Charlie Harper
Footballguy
BP on what he would treat himself with if he had Covid. "iViG or convalescent plasma" with currently available treatments. Would be hesitant with dexamethasone. Would call Jay Lazari and ask for some LL.
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***OFFICIAL CYDY/Leronlimab Thread*** (6 Viewers)
- Thread starter This_Guy
- Start date
Charlie Harper
Footballguy
On other CCR5 competitors: most are small molecule with toxicity. There's others on the way, especially once you show proof of concept. Just have to be prepared on the your strengths and weaknesses.
On upcoming review of CD12: S/C better metric "deaths". Explained NP stating there's a lot of deaths as "unfortunately a good thing for statistical analysis."
On Primary vs Secondary on Phase 2:
Following precedence set with Remdisivr which changed primary endpoint. Either one (1st or 2nd) can get you an EUA."
BP hasn't even seen the new shirts. Haha.
On upcoming review of CD12: S/C better metric "deaths". Explained NP stating there's a lot of deaths as "unfortunately a good thing for statistical analysis."
On Primary vs Secondary on Phase 2:
Following precedence set with Remdisivr which changed primary endpoint. Either one (1st or 2nd) can get you an EUA."
BP hasn't even seen the new shirts. Haha.
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Capella
Footballguy
Charlie Harper
Footballguy
Also mentioned they haven't been in touch with the White House.
Charlie Harper
Footballguy
I know BP has a lot riding with CYDY but when you hear him speak during these interviews it really seems like he truly believes in the drug.
While he's the antithesis of NP, they both seem real genuine to me when they speak. Then again I thought the same of my ex-GF until she cheated on me.
While he's the antithesis of NP, they both seem real genuine to me when they speak. Then again I thought the same of my ex-GF until she cheated on me.
Bluto Blutarsky
Footballguy
Chaz McNulty
Footballguy
If you want to truly get out, make sure you don't watch the Dr. P interview. Otherwise you'll end up buying more.
Dwayne Hoover
Footballguy
I watched the Patterson interview and am glad I added more shares today. Even Nader's proactive video, as silly as it was, I'm buying his sincerity. Haven't felt as confident about this in a while, we should be good.
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Jayrok
Footballguy
Charlie Harper
Footballguy
I don't recall him saying that out right, but he did say he was part of the team that looked at whether the SAE in m/m was due to LL or something else. He also used "we" and "us" a lot.
Don Hutson
Footballguy
Bruce Patteson explaining about his paper in interview with Dr Yo:
https://investorshangout.com/post/view?id=5846390
What is going on with paper: Again I, I’m frustrated by the Journal it up the COVID endemic forcing people to publish preprints; because people who don’t understand the publication process know that it’s a relatively long process, is obvious accelerated in COVID and, and clearly you know, there was, there is several issues, I mean the main being no controls, right? and you know, these patients beyond critical and we are blessed that hum … some of the other coauthors and myself had great collaborators who stepped up the plate and said: listen I got some critical controls that haven’t been treated and let’s ad add those to the paper.
