***OFFICIAL CYDY/Leronlimab Thread***

[IC FBGCav 5,664]

8 hours ago, Dwayne Hoover said:

Chet did more than his job a long time back and definitely thanks for turning us onto it.  He seems to have Irish Goodbyed though so I'm going to take that as a sign of that he has exited entirely.

Also not seeing Golf Guy much either, perhaps he is gone now too.

Golf Guy  banned

[IC FBGCav 5,664]

I still got 35k in shares.

[IC FBGCav 5,664]

10 minutes ago, Whyatt said:

Did I hear correctly, Nadar will send a copy of the M/M Topline Report to anyone who emails him and requests it?

Let me know if anyone receives a copy.

you wanna bet now?

[IC FBGCav 5,664]

I am golf guy fyi for our slower members.

[IC FBGCav 5,664]

I'm too drunk, what happened?

[Dwayne Hoover 365]

8 minutes ago, IC FBGCav said:

I'm too drunk, what happened?

We know there are 45 deaths in the severe critical trial, we just don't know which arm has what portion.  Its enough deaths that it could be statistically significant if leronlimab is a lot better.

Other than that, I don't think the call went great.  No mention of a Nasdaq uplist yet.  NP does say again that he's 100% sure that they will eventually be approved for HIV but its hard to believe anything from him at face value.

Something about Patterson's paper being rejected which Im trying to get more details on.  Doesn't sound good though.

[IC FBGCav 5,664]

6 minutes ago, Dwayne Hoover said:

We know there are 45 deaths in the severe critical trial, we just don't know which arm has what portion.  Its enough deaths that it could be statistically significant if leronlimab is a lot better.

Other than that, I don't think the call went great.  No mention of a Nasdaq uplist yet.  NP does say again that he's 100% sure that they will eventually be approved for HIV but its hard to believe anything from him at face value.

Something about Patterson's paper being rejected which Im trying to get more details on.  Doesn't sound good though.

All good points, my biggest one i made earlier was why was Patterson only one on board.  

But as to my position on this stock.  I was 100% up front.  I sold, everyone knew.  I bought a mountain home with the proceeds.  Everyone knows.  I got 35k shares.  Everyone knows.

I have been skeptical of everything during this and transparent.

 

[Getzlaf15 10,807]

1 minute ago, IC FBGCav said:

All good points, my biggest one i made earlier was why was Patterson only one on board.  

But as to my position on this stock.  I was 100% up front.  I sold, everyone knew.  I bought a mountain home with the proceeds.  Everyone knows.  I got 35k shares.  Everyone knows.

I have been skeptical of everything during this and transparent.

 

sell those 35k and build me a poker room on the mountain home.

[IC FBGCav 5,664]

Just now, Getzlaf15 said:

sell those 35k and build me a poker room on the mountain home.

Looks like that's about all they will be worth.  Bring your own play chips. 

[IC FBGCav 5,664]

I don't know why chet is silent.  I texted him ty for getting me this mountain home and showed him the listing (and said he could slum it there for free anytime he wanted)and he texted back, ty.

I didn't talk to him a month before that or since then.  When I was all in on my daughter's analysis, I burned bridges.

Edited October 1, 2020 by IC FBGCav

[Chaz McNulty 838]

1 hour ago, Dwayne Hoover said:

With that many deaths, there is a chance for this to be significant.  Even if not quite significant enough to get EUA, it should hopefully broadcast to the critics that the drug does work.  Of course the data won't be released so we won't know until the trial is over.

Still don't think I want to be holding all my shares into this event but there is some reason to be slightly optimistic

If they are anywhere near significant, they will release the news and take a fine if needed.

[Chaz McNulty 838]

From Bruce Peterson.

https://twitter.com/brucep13/status/1311479186645757957

Been doing CCR5 Receptor Occupancy since 1999 for the likes of Pfizer and Schering Plough and soon 2 others. Just went through due diligence with MDBio! Our record stands!!! #incelldx

@brucep13

6:32 PM · Sep 30, 2020·Twitter for iPhone

[Dwayne Hoover 365]

28 minutes ago, Chaz McNulty said:

If they are anywhere near significant, they will release the news and take a fine if needed.

The fine is a penalty on their data and they wont know if significant or not.  You think they would do that?

