 to 6 weeks and that CM is hoping the independent valuation done for this application will determine their value to be much higher than our current $0.06 share price and that this will somehow spark a rapid growth in share price to get us out of the hole we're stuck in. And, that he is only using this to uplift the stock now, and down the road after acquiring partnerships, grants, etc... they will legitimately file an application after having reached some clinical significance in their DMT Phase 1, the ipf phase 2 and heading into the start-up of a chronic cough Phase 2...
Legitimately, I cannot figure out what they are doing right now.
It's interesting that the person you quoted for timelines came up with, essentially, the same numbers I have. Prior to this NASDAQ PR, I had been trying to put together a timeline of potential events and dates based upon their press releases and what we sort of guesstimate for how long it takes to get a pre-ind meeting and an mhra meeting, as well as some other timelines.
Anyway, here's some of what I've compiled with some updated dates and numbers. This was done for my own info and I didn't have plans to share, but with this Nasdaq PR I figured I'd throw it out there, so critique what you will.
In the next 4-6 weeks, potential catalysts... (potential = possibilities and probabilities, of which I am neither a statistician nor do I have any insight as to what they are running right now.)
Dates to remember- 4-6 weeks for Nasdaq application process (Oct 21- Nov 18/Dec 2 = 4 and 6 weeks, respectively from PR).
Below, the first date is when the PR was released and the next set of dates is when the expected timeline for release should be. It's been stated pre-ind takes 30 days, but I've found where it can take up to 60, so I've done numbers for both.
1. SCLC PR = (Sept 22 - Oct 21/Nov 19 = 30/60 days, respectively) Sclc US pre-ind update should be due/coming in days based on others list of 30 days for pre-ind meetings; 1-2 weeks very high possibility, 3-4 weeks extr. High probability; my research showed up to 60 days for pre-IND, should = 100% probability of PR before Dec 2.
2. CC PR = (Oct 8 - Nov 6/Dec 5) CC US pre-ind update due within the next few weeks; 4 weeks high possibility, over 90% probability by Dec 2nd. (100% probability if it takes 30 days for pre-ind)
3. Data release on DMT- 2nd phase of preclinical data within the next 30 days due on Duration and Dosage for best outcomes of new brain growth... 1 - 72 hour bolus and continuous dose,
(June 17- PR- acquire all permits/licenses to manufacture cGMP DMT, announce Hammersmith starts preclinical dose/duration part 1.)
Sept 7- (June 17- Sept 7 = ~12 wks/83 days to announce part 1 results- 40% neuron growth; estimates of 3 months per part for preclinical work was about right)
(10 wks/12 wks from Sept 7 = Nov 15/Nov 29 = 70/84 days)
Based on 83 days to part 1 PR release, there's an 84% probability of PR by week 4 (Nov 18) of Nasdaq application and 100% probability by week 6 (Dec 2).
This timeline also falls in line with CMs statement of CTA application in Q4.
4. MHRA meeting and possible start date, Q4?
Based on above timelines, probabilities for final data on preclinical DMT mouse studies in Q4 should be 100%. Start of Ph1 in Q4 is mildly possible, low probability of seeing first participants, ~33%, but possible to complete set up of Safety study of first humans; especially interesting is blood pressure outcomes for viability in hemorrhagic stroke.
Low probability of seeing first participants in Q4, but completion of Ph1- safety and sub-hallucinagenic dose studies could be complete by end of Q1. With 100k strokes per year in the UK (~8.3k/mo) there's a high probability to have stroke victims immediately available for 2a, possibly in Q2; although first 2a is only for combined recovery with CIMT, hopes to expand Ph2 into immediate stroke tx w/ good BP (blood pressure) data is a possibility. However, nearly 100% of pt should be eligible for initial study roughly 72 hrs after incident.