and then, you know, by the time we add those we had day 14th data which made everything even more powerful like I said this inverse correlation between CD8s coming back up and plasma viral load going down, absolutely critical, now people are coming out in reverse saying that is the CD8 deficiency ah, or the recovery of the CD8s ahmm that is eventually, you know, going to eliminate a virally infected cells. So then, we included CD 14th day and then, of course, it was outcomes: you know all 11 patients had incredible immunologic response the outcomes were good for this particular population, 8 out of eleven, or 7 out of 11 were transplant patients on top of everything else .. ah I just had not been addressed … So in fact, I checked on it today and it's, it's in process I think they are probably close to a decision, and then the journals when there is a decision will get it out in e-pub relatively quickly. But if you talk about the time from submission to going out in e-Pub in 3 months I mean, under normal circumstances, we would be popping the champagne bottle in how fast that is, right ??? some publications normally take 6, 12 months from the time they are actually submitted to the time they are out in print. so you know, I get the frustration, I’m just a frustrated at the pace, but you know what ? after publishing 150 papers, nothing, this is business as usual. Are the political things going behind the scenes? possibly ahh. But, in the day is gonna come out; I mean, the bottom line is: you don’t write a great paper and doesn’t get out anywhere is only matter of which journal gets it out there … at the end of the day, it does not matter, right??? if it is in a top tier Journal it's fine but it doesn't have to be, you know, solely New England Journal, Lancet, Nature, Science, you know, I published in all those before and yes, is a great honor but you know what ? they accept one in 100 papers so … yeah there’s other papers on Leronlimab that have undergone the same fate, so, we are in the same boat and I think the recurring theme is: lack of control patients and, obviously, that is going to come in the clinical trials and certainly in the IND’s we didn’t have controls, we didn’t have placebo controls, we went out and got them from our obviously some great collaborators of ours which made the trial much more than just, you know, just, looking at Leronlimab, we had to look at what was going on and repeat the entire assays that we did on the treated patients on the controls, so you can imagine the study size actually double, you know, in the course of, this being evaluated, so again, yeah there’s every reason in the world why, you know, it’s taking this long, but like I said, with, after 150 publications there is nothing that is unusual about this in the least
https://investorshangout.com/post/view?id=5846390
What is going on with paper: Again I, I’m frustrated by the Journal it up the COVID endemic forcing people to publish preprints; because people who don’t understand the publication process know that it’s a relatively long process, is obvious accelerated in COVID and, and clearly you know, there was, there is several issues, I mean the main being no controls, right? and you know, these patients beyond critical and we are blessed that hum … some of the other coauthors and myself had great collaborators who stepped up the plate and said: listen I got some critical controls that haven’t been treated and let’s ad add those to the paper.
and then, you know, by the time we add those we had day 14th data which made everything even more powerful like I said this inverse correlation between CD8s coming back up and plasma viral load going down, absolutely critical, now people are coming out in reverse saying that is the CD8 deficiency ah, or the recovery of the CD8s ahmm that is eventually, you know, going to eliminate a virally infected cells. So then, we included CD 14th day and then, of course, it was outcomes: you know all 11 patients had incredible immunologic response the outcomes were good for this particular population, 8 out of eleven, or 7 out of 11 were transplant patients on top of everything else .. ah I just had not been addressed … So in fact, I checked on it today and it's, it's in process I think they are probably close to a decision, and then the journals when there is a decision will get it out in e-pub relatively quickly. But if you talk about the time from submission to going out in e-Pub in 3 months I mean, under normal circumstances, we would be popping the champagne bottle in how fast that is, right ??? some publications normally take 6, 12 months from the time they are actually submitted to the time they are out in print. so you know, I get the frustration, I’m just a frustrated at the pace, but you know what ? after publishing 150 papers, nothing, this is business as usual. Are the political things going behind the scenes? possibly ahh. But, in the day is gonna come out; I mean, the bottom line is: you don’t write a great paper and doesn’t get out anywhere is only matter of which journal gets it out there … at the end of the day, it does not matter, right??? if it is in a top tier Journal it's fine but it doesn't have to be, you know, solely New England Journal, Lancet, Nature, Science, you know, I published in all those before and yes, is a great honor but you know what ? they accept one in 100 papers so … yeah there’s other papers on Leronlimab that have undergone the same fate, so, we are in the same boat and I think the recurring theme is: lack of control patients and, obviously, that is going to come in the clinical trials and certainly in the IND’s we didn’t have controls, we didn’t have placebo controls, we went out and got them from our obviously some great collaborators of ours which made the trial much more than just, you know, just, looking at Leronlimab, we had to look at what was going on and repeat the entire assays that we did on the treated patients on the controls, so you can imagine the study size actually double, you know, in the course of, this being evaluated, so again, yeah there’s every reason in the world why, you know, it’s taking this long, but like I said, with, after 150 publications there is nothing that is unusual about this in the least
Don Hutson
Footballguy
Patterson's paper not being published is still annoying. It was supposed to be published in a week's time. They didn't say it being published in a week's time was a hope. It was put forth as matter of fact. So to now have him say that these things take months just means that the original statements were likely intentionally misleading.
Have we ever figured out if Patterson exercised his warrants on April 30th and whether he subsequently sold stock? We know Nader and Scott Kelly sold $12 million and $3 million in stock on April 30th. Patterson's name was on the list of people exercising warrants in SEC filings but then we were told that he didn't. Did he sell stock at the time that he was giving misleading promises about his paper?
