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The fact they have purposefully chosen to do an early data release on an open label trial is a huge indication the data is positive.
Earlier I described why: releasing early means you are not benefiting from achieving full trial "power". This refers to the ability to detect a meaningful difference if one exists. If you show early results, with fewer patients, you are less likely to show positive signal than if you wait... because the more patients, the easier it becomes to find a positive signal (statistically speaking) TRANSLATION: there is only one reason companies do this... the data is overwhelmingly positive and they want to show us ASAP.
This is typically good news. Usually if the company is uncertain if the drug is working, the last thing you would do is release early results. There is a statistical reason for this. In order to demonstrate "positive signal" a trial needs to have sufficient "power". Power is attained by enrolling enough patients. So what this means is that if your placebo and treatment drug both work almost similarly, then you need lots of patients to detect a difference between them. If you have a treatment drug that works like a miracle with huge positive signal, you only need a few patients to demonstrate the signal.
I.e. if they are releasing the results early, this means that they must be confident they have a signal and don't need tons of patients to demonstrate the signal, otherwise they would wait to the end.
Also, now that they have put this news release out, any insider buying (because they know the drug is working) can be covered up by the company chalking it up to "buyers saw we were releasing a data readout" and nobody will ask any questions... IMO this is a way for the company to allow insiders to get there shares. I bet the share price is about to run up.
Lastly, I am not sure why the share price dipped on the vaccine news. Even if the vaccine was 90% effective, not everyone would get it, and theres always going to be people getting sick from COVID so there will always be a need for treatments to help decrease lung injury. Vaccines aren't cures. The fact people sold today shows they have no idea whats going on scientifically speaking.
The doctor wont know if patients are benefiting because trial data is collected in a blinded fashion. The doctors are blind to the data/outcomes. Thats why its a blinded randomized control trial
WHAT! That is the most unethical thing I have ever seen someone write on this board. That is absolutely NOT how clinical trials work. If a enrolling doctor EVER was to coax a patient into taking medication when they don't meet the trial legitimately for the actual indications to provide therapeutic benefit, that doctor would go to jail.
You should do a google search for "clinical equipoise" which is mandatory for patients being enrolled. It means it is unclear whether the drug works or not and so it is ethical to randomize patients to drug or placebo, because we legitimately don't know what works. You should also google search on how randomized trials work.
Honestly, I means this politely, but the fact you think a doctor could encourage people to join a trial without informed consent and actual need shows you need to do some reading mate.
I am not sure what the concern is about here. There are lots of patients for them to enroll, and they have stated they are almost done... >75%, so clearly the end is coming soon. What does it matter if it's one or two weeks later than YOU and I would expect? There may be reasons from a trial perspective it's taken longer, for example patients being excluded from the trial. These trials are incredibly complicated matters and they are enrolling patients internationally at certified medical centres, working with certified doctors and scientists, according to .Gov certified inclusion and exclusion criteria that are very complicated.
Agreed. If the data from Phase 2 is solid, they will be approached by big pharma, far before Phase 3 concludes. If the data is OK, we might not get an answer until the end of Phase 3. If the data is poor, then we turn our sites to IPF and chronic cough trial.
Full enrollment in a clinical trial is a massive undertaking and isn't rushed to give a press release. It will happen in due time. There are plenty of COVID cases and enrollment has been on target thus far.
Good question, here's my thoughts:
Brain, Behavior, and Immunity is a reputable, peer-reviewed, scientific journal. This means that all manuscripts accepted for publication have undergo rigorous scientific review, usually by at least two scientists who are experts in the field.
