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These results were poor. It’s not the companies fault they did an amazing job coordinating an international trial in such a time frame, but don’t try and spin it to something it’s not.
My points have been that (a) I anticipated dilution (b) I suspect dissapointing covid results (c) they now have no scientist running their company so... why should I stay invested?
I am not saying things won't turn around some day... but right now risks of being in > than being out...
Almost all phase 1's fail. These guys claim they repurpose drugs to skip phase 1... so what are they doing running a phase 1? Oh right, THEY are not running a phase 1. Two guys in vancouver contracting the work. They should stick to running trials where they dont need to do this preclinical work IMO
DILUTION. I said this was coming. One of the reasons I got out (for now). High risk.
They’ve already said the primary endpoint was negative and the secondary endpoints were not statistically significant indirectly by Telling us they only found “a trend toward” a signal.
Not one of their releases of the preliminary data found signal. They use the term "a trend toward signal".
"A trend" toward signal is a common way to make a non-significant result sound important. But at the end of the day if p<0.05 that is statistically significant. If p>0.05... it is not significant.
Signal is p<0.05. Anything above 0.05 is not signal. "A trend" is often used to refer to anything that is almost <0.05 but is not. Example p = 0.10 = "a trend". This is not signal. This is not significant. Know how to interpret results so you dont get dooped at the upcoming news drop.
1. So who is reviewing it? Any idea? 2. They are paying themselves large amounts at the expense of diluting your shares and they have no revenues. Never had any revenues. None of these companies include the sister. All fundraising, not a single dollar in sight. Ever. 3. So the trial is complete and has been. Why would the data still be "unlocked". Fishy, makes no sense. Trial data FULL READOUT should have occurred by now. The Romania fire is just an excuse. Their ELECTRONIC data should have been with the company when the trial finished... a while ago... 5. You don't just get to manipulate data, thats not how rigorous science works, they manipulated the data to try and save face because data for 75 would have been an even bigger flop. 6. They've been in penny land for years. And they will continue to be until make they have good results from IPF and CC but thats clearly a year or more away given that they are hardly enrolling. DMT for stroke is YEARS away. This is doomed for penny land for the foreseeable future. 7. It's not a long term efficacy trial... why are you commenting on long term efficacy?
I can't imagine why one would risk holding their position for the next release. We already know that for 125 patients the data was a flop. Why would anyone expect anything different for 150 some odd patients.. it's going to be the same!
Point 1: Independently reviewed by who? Who made the decision to increase the sample size to try and find signal? The executives did. Why not start a new trial? They have chronic cough running, and if they believed Phase 3 covid had a chance, you would think they would focus on that. But what's most important as a red flag is the timing. They dropped prelim data news which was a flop, and shortly thereafter planned a new phase 1. thats the red flag. its classic, pump the SP up before dropping the final news (flop).
2. what you're proposing is that there be no accountability. are they free to pay themselves ANYTHING. They make zero profits, thus they should be paying themselves much less than they are (400k... are you kidding, with no revenues, using money they fundraised :O through dilution at YOUR expense...)
3. they have changed the number of patients in the data readout to find signal, and delayed the final results ... if the trial was completed before this fire, than why is the readout being delayed? Proof of the fire?
4. There's only so much time in the day. Running a pharma company takes A LOT of time. This further supports my point about the execs being over paid. You think mark williams deserves hundreds of thousands of dollars for working at Algernon making no revenue and also spending his time (what %?) at his own (separate) company?
5. You are speaking as a non-scientist. In science, if you say you will read out using x number of patients, and you manipulate that because x patients didn't find signal... that's unethical and simply a ref flag of whats to come in the final readout.
6. Dilute and dilute ... but the fact is that hitting the jackpot in penny land is rare and more likely you will be diluted to dirt. Most of us who have been around since breathtec understand, these guys dilute and dilute and have NEVER generated a single dollar... university of florida who?
7. I don't prefer pumping. I guess just compensating for no revenues and a flopped prelim data readout....
Incorrect, the data safety monitoring board did not say there is possible benefit. You made that up. All they said was the drug didn't hurt anyone. Determining efficacy is not the job of a data safety monitoring board lol.
also... the company told us it didn't work when they gave us the read out for 125 people!
ive been around this and the sister sites since westpoint resources days. Even though I sold out, does that mean conversation is over? I posted many discussion points. So far only one person has discussed them with me. I just made the decision im not holding my position through the COVID data release because of red flags. Doesn't mean I will never trade this again. Im just betting against the final covid readout. We already know the data for 125 was a flop so...
Point 1: Independently reviewed by who? Who made the decision to increase the sample size to try and find signal? The executives did. Why not start a new trial? They have chronic cough running, and if they believed Phase 3 covid had a chance, you would think they would focus on that. But what's most important as a red flag is the timing. They dropped prelim data news which was a flop, and shortly thereafter planned a new phase 1. thats the red flag. its classic, pump the SP up before dropping the final news (flop).