Have we ever figured out if Patterson exercised his warrants on April 30th and whether he subsequently sold stock? We know Nader and Scott Kelly sold $12 million and $3 million in stock on April 30th. Patterson's name was on the list of people exercising warrants in SEC filings but then we were told that he didn't. Did he sell stock at the time that he was giving misleading promises about his paper?
djmich
Footballguy
Been thinking about this some. Like most, I'm conflicted about CYDY.
I wish they would be better communicators, more transparent. Instead they chose to release tidbits of data and are not filling in the blanks adequately (quantitative blanks, contextual blanks, any blanks). So, everyone is left to speculate and unfortunately there are a lot of plausible bad scenarios given the details we have to work with.
Here's my positive speculation scenario. COVID is new, COVID is not cancer with well established methods of medical evaluation. Not only are we still learning about COVID but these trials were setup earlier on, I think safe to say we've learned some over the past few months. My point is I think it is hard to establish the "endpoints" perfectly in this environment. I know others haven't and have changed the endpoints. I think it is entirely possible that the CYDY team is looking at the data and seeing good, positive results in certain areas. Not so positive in other areas. That isn't necessarily a death knell. They are probably also trying to "understand" why not positive in other areas and what that means. This is an important task. This is where you can't just plug data in excel and press F5...why it takes time.
My suspicion is that what they are observing in particular is that they are not finding statistical significance in many if not most of their endpoints on day 14. This is not good because I think most of the primary endpoints are day 14. However, in hindsight I'm not sure that is the right measure for a few reasons.
Who cares if it doesnt make a difference by day 14 you might ask. Two reasons:
The big question will be, will these guys be able to tell this story adequately to prevent Adam F from killing them. Honestly, I hope that once this is done, it is with the cooperation/input of the FDA and its not Nader vs Adam F (Nader will lose)....its Adam F vs the medical community.
Last note, I think the CYDY team is banking on some of the prelim results from S/C to really help pull this through and that is part of the overall delay. From the calls you can tell they are trying to get that in front of FDA quickly.
I wish they would be better communicators, more transparent. Instead they chose to release tidbits of data and are not filling in the blanks adequately (quantitative blanks, contextual blanks, any blanks). So, everyone is left to speculate and unfortunately there are a lot of plausible bad scenarios given the details we have to work with.
Here's my positive speculation scenario. COVID is new, COVID is not cancer with well established methods of medical evaluation. Not only are we still learning about COVID but these trials were setup earlier on, I think safe to say we've learned some over the past few months. My point is I think it is hard to establish the "endpoints" perfectly in this environment. I know others haven't and have changed the endpoints. I think it is entirely possible that the CYDY team is looking at the data and seeing good, positive results in certain areas. Not so positive in other areas. That isn't necessarily a death knell. They are probably also trying to "understand" why not positive in other areas and what that means. This is an important task. This is where you can't just plug data in excel and press F5...why it takes time.
My suspicion is that what they are observing in particular is that they are not finding statistical significance in many if not most of their endpoints on day 14. This is not good because I think most of the primary endpoints are day 14. However, in hindsight I'm not sure that is the right measure for a few reasons.
- This is mild and moderate population. Most people are going to exit healthy by day 14 in the mild group...the "survival rate" for COVID is high. The test population is really not that big when you consider the high recovery rates without medication. I would imagine a statistically significant p value in this population is going to be incredibly difficult.
- We are seeing what appears to be improving COVID recovery rates over the last month, I think that is a changing variable from when the trial parameters were originally started.
- I believe they have referred to 3 tests now, it looks like they may be trying to separate the moderate from the mild as the moderates are less likely to recover by day 14. So...you have a better change of "seeing" a difference in moderates performance however the downside is that you've greatly reduced your already small sample size and statistical significance will be harder.
Who cares if it doesnt make a difference by day 14 you might ask. Two reasons:
- I would be surprised if it doesnt make a difference by day 14, however this trial size is not large enough to achieve statistical significance at day 14 due to the high recovery rate. That doenst mean it does not work, it means the trial is not setup with enough participants to measure this properly.
- IF this is true. Still a big / unknown if...but we have some information that provides hope. If this is true, I would expect much higher change of seeing positive impact by day 14 in the S/C trial. Recovery by day 14 is much less likely. We know there have been a decent amount of deaths in fact. Due to this, if the medication works proving statistical significance is much more possible.
