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***OFFICIAL CYDY/Leronlimab Thread*** (4 Viewers)

Polish Hammer said:
Very fair. And from a practicality standpoint, I'm not sure it's super fair to do the traditional primary/secondary endpoints for trials against a disease as ravaging and complex as COVID seems to be. I think (not 100% sure) that the primary endpoint is used to determine how useful it is in an area that is most important for that patient population but then also to determine how powered the study needs to be (enrollment) to fairly determine a thumbs up/down against that endpoint.

Truly, I'm not an expert in devising clinical trials so I couldn't say for sure. I think I had posted elsewhere that I actually preferred some of their secondary endpoints as more objective anyway. It would be interesting to learn when this study was developed why they specifically chose that composite score as their primary and why they chose a 14 day interval.
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If failing the primary endpoint is generally a failure and death knell across the board, then I don't understand the purpose of secondary endpoints at all. You make the primary or you don't. The end.

 
Don Hutson said:
There are like 70-80 endpoints.  I'm sure a few of them look good.  The placebo might have some that look good, too.  A p value of .05 means that is has a 1 in 20 chance of being due to randomness.  So having 3 or 4 endpoints with a p value of .05 means nothing.
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Having 3 or 4 endpoints with a p value of <=.05 definitely means something, especially if those endpoints are clinically significant.

 
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The best part of this thread, by far, is everybody with their AA degrees in English lit trying to determine which P values are significant. 

 
Jayrok said:
Exactly.  AF and his ilk get paid, I presume, based on traffic and hits on the site, twitter comments/retweets, etc.  
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They make their money by shorting before the hit piece is published, then buying back after the effects of the article lower the price.

The rest is gravy.

 
I look at it like this. NP reacting to AF by throwing a gauntlet at him shows he cares about the shareholders. We are not a big company that can just ignore an annoying fly and its apparent NP takes everything personally about the stock and its credibility.  

This stock is such a roller coaster. Yesterday everyone was pretty much happy after cc.

The Night King does a hit piece, stock price goes down and not so many happy people.

 
Capella said:
The best part of this thread, by far, is everybody with their AA degrees in English lit trying to determine which P values are significant. 
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Haha, I have one of those!   BA degree so Im more of an expert to weigh in on this matter, especially if it involves Hamlet and King Lear

 
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Moonlight said:
I look at it like this. NP reacting to AF by throwing a gauntlet at him shows he cares about the shareholders. We are not a big company that can just ignore an annoying fly and its apparent NP takes everything personally about the stock and its credibility.  

This stock is such a roller coaster. Yesterday everyone was pretty much happy after cc.

The Night King does a hit piece, stock price goes down and not so many happy people.
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He's protecting the company, in his eyes.  If stock price drops enough where they can't get listed, that would be a huge problem and could set the company back years.  They're within weeks of this milestone, providing them access to capital to do all the things they dream of (and become fabulously wealthy), so it's understandable you want to come out strong against these attacks.  But still.  

Maybe with their 25 million dollar loan, they can hire an effective spokesperson to handle this stuff.

 
Bob Sacamano said:
If failing the primary endpoint is generally a failure and death knell across the board, then I don't understand the purpose of secondary endpoints at all. You make the primary or you don't. The end.
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It was said that failing the primary endpoint in a phase 3 trial is a failure and death knell.  Phase 2 (M/M discussed yesterday is a phase 2 trial) not meeting the primary endpoint isn't a failure across the board.  That's why they have secondary endpoints.  If some of those are met with good results, it shows benefit to the patient, that's good and useful to the study. 

NP mentioned this using lowering blood pressure as a secondary endpoint (along with cough, fever, etc.) as an example.  If you don't lower blood pressure but do reduce fever and/or cough, the FDA wouldn't say you reduce fever and cough but you didn't lower blood pressure, so you fail the trial.  Point of the secondary endpoints in phase 2 is to see what/how many of the secondary endpoints the drug can benefit the patient and be useful against the disease.  It's phase 3 where it's crucial to meet the primary endpoint or else the show is over.  That's how I understood it at least.  

 
Dwayne Hoover said:
If they keep having problems getting any traction from the FDA, perhaps a buy out with a big Pharma would help.  There is always that hope.  With the kind of lobbying and political capital necessary, I have less doubt this would already be in use if BP was behind it.
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I'd have no problem with a buyout.  I wonder if AF and stat would write hit pieces if their buddy, GILD, bought Leronlimab.  Can't imagine they would.  

 
Mortality rate data on Monday (hopefully) is going to be key.  My friend put a spreadsheet together that looks at where the results become statistically significant.  I don't know how to share the file but will post it if someone explains how and there's interest.

 
If these are SHORT ATTACKS today, then one would expect a fairly significant (p value of .0325 by my estimation) increase in the share price as we get closer to the end of the day.

 
chet said:
Mortality rate data on Monday (hopefully) is going to be key.  My friend put a spreadsheet together that looks at where the results become statistically significant.  I don't know how to share the file but will post it if someone explains how and there's interest.
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Does the pope short CYDY?

Of course we're interested.

 
chet said:
Mortality rate data on Monday (hopefully) is going to be key.  My friend put a spreadsheet together that looks at where the results become statistically significant.  I don't know how to share the file but will post it if someone explains how and there's interest.
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Can you just copy and paste it to a google sheet?

 
chet said:
Mortality rate data on Monday (hopefully) is going to be key.  My friend put a spreadsheet together that looks at where the results become statistically significant.  I don't know how to share the file but will post it if someone explains how and there's interest.
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Function/print screen and then attach.

 
adonis said:
Does the pope short CYDY?