The findings highlight the concept that NMDA receptors are upregulated in lung tissue that is infected. This is problematic as I have posted about for, NMDA receptors play a role in neuronal hyper-excitability and likely regulate acute (short term) microvascular permeability (aka leaky blood vessels that allow immune cells in and the lungs to get soaking wet making it hard to breath). If you decrease the NMDA receptor activation using a NMDA antagonist (aka a blocker) than you can prevent the leaky blood vessels, the immune cells, and the problems with the oyxgen levels for the patients and their breathing. These inflammatory cells are upregulated meaning that their are way too many and this so called cytokine storm is directly responsible for problems such as neurological symptoms and blood clotting and strokes and seizures... for an open access review of this thing, see the link below. I do disagree with one aspect of the Dallas study... they say this process is not neuronal, and that makes no sense, because the NMDA is on the neurons, and the neurons interact with the microvasculature and so do the cytokines. It's a big mixing pot. They are all intricately involved. TGF-beta signalling seems to be involved in later/long term microvascular permeability and so I would be surprised if angiotension receptor blockers which inhibit TGF beta, also could be beneficial here.
This paper I link discusses NMDA receptors and cytokine storms:
https://fluidsbarrierscns.biomedcentral.com/articles/10.1186/s12987-020-00216-1
and others (not free)
https://link.springer.com/article/10.1007/s10456-020-09753-7
https://journals.sagepub.com/doi/10.1177/1076029620962853?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub++0pubmed&
https://rcm.imrpress.com/EN/10.31083/j.rcm.2020.03.126
At the end of the day, keep in mind, this is kind of like the super computer I discussed previously finding an association. That's all fine and dandy, but they need to do the tests to see whether something ACTUALLY works. Thankfully they have done a stellar job, actually A1 job getting an international trial off the ground in record time.
Peace for now
This stock is flying under the radar big time...
To clarify: A sample size calculation is just a small portion of trial design. I agree, they use 2b to determine sample size for phase 3 (because 2b gives them an idea of the expected reduction in symptoms necessary to be considered clinically significant), but the way they go about delivering the medication, testing the patients, collecting the data, will be similar.
They will have professional statistician dealing with the data. It will be a lot of work. Especially coordinating the analysis from data collected across sites internationally. The process won't be quick. It won't be williams or swain doing that. Dr Swain is just a guy who founded a small-cap investing website BioPub, he might help pump the stock. Phase 3 doesn't require further trial design either, it will be a continuation of Phase 2b as long as the data is positive it will be a straight shot into it.
COVID Trial Completion will be any day based on the prior trend of 25% enrollment per ~3 week period (we hit 75% over 3 weeks ago).
They are running a multi-national clinical trial, government approved. Period.
They brought in a scientist, secured IP on a safe drug, and coordinated international trials running in hospitals, verified by the government, in an unprecedented amount of time.
If you don't want to play the odds of a huge score, than why are you still posting here?
precisely. If it doesn't work for covid in phase 2, then we will turn our attention to IPF/chronic cough
At the end of the day, all that matters is the Phase 2b trial data reading. You, me, the rest of us, we don't need to worry about any other logistics. That's because if the trial data is positive, this will sky rocket out of control. Sure, Phase 3 would happen. But it wouldn't matter, because we already got safety approval, we know its safe. So if phase 2 shows it works, this will explode and they will have deals coming at them from every angle from big pharma
If they have positive phase 2 data and head into phase 3... big pharma will buy them out for mega money
we already know its safe, it got approval from the safety board
Buddy. They are running an international trial. Go to clinical trial .gov. This is the real deal. You can't deny the fact this is internationally registered on government websites for everyone to see
youve been on this board for years trying to talk this down. i see through that. You can't deny this...
https://clinicaltrials.gov/ct2/show/NCT04382924
There are a few concepts at play here:
1. Coronavirus infection is associated with a massive release of pro-inflammatory cytokines (e.g. TNF alpha and interleukins)
2. Pro-inflammatory cytokines can cause leaky vessels and lead to conditions like ARDS (lung disease)
3. NMDA receptors play a role in small blood vessel permeability
4. NMDA receptor antagonist ifenprodil can inhibit the excess glutamate related toxicity and decrease blood vessel permeability leading to less lung disease
My 2 cents:
Look back through the news releases and you will be able to see that they have been enrolling patients VERY fast across their sites. They have been recruiting 25% of patients every 3 weeks approximately. They hit 75% nearly that long ago. We will have news on 100% this week.
