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Over promise, under deliver. This is what I see here, and nobody is to blame outside of management.
We saw it with the South Korea trial, and now we are seeing it with the highly anticipated 2b/3 trial. Christopher Morneau has touted an expected "first patient enrolled" before the end of July for the past 6 weeks. It is now the last trading day in July and still no news.
Let me repeat: Over promise, under deliver
It is managements responsibility to execute on delivery dates at which they made. If there is any doubt that a date cannot be obtained, it is then management's responsibility to give the market a new date of which is achievable.
This isn't rocket science.
AGN/PF's price will now sink lower if news doesn't come by 4pm, and it (the price) should! Chris wants new investment in this company, but fails to deliver whilst giving market expectations.
Still Long, but deeply disappointed.
B. O. B.
I took a hard look at other "bio-techs" and pharmaceutical companies today trading on the cse/tsxv/otc markets and came to a conclusion :
As much as Algernon Pharmaceuticals has been exhausting to hold, and frustrating to watch, there isn't any others on these exchanges that I'd sooner own during this time.
Maybe this is..
JMO. Who really knows?
B. O. B.
Interesting to note that AGN/PF has removed Canada from their phase 2b trial. I understand our containment has been great but in just recent news there has been an uptick in cases in Western Canada and Southern Ontario.. I thought Chris wanted to "cast a big net".
Anyways, I thought Thursday would be the day for "the real news".. It's now either a halt (Imo would be silly) or a Friday news drop. I wouldn't be surprised if both don't happen..
I think we all would feel much better holding this bag knowing patients were being actively dosed. Still no update on clinicaltrials.gov as well..
As always, time will tell. How much time? Who knows.
B. O. B.
2 gaps in the chart were filled on the Canadian side today. Tested support @ .32 and bounced nicely.
Just your typical manipulation. Market makers are still in control of this stock and will be until retail and big money starts pouring in.. I still think (jmo) that we will see a big uptick in sp leading up to a data readout, just might not be right away. The manipulators still know they have a few more months to mess with the price, and they will. JMO.
A good example (jmo) is how SNG (London Stock Exchange) traded leading up. Very all over the place between £20 and £80 during its phase 2 trial (before phase 2 it was much lower) before its data readout propelled it to £220. They now have a market cap of around $550 cad, and holding steady.
Jmo, let's see what the next news will do,
All I can say is none of us know..
B. O. B.
So they started screening patients in Miami today and will have first patient dosed by the end of this week.
One thing I thought I caught earlier in the webinar - did Chris say that first patient dosed for IPF would be by the end of this week as well? I swear I heard that? Anyone else?
Also, if a phase 3 happens, they will be going back to the market, but.....
The companies valuation will be much much higher, according to Chris.
Let's tune in @ 3:00 pm (Facebook live) to see what else is up.
All in all, great presentation by Chris Morneau, an excellent orator.
Looks like we are On Time!
B. O. B.
Reminder to everyone that Algernon will be presenting live on proactive at 1pm est.
Link to join webinar:
https://event.webinarjam.com/register/1/9pyogug
Also, Chris Morneau will be giving an update on ifenprodil afterwards via Facebook live at 3pm est.
Link to join Facebook live:
https://m.facebook.com/AlgernonPharmaceuticals/videos/3560737253937573/
B. O. B.
Busan South Korea just received a bunch of new covid19 cases. This is where Algernon's SK trial is being held.
Shout-out to PakG1 over at CEO.Ca for the new information.
http://m.koreaherald.com/view.php?ud=20200623000249
Some more recent findings on the glutamate receptor NMDA and it's reaction to covid19:
"A study conducted by German researchers has shown that the neurological symptoms observed in some patients with coronavirus disease 2019 (COVID-19) may be caused by autoantibodies targeting the brain.
Antigens for the autoantibodies included proteins that are well-known in clinical practice, such as the glutamate receptor NMDA, as well as various undetermined antigens in several parts of the brain.
The team says that although some autoantibodies still need to be identified, they may at least partly explain the multiple organ disease that can occur in COVID-19 patients and help to inform immunotherapy decisions in certain cases."
With my little understanding of Ifenprodil, it might be able to block the autoantibodies at the NMDA receptor. Maybe someone here more sciencey can shed more light. Another excerpt of significance:
"The researchers say that one patient with a high level of serum IgG autoantibodies against NMDA receptors required cardiopulmonary resuscitation. The raised IgG level may have reflected NMDA receptor encephalitis, which often causes arrhythmia and autonomic dysfunctions, they add."
In my opinion, we are on the right track by testing a NMDA receptor antagonist against this virus, and just recently, more information is linking this glutamate receptor with COVID issues, especially respiratory.
Link to article:
https://www.news-medical.net/amp/news/20200707/Cerebrospinal-fluid-autoantibodies-target-the-brain-in-some-COVID-19-patients.aspx
B. O. B.
Excellent interview. And thanks for the acknowledgement SoulTsunami, always the first to news!
