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It's all speculative at this point. Unless you have some objective evidence?
If they announce positive data and Phase 3 is going ahead, then usually companies in Phase 3 which have positive signal in Phase2b human trials and unanimously have passed safety check points, hit market caps of half a billion or more... So... would be much more than $2
If you wonder if the data is good, check this:
Toledo Doctor Says Drug is Working Early in the Trial
To be honest, I don't know what more the average investor could ask for, aside from one of the Doctors actually saying the drug appears to be working... ESPECIALLY early in the trial. It then goes on to pass all safety check points. I think we have a winner just saying. Again, see that smirk on Chris' face says it all.
Saw the smile on Chris' face during the interview today. That smirk is the sign of positive data.
Can someone provide a link to that Doctor's commentary?
Yep, buckle up for a wild ride
As with any pharma stock releasing Phase 2 results. The question is, how much do you believe in the science. You appear new to this board in particular, it's easy to dig back and find our stance on the solid science.
Wonder if some positive trial data has leaked
Enrolling trial sites:
In case anyone was wondering where our patients are coming from:
Locations
United States, Florida
Westchester Research Center Recruiting
Miami, Florida, United States, 33155
Contact: Aimee Gonzalez
United States, Illinois
Affinity Health - Loretto Hospital Recruiting
Chicago, Illinois, United States, 60644
Contact: Maria Iliescu-Levine
United States, Missouri
Heartland Regional Medical Center Recruiting
Saint Joseph, Missouri, United States, 64507
Contact: Gautam Balakrishnan
United States, Ohio
Promedica Health: Toledo Hospital and BayPark Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Maria Matal
Australia, Queensland
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia, 4102
Contact: Andrew Henderson
Australia, Victoria
Royal Melbourne Hospital Recruiting
Parkville, Victoria, Australia, 3050
Contact: Adam Deane
Philippines
Makati Medical Center Recruiting
Manila, Philippines
Contact: Maria Tarcela Gler
Philippine General Hospital Recruiting
Manila, Philippines
Contact: Joel Santiaguel
Lung Center of the Philippines Recruiting
Quezon City, Philippines
Romania
National Institute of Infectious Diseases Recruiting
Bucharest, Romania, 021105
Contact: Adrien Streinu-Cercel
True, part of the beauty of this. It all comes down to whether you believe in the science or not. I for sure do. Locked and loaded baby. Ready to score BIG. The best part is that if the trial data is good, none of us will have to worry about selling our shares for a long time because the only direction for it to go will be up (if its positive in phase 2 it will almost certainly be in phase 3, and big pharma will be swooping in with MASSSSSIVE offers)
Wow, you know tcm55 better than he or she knows themselves!
Well, was right about the study closure part. The data read out part makes sense in terms of needing some extra time to let patients finish the trial though.
The problem lies in the immense complexity around running clinical trials in Canada. Many hoops to jump through. Case counts aren't as high. Might be issues with having the third party companies helping run the trial. Etc.
I'm hoping for some sweet news this wk!
Need 168 patients for trial closure and they can put out the data read. As far as I am aware, based on how quickly they were enrolling and the abundance of cases, we should have trial completion within days (as of a week ago they only need 14 patients)...
As such, just my prediction that we get study closure this wk and some data...
Activation of the sigma receptor is a block box. Ifenprodil activating this receptor might have huge therapeutic potential. Needs more research. What we are finding out quickly is the interconnection between neurological system, endocrine (hormones...) system, and inflammatory system. Blocking NMDA receptors likely has impact on decreasing local/circulating immune cells in the lungs, reducing hyperexcitable neurological response that is damaging, and also blocking leaky microvasculature so less acute lung INJURY and ARDS
There's been quite the uptick lately indeed. Not surprising, big data drop coming could be a gold mine
? Why not... they only need "13-14 patients" as Chris said verbatim... I would assume they are done and we are getting that news very soon. Highly likely early next week
Don't forget! We have solid studies supporting ifenprodil for acute lung injury!