If the trial data is positive, this will be ground breaking and the share price will explode as it moves into phase 3.
We already knows it is safe because the safety data monitoring board approved it a while ago. That was the biggest hurdle and we are past that.
Thanks. Have been super busy lately so haven't had time to get on the board.
Anyway, I don't know I would have added much anyway because it's a waiting game for the trial to complete.
That's not exactly how it works. The data is reviewed in professional fashion by statisticians and associated scientists. The data is reported in a objective way by the company: i.e. they will report if there was or was not statistical significance with respect to the primary and second disease outcomes. These outcomes are reported on the clinical trials .gov website which is freely available.
Then... later... Dr. Williams will probably have a press release giving his opinion on things... but... if the data is good, he will say "moving forward to phase 3"... if it's bad... "drug doesn't work, so we will just continue with chronic cough/IPF"
Hey folks - whats up - been busy with work so haven't been on here at all lately
Also can't find their patents?
USPTO
Can someone point me in the direction of these please
No korea trial?
Why is the trial not registered with their trial registry...
korean clinical trials registry
Where did AMG go?
paid for by the 250k they gave away
sure. if the goal is simply to keep the share price where it is, i agree. but overall, the pattern of behavior here is ruthless.
Classic pump. Some news after the fundraise to mitigate and get people to forget as quick as possible
These guys have been pumping stocks and fundraising for years, nothing has ever paid off. Sure, maybe this will be different, but the fact they pump hard and then shaft shareholders over and over is concerning. family and friends definitely making gains. now what, they let the price fall, family and friends buy back in? they pump again?
i like the science here, but frustrating is what this is. All along they've had good ideas. But they have consistently shafted everyone. over and over. they told us in the biopub (2 ago) that they didnt need more money. And honestly, they dont need 6 million. ruthless..
Yeah the other important thing to consider is they have fundraised WAY more money then they need right now. They completely took advantage of shareholders using the hype they built. They didn't need to raise 6 million right now.
ahahahah
Agreed, was risky before COVID. But the IPF data is legit. Takes a lot of the risk out of the equation. Thats real science data. That was tested for the same disease process. Tested by Mark himself. For COVID the risk profile is different. We are extrapolating an inferred benefit from work other scientists have done, for a different virus (infleuzna). Probably similar, but again, risk profile is different.
Agreed, need to have the money in order to go multi-continental. Just pissed me off they made it seem like they were well situated to make that happen before another PP. I am bitter. I'll get over it.
Infecting the cells of the gastrointestinal tract. Source of diarrhea.
I suspect this infects the nervous system. Infection of the endothelial cells of the lungs could lead to pulmonary cytokine storm and leaky capillary (small blood vessels).
https://science.sciencemag.org/content/early/2020/04/30/science.abc1669?utm_campaign=SciMag&utm_source=JHubbard&utm_medium=Twitter
Maybe just legitimate feelings of frustration. Getting owned by private placements and dilution over and over and over.
They shall pass.
There's only one way to find out. As many here would agree, South Korea is the right next step. As others have pointed out, Japan may have been a better choice. Who knows the rationale. Either way, patient numbers are low (fact), as investors what we know is that they are going to run the trial regardless (also fact). For the longs, probably doesn't matter if the trial is stopped for low enrollment. For the shorts it might. They need to move fast on Canada and the USA.
The whole COVID thing is a risky play to begin with. Wasn't the reason I invested in them. I like the science behind the IPF data they have. But hey, if we can make something happen with COVID we will be laughing. I do believe the drug will work if they can use it on sick patients.
Fair enough
It was a smart move to go forth with South Korea. No faulting them for that. Just unfortunate it's the one place that cases have dried up.
The solution is always more liquor!