B. O. B.
Not sure if this has been posted here before..
A single blind study for small cell lung cancer tumour growth inhibition, combining Ifenprodil with chemotherapy, was done in 2018.
Researcher William G. North (PhD) presents the case in a short video attached to this link.
Excerpt below:[color=red][/color]
Background: Small-cell lung cancer (SCLC) has a poor prognosis since there is currently no effective therapy for commonly recurring disease. In our previous study, both primary and recurrent human tumors have been shown to express functional N-methyl-D-aspartate (NMDA) receptors, and blockade of these receptors with GluN1 and GluN2B antagonists decreased tumor cell viability in vitro, and growth of tumor xenografts in nu/nu mice.
Materials and methods: In this study, we examine the influence of the GluN2B antagonist ifenprodil and the channel-blocker antagonist memantine, on cell viability and growth of tumor xenografts of recurrent SCLC (rSCLC) in mice.
Results: Both antagonists significantly reduced cell viability and levels of components of the ERK1/2 pathway, increased apoptosis, and at very safe levels significantly reduced the growth of tumors in mice. Each antagonist and topotecan had additive effects to reduce cell viability with significant synergy demonstrated for the case of memantine. More significantly, combination treatments of xenografts in mice with ifenprodil and the chemotherapeutic agent topotecan produced clear additive effects that completely stopped tumor growth. Moreover, the ifenprodil and topotecan combination showed excellent supra-addition or synergy of inhibition for tumors ≤300 mm in size (P=4.7E-4). Combination treatment of memantine with topotecan also showed clear addition but, unlike ifenprodil, no synergy for the doses chosen.
Conclusion: Since topotecan is a drug of choice for treatment of rSCLC, our findings suggest that combining this agent with NMDA receptor blockade using the GluN2B antagonist, ifenprodil, will significantly improve patient outcomes.
.....
I'm sure this has been brought to the attention of the more "informed" in the past. I just want to bring it to the attention of newer interest.
It appears to me that Ifenprodil could be an effective antagonist on an array of different lung type diseases. JMO
Link:
https://www.dovepress.com/small-cell-lung-cancer-growth-inhibition-synergism-between-nmda-recept-peer-reviewed-article-CPAA
B. O. B.
Gap filled on Canadian side today, was going to happen regardless of news. Nice consolidation after a big run up. Should continue late this week.
Jmo
B. O. B.
A therapeutic drug in the UK just had a good data readout and it's stock soared as much as 550% in the trading day.
"Shares of Synairgen Plc, a tiny pharmaceutical firm born out of a U.K. university, soared as much as 552 per cent after the company said its experimental drug cut the risk of developing the worst symptoms of COVID-19.
In a clinical trial involving 220 subjects, the probability of a patient requiring ventilation or dying dropped 79 per cent for those who got Synairgen’s SNG001 versus those who received a placebo, the Southampton, England-based company said in a statement. Those receiving SNG001 also were more than twice as likely to fully recover from the illness, it added."
Also, this little company's stock appreciated immensely before the data readout, with a year to date gain of 3194%. Market cap conversion from £ to $ equates to about $400 million USD.
A 400 mill mc for AGNPF would be around $3 usd, but I believe the fact that it trades in the North American markets would propel that mc much higher.
Not sure if this is the best comparison but they are both small companies with therapeutics for covid. Shout out to PigeonCap on twitter for this added comparison.
https://www.bnnbloomberg.ca/-1.1467821#_gus&_gucid=&_gup=twitter&_gsc=SvNCAVD
B. O. B.
Bang on AMG!
Price predictions based actual substance rather than being pulled outta thin air, rare indeed.
B. O. B.
In hindsight I was a little harsh there, and for that I am sorry.
I understand your are just searching for added information, please ignore my rudeness.
B. O. B.
Wrong smoki. They received FDA approval on June 3th 2020. *8* days after submission (very fast).
I can't understand why some people ask the most basic dd questions on stock forums when a 30 second google search is all it takes..
Anyways, Imo speculation is going to drive this much higher once "first patient dosed".
B. O. B.
https://www.globenewswire.com/news-release/2020/06/04/2043925/0/en/Algernon-Receives-U-S-FDA-Clearance-for-Multinational-Phase-2b-3-Human-Study-to-Evaluate-Ifenprodil-as-a-Potential-Therapeutic-for-COVID-19.html
50 Florida hospital ICUs hit full capacity. Westchester General is listed, they have 7 ICU beds at full capacity..
https://www.beckershospitalreview.com/patient-flow/50-florida-hospital-icus-hit-capacity.html
Also, Florida add 4,695 new corona virus cases, with: 2288 new cases per day during July 1-7 in Miami-Dade region, where Westchester General Hospital is located.
https://floridapolitics.com/archives/347342-south-florida-4695-covid-cases
We should have no problem dosing our first patient in Miami, we are right in the thick of it.
