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The trial design here is important.
As discussed by the Company in previous video communications...
The South Korea trial is looking at patients already on mechanical ventilation. These patients might not be as salvageable. They might be too far gone. And there is fewer of them.
The Canada trial is treating patients BEFORE they end up on ventilator. This means WAY MORE ELIGIBLE PATIENTS.
Also they state they are going to be submitting for trial approval and US FDA and Australia.
Planting seeds internationally. Imagine, running trials in multiple countries at once. Like I said, beast mode.
Not much on the ask side. Looks good.
They would definitely have to submit revisions and these never get accepted on the first submission. They probably won't update us until the final approval is given. Still, should be soon.
Yes, a handful of studies in the Phase 3 ring. More importantly, testing in my home land. This is a BIG deal. If it's approved in Canada... USA will be all over it. Fast track through FDA for sure.
These guys are literally going beast mode.
To be clear:
South korea "results" will not be arriving soon. They have to start the trial first man. The next step is getting the South Korean government and health authorities to accept their trial application. It is, and has been, under review.
When the trial commences, this is going to get even more media attention. It will probably take a couple of weeks of the trial up and running to know whether Ifenprodil saves the lungs and neurons as we hope it will.
And also don't forget, this isn't a one trick pony.
I personally am more interested in what this can do for chronic cough then for covid. Why? Because I have reviewed the scientific studies done by Mark Williams showing that Ifenprodil beats Big Pharma's best medication for chronic cough and IPF. You know what that means? Billions of dollars.
Should have South Korea trial approval any day
Toronto
Where's everyone from, I will start:
Canada.
Nice. Invest in the science. Don't forget that they have already done animal studies showing this drug outpeforms the Big Pharma industry best in reducing chronic cough for idiopathic pulmonary fibrosis. A
Also... keep in mind that we should hear news regarding the South Korea trial any day now.
That will surely result in a take-off in share price ...
This is just the start.
Other funds will add as the media blitz ensues and trials commence.
Trading volume has been steadily increasing.
This stock is underappreciated. Despite some decent news articles, few know about it.
Funds adding to their position. Lock and load folks. The media blitz is about to begin and trial approval will arrive soon. This ship is about to blast off.
Can't argue with the science.
Should see FDA study submission soon also.
HA! Too much fake news out there. We need to keep the people of this board informed. Main stream news are pumping ridiculous articles to try and save the market. CNBC, CNN, on, and, on.
"Vaccine soon"
"Gilead drug might save the world"
"Country to open up soon"
It's all BS.
For those that are reading the scientific literature being published in NEJM, Nature, Science... it's very obvious this situation is anything but controlled. The molecular biology of the virus indicates its mutating very quickly. We know from past coronaviruses that vaccines are near impossible feat for these viruses.
The news will literally pump anything to save the market. And hey, it works, clearly as indicated by the past week or two.
Just wait until all of the quarterly reports reveal how hard the economy is hit.
Just wait until the USA releases social distancing restrictions too early (which they will, i promise you), and the virus rates spike.
It's going to get a lot worse before it gets better.
Bloomberg: Maybe no vaccine possible
World expert scientist from Imperial College says that this virus may be impossible to create a vaccine for
Coronaviruses are almost impossible to create vaccines for. The more research I do, the more I agree with this Imperial College of London world expert. It might not be possible. The virus mutates too quickly.
This has HUGE implications...
Read between the lines. Find the real science and data.
Tech review
Algernon Name Drop
A couple things to remember:
1) You can't rush science.
Speaking as someone who has worked on these before, it is important to know that just creating a study design, let alone writing an ethics application for a clinical trial can take months. And that's working fast. Somehow, and I am truly not sure how, our CSO Mark managed to submit clinical trial applications for the Phase 2 clinical trial South Korea COVID study AND the Phase 2 clinical trial idiopathic puplmonary fibrosis study. He did this in a matter of weeks. Again, not sure how, but I am very impressed with that speed. Now... regulatory approval for trials can take weeks as well. I know Algernon said that because of COVID that these things can get approved within days, but I do not think thats reasonable. It does take at least a week or two for the submitting investigators to get feedback from the hospital/health authority and submit revisions. These things almost never simply get accepted first time around. The reason: people's lives are on the line. South Korea is going to be cautious about letting a Canadian Company start running a trial in their neck of the woods. And thats normal and to be expected. Thats why we have our CRO Novotech helping out. Like they said in the recent interviews. They have had 10-15 people working around the clock to get this up and going. We should hear very soon, but investors who have no science background should have patience and remember that this can take time. It will happen. And we will get approval soon.