2. what you're proposing is that there be no accountability. are they free to pay themselves ANYTHING. They make zero profits, thus they should be paying themselves much less than they are (400k... are you kidding, with no revenues, using money they fundraised :O through dilution at YOUR expense...)
3. they have changed the number of patients in the data readout to find signal, and delayed the final results ... if the trial was completed before this fire, than why is the readout being delayed? Proof of the fire?
4. There's only so much time in the day. Running a pharma company takes A LOT of time. This further supports my point about the execs being over paid. You think mark williams deserves hundreds of thousands of dollars for working at Algernon making no revenue and also spending his time (what %?) at his own (separate) company?
5. You are speaking as a non-scientist. In science, if you say you will read out using x number of patients, and you manipulate that because x patients didn't find signal... that's unethical and simply a ref flag of whats to come in the final readout.
6. Dilute and dilute ... but the fact is that hitting the jackpot in penny land is rare and more likely you will be diluted to dirt. Most of us who have been around since breathtec understand, these guys dilute and dilute and have NEVER generated a single dollar... university of florida who?
7. I don't prefer pumping. I guess just compensating for no revenues and a flopped prelim data readout....
I'm getting tired of hearing the same repeated negative garbage over and over so I'm going to provide some.... OTHER POSSIBLE VIEWS.
1. Why on earth would they not start new trials as they previously stated they would for 2021. Do you suggest everyone working at Algernon should just sit back doing nothing while awaiting results that are being INDEPENDENTLY REVIEWED? You later state money is being wasted by this organization yet you want them to sit around doing nothing getting paid? Contradiction.
2. Why would management not pay themselves well? Maybe you don't think they're worth their salaries, but do you know if they work 20 hours a week or 80? I venture a guess neither you nor I have any idea how hard they're working. Maybe to keep a good team on board a good salary is required?
3. Enrollment is enrollment, if there's not enough patients for your trial it is slowed down.... nothing can be done about this unless they find more hospitals that may have more patients. I hope you're only talking about delays that are Algernon's own fault here? Surely you aren't pissed off at the 5 people who died in a hospital fire slowing the growth of your bank account? Takes a special kind of....
4. I personally work for companies and do self employed work as well. Does that mean I provide garbage work for the companies?
5. Why on earth would they not provide interim data using all the patient data available. Sure the plan was only 75 patients, but if you have data for more, why not include them to provide a stronger signal? In what world does the fact that the primary endpoints weren't as strong yet some secondary endpoints showed great potential mean the science failed? Have you seen what's available on the market currently? Jokes. Literal jokes are the current treatment. If Ifenprodil saves even 10% of the people who were going to die it would be incredible and used worldwide.
6. Dilution is the name of the game in all penny stocks. If Ifenprodil is successful and the market reacts strongly, we'll still be laughing all the way to the bank.
7. I can agree a lot of the news releases are fairly fluffy, however would you prefer sitting around not having any idea what's going on? Do you ever read the msg boards or companies that play it that way? It's an absolute sh*show of speculation about what the hell is even going on. I'll take some fluff with my beef any day of the week over radio silence.
It does nothing for your credibility here given that you won't have a conversation and discuss negatives about a company, you only want to focus on the positives... but lets be real... lots of red flags
1) Starting a new research program before the last open trial hasn't released data yet! Classic move. Pump up the SP before dropping the bad news. Try to get excited about a phase 1 DMT study... it would be YEARS before ever getting to a phase 3, and most phase 1 flop... that's proven... 2) Execs paying themselves monster salaries with NO revenues. 3) Delays upon delays in delivering data... 4) Mark Williams working on another company... so is Kal! 5) Increasing the number of individuals in the preliminary trial results that flopped, in an effort to improve the statistical power to search for signal. I mean these guys literally included extra patients in the early data reading because they found nothing with fewer numbers... so FOR AMG/MONEY SHOT: THE SCIENCE FAILED 6)dilution upon dilution and Kal insider trading. 7) news releases every other day with no real material reporting just pumping
Algernon has manipulated the prelim read out. fact. Changing the sample size at the last moment is NOT acceptable. It is data manipulation and unethical. The data safety monitoring board has nothing to do with them reporting their data, they only comment on the safety of the patients.
They found their primary outcome failed. They were scavenging for a secondary and had to manipulate the number in the analysis to try and find signal. This does suggest that the numbers from the final analysis will be weak.
Hence why im out.
VANCOUVER, British Columbia, Dec. 15, 2020 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company, is pleased to report, in a descriptive format, positive trending interim data for the Phase 2b part of the Company’s Phase 2b/3 clinical study of Ifenprodil for COVID-19.....[...] "While the Company originally advised that the interim data set would be based on 75 patients, this was increased to up to 123 patients for some of the endpoints owing to the availability of the data."
VANCOUVER, British Columbia, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company is pleased to provide an update on the final data set of the Phase 2b part of the Phase 2b/3 COVID-19 Ifenprodil study.
The Company reports that due to a fire at the Romanian Hospital site, there was a delay in completing the site audit as planned.