B. O. B.
Key point in this video : Site initiation visit for Miami next week, after which enrolment will start. Looks like we are on track for this trial to start by end of this month!
Also, Chris Morneau seemed very happy/excited in this video, he exuded alot of confidence, much more than the last proactive video.
Great interview.
B. O. B.
Wait, after paying over $600 you still don't know how many shares Dr. Kss owns?
Eeeek...
B. O. B.
I understand.
I believe the market will react favorably to "first patient dosed" news though, and here's why (in the lense of a gambler, we are talking about the otc/cse casino lol):
Investing pre clinical trial start: You have really 3 outcomes here,
1) drug works
2) drug doesn't work
3) Trial never starts
Investing post clinicacal trail start: You've got 2 outcomes,
1) drug works
2) drug doesn't work
...
In my experience, biotech stocks are very binary, and investing before a trail is very risky, but that can come with a much greater return as well. We still have 2 possibilities (one being greater) that could hinder our stock price:
Possibility - Trial never starts
Greater possibility - Trial get delayed
The market is very iffy on how legitimate management is here bc of past antics ie: the whey they handled the latest pp, the foolish spending of company money on advertising/promotion, etc. The market wants to see that they are more than just talk, more than just another cse penny stock jumping on the latest bandwagon. They have a real opportunity here to prove themselves.
I didn't feel overly confident watching that latest Proactive interview with Chris M. He seemed very somber and didn't exude much confidence, I hope it was just the day and nothing else, but my guard is up and a delay in the 2b/3 trial wouldn't surprise me one bit.
P. S. Thank you AMG for your continued insight, we may misread and poke from time to time, but the discussion is still appreciated.
B. O. B.
Imo "first patient dosed" does matter, a lot. Before a human patient is ever dosed/Phase trial is ever started, a company in biotech is purely speculative.
Reason: the trial may never start.
This is a real risk in nano-cap pharma stocks and a lot of big money won't touch them til a human trial is underway.
As we all know, there is a lot of hurdles in the way for a company before a human is ever dosed, and there is always the question of legitimacy, and the answer to that question becomes clear once a real drug enters the blood stream of a real live breathing ill homo-sapien. So far, the company has just tested mice..
Time will tell, 20 more days to start recruiting for phase 2b/3, and if they can't do that, we can declare another delay.
B. O. B.
There's only one way to make the market view otherwise, and that's to start dosing patients. Until then, we are at the mercy of the hands that pull the strings
B. O. B.
Link to latest updates on clinicaltrials.gov updated by the company July 9th.
https://clinicaltrials.gov/ct2/history/NCT04382924?V_2=View#StudyPageTop
That was a well timed news release wouldn't you say?! One day after BELLUS Health Flunks it's chronic cough trail, Algernon starts it's screening for phase 2 chronic cough.
I will say, the chart sure has bottomed and AGN/AGNPF is looking bullish again. I suspect that we get a nice little run up going into the end of the month. JMO
Onward and upward!
B. O. B.
Did anyone notice the news from BELLUS Health this morning?
– Primary endpoint of placebo-adjusted reduction in awake cough frequency did not reach statistical significance –
https://www.google.com/amp/s/business.financialpost.com/pmn/press-releases-pmn/business-wire-news-releases-pmn/bellus-health-announces-topline-results-from-its-phase-2-relief-trial-of-blu-5937-for-the-treatment-of-refractory-chronic-cough/amp
B. O. B.
Thank you FatCatz, I totally missed that information..
Well this was the first week in 4 that we closed the week higher than we opened, that's a good sign. Anyways, thanks for the insight on my many questions, I understand is only speculation, and we will know a heck of a lot more come the end of the month. It's either they start on time or they don't, guess we wait 3-4 weeks and see.
Have a great weekend and happy 4th of July to my neighbours to the south.
La revedere!
B. O. B.
Thank you are that perspective. I'm just trying to make sense of it all.
As for Dr. Mark Williams, well, I have faith in half of Algernon's management team, I think you know which half that is..
B. O. B.
Reiterate* not illiterate, although illiterate may be appropriate here (lol)..
B. O. B.
No sure if I follow you here tcm55..
SK was a completely different trial, it started because Algernon apparently wanted to "get the ball rolling" and a chance at dosing patients (Ifenprodil was an already approved drug in SK and Japan, but the chose SK because Japan was too expensive to run a trial). At the time of enrolment, South Korea was already the best country in the world at containment. It really appears (I'm not saying it was) to some that the whole SK news was to pump the stock for a PP.
Now, in regards to Australia. Australia is part of the 2b/3 multinational trial, not a separate trial as you applied in your post!