(MHRA meeting, no solid timelines found on scientific meeting requests, however some notes indicate 10 days written submission prior to set meeting and written answers supplied within 30 days post meeting, so indicating at least 40 days and probably likely the same 60 days as the pre-ind US, though some say 30 max.) (Oct 13 - Nov 18/Dec 2 = 35 days/49 days = ~58-82% probability of PR by Nov 18/Dec 2)
(Start of Ph1 DMT trial prior to Nasdaq Dec 2 = ~0%; CTA to be submitted in "Q4," per CM; appears within statistical reason. 14 Days to approval of "Ph1 healthy volunteer studies" per MHRA guidelines. (See site below.) = 100% probability in early Q1 of Ph1 healthy volunteer start, provided all goes well in timelines stated)
https://www.ct-toolkit.ac.uk/routemap/cta-submission/
5. CC/ipf study reaches 100% next 2-4 weeks, with topline data around end of Q1/Mar
Last week Australia was stopping there stay-at-home restrictions and by November 5th, which is in 2 weeks, stated their largest cities will be 80% vaccinated with most restrictions lifted. We know Algernon has a contingent wait list of more than enough people to satisfy their 20-person study, and may have upwards of twenty two or more people that can enroll in the study based upon the waitlist they talked about. So they can go to 100% fulfillment, which means 14 weeks to finish and perhaps 18 weeks until final read out data in March, 2022, if enrolled the week of Nov. 5.
They have stated nothing about ending the trial. So, by Dec 2, Nasdaq week 6, there's a 0% chance of reaching enrollment and a PR if Australia stays closed, and should be a 100% chance, dependening on length of on-boarding process, if they open by Nov 5. Big unknowns.
I do not remember hearing of nor reading any scientific studies published disclosing Algernon's so-called
"... data[, which] showed that patients' cough counts at these two post-treatment times ['4 and 12 weeks'] were lower than at baseline."
Yes, "positive trends," were mentioned, but nothing more specific, that I recall.?. Not that this is very specific, but "trending" toward being more specific.
Also, don't recall CM either using the words or broaching the topic of a placebo control.
Perhaps, they may actually accomplish a real trial setup this time. Hell, even statistical significance was brought up again in this article.
Anyone else remember these things being discussed or released somewhere?
M$ I get your frustration.
I don't usually post this much in a 5-year span. I don't know why I'm doing it now, other than possibly sensing The Winds of Change towards a chance at legitimacy somewhere down the road. I do believe in Ifenprodil, I do believe the DMT for stroke has a legitimate shot. I do not believe in Christopher Moreau. Giving some credit, I do believe that he seems to be putting in effort to read studies and educate himself medically on what Dr. Williams has been trying to do with Algernon's program. Though I do believe he's been in way over his head, after three years of bumbling and stumbling his way through he may finally be bumbling and stumbling into the right clinicians and correct studies within the best countries to bring Algernon into possible, maybe even probable success, as long as he doesn't "cock it up," as they might say.
So, here are some of my take aways and questions from this weeks video sessions, IF all is to be believed.
The Good (a) and not-so-good (b) of things we learned from Algernon vids yesterday, and things I'd like to know (c), IMO,
1a. Good- Dr. Mark, Algernon's drug repurposing Mastermind, is back
1b. Not-so-good- Chris is still in charge
1c. What happened?? Is our new Board Chairman putting the smack down?? Mark for eventual CEO replacement??
2a. Good
-Chronic cough data (of 14 ppl) trends well
-pre-IND US filing update coming soon
2b. Not-so-good
-You need strong data from 19 of 20 ppl, mimimum, to reach a p-value of <=.05 (we have 14 ppl)
-CC/IPF trial is stuck in hell AU/NZ not going anywhere (8 ppl signed up and can't take part from lock down)
2c. ??
- so, did all 14 ppl strongly trend well??
- why is IPF left out of CC study USA??
- Is it for ease and expediency of trial (maybe a faster outcome, like Bellus Health), or insufficiency in IPF data??
-will this now be open for all adults with CC (roughly 11% of American adults)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7167208/#:~:text=Introduction-,Chronic%20cough%20is%20a%20common%20complaint%20in%20the%20general%20population,life%20%5B2%2C%203%5D
- will they open up this US trial to pediatric patients, as 5-10% of US children get chronic cough, as well, and account for 30 million doctor visits each year
https://www.rush.edu/news/chronic-cough-kids
-as for our current trial, Is the AU/NZ trial continuing and why??
- time to work with AU/NZ govt for a much bigger refund on trial investment, perhaps??!
