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? They are enrolling only sick patients at one site. There are less than 10 cases per day and most would not be sick, across the whole country. What evidence do you have to support this claim of being able to complete the trial without issue?
Why the next few weeks?
We need to have patience... South korea new COVID-19 cases are less than 10 per day for the *whole country*, and the number of sick patients would be even less than that.
To make money in the COVID business, Algernon is going to need American and Canadian trials. asap.
ahaha no Shell3 i wasn't talking about you. We value your DD.
A little over a month ago it was all good DD around here. Drowned out now.
Again, never said it's game over. Just said lots of volatility and manipulation in pennyland.
AMG, I stand by my point and its not a negative one. It's not game over, i'm just saying its an uphill battle.
And yes, I hope we do get a data readout at that time. Just be prepared for slow enrollment.
There's a difference between negativity and keeping it real. There are lot's of people here to do the pumping. That's not my job. Science, data, keep it real.
What we post here isn't changing investor sentiment or share price. It's a forum for honest discussion.
All I am saying is that one should expect volatility. I'm not flip flopping my opinion here. I said expect volatility, and the next day the share price drop >10%. IMO I was just stating the obvious. The manipulation of the SP here is ridiculous. I was just venting.
Maybe somebody should do the math, how many days out of the last two months has the share price changed by >5% in either direction?
MOST.
Unfortunately, Algernon has an uphill battle to fight being just Mark and Chris. These big pharma companies have billions and can run HUGE trials and get them done quick. To be clear, while I do think Ifendprodil could potentially save the lungs in the sickest patients, big pharma is making moves at unprecedented speed which makes it tough even in the best of circumstances for Algernon to keep up.
We got a nod from Health Canada. Everyone needs to remember thats not trial approval. Its just a nod. We still need to find people to run the trial, submit ethics to hospitals, etc.
Fauci's most recent statements indicate Remdesivir will be made widely available to everyone, including this sickest.
We need to try and keep this as black and white as possible. Fighting against big pharma under deadlines is an uphill battle. Diluting shareholders is BS and I don't like the fact they did this despite saying they didn't need to on multiple occasions. I'm a bit pissed TBH. But I will put that aside. Watching the ridiculous volatility over the past few days is a testament to the fact no one is watching this and its getting manipulated in penny land. Probably will continue to for a while.
My last thought for now. The only thing thats going to shoot this stock up where we all want it to be is data. Period. Unfortunately, thats going to take a while. Expect volatility. If people are cool with holding long (e.g. until next year) I think its likely to see gains related to the IPF study. Im starting to think short term big pharma is going to F*** this over based on everything thats moving at warp speed. Penny land. FML.
Be careful folks. Expecting some further volatility. Especially now that Fauci just announced Remdesivir is the standard of care for treatment and has a monoclonal antibody they will add to it.
? yes the currently registered one is for safety... im talking about the FDA IND they have yet to submit...
I think the American and Canadian trials would be huge. A game changer really. I think the team needs to discuss the South Korean trial enrollment during the BioPub interview. South Korea doesn't currently have enough new cases per day to actually provide enough patients that are as sick as required by the trial. I know they only want 40. But they want 40 sick patients. There are less than 10 regular cases per day, and im sure a fraction are sick. Not to mention, its one investigator at a single hospital. The less than 10 per day is for the country. Anyway, that's my only consideration at this point.
Canada and US both still have enough sick patients, so I think the emphasis needs to be placed there.
I would expect volatility in the short term as a result. Especially if the South korea trial gets halted early for not being able to enroll patients. But if you're holding long then it won't matter because hopefully your have canada and usa and then IPF stuff.
The volatility is sickening
Not sure about the supercomputer but remember that the Supercomputer is testing a model of viral infectivity, and looking at drugs that could prevent the drug from being able to infect human cells. This would stop spread. Ifenprodil may impact viral spread (as I have eluded to before). Indeed, the first model of the super computer testing listed Algernon as a drug option. However, Algernon is specifically looking at Ifenprodil to decrease cytokine storm as you mention.
