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Re: changes_iv post# 43243

Wednesday, 11/10/2021 8:14:33 AM

Wednesday, November 10, 2021 8:14:33 AM

Post# of 44690
Kpags2 hours ago
@Big obviously you couldn’t answer my simple question? 70% of the study had a 22% reduction in mortality. Hard to believe that is just statistical chance? Further data will prove this out but it doesn’t need to since NIH EP is well designed and Taylor made for Aviptadil impact.

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FC
FC7 hours ago
@Kpags the correlation between these and the biomarkers will be even more interesting. No chance for just chancesmile Let's find out more next week.

Reply1
Kpags
Kpags8 hours ago
@Big I am not an idiot. Raw data 70% of the study had a 22% decrease in Mortality at day 60? Explain that Please? Was that chance? Please give me your honest answer

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FC
FC9 hours ago
@Big the more you talk, the leakier you aresmile Remember, numbers don't lie.

Now let me prove why you are a fake. You said you treated 22 EAP patients in your hospitals. Fine. Do you know how many total EAP patients NeuroRx has granted? By the time they reported 60days trial data, the number of EAP was 240 (196 of these received maximal intensive care, the rest went to palliative care). So congratulations according to you, you happened to treat 10% of the total EAP. The direct consequences are:

1. This made your hospital on the top of the EAP hospital list. So 5% can be easily verified with NeuroRx. Also what made NeuroRx stick with such a low competence hospital for EAP? Keep in mind the overall survival rate for EAP in maximum care setting was 65%.

2. Your 5% propelled the rest of EAP program's survival rate to 72% - this figure is higher than the Aviptadil arm in the RCT trial. Your faking number is creating a dilemma that you can't argue away.

You are no doctor. Now stop your all nonsense and be a decent human for once.
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Reply1
Big
Big9 hours ago
@FC we had 1 patient survive at the 28 day mark out of 22 treated. All extremely ill. Not exactly 5% but close enough. The one "survivor" eventually died.
I'm board certified in infectious diseases and critical care--I spent years at the NIAID. And, as I've been saying all along, I'm writing a paper on how companies spin data to deceive enthusiatic but uneducated investors.
FC-- use common sense--if adviptadil reversed SARS-CoV-2 lung damage as touted by the developers, why aren't smart docs beating the doors down to get it to treat their dying patients?? It's because smart docs can read an article that was published in the pay-to-publish Journal of Infectious Diseases and Treatment and immediately see the enormous flaws in the study design, execution, and analysis. The average layperson sees a stock price of 0.40 and a p < 0.00001 and gets an erection (all for all the wrong reasons).
You're probably too young to know this, but years ago VIP was the miraculous answer to ARDS. That didn't pan out ...
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Reply1
FC
FC10 hours ago
@Big all right. There is no need to waste more time with you. You think giving me a very low number would help with your argument. You have no idea how statistics work. You can't even fake properly lol

Physicians are heroes of this pandemic. Please for sake of you and your family stop being an imposter.
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Reply2
Big
Big10 hours ago
@FC about 5% at 4 weeks.

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FC
FC10 hours ago
@Big what was the survival rate for your EAP patients? I just need this piece of data from you.

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Big
Big10 hours ago
@FC wow..again, wow...what part don't you believe? My credentials? I did my MD PhD at Columbia. Or my analysis. I'm not a troll. I'm trying to understand how apparently educated and sophisticated investors can be strung along for so long and continue to have faith in results that should not require faith. Why do you believe that adviptadil "works". You understand the p value you cited was a result of a manipulated analysis (for example, the p02 value reported for the adviptadil group was the admission value and not the value when the patient received the drug--big mistake)
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Reply2
FC
FC10 hours ago
@Big you claimed you have used Aviptadil under EAP. I am not gonna ask which hospital you work for. Please just show me one piece of data. What was the survival rate for your EAP patients?

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FC
FC10 hours ago
Haven't seen so many trolls in my thread lately. Yeah, MD, PhD, my #$%$, you Big liar can't even pass the high school reading comprehension test. And look he is talking about trial design blah blah.

@GeraldS dude you are super annoying. If you can't understand TH, RCT, DSMB, why are you even here investing?

All the numbers in my post were from the phase 2b/3 RCT trial except the 81% survival rate which was for the 21EAP study. They have clearly shown Aviptadil at least achieved clinical significance in the trial.