The big question will be, will these guys be able to tell this story adequately to prevent Adam F from killing them. Honestly, I hope that once this is done, it is with the cooperation/input of the FDA and its not Nader vs Adam F (Nader will lose)....its Adam F vs the medical community.
Last note, I think the CYDY team is banking on some of the prelim results from S/C to really help pull this through and that is part of the overall delay. From the calls you can tell they are trying to get that in front of FDA quickly.
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Sand
Footballguy
Really want to do the Roan Mountain section, which is a bit north of this. Let us know how this goes.
Capella
Footballguy
Capella
Footballguy
If they find significant difference in day 3 for the drug vs the placebo but less significance by day 14, can they change the endpoints?
Don Hutson
Footballguy
I am objective. I truly see things from both sides. There are a ton of red flags. You being so upset by my very reasonable questions shows how unobjective you are.
Capella
Footballguy
Upset? I could lose every dollar of this money I have on cydy and it won’t change my life at all. You’ve been substantially more bearish this week, including making broad declarations that are simply untrue multiple times.
Dwayne Hoover
Footballguy
This is totally fair, Im 100% with you on this one. Patterson is not surprised that it takes this long and I'm sure that's right.
So where did the paper was going to get published this week (end of April) come from? We know Nader said it but you know who else said it the same week, Dr Yo. Was Dr Yo talking to Nader or Patterson at that time?
Nader absolutely sold his shares the same week that he pumped the paper. Its certainly a red flag whether there is any substance to it,, we still don't really know.
I will say this though, I'm starting to believe Nader a little bit. He's 100% in over his head and shouldn't be driving this but I'm less convinced these days that he's playing a long con. He truly believes in this, now maybe h'es just got a bad evaluation, that's always possible but I really don't think he is trying to intentionally mislead anyone.
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Don Hutson
Footballguy
Capella
Footballguy
Dwayne Hoover
Footballguy
Every time I watch Patterson, I come out of it pumped up about leronlimab. Have to admit though and I know Capella was half joking half serious when he said it yesterday but a lot of us have no background to say with any reasonable doubt that what Patterson is saying is scientifically right.
I had never heard of Rantes 4 months ago and at best have a high level understanding of it right now. I do know panties however.
I'm not a religious person because I cant have faith in anything I clearly don't understand. This although scientific does require some of the same faith. Patterson has credentials for sure and he's either really going to be up for a Noble prize or he's got a terrible read on this. I have no way of saying for sure which is right.
It does bother me that Dr Yo and Dr Been are the ones breaking this. I trust many mainstream media sources and it definitely bugs me that no one is picking this story up. If Patterson is right about this, shoudn't some crack reporter at least be talking to him and giving him a little press?
Everytime I get excited, the practical side asks, is this really possible?
I had never heard of Rantes 4 months ago and at best have a high level understanding of it right now. I do know panties however.
I'm not a religious person because I cant have faith in anything I clearly don't understand. This although scientific does require some of the same faith. Patterson has credentials for sure and he's either really going to be up for a Noble prize or he's got a terrible read on this. I have no way of saying for sure which is right.
It does bother me that Dr Yo and Dr Been are the ones breaking this. I trust many mainstream media sources and it definitely bugs me that no one is picking this story up. If Patterson is right about this, shoudn't some crack reporter at least be talking to him and giving him a little press?
Everytime I get excited, the practical side asks, is this really possible?
Don Hutson
Footballguy
Topline results come out in a few days when they are good according to all of our sources in the pharmaceutical industry including Golf Guy's daughter. We haven't heard one person inside the pharma industry say anything different than that. You can believe it's not true if you want. But for me to believe the sources with inside knowledge of the industry does not make my opinion a "simply untrue broad declaration". And the fact that you get so emotionally upset shows how incapable you are of hearing an opinion that differs from your completely faith-based opinion.
Capella
Footballguy
Yea my only concern is we are getting conned. That’s why it is annoying social media presence is the rantes panties guy — seems like more should be on board if this was as great as people think. But then I counter that with the other doctors cydy brought on board to their staff — they all seem extremely legitimate and while doctors can be scheisters too, seems to make it less likely.