-it's an open label study, for crying out loud! It's time to have Novotech work with the govts to extend protocols and send medical professionals into 8 homes, set up 24 hour cough study equipment with video surveillance for initial cough per minute/hour baseline records, use on day 0, 1, 16, 30, 90...whatever...and give them a frigen bottle of open label pills, and direct them to take them "PO Q3" or as directed at specific times all on video record so that cough counts and accountability can be proven. Figure it out already!
3a. Good
30 days or less for rSCLC pre-IND meeting, announced 9/22 (t-minus 28 days, on/before 10/21 for update)
3b. Not-so-good
we now know Algernon does not have or will not be using an IV ifenprodil solution, as stated by CM in minutes 3-4 of vid with Cindy Edwards;
- Dr. North, in his animal studies, used a different delivery method than will Algernon ("peritoneal" vs. "Oral," respectively) so phase 1 dosing trial is where this starts;
3c. ??
IV bioavailability is always better, so will efficacy of oral ifenprodil (broken down/delivered by ingestion/digestion), be the same as Dr. North's findings with direct delivery through circulation
(I cannot find any correlative data studies on bioavailability between IV and Oral ifenprodil. Only the human IV bioavailability Data Sheet and a study that showed oral rat bioavailability.)
4a. Good
-Algernon now manufactures it's own supply of ifenprodil,
- doesn't need the supply from Japan anymore
- stated by CM around minute 11 to also having inventory (so we have supply now let's get good trials going and build demand. Strongly agree with M$ that starting trials does little for company value, finishing strong trials does!)
-now have freedom to move ifenprodil to countries with whom Japan supplier may not have agreed (for note, Japan and AU have very strict healthcare standards and drug manufacturing and workwell together as countries, in this regard, essentially tops in the world, so would be my guess that Algernon was bound very tightly by Japan supplier, just an educated guess)
- now, onward and upward to the US and UK, "huzzah!"
4b. Not-so-good
-Took years and millions of wasted dollars on possibly valueless trials to get here (some data, like safety, IL-6, from Covid study, and trends from IPF/CC may still serve some beneficial purpose)
4c. ??
Are they still using/bound by trial setup (?) to use the supply from Japan, or have they started using their own supply??
When will they have an IV solution??
Do they/will they have a liquid oral solution vs pill form- tasty cherry flavor for the kids, which will be much easier for consumption if/when they move the study toward younger or non-pill swallowing patients??
5a. Good
Mr. Moreau likes to address "shareholders" in his videos
5b. Not-so-good
He likes to do it with a smarmy smug smirk on his smacker ( figured I'd complete the alliteration).
5c.??
??can/will he go back and watch his numerous videos where he tells the "shareholders" what they "need to remember" and watch for the smarm and smirk of know-it-all arrogance that immediately proceeds those words and preceeds whatever he's going to say next??
And, will he begin to understand that while some of us know what the F we're talking about, and while some of us know nothing about what the F we're talking about, that as the people who are following his company, buying his company's shares and helping to try to build it's value, all of us need to be shown respect, otherwise you get people like M$, myself, and others really PO'd and possibly dumping his companies shares, it's value and it's respectability in this space?? Yes, Kal be damned.
Just start with the truth and keep a straight line from there. Your withholdings, half-truths, and non-truths have come to light over time anyway, so you just look pathetic as a leader when they do.
Namaste
True, Novartis makes it, but looks as a license deal with GSK under Brand name Hycamtin. See links below. Could be wrong, no matter...
Also, looks like Novartis just terminated a phase 1b/2 small cell lung cancer trial in August, 2021, so perhaps a great time to partner. There are generics, yet perhaps a combo therapy with a major player could warrant several years of new patent protection for each and a nice partnership agreement for Algernon.
https://adisinsight.springer.com/drugs/800000829
https://en.m.wikipedia.org/wiki/Topotecan#:~:text=After%20GlaxoSmithKline%20received%20final%20FDA,I%20inhibitor%20for%20oral%20use.
https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Topotecan
Hopefully a partnership with GSK or Merck, someone involved with topotecan in the US and Europe.
Perhaps, grant funding through our partnership with Dartmouth, or the PHS, NIH/NCI, Israel's Ministry of Health, Canadian Health Ministry...
Or a nonprofit group/ foundation like..