There is another piece of data that you might find interesting. There were 36 MV patients enrolled. The survival rate at 60days were: 58.6% (A) : 0 (P). The p value was 0.001. Clinical trials are always full of surprise.
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Mark
Mark11 hours ago
I just let NIH 3b clinical trials play out. No rush https://www.nih.gov/research-training/medical-research-initiatives/activ/covid-19-therapeutics-prioritized-testing-clinical-trials
Bullish

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Big
Big11 hours ago
@Mark did you read the Journal of Infectious Diseases and Treatment article? It was horrendous--they even mislabeled the exclusion criteria as inclusion criteria. As a fellow physician, what makes you believe this drug has efficacy? Very curious.

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Mark
Mark11 hours ago
@GeraldS Hello, Gerald. Yes, I am a medical professional and I do respect research currently being done at NIH. 3b clinical trials is still being conducted and we will get more updates next summer.

I am invested for long term and I do not get too excited about temporary gyrations in the stock market.
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Bullish

Reply31
Richard
Richard11 hours ago
@GeraldS
I think there isn’t much money left !
They have asked for
Or received government
Monies for the Studies

It is costly to run and operation like this
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Neutral

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GeraldS
GeraldS12 hours ago
@Mark Without a double blind clinical trial how can you make such a statement? Your just keeping us holding on to false hope. The only way we're going to recoup our money now is a law suit.

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GeraldS
GeraldS12 hours ago
@Mark What are your qualifications to guarantee the ultimate success of Zyesami? Are you a wishful thinker, or a shill, and accomplice to the gang pushing an ineffective treatment. Who are you? Sadly, people can come on this discussion site in total anonymity. I suppose it's a double edge sword, but it does open us to being swindled.
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Big
Big12 hours ago
@GeraldS 100% agree.

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Big
Big12 hours ago
@Mark...if adviptadil was such a "game changer" as you say, demonstrating its efficacy would have been easy. There have been two failed EUA applications. I'd reflect on those facts before encouraging folks to invest.

Reply12
GeraldS
GeraldS12 hours ago
@Big What are these unethical companies going to do with the millions of dollars we've invested in them? Live the high life like the super rich? Is that their point? Or do they have other projects they want to finance that are legitimate? It's beginning to look like legal theft. The intitial trials were enough to show it didn't work, and they're just stringing us along. I wish the FDA would be more transparent and clamp down on companies who are intentionally stealing from investors.
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GeraldS
GeraldS12 hours ago
@wax The patience story is why he are still here losing our pants, socks, and underwear when we could have walked out after losing just our coat and tie!

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Mark
Mark12 hours ago
Unfortunately most laymen wouldn’t notice the difference between antivirals from antibacterial medications.

Pfizer and MERK drugs only targeting patients suffering from viruses but not bacterial infections. Millions of more people suffer from Bacterial then viruses infections.

Amazingly. ZYESAMI drug helps patients from viruses, bacterial and other pulmonary complications.

Even long after Covid viruses are eradicated, ZYESAMI drug will be forever needed and long term investors will all become millionaires.

We have many medical professionals on this forum. I would like your input.
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Bullish

Reply2
Mark
Mark12 hours ago
Many investors seems to be confused about FDA EUA. FDA never rejected ZYESAMI potential but it wants more then few dozens trials before they will approve the drug.

Dr. Fauci and many others know the potential of ZYESAMI is game changer.

Both Pfizer and MERK drugs are antiviral drugs. It only targets patients suffering from respiratory complications related to viruses but not bacterial infections.

ZYESAMI drug is comprehensive drug for viruses, bacterial and other pulmonary complications. It’s miraculous drug and not just antivirals
Ike Pfizer or MERK.