2. Know the science
Everyone was posting about this Gilead drug and wondering what that means for Algernon. First of all, anyone asking that question at all is showing to the world that they haven't done their due diligence properly and they are undereducated if they are investing in this stock. If you don't know why these things are different, you probably shouldn't be investing. The reason to invest in this stock is the science. The science is legit. So know what the drugs do and then you will feel confident in this company. I'll recap for those who haven't done so... Ifenprodil decreases acute lung injury, this is an endpoint. Acute Lung Injury and Acute Respiratory Distress Syndrome are bad outcomes. So once they have already developed, the severity of how bad they are, determines if the patient lives or dies. Ifenprodil will decrease the severity of this bad outcome. It does this (potentially) by decreasing the inflammatory response which is known to be high (as all the New England Journal of Medicine papers are showing - their is a cytokine storm). The neurons get hyperexcitable and die. The capillaries get leaky in the lungs and they sop with fluid and the patient can't breath. Ifenprodil is an NMDA-antagonist and NMDA is located on the postsynaptic membrane of neurons where if it gets too activated it lets calcium into the neuron and that triggers a death cascade. Mark Williams has said he thinks this drug decreases the hyperinflammatory response. Gilead is working on a drug thats more than a year away from being ready for market. It needs to get tested through a complete phase 3 trial before it would EVER be available for global use and thats at least a year away. The American banks and news use stuff like this to pump the market and try and help halt the global meltdown temporarily but this thing isnt' close to being ready and scientisits and doctors know this. Plus, the mechanism of action is completely different. It works as an anti-viral, helping decrease the rate of replication. Yes this can help patients get better, but patients will still get sick. This isn't a vaccine. Hell, even if we had a vaccine, patients would still get sick because not everyone would get it. So.. end of the day... it has no bearing on our drug and our progress.
Twitter posts have no bearing on anything to do with Algernon.
Show me high quality double blind randomized controlled trials. That I will believe.
People listening to Trump talk nonsense about medications that have no scientific testing drives me nuts.
Show me science. That's all that matters. Not Twitter posts by some nobody.
That medication would be used to slow viral replication. Not the same idea or mechanism of action as Ifenprodil. Regardless if you slow viral replication, some patients will develop lung injury. Those are the patients we would be treating with Ifenprodil. Ifenprodil doesn't work on viral replication.
Two separates mechanisms/purposes. No bearing on the other.
HA!
I agree, however, those technicals mean nothing when a company announces acceptance of a trial for a disease killing off a good portion of the planet. Those technicals apply to everyday trading under "normal" circumstances. These guys are going beast mode for a home run... nothing around here is normal.
Science doesn't care about share price predictions.
NMDA antagonist. Patented for respiratory disease. Shown to decrease mortality >40% for acute lung injury and acute respiratory distress syndrome, same as COVID causes. Global demand, people dying around the world; people need a therapy now. Algernon has a safe one.
NMDA antagonist alters immune response, decrease neuronal hyperexcitability. Decrease glutamate excess. Save the neurons. Save the T cells. Save the pulmonary capillary endothelium. Save lives.
Better than the best big pharma has to offer.
Watch what happens when they get trial approval this week.
People like you always show up once penny's run. Love showing up trying to short. Can see right through it. Shorts will get wrecked upon the news drop. Could come any minute.
Approval could come any minute. Globally hospital ethics review committees are expedited/fast tracking approvals for COVID trials.
Science prevails. Doc Williams has done the studies. Science has shown with clear, real, undeniable data that his compound/drugs outperformed the best Big Pharma has to offer. Better than that, NMDA-antagonists modulate the immune response. They decrease neuronal hyperexcitability and prevent cell death. They alter the endothelial permeability and will decrease acute lung injury and ARDS. More than a one trick pony. Multiple trials ahead. Even though I am ALL FOR THE SCIENCE. The one thing nobody can deny... the FDA invited them to submit for a trial. What more could we ask for.
South Korean trial approval could happen at any time. Play safe folks.
Be careful, South Korea getting back to them with trial approval any minute.
Agreed. will be a media storm
Some more science:
Today Mark Williams said (im paraphrasing):
They are about to unleash a media flurry over the next month as their first trial is approved. Once this gets noticed it's going to be a rocket ship.
So they do read what I write
And they have already shown in animal studies that THEIR drug has outpeformed the best drugs BIG PHARMA has to offer.
You know why?
The reason they can be transparent is because they have real science behind what they are doing.
The real scientific data has caught the attention of the South Korean doctors, Novotech, Australian doctors, USA FDA, Health Canada.