The most important thing to remember is that it;s an NMDA antagonist, and this will help dampen the glutamatergic hyper-excitability response and can prevent cell death. Probably has an impact on the microvascular leakage of the endothelium by decreasing the cytokines that increase the leakage.
You need to expand your mindset. This company is working on A LOT more than just the South Korea trial. We will get news about Health Canada approval for a trial, and also we are soon to be submitting trial application to the FDA IND program. BIG things coming down the pipeline. This will create value in the short term.
In the long term, we have already submitted our trial application for a Phase 2 run in Australia for Ifenprodil to decrease chronic cough for patients with idiopathic pulmonary fibrosis. When we hear back from that, it will also create value.
I mean there are literally a handful of MAJOR news releases that we should be hearing back about (probably before May 8th). This thing is just ready to explode. Look at the MC, its so small for a company running Phase 2 clinical trials its insane.
Many drugs failing:
Remdisivir failed according to the WHO in leaked documents (posts from a day or two ago). Now there is a new study published in the top medical journl NEJM which shows that Lopinavir and Ritonavir (the next "most likely to work" medications) have failed.
https://www.ncbi.nlm.nih.gov/pubmed/?term=A+trial+of+lopinavir-ritonavir+in+adults+hospitalized+with+severe+COVID-19.+N+Engl+J+Med+2020
In this open-label trial, researchers in Wuhan enrolled patients hospitalized with COVID-19 and oxygen saturation of 94% or less on room air. They randomized the patients to receive standard care (n = 100) or standard care plus an HIV-medication called lopinavir-ritonavir (Kaletra; 400 mg/ 100 mg; n = 99) twice a day for 14 days. They found no statistically significant difference in the duration of illness. Although the patients treated with lopinavir-ritonavir had 5.8% fewer deaths, this was not statistically significant. But in order to detect this difference a study would need more than 800 patients in each group. Stay tuned - hopefully, this will be studied further.
Bottom line
A randomized trial of 199 patients found no evidence of benefit for lopinavir-ritonavir in patients with COVID-19.
We aim to please
Given the immense number of day traders around during these exciting times, I would just like to point out that this is an immense buy opportunity...
Headlines: "Pharmaceutical company gets covid-clinical trial approval and drops 7%"... LOLOL. Not for long.
ahah no worries. you're posts are far more exciting then mine!
That's really a non-issue. Because if they get a positive signal in the human trial, this share price is going to sky rocket and they will be immediately approached by Big Pharma for a bidding war buyout. That's what the CEO said he's hoping for. Big Pharma would take over and ramp up production.
Thanks to the other moderators for responding, quicker than I could.
What I will add to their responses:
There are two things going on here...
1) We have existing drug
2) We are making more drug
So, for point 1:
We have enough drug in hand that we can supply the Phase 2 trial in South korea
So, for point 2:
We hired a chemical company in the USA to not only make more Ifenprodil for us but also look into making it in a more streamlined fashion.
Additional point:
We are going to secure IP on a novel formulation for IV use.
The implications of this go beyond our trials. If others want to use it by IV, they will be going through us.
My thoughts on the science!
Thanks for the support. We are in this together. Go back through some of my old posts, I have detailed a lot of the science that backs Ifenprodil. Also the BioPub interviews provide an immense and thorough overview of this company and their goals/trajectory. But hey, you asked for it so let's recap:
1. Pre-clinical research: Ifenprodil has been tested in animal studies by Dr. Mark Williams (the CSO) who found that Ifenprodil and another sister compound which is also patent protected (by Algernon) for respiratory diseases, both outperformed Big Pharma's best drugs for chronic cough and idiopathic pulmonary fibrosis (IPF). So we expect this to become the next drug for chronic cough and IPF after human testing.
2. Safety of Ifenprodil: Ifenprodil has been tested inside and out in many previous studies for the central nervous system and other conditions. Many have been posted by me. The safety profile is well-established. This saves A LOT of money. Hundreds of millions to be more specific. Because we jump right to Phase 2 studies. One of the reasons we chose South korea is the drug is legal there. So we are starting the Phase 2 trial for COVID (see below) at WARP speed.