Capella
Footballguy
Emotionally upset
Yea I’m sobbing over here. Stop projecting, you’re the one in your feelings here. While those people certainly have excellent knowledge, covid is an unbelievably complex problem that nobody has dealt with before and the delays have been adequately explained imo.
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Don Hutson
Footballguy
You've been making personal attacks toward me simply because my opinion differs from your opinion. I would say that indicates that you are getting emotionally upset. I am annoyed at the personal attacks toward my character but I am not even 1% annoyed that anyone has opinion different than mine.Emotionally upset
While those people certainly have excellent knowledge, covid is an unbelievably complex problem that nobody has dealt with before and the delays have been adequately explained imo.
Capella
Footballguy
Capella
Footballguy
Total waste of time, sorry for derailing things.
Hudson > the feurenstein post was an obvious joke and not a personal attack. I’ll stop engaging you if you can’t tell the difference.
Dwayne Hoover
Footballguy
I don't completely disagree here either. There are definitely some warning signs that the top line number may turn out to be inconclusive at best. Patterson did say last night that there were 30 to 40,000 data points to analyze so what part of the evaluation those go into, I also have no way of knowing for sure. I think we may have what is going to be a very nuanced trial to analyze and an underpowered one at that.
If things are really improving at day 3 though, that sounds incredibly good to me. What am I missing here?
Whatever the death was, I'm almost certain that was on the leronlimab arm. Might be unrelated but may also be nuanced enough that its going to require a very good explanation.
For the mild to moderate, we may be looking at a phase 3 trial. Hopefully we get EUA but I don't get the feeling this tiny company is going to get any breaks. Its a home run or nothing.
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Dwayne Hoover
Footballguy
Last thought for the morning.
A big issue I see right now is timing. Leronlimab may be a solid candidate to be in the mix but the longer this drags out, the better chance some BP is going to have something that surpasses it.
A phase 3 trial would honestly be good news if not for the race to get to market here. This is a big concern for me and also how political it all is. One thing that I don't have much faith in is Nader's ability to get through any of that and sadly it may be necessary.
A big issue I see right now is timing. Leronlimab may be a solid candidate to be in the mix but the longer this drags out, the better chance some BP is going to have something that surpasses it.
A phase 3 trial would honestly be good news if not for the race to get to market here. This is a big concern for me and also how political it all is. One thing that I don't have much faith in is Nader's ability to get through any of that and sadly it may be necessary.
Capella
Footballguy
For this it will all come down to the severe trial. If they can show people largely aren’t dying because of this it’s golden. That will be major headline news that no government could deny.
Chaz McNulty
Footballguy
Really. C'mon Dude. You are choosing and cherry-picking what you want to believe. You need to know that you made the right decision, convince others of this, so that when the stock takes off (speculative) you can sleep at night.
There are a ton of other sources that say it takes 6 weeks or more typically from the end of trial to bring the data forward.
You may be right and you may be wrong. But please stop presenting these like facts.
djmich
Footballguy
Sure seems like this.
I will say, aligned with wrote I wrote earlier, I don’t think they have positive topline on the primary 14 day endpoints. That’s gonna be a problem, particularly for stock price (otc, terrible communicators). I do believe there are positive results. What happens next I don’t know, optimistic, but history says stock gonna take a hit unless the mgmt team delivers.
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Chaz McNulty
Footballguy
I never heard anything about a week's time. When you are presenting something as fact, can you please provide a link.
Chaz McNulty
Footballguy
They may not, but I think there will be enough there in the secondary endpoints. If they prove to be better than REM, and can somehow get the data out to the media, I think it will be accepted.
They also have a shot with the S/C trial. I just wish they had more participants in the early peak.
Steeler
Footballguy
This seems like really good news to me. If the primary endpoint was 14 days for m/m, but the real benefit can be shown after 3 day, then perhaps they can change the primary endpoint like Remdisivir. If people on LL are better (by whatever measures they are using) than control group after 3 days and (hopefully) after 10 day why couldn't they change the primary endpoint to show this helps reduce the number of days someone is affected by COVID? Would be pretty big news if they can show this improvement.
djmich
Footballguy
Agree. And, the one thing we have going in our corner is that the world is desperate for anything here. With a clinical trial completed, if there is anything grab onto I cannot imagine LL will still be left in the dark (as it is now...and Capella points out is one of the concerning elements...why not noticed more)
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Charlie Harper
Footballguy
I understand why this company is unheard of. We know about it from a guy on fantasy football message board in a thread called "Stocks" and the only consistent media coverage is a biotech short.