VANCOUVER, British Columbia, Feb. 10, 2021 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company is pleased to announce that it has decided to review its protocol for its phase 2b/3 study of Ifenprodil for COVID-19, to consider adding lung scarring as an additional endpoint if sufficient data is available from a significant number of patients.
SEARCHING FOR ADDITIONAL ENDPOINTS ADDING ENDPOINTS MANIPULATING PREFORMED SAMPLE SIZE IN AN OPEN TRIAL
ahaha who is dr suarez from westchester... sounds like the wizard of oz ... you can't claim one random person to be talking things up is credible and worth my consideration... Algernon themselves said their primary end point failed... why do you think the stock price dropped after they released the prelim data
And i'm pretty sure i have been around this board holding a large position longer than most people here except a very select few...
I am not commenting on more patients being added to the trial. I am only commenting on them conducting a preliminary analysis with MORE patients included in the analysis. This DOES increase statistical power. And we don't need to make assumptions here, there are two key facts. It's an OPEN trial, so they could tell whether patients are getting better or not, and then decide to analyze an increased fraction of the patients to improve the chance of finding signal AND also they went against their word, they broke the golden rule of clinical trials. If you say you're going to analyze data on 75, then give the result for 125 (for example), that's unethical, there's a conflict of interest, it's clear that's to try and improve signal when you suspect it's poor. And im not assuming they looked at the data. I know it's an open trial so they could see the lack of result before their very eyes...
there's no accountability here, the general public aren't scientists, so they are unlikely to say something when the company which has nobody to hold it accountable decides to change the number in the analysis to improve signal.. people need to open their eyes. this is manipulation... it's unethical...
Pumping another story of some phase 1 idea is just another way to distract from the fact that poor results are about to be released from the covid study
if im wrong, ill admit it, but I bet im right. Hence the reason I cashed out.
1) Starting a new research program before the last open trial hasn't released data yet! Classic move. Pump up the SP before dropping the bad news. Try to get excited about a phase 1 DMT study... it would be YEARS before ever getting to a phase 3, and most phase 1 flop... that's proven... 2) Execs paying themselves monster salaries with NO revenues. 3) Delays upon delays in delivering data... 4) Mark Williams working on another company... so is Kal! 5) Increasing the number of individuals in the preliminary trial results that flopped, in an effort to improve the statistical power to search for signal. I mean these guys literally included extra patients in the early data reading because they found nothing with fewer numbers... so FOR AMG/MONEY SHOT: THE SCIENCE FAILED 6)dilution upon dilution and Kal insider trading. 7) news releases every other day with no real material reporting just pumping
Someone please tell me why this should be a hold... all the signs point to this flopping on the next data release...
the promises WERE HIGH... PREVIOUSLY... but the prelim data wasn't good... such is life
Im not asking for any credit, im just contributing to the board and giving my opinion. People just don't like to hear negative opinions when they are invested. It's uncommon for shorts to tell you their shorts. I just DGAF and am going to be open about this...
Too many red flags here. And it's not just the fact that these guys have been known to pump and dump for years at the expense of shareholders with dilution upon dilution and Kal insider trading. Execs paying themselves monster salaries with NO revenues. There's other reasons. I have been around pharma for long enough to recognize them.
Delays upon delays. Starting a new research program before the last open trial hasn't released data yet. Classic move. Pump up the SP before dropping the bad news. CSO working on another company. Increasing the number of individuals in the preliminary trial results that flopped, in an effort to improve the statistical power to search for signal.
Good luck to this who plan to hold through news. All the signs are pointing to a big flop coming.
"The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (“drug”) to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphan status”). For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria specified in the ODA and FDA’s implementing regulations at 21 CFR Part 316. Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits for qualified clinical testing. A marketing application for a prescription drug product that has received orphan designation is not subject to a prescription drug user fee unless the application includes an indication for other than the rare disease or condition for which the drug was designated.
A sponsor seeking orphan designation for a drug must submit a request for designation to OOPD with the information required in 21 CFR 316.20 and 316.21. Each designation request must stand on its own merit. Sponsors requesting designation of the same drug for the same rare disease or condition as a previously designated product must submit their own data and information in support of their designation request. The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well-controlled studies."
can't promote other stocks here as you know but would recommend taking a look at them.............
they recently acquired Sairiyo Therapeutics Inc. who manufacturers psychadelics, they also have some world experts on advisory, and they have FDA filing submitted so... trading at fraction of price.... decent sheets,etc
scientifically speaking, I think it's anybody's game to take the lead on
Not to disappoint people here, but this is anecdotal evidence of one person's story... we already know that the company said the WHO scores didn't change... which is the story of hundreds of patients...
so, I believe the trial results of hundreds, before I believe one persons story...
HOWEVER, we still wait for the final data set with time to ventilation... but again, the real data for hundreds of people is what we care about, not one persons story from the public media
im all about the science, and we need to stick to objective data
The preclinical data supports ifenprodils role regarding immunomodulatory effects and the cytokines are heavily involved in microvascular permebility (when we think about how acute respiratory distress syndrome is caused by leaky vessels in the lungs secondary to influenza... ifendprodil should stop that same process in COVID)...
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