This is the real deal.
This is going to 1-2 dollar range immediately once their first trial is underway (aka this week or next).
Ifenprodil is the only NR2B receptor antagonist available. These guys said they have the rest of the family patented. And they saw signal with one of their other molecules too.
BioPub key points from today:
1) Mark and Chris "working 20 hour days".
2) The virus H5N1 has 50% mortality rate. Ifenprodil reduces mortality for this virus by 40% and reduced acute lung injury and lung inflammation. Drug approved in Asian countries. Shout out to the investigations for chronic cough and idiopathic pulmonary fibrosis study. Australia, 41% refundable tax credit. Ethics approval agency there is "easy to work with". Drug works so well for H5N1, should work in humans for COVID-19.
3) Drug also helps lungs in low oxygen environments (another separate study they found)!
4) Goal: Try to advance clinical trials as quickly as possible. Use repurposed drug that has known good safety profile.
5) Updates: Decided to move forward in South Korea where Ifenprodil is approved. Working with Novotech who invests in the company and is going to run the trial with physician investigators. Also plan to try to do CoVID trial in Australia. Now have positive feedback to aggresively move to Phase 2 IND trial in the USA. Also working with Health Canada. Positive feedback to run a trial also.
6) Mark Williamss update:
Submitted for approval 40 patient trial in South Korea. To look at severe pneumonia. Goal: Try to quickly return lung function to normal levels. Try to decrease mortality. If we can avoid use of respirators, that would be excellent as the drug can decrease strain on the intensive care units. Filings done last week. Expedited review should be back imminent. "DOSING PATIENTS SOON!". Additional study trying to save patients already on ventilators. Could prevent death in that group. Adapted trial design to look at lung function or mortality as primary endpoint. This is an ideal study design. UPDATE MINUTE BY MINUTE. COMMISSIONED BIOSTATISTICIANS TO DESIGN THIS!
Mechanism of action: Why does this work so well.
Mark's thoughts: what could happen is that initial release of glutamate, there are NMDA receptor on neutrophils, increased CD11b, increase ICAM-1 excpression in the lung. Traffic neutrophils from lungs. Neutrophils could be releasing glutamate in the lungs and on T cells. NR2B subunit paper 2014 ifenprodil modulated t cell activity and reduced it. Its conceivable that (1) stop trafficking of neutrophils (2) decrease glutamate (3) decrease t cells (4) decrease the cytokine storm because this might be the biggest issue. Also high likelihood of anti-fibrotic effect.
Recap: test with severe pneumonia in south korea. then another trial with patients on ventilators.
Glutamate is a danger signal. It's the bodies approach to kick start the immune response. Too overactivated becomes pathological.
"We are not exclusively covid". Our drug should work for other lung injury disease. Just COVID is the priority right now.
Mark Williams continues:
Responds to Dr. Kiss about his long winded question about fibrosis in the lung. Williams goes on to say that he thinks Ifenprodil will slow down fibrosis.
Running four weeks trial for COVID.
Phone rang. Mark says... Might be the clinical trial calling...
Advantage to repurposing is doing things in months instead of years.
Animal models: Ifenprodil may be an improvement for chronic cough as no loss of taste.
Drug might be able to use prevent COVID-19. This would be huge because it could increase the number of people taking the drug.
Dr. Kiss asks what is the plan, synopsis...
Williams:
Good feedback from Health Canada and FDA
Adaptive design study
Run those studies in North America
Waiting to hear from Biostats guys
Dont need a huge number of patients to see a signal
Example: Start the trial, adapt by redoing power calculation to know the sample size needed once you have a signal showing
Dr. Kiss:
What happens if you get positive signal?
Still going to do IPF studies even if COVID studies positive
in fact COVID signal might indicate IPF patients will benefit.
Might be able to get IPF information indirectly from COVID.
Cost mitigation is the big difference between this work and normal trials. Compressing into days and weeks what normally takes months.
Working urgently to file Health Canada Trial Application.
Should be hearing back urgently from them as everything is expedited.
Novotech: DOING WHATEVER IT TAKES. 10+ person meetings.
Biopub online live now
Unprecedented productivity. Mark Williams working overtime.
Unheard of to get FDA feedback that quickly.
And Health Canada...
AND SUBMIT pulmonary fibrosis study protocol.
AND submit ethics for south korea covid trial.
What the hell.
BioPub link here.
Big news coming soon
Interested in the webinar? Save this link to join us:
https://lnkd.in/gQ8DwMn
We now have FDa, Health Canada, and Korea and Australia on board for COVID trials. Going to get really interesting really fast.