There's so many drugs it would be hard to pick this HIV drug from a 10 person company. There have been a few articles and news stories, which seems appropriate. If there's positive results though it should blow up easily.
Charlie Harper
Footballguy
They don't have to change any endpoint for phase 2. That's the purpose of a phase 2 trial - using the shotgun approach to find how it helps.
Phase 3 is where it's do or die on the primary endpoint because generally they take the findings from phase 2 and use that the develop the primary endpoint.
It is really good news because Remdisvir set such a low bar, that if any of the endpoints hit LL should be approved for EUA.
Who's going to stop a safe drug that:
- Decreases time to resolution
- Decreases NEWS score
- Increases baseline oxygenation levels
- decreases acuity
- decreases needs for ventilation or supplement oxygen
- shows impact through bloodwork
Not saying LL will do ALL of the secondary endpoints but pick any combo of 2 points and would you be able to keep that drug off the market? If it shows statsical significance in 2 and maybe even 1 of these things, who cares that a qualitative 1-12 score failed?
Don’t worry about it. He’s been on the attack and like you said making untrue assumptions. He’s gotten into iFights before. It’s sort of sad. It’s the typical everyone else is emotional and I’m so objective except when people disagree with my opinions. I’ve met plenty of people like that who think they are so smart and anyone who disagrees with them does not understand that he’s just trying to protect us. Makes you wonder if we’ve got some aliases running around saying the same stuff like anything AF says, but in a super objective way. Tuning out people like this helps make life normal.
None of the people in this thread know if they are right or wrong. Everything right now is conjecture or assumptions. We’ll find out soon enough.
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Dwayne Hoover
Footballguy
I'm happy that Don Hutson is coming in here and trying to poke holes. Some good information comes out of the rebuttals.
I run a daily analysis that consists of should I take some off the table now and lock in profits, maybe purchase some back at a lower price or should I be adding more now?
It's been like this for months. Also have a count in the 30s of buys and sells. Added more Friday and trying to debate if I should add even more on Monday.
I run a daily analysis that consists of should I take some off the table now and lock in profits, maybe purchase some back at a lower price or should I be adding more now?
It's been like this for months. Also have a count in the 30s of buys and sells. Added more Friday and trying to debate if I should add even more on Monday.
Dwayne Hoover
Footballguy
I don't have a link but this is a fact.
The last week of April, Nader stated that BP's paper was going to be published that week. He actually went one step further and promised it was going to be "published in a prestigious medical journal" This was a day or two before the Nader stock sale..
Also the same week Dr Yo had one of his youtube webcasts and stated that Patterson was going to be published in a supplemental issue of Nature that week.
Where did Dr Yo get that info from? Nader or BP? We know BP is saying now that he knew it would take months but is this an about face?
Was Nader trying to pump up the sp before he sold?
Bluto Blutarsky
Footballguy
My big take away from last night was Dr Patterson saying that the m/m patients issue was more immunological than virological. That’s why we see such a big reduction SAEs, because LL prevents the body from raising IL-6/8 and then rantes iirc
this would also explain the many different ways LL can help other diseases, because it’s not disease specific, but cell specific.
this would also explain the many different ways LL can help other diseases, because it’s not disease specific, but cell specific.
djmich
Footballguy
I say to myself this random fbg can’t know what he is talking about...and then I look at your profile pic and you sure do look like a doctor.
Bluto Blutarsky
Footballguy
Better?I say to myself this random fbg can’t know what he is talking about...and then I look at your profile pic and you sure do look like a doctor.
adonis
Footballguy
I feel like, win or lose here, we’ve all learned a valuable lesson about what is and what is not panties.
caustic
Footballguy
I’m not familiar with the Remdesivir data, but in general I strongly disagree with this. Everyone uses the 1%/5%/10% significance levels because it’s convenient and ensures uniformity across research, but there isn’t a meaningful difference between a p=0.05 result and a p=0.06 result. Significance should be treated like a continuous variable, not a discrete one.