The Lung Cancer Research Foundation,
The American Lung Association,
Upstage Lung Cancer,
International Association for the Study of Lung Cancer (IASLC),
Lung Cancer Foundation of America, or
CancerCare.
Hopefully, Mr. Bloomfield has some solid ideas and connections.
One down! About f[]@k!ng time. Welcome back, Dr. Mark. A couple more additions and subtractions to go.
Agree with your point from a couple weeks back, which I was about to reply to before all the crap hit the fan- that it is now time for female diversity in leadership, preferably with PhD., MD, MBA level experience. No one particular in mind. Just no one associated with the names Mahli or Attariwal.
Full-hearted agreement with that! Change management, extend the Board, involve any number of our world renowned advisors in a much more meaningful way. Add someone from Dartmouth, etc...
Although, if I were them, I wouldn't join until those you mentioned were removed.
Here's to hoping today's addition adds legitimacy, prominency, and solid beneficial change, especially in the financial partnerships our new Board Chairman might inspire.
An even longer background..
He's speaking at The Montreal Family Office and High Net Worth Annual Conference in November
https://montreal-wealth.com/mr-harry-j-f-bloomfield/
Let's hope legitimacy follows and Kal's stench is cleansed away.
"While the mechanism for selective synergy of NMDA receptor blockade with topotecan is still to be resolved, it is clear that ifenprodil and topotecan together seem to exert a profound effect on tumor xenografts of rSCLC. The data from this and our other studies allow us to conclude that there is good reason outcomes for patients with this disease could be significantly improved by including NMDA receptor blockade by ifenprodil with currently preferred topotecan treatment."
https://www.dovepress.com/small-cell-lung-cancer-growth-inhibition-synergism-between-nmda-recept-peer-reviewed-fulltext-article-CPAA
That was from 2020
5th report
https://thecse.com/en/listings/technology/cannabix-technologies-inc
Scroll to the bottom and hit on form 7
FEB 5TH, it announces the patent, the 5M shares as milestone payments to CB Inc, 225000 options exercised and 2M warrants exercised during January.
Senate Democrats Announce Steps to Federally Legalize Marijuana in 2021
"In the early part of this year, we will release a unified discussion draft on comprehensive reform to ensure restorative justice, protect public health and implement responsible taxes and regulations,” the senators said. “Getting input from stakeholder groups will be an important part of developing this critical legislation.”
https://www.marijuanamoment.net/democratic-senate-leaders-announce-steps-to-federally-legalize-marijuana-in-2021/
"Now with Democrats in control, advocates and lawmakers are preparing for a deluge in marijuana reform proposals that could see floor action and make their way to President Biden’s desk. That includes a bill to federally legalize cannabis and promote social equity that the House passed last year.
Already in 2021, two congressional marijuana bills have been filed: one to move cannabis from Schedule I to Schedule III of the Controlled Substances Act and another to prevent the U.S. Department of Veterans Affairs from denying veterans benefits solely because they use medical marijuana in compliance with state law."
https://www.marijuanamoment.net/chuck-schumer-lists-marijuana-as-a-priority-in-first-post-election-cannabis-comments/
I said, in my opinion, a couple weeks ago, that I thought in order to reach $1.60, we'd have to have three things- announcements of the patent (which we all knew was coming), the Democrats being sworn in to give them control of Congress and the White House (bringing marijuana decriminalization, if not full legalization, to reality this year and driving up the sector), and a press release about starting third party testing in California.
Well, looks like we may hit $1.60 with sector and marijauna reform momentum. We'll see.. Now, Canadian pricing being over $1.60 and the warrants from the private placement being extended signal to me, in my opinion watching what happened 3 years ago, that they'll want to see this get to at least $2.20+ Canadian to let the warrant holders know it's time to really get back in the game. This will also help Cannabix increase their financial position greatly at a time they're moving ahead with 2 devices, supposedly.
But, I did feel with all their misleading statements of having a finished product in January 2018, and all their bogus timelines of these past 6+ years that they may need to show a working product in order to regain trust and the momentum of early 2018.
It appears, if this pattern continues, that a press release might help bring this close to all time highs. And, video and picture evidence of working devices in action would make this very very interesting from a price perspective.