Of course we're interested.
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All things being equal, the p-value goes down as the number of deaths rises.  In a 99 person trail (33 placebo and 66 drug), equal deaths in placebo and drug becomes statistically significant at 10 each (p value = .0483).  

@McBokonon suggested saving it to a google sheet. 

FYI: Looks like my friend colored some cells as green that were bigger than .05.

 
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siffoin said:
Don't most Mild/Moderates recover on their own after 14 days?  If so what LL does between (on day 3 for instance) would seem most important to me anyways.  I mean if it took on average 10 days to get over a common cold and I could take a new drug Shaqlimab and get over it in 3 days that's incredible.  Sure in compared to the placebo group - both groups would have high recovery rates after 10 days, but improvement after 3 days would be a game changer.
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What is the ticker for the company making Shaqlimab I want to get in on this one early.

 
adonis said:
Makes sense. I'm just under the impression (asking for input in case it's false) that most clinicians are responding to phase 3 trials as those are the ones that guide clinical decision more often than phase 2 results.  Phase 2 results, again maybe I have this wrong, are often used to figure out safety and how effective the drug is in various areas.  That's why I think treating primary endpoints and secondary endpoints in phase 2 trials as the same as in phase 3 trials isn't necessarily fair.  

If the phase 2 trial shows promise on the primary but doesn't hit "significance" but quite a few meaningful secondary endpoints show "significance" and are beneficial for the patients, that would likely lead to a phase 3 trial focusing more on those areas in which significance was shown, with a shift in how the phase 3 primary endpoint was geared.

In the phase 2 trial we have here for m/m, it was initiated with collaboration from the FDA to highlight what they thought early on would be the most significant data points, and they included a slew of meaningful secondary endpoints as well to make sure they were capturing how effective the drug was, if at all.  If it turns out the primary endpoint wasn't a good choice, but a fair number of secondary endpoints that are relevant and important to clinical improvement for patients, the results won't be dismissed just because they didn't hit their primary endpoint.  This trial was a scattershot of endpoints to judge efficacy of leronlimab.  Its efficacy doesn't rely solely on the primary endpoint, in other words, but in the bigger picture of how the drug can help people.

If the secondary endpoints that are significant can be presented in such a way to show that clinical benefit can be offered by using the drug, it'd be foolish for anyone to dismiss the trial based on the primary endpoint missing "significance", if the secondary endpoints show statistically significant efficacy in areas that are important for patient wellbeing.

All this said, i'm not really arguing with you...just making points that are up for refutation by anyone.  Looking for feedback on these views.
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How many endpoints did Remdisivir hit the required p-value to be called statistically significant in?

 
OC Woman Credits Experimental Antibody Drug for COVID-19 Recovery

BY NATALIE BRUNELL SEAL BEACH PUBLISHED 8:41 AM ET JUL. 31, 2020

https://spectrumnews1.com/ca/la-east/coronavirus/2020/07/30/oc-woman-credits-experimental-antibody-drug-for-covid-19-recovery

SEAL BEACH, Calif. — Hooked up to ventilators, overwhelmed with fatigue and pain, Samantha Mottet recalls thinking her time had come.

“I really felt the fear of death. It was very scary. It felt like I’m never going to see my family again. My parents again. How fast 55 years went,” Mottet said.

Mottet, who lives in Seal Beach, calls her recovery from COVID-19 a miracle. As a liver transplant survivor, she was a high-risk patient and at her worst in the battle against the virus, Mottet was placed in an induced coma.

She said all she could think about was her children and the pain this would cause her mom and dad.

“I really fought for them,” Mottet said as tears filled her eyes. “It was not looking good. On April 1st I was gravely ill and they were calling my family to come down from Oregon. And that’s when Dr. Yang stepped in with the Leronlimab. He calls it his hail mary.”

Mottet says her UCLA Medical Center physician, Dr. Otto Yang, asked her husband if he would sign off on an experimental treatment called Leronlimab.

Leronlimab is an artificial antibody that works to fight the virus when the body’s immune system response overreacts. It was initially developed to treat HIV.

“Within 24 hours, I needed less oxygen. And by my 55th birthday on April the 5th, they were removing the ventilator and then I was able to go home,” Mottet said.

Dr. Yang tells Spectrum News part of his role at UCLA was to come up with experimental treatments to offer COVID-19 patients like Mottet. He said at the time, back in April, he didn’t have many options.

He learned of Leronlimab through a colleague and requested it from the FDA under compassionate care.

“We don’t know for sure if the Leronlimab was what turned her around. I believe it probably did, the improvement she had after she got the drug was dramatic,” Dr. Yang said.

The drug is now being studied in a placebo-controlled clinical trial and UCLA is one of the trial sites.

Dr. Yang said not all of his patients responded to Leronlimab as well as Mottet and the trial results will offer more insight into its efficacy. But when he last read her antibody count, it was over 100,000.  

“She’s about 10 times higher than the typical person’s antibodies,” Dr. Yang said.

Dr. Yang recently published a study on antibodies in COVID-19 patients in the New England Journal of Medicine, and found that antibodies fall sharply in the first three months after battling the virus, especially in mild cases of COVID-19.  But Mottet was a rare exception.

“I feel like the safest person anybody can be around right now,” Mottet said.

Mottet is now back to doing all the things she enjoyed before COVID-19, but she has a completely new lease on life and is grateful to her team of doctors for risking their lives to save hers.

“I wake up every morning and thank God that he let me live,” Mottet said. “I wasn’t ready to go and I’m enjoying my adult young children and hope they get married and that I have grandchildren. And I just feel so thankful to be here.”

 
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