Australia, what is taking so long? Algernon applied for ethics approval way before they applied to the FDA, and still no reply? Australia has hardly any covid19 patients, why bother? Oh wait.. NOVOTECH!
Let's talk about Canada, they applied to HC and got approval on April 30th. At the time Canada was full blown epidemic, this is a Canadian company, and they have yet to dose a patient in Canada? After 63 days?
Now let's talk about The US, they recieved FDA approval on June 5th, 27 days ago. Since then, the only real news we got is they are adding two new countries to their multinational trial, still nobody dosed.
Let me illiterate:
Algernon 2b/3 multinational trial, 5 countries involved,
Canada (approved)
U. S. (approved)
Australia (pending)
Romania (pending)
Philippines (pending)
Out of the 5 countries listed above, 2 have the most daily cases, Can and the US. And the ONLY 2 countries approved for trials are Can and the U. S.
Yet we still wait.. Seems to me Algernon is not too keen in dosing on this continent for some reason - Novotech.
Fishy.
Jmo
B. O. B.
I disagree with your logic here AMG. Why would Algernon need 5 different countries to tap into a "diverse" test pool? Are you saying Canada and the United States isn't diverse enough? I don't think Algernon will have any problem finding:
Young or old
Black or white
Male or female
Compromised immune system or healthy,
In America!
There's more to this and I think Novotech is the reason, why is this bothering me? Because if Algernon is imited to countries Novotech operates in, there is definitely going to be further delays.
B. O. B.
And.. If that's the case, they are limited to countries that *don't* have many severe covid19 cases, whilst having clinical trial approval in Canada and the United States.
This is a micro cap pharma..
BTW I am long and want them to succeed, Just a bit baffled.
B. O. B.
Am I outta line thinking Novotech plays a big role in the 2b/3 trial? Why might this be concerning?
My opinion only! :
The company comprises of 2 people (and a drug) Chris & Mark. They obviously need help (hence through partnership with a CRO) "Novotech". *MAYBE* Novotech doesn't operate in North America, they are headquartered in Australia and operate through South East Asia.
It seems to me that Algernon seems very keen on acquiring patients in Australia (and now the Philippines and Romania). Could it be that they don't have the resources to stage a trial in North America alone?
I think it's a valid question.
B. O. B.
Thanks kotato for your speculation. I sure hope you are wrong as that would be the Weasleist thing a management team could do, but in penny stocks, anything could happen.
I however think it has more to do with their CRO than anything else, which leads to more questions:
What is Novotech's role in this 2b/trial?
Can Novotech assist/take part in the trial's taking place in Canada and the United States?
....
We know that South Korea is an "investigator lead study" lead by Algernon's CRO Novotech. We have also been told that the 2b/3 multinational trail is company lead, so lead by Algernon (Chris and Mark?).
With Novotech being an Australian company that covers South East Asia, are they able to assist in North America as well?
Is it possible that Algernon is trying to recruit as many patients as possible in countries Novotech operates in the further use their resources and expertise?
Maybe I'm getting way off base here, but I feel we aren't being told the whole story.
B. O. B.
Well it wouldn't be Canadian of me if I didn't apologize for the use of that term, so I'm sorry. I love America and have family and friends there, so please excuse me for my moment of insensitivity.
The question still stands. Why is Algernon branching out to these other countries? I understand Chris's logic of casting a big net, but the numbers are rapidly growing in the U. S. and AGN has FDA approval. Can first dosing in the U. S. happen if Aus is out? Do we need to now wait for Romania and the Philippines?
I understand these questions maybe left open and I will send an email to the company as well, but anyone here have an inclination?
B. O. B.
A good question has been raised here..
If there are so many new corona virus cases daily in the U. S., 40 thousand per day, and Fauci is now predicting up to 100,000 cases per day in the near future, than why bother with:
Australia
Romania
Philippines?
Surely they can find 150 patients in "Merica" alone..
Maybe their CRO plays a role? Any insight?
B. O. B.
Some may not agree.. But my opinion now is the downside risk has been greatly reduced at this price. Let's assume U. S. prices even though I'm Canadian eh?! A boot, I mean about this price, if you were to buy in here at $0.14c, and if the covid trial is a bust, we are looking at a price of let's say .5cents USD. A loss of 75% of what you put in, but if the 2b trial is a success, and we merge into a phase 3, well we can assume that the stock price will be well north of $1 USD, so a gain of 600% minimum. And to top it all off, if we can take Captain Chris for his word, we will likely know by end of September, "IF" everything goes as planned.
I've been pretty disappointed on this stock's performance as if late, but I truly feel a bottom is near.
P. S. I'm in a .345 cad ( for a large sum) and bagholding, at around the pp price..
I'm sure we will see some more consolidation, but not for much longer.
B. O. B.
I noticed that as well, but it's actually a very well written piece by Joseph Morton.