"Ifenprodil and Flavopiridol Identified by Genomewide RNA Interference Screening as Effective Drugs To Ameliorate Murine Acute Lung Injury after Influenza A H5N1 Virus Infection"
Ifenprodil for ALI
"Due to the limitations of effective treatments, avian influenza A H5N1 virus is the most lethal influenza virus strain that causes severe acute lung injury (ALI). To develop effective drugs ameliorating H5N1-induced ALI, we explore an RNA interference (RNAi) screening method to monitor changes in cell death induced by H5N1 infection. We performed RNAi screening on 19,424 genes in A549 lung epithelial cells and examined cell death induced by H5N1 infection. These screens identified 1,137 host genes for which knockdown altered cell viability by over 20%. DrugBank searches of these 1,137 host genes identified 146 validated druggable target genes with 372 drug candidates. We obtained 104 commercially available drugs with 65 validated target genes and examined their improvement of cell viability following H5N1 infection. We identified 28 drugs that could significantly recover cell viability following H5N1 infection and tested 10 in an H5N1-induced-ALI mouse model. The neurological drug ifenprodil and the anticancer drug flavopiridol markedly decreased leukocyte infiltration and lung injury scores in infected mouse lungs, significantly ameliorated edema in infected mouse lung tissues, and significantly improved the survival of H5N1-infected mice. Ifenprodil is an antagonist of the N-methyl-d-aspartate (NMDA) receptor, which is linked to inflammation and lung injury. Flavopiridol is an inhibitor of cyclin-dependent kinase 4 (CDK4), which is linked to leukocyte migration and lung injury. These results suggest that ifenprodil and flavopiridol represent novel remedies against potential H5N1 epidemics in addition to their proven indications. Furthermore, our strategy for identifying repurposable drugs could be a general approach for other diseases.
IMPORTANCE Drug repurposing is a quick and economical strategy for developing new therapies with approved drugs. H5N1 is a highly pathogenic avian influenza virus subtype that can cause severe acute lung injury (ALI) and a high mortality rate due to limited treatments. The use of RNA interference (RNAi) is a reliable approach to identify essential genes in diseases. In most genomewide RNAi screenings, virus replication is the readout of interference. Since H5N1 virus infection could induce significant cell death and the percentage of cell death is associated with virus lethality, we designed a genomewide RNAi screening method to identify repurposable drugs against H5N1 virus with cell death as the readout. We discovered that the neurological drug ifenprodil and the anticancer drug flavopiridol could effectively ameliorate murine ALI after influenza A H5N1 virus infection, suggesting that they might be novel remedies for H5N1 virus-induced ALI in addition to the traditional indications. "
if they announce positive phase 2 data this thing is going to be a missile. I mean there are no really solid covid-19 treatments, if we have data showing this will be the first good treatment it would be hard to comprehend what will happen to the share price, it will be insane. Big Pharma will be approaching from left, right, and center. A treatment for billions of people... these guys would be sitting on an absolute gold mine
Depends how much you have invested i guess!
We have been promised some results soon. The excitement is killing me!
This is a very relevant point. Not everyone will take the vaccine. There disease has spread so quickly, even with many people taking the vaccine and amazing public health measures, it would still take years if not decades to control this. As such, we need treatments, not just vaccines. People will get sick, and those sick people need medication that can reduce the disease severity. The fact Chris and Mark are in the middle of their pre-liminary data analysis and have now said they think this will be in the Top 3 treatments, to me says we have a winner. Time is ticking.
The patient's don't see the progress of others taking the drug. That would go against all rules of confidentiality and medical privacy. The doctors can see who's benefitting but John Smith can't look across the hall and see Joe Blow doing better...
People drop out because they know they are not getting the drug and so thus there is no motivation to stay in the trial. That simple.
Yes, typically if a placebo is given, a study would be blinded. That way it can truly be a placebo... if it was open, that would defeat the purpose. However, that is NOT what we have here with Algernon. As mentioned by AMG, there is no placebo. We have an open label (NON blinded) trial. Instead of placebo, we have standard of care, meaning regular best medical treatment. The treatment groups get low or high dose of drug.
Not necessary. Look at what Pfizer and Moderna just did. They reported prelim data and trials aren't done. As mentioned before, mostly boils down to the fact it's open label and not blinded, so doesn't matter if patient's and physicians know about who's getting the drug or benefiting.
Tnx. Im invested long. Will stick around and hopefully facilitate and participate in some good discussion. We have multiple trials running to keep our wheels spinning and Dr. Mark on the helm with the scientific brain to keep the new trials coming.
Think about if you were them. They told you that they want to drop a early data read out. To maximize gains, wouldnt you drop the data, then follow that with complete trial enrollment news shortly thereafter? Just my theory...
Yes, the key is that it's a preventative medicine, not a treatment.
Cool photo. The Lancet is our holy grail of peer-reviewed medicine. There is no doubt that any respiratory medicine widely utilized is going to draw in billions.
I think that it's important to draw attention to the fact that ifenprodil is being trialed for treatment of acute lung disease. Yes, we are treating COVID patients but the pathology we are treating is acute respiratory distress syndrome secondary to acute lung disease with leaky microvasculature and increased inflammatory cells with proinflammatory cytokines. The reason this is important, is because influenza has the same underlying pathology.