2. Phase 2 trials for IPF and chronic cough: after receiving these positive results, Dr. Williams brought to the attention of Algernon that he found a postive signal, not only that, but he beat big pharma's best competitor drug. So the next step is Phase 2 trials. Algernon has submitted a clinical trial application in Australia, where we will get 40% rebate on the clinical trial upon completion. Again, saving money. They engaged Novotech, a world leading Contract Research organization to run the trial. That should start later this year. Needs to be approved first. We should hear about that in the coming month or two.
GILEAD DRUG FLOPS
GILEAD DRUG FLOPS
Uh Oh.
BREAKING: Health Canada -> 1.1 billion for drug research
Health Canada announces funding
This is perfect timing as our trial awaits Health Canada approval!
They are working 20 hour days and have literally NAILED every single timeline they have said they would.
Not only that, incredible transparency with investors.
Team is literally and figuratively going beast mode.
It is IMO hard to fathom how they have completed on these timelines given how much work these trial applications are.
If the trial is approved in Canada they would likely get some federal funding. Lots going around.
We post this most days here:
To be clear, Algernon is testing Ifenprodil as a potential treatment, not as a vaccine. Big difference. Read some of the hundreds of posts here to catch up.
Refer to the BioPub interviews which are public. The CEO said they have enough funding.
They will be the first because they accepted the trial application so quickly. Agreed, efficient process there from healthy regulatory perspective. However, Canada is fast too. I bet we hear back from Health Canada soon. Also, our numbers in Canada are still rising, so lots of patients too enroll.
I am pleasantly surprised with how short the timeline is for us getting the trial started and how long it will take to conduct. The fact that it will be up and running in just weeks is remarkable in the medical realm. They truly are fast tracking anything and everything covid related.
You won't have to wait long
This is a fundamental process that should not be underestimated. It's the reason we are doing clinical phase trials as a small company. Huge upside potential.
97% mortality rate COVID-19 above 65 years old on ventilator.
For those who enjoy the science:
There was an article published recently from physicians in New York, published in the top medical journal (Journal of the American Medical Association) which shows some VERY SCARY numbers. When reporting the mortality (death rate) for people who end up on a ventilator, 88% overall die. 97% of those over 65 years of age died. THIS IS INSANE. This is unheard of.
New intellectual property
Algernon is a drug re-purposing company that investigates safe, already approved drugs for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.
Algernon has filed new intellectual property rights globally for NP-120 (Ifenprodil) for the treatment of respiratory diseases and is working to develop a proprietary injectable and slow release formulation.
TRIALS TO BEGIN!
Four week trial! This is amazing. Positive result = fast track through FDA and Health Canada. May 8th start date!
Smart move, right before their massive news.
Hang on for dear life.
As our kind friendly moderators have already mentioned, to be clear, this is a NMDA-antagonist that is suspected to modulate the immune response and decrease acute lung injury. It is a known neuroprotective agent and I have posted literature supporting this claim. NMDA receptors sit on the post-synaptic neuronal membrane and are regulators of the hyperexcitability response. They can be involved in neuronal death. Antagonizing this is advantageous. There role has been explored in idiopathic pulmonary fibrosis where our ifenprodil outpeformed the best big pharma has to offer in decreasing cough frequency and the phase 2 trial is planned and ethics application is submitted in australia (where we get a tax rebate on 40% of the trial fees and where our partner Novotech lives). Novotech is the CRO who will be conducting our trials and is a world leader. They are also invested in algernon, just like Alpha North Asset management.
To be clear, NMDA-antognism is a TREATMENT. Not a vaccine. Vaccines prevent illness. Treatments help those who are already sick.
First comes news $AGNPF
These guys have been working 20 hour days. No rest for the wicked.
Interesting to see so many new faces around here. Just another sign of the attention this is starting to get. I imagine that are Floridian marketing friends are going to start laying down the hammer soon.