FDA will soon or later must approve ZYESAMI. NIH is still enrolling and conducting 3b clinical trials. I guarantee ZYESAMI will make make investors millionaires
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Reply32
Big
Big13 hours ago
@GeraldS you are 100% correct. I wish folks would stop throwing their money away. Based on the data we've seen, there's not one credible and objective (i.e. not holding stock) academic physician who thinks adviptadil improves severe COVID-19 respiratory failure. No one, of course including me. Yet folks are throwing more cash at a .06 stock??? Why??
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Reply22
Big
Big14 hours ago
Potent not patent lol

Reply11
Big
Big14 hours ago
I don't know where to start. Powering a study (basically, how many patients to enroll) is a statistical procedure based on mutilple estimates/assumptions (most important how much of an impact the drug under study will have on the primary endpoint). It isn't "just enroll a few more patients and we'll see what happens". In GENERAL, the more patients you need to see a significant difference between groups, the weaker the effect of the agent being studied. For example, if a blood pressure medication truly dropped your systolic pressure by 3 points (very small benefit), you may have to power your study to enroll a million people to tease out such a tiny benefit. If the med was more patent and dropped your pressure by 20 points, you may only have to enroll couple hundred subjects. The point is sample size must be pre-planned during study design.
If adviptadil "worked" and had "clinical significance" the FDA would have granted the EUA. There is no conspiracy. The analysis published in the Journal of Infectious Diseases and Treatment "article" is not sound science. The article is littered with basic "mistakes"-- mislabeled scans, wrong table titles...again, the FDA re-analyzed the data correctly and found no benefit--I truly wished the med did what the company claims it does, but it didn't. This is why I'm here--writing a paper on how unethical biotech companies can spin data so investors give them money
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Reply11
GeraldS
GeraldS14 hours ago
I'm sorry, but you're just beating a dead horse. Why do we do blinded studies? When you do a blinded study you can't fake the results. For all we know they chose 'controls' that were less likely to survive, either intentionally, or subconsciously. We just have no way of knowing. The blinded study so far showed no positive results whatsoever based on the agreed end point, survival at 28 days. Doctor Javitts went back and cherry picked the data after the unblinding to find 'significance'. That's just not done... Period. And that my friends is the story so far. I so wish it were not true. You folks think I'm bashing? No, I'm the one who'se bashed, along with the majority on this site....the believers. Also, we do not know the results of the later blinded study on which the FDA made its decision. If anyone does, I and the rest of us dearly want to see it. 131 patients is more than enough to show "may be effective" as a criteria.
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Reply11
GeraldS
GeraldS14 hours ago
What is TH? test hospital? You didn't bother to define it. RCT Random Control...T? DSMB? Why can't you spell it out then use initials in paranthesis, to save time of me guessing or trying look up and elimination? Very annoying. Also, where did you get these numbers, as I have not been able to find them. It drives me #$%$ when I try to read this stuff. You ought to learn standard protocol for write ups. You could start by Googling it, or even reading a report from New England Journal of Medicine, or Nature, to see how professionals do it.
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Reply3
12345
1234518 hours ago
@FC you are correct my mistake it was not the open label it was the phase 2/3 fast track

Reply21
FC
FC19 hours ago
@wax right we certainly need patience here. Don't bank on NIH to turn up something before the trial completes. A 3 standard deviation on all-cause mortality advantage is a very high bar. The accelerated approval pathway might have a merit here. Let's see what they come up with in next week's conference call.
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Reply21
wax
wax19 hours ago
@FC ... taking into consideration Aviptadil is a synthesized peptide found in every creature walking the planet that breathes air, whether it works or not isn't the question. The question is how WELL does it work ... how effective is it ??
Does it do enough to justify EUA for covid ??
First ... shame on the FDA for approving all of these man made chemicals with a list of side effects longer than my arm and ignoring a natural peptide.
Second ... ACTIV-3b trial is coming up on the half way point of registration so, we may see something other than safety data sooner than later.
We just have to be a little more patient.
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Reply51
Kpags
Kpags19 hours ago
@FC I think FDA has to approve accelerated approval then they can use the bio marker data. If the fda approves that and/or BTD that would go a long way.

Reply2
FC
FC20 hours ago
@12345 you said "also in that article the DSMB suggested based on those open label results that 144 is possibly sufficient to achieve stat."

Now let's look how the SeekingAlpha articles says:

"On July 16, 2020, Relief Therapeutics and NeuroRx announced that the Data Monitoring Committee conducted a planned review of the first 30 patients treated in the Phase II/III Fast Track trial (Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure (COVID-AIV)). Per the release:

The committee determined that the study appeared capable of reaching a statistically significant endpoint within its 144 patient sample size and voted for the study to continue until its next scheduled evaluation in four weeks."

I don't know where you got the idea DSMB based the recommendation on the open-label study - that's certainly NOT what SeekingAlpha was saying.