So translation: if this drug works for COVID... influenza trial will follow. If it works for covid, it will almost certainly work for influenza (since same pathology). As such, we will be scoring bigger than most realize.
30 million people x 2 doses per person
Part 3: Why you shouldnt worry about pfizer news:
- 90% ... they didnt tell us anything about differences within that 90%, i.e. are there certain populations you achieve 90% and others that dont? Younger vs older? race and ethnicity? immunocompetent vs immunocompromised? we probably wont know how its going to perform overall until its used in large populations people
- thats not going to be the only preventative therapy - there are going to be more vaccines.. in fact to be honest, pfizer could never supply the whole world, you need other companies ... because you need billions of doses
- vaccines arent treatment, they are preventative therapies, people will still develop COVID and get sick and for that, you need drugs that help decrease acute lung injury like ifenprodil
- i mean EVEN IN CANADA ALONE you would need two doses per person at least and thats 70 million doses and pfizer cant supply the world with that
- there nowhere close to being able to supply that
Part 2: Why people shouldn't worry about Pfizer vaccine
- Vaccine has to be supplied to various countries via advanced purchase agreements... pre-arranged with companies to purchase the vaccines in advance of knowing if they worked
- Canada and USA are examples that have advanced purchase agreements.
- Each country wanting to use vaccine need to provide the data to the regulators
- FDA and Health Canada will look at those results and rest of the data
- rolling submissions have been carried out (typically companies wait until they have all the info ready and then present it to the FDA and Health Canada as one package, and then FDA and Health Canada have very rigorous and laborious process of reviewing data) with FDA and health canada agreeing with a number of manufacturers, most advaanced to do a rolling submission
- ad data becomes available, companies submitted it to FDA and health canada so start reviewingf data on manufacturing and testing so that they can get ahead , but this takes MONTHS AND MONTHS AND MONTHS to review
- FDA and Health canada will then have to sign off, and THEN they can apply for emergency use authorization (or "interim order") so that public health could deliver vaccine and this would only be for use in "priority groups" determined by FDA and Health canada, to start
- NAC on Immunization said a week ago who priority groups are and laid out groundwork for doing this
- local regulators would then decide on distribution
- e.g. of priorrtity groups: frontline health care workers and indigenous populations, older individuals
Part 1: The reason people shouldn't be worried about Pfizer vaccine...
- Results are only from interim analysis
- They need to finish trial
- They need emergency use authorization
- vaccine only to start being used in places where they get licensure of the vaccine
- regulators have said before they want at least two months of safety data on ALL participants before they would even consider starting to use vaccine in the licensed places
- press release suggested that this at the earliest would be Dec or new year
- What does this mean? in various countries they could apply for this release, that the vaccine can be used before you could go to a store and buy it
- Public health would be able to use some emergency doses to start immunizing priority groups and begin a process as they complete the study to get full authorization for it's use.
It's worth noting that Pfizer CEO opens 10b50-1 plan day before dropping news about vaccine.
Sketchy Selling
It's troubling to me that the general counsel or the internal controls of these companies would consider it legitimate to adopt a 10b5-1 plan one day before a major vaccine announcement," said Taylor. "If this isn't a wake-up call for the SEC and a wake-up call that we need to reform these 10b5-1 plans, I don't know what it is."
As someone pointed out recently, it's an open label trial. So the doctors enrolling patients and treating them probably went back to the company and said people are doing really well. The reason for an early release? Secure major funding from big pharma for phase 3 (i.e. a partner) and also get the process for emergency access approval from the FDA started EARLIER. Why wait.
Wow this is a huge finding, well done
While it's a good question, it's a bit of a moot point because they are telling you they are going to give you something better than simply announcing trial "complete enrollment", instead their going to actually give you DATA. This is truly make or break. I mean if these guys have good data, this stock share price is going to sky rocket out of control. If not, well we move forward to IPF and chronic cough. The reason I have faith, is because no company would ever release bad data early... AND ... no company would release early data if they were unsure ... there is scientific reasoning for this
1) Release the good data early = secure big pharma funding for phase 3 now, rather than when phase 3 needs to start (that would cause delays)
2) if you release early data with less patients, you have less trial "power" when looking for positive signal... you could easily increase trial "power" by waiting for more patients to be enrolled which would increase your likelihood of finding positive signal... but clearly they don't care and are releasing data for less patients which is highly suggestive they have big signal
As this is a discussion board, I am happy to discuss any points that you feel I have been "critically wrong" regarding