Here's the post on cannabix from UF
http://innovate.research.ufl.edu/2021/01/12/cannabix-technologies-patented-marijuana-breathalyzer/
$1.60, it's possible. How probable? I'd guess little over 50%, maybe up to 60% this month or next with the right catalysts.
The right catalysts are key to that number though. Why? Because we know the patent is coming in 5 days, January 12, they told us January is when they are expecting to roll out third party testing in California, and now a major catalyst to the industry just happened yesterday- there is a Democratic Congress and President, which will get major pressure to and who have already promised to roll out bills on descheduling marijuana as a class 1 in the first quarter of the year.
So, what else does Cannabix have to tell us?
Plus, other industry catalysts, based on what Congress has talked about recently, I'd imagine strong money for research projects, and possibly banking bills to support the industry, etc... We've all seen how this likes to run with the rest of the industry.
It's like the Canada going legal catalyst of three years ago, only times 10 in terms of size and 100 times the scope.
Additionally, history showed us it's possible when three years ago, this month, Cannabix announced it's completed faims device, which was false, of course, but nonetheless, sent this up to around $3 (US), so anything similar to that to start this year could affect the price like you're hoping. Depends on what they announce, when they announce it, etc...have people moved past their skepticism of Cannabix or can Cannabix show viability and move past the skepticism..
So, again, what else does Cannabix have to tell us, more importantly, is what else do they have to show us? Anything for all their efforts and years? Big question mark..
We also know the 3.7 million private placements shares are at $1.60 (CAN) buy in, so this will have to make a serious run to make sense for them to want to cash in on what's left. So, getting to $1.60 US would seem to be about the minimum they'd want to shoot for, but Cannabix has to get their crap together, in terms of actually having legitimate working products now, in my opinion. For 6 years they've been so full of it about their products and when they'll be ready that who knows.
So, possible, and things are aligning to be probable, but it's Cannabix... the only things they seem to produce in six years are catalysts, not products. This time, they might need products inorder to reach previous heights or higher.
JMO
Only Jan. 5 report news;
On December 24, 2020 the Company granted 455,000 incentive stock options to consultants to the company, exercisable at $1 per share for two years.
(Appears to be all the engineers/consultants hired in the past year... Paknahad, Maata, Sahabjavaher, Mehta, Ebrahimi, Diaz)
On November 20, 2020 the Company announced the extending the expiry date of 3,681,500 outstanding share purchase warrants. The warrants were issued pursuant to a private placement completed in December 2017 with an exercise price of $1.60 per common share were set to expire on December 7, 2020. The warrants have been extended for 24 months to December 7, 2022. All other terms of the warrants remain the same.
Here's their application to go along with your find!
https://patents.justia.com/patent/20150305651
And, here's the listing of notice of allowance for the patent on UF's website
https://innovate.research.ufl.edu/2020/10/30/cannabix-technologies-notice-of-allowance/
Always found it interesting that UF lists Cannabix as a University of Florida startup.
Great find!
No, in fact though, this patent is for the original application that Kal and Dr. Attariwal applied for under Cannabix Breathalyzer Inc, before coming under company change as Cannabix Technologies Inc, who currently holds patent rights. So, this is great news!
Even though I'd totally rebuff Kal's right to 5M shares for what doesn't represent anything he and Dr. Raj originally acquired or were working on, I digress that at least Dr. Yost and many others deserve great credit for assembling a working device.
Dr. Hoorfar's patent is assigned to UBC (see link below), which we also have rights to when and if a patent comes.
https://patents.google.com/patent/US20180120278A1/en
California provides info on its grant fund program and it's main goals. Aligns with what Cannabix and Alipour Medical Centre are doing together.
https://www.chp.ca.gov/programs-services/programs/cannabis-tax-fund-grant-program-overview
Another historic 'bipartisan' House vote to legalize new aspects of and to expand marijuana research in allowing for unlimited research-based growers and research facilites, while allowing both governmental and commercial use growers to be used for research purposes, and even to allow interstate commerce of the drug for research purposes.
https://www.marijuanamoment.net/house-approves-marijuana-research-bill-days-after-voting-to-federally-legalize-cannabis/
Momentum continues.. but need to see working units, video, potential research findings and more pertinent and concrete-proof in press releases from Cannabix in coming days and weeks.