Edited October 1, 2020 by Dwayne Hoover

[ConstruxBoy 1,136]

7 hours ago, IC FBGCav said:

Golf Guy  banned

I, for one, am shocked at that news. 

[Don Hutson 1,804]

7 hours ago, Chaz McNulty said:

From Bruce Peterson.

https://twitter.com/brucep13/status/1311479186645757957

Been doing CCR5 Receptor Occupancy since 1999 for the likes of Pfizer and Schering Plough and soon 2 others. Just went through due diligence with MDBio! Our record stands!!! #incelldx

@brucep13

6:32 PM · Sep 30, 2020·Twitter for iPhone

We are smack dab in the middle of a good old-fashioned cat fight

[Jayrok 3,658]

14 hours ago, Dwayne Hoover said:

What is the story here?  This has always been a red flag for me.  They were talking about that paper being published in late April.

This is from another board:

Quote

I heard Dr Bruce Patterson talk about why his paper was rejected.
There were no control patients.
So Dr Patterson connected with other doctors who had treated critically ill Covid-19 patients that could be classified as controls. Analyzing their tissues/blood samples was then done. Then the manuscript had to be rewritten and resubmitted.
This accounts for at least part of the delay in publication.

As a scientist, it is my experience that controls are always required for publication of scientific work.

Here is the original preprint:
https://www.medrxiv.org/content/10.1101/2020.05.02.20084673v1
There are no control patients.
A part of the Abstract is here:
"Here, in 10 terminally-ill, critical COVID-19 patients we report profound elevation of plasma IL-6 and CCL5 (RANTES), decreased CD8+ T cell levels, and SARS-CoV-2 plasma viremia. Following compassionate care treatment with the CCR5 blocking antibody leronlimab, we observed complete CCR5 receptor occupancy on macrophage and T cells, rapid reduction of plasma IL-6, restoration of the CD4/CD8 ratio, and a significant decrease in SARS-CoV-2 plasma viremia. Consistent with reduction of plasma IL-6, single-cell RNA-sequencing revealed declines in transcriptomic myeloid cell clusters expressing IL-6 and interferon-related genes. These results demonstrate a novel approach to resolving unchecked inflammation, restoring immunologic deficiencies, and reducing SARS-CoV-2 plasma viral load via disruption of the CCL5-CCR5 axis, and support randomized clinical trials to assess clinical efficacy of leronlimab-mediated inhibition of CCR5 for COVID-19."

FWIW

[Don Hutson 1,804]

Below is a link to Investors Hangout where someone made p value charts.  He seems more credible than the other people trying to do p values.  To get a p value less than .05, the LL arm would have 23 deaths and the placebo arm would have 22 deaths.  That would produce a p value of .03447.  However, some people on the boards are saying that a p value of .05 will not be good enough to have the trial stopped for efficacy.  They are saying a p value lower than .005 will be necessary.  To achieve a p value lower than .005, the LL arm would have 20 deaths and the placebo arm would have 25 deaths.  This would result in a p value of 0.00349.  Obviously, we are in unique times and no excellent treatment exists so what p value will be necessary is anyone's guess.

https://investorshangout.com/post/view?id=5914267

[Charlie Harper 1,148]

The powers that be have to know the p-value by now. So what do we think the silence so far means?

[Don Hutson 1,804]

41 minutes ago, Don Hutson said:

They are saying a p value lower than .005 will be necessary.  To achieve a p value lower than .005, the LL arm would have 20 deaths and the placebo arm would have 25 deaths.  This would result in a p value of 0.00349. 

A p value below .005 is going to be very difficult to achieve if the above numbers are true:

Treatment arm

110 alive    20 dead

Placebo arm

40 alive      25 dead

 

[Chaz McNulty 838]

1 hour ago, Don Hutson said:

We are smack dab in the middle of a good old-fashioned cat fight

This came from the CDC, not CYDY (CYDY reported it as the reason they were being delayed).  The cat fight is between BP and the CDC.  Weird, because he seems like he's one of the experts on Rantes and CCR5.

[Chaz McNulty 838]

8 hours ago, Dwayne Hoover said:

The fine is a penalty on their data and they wont know if significant or not.  You think they would do that?

Definitely.  I'm beginning to think the bar is so high for this company that FDA approval will not come.  They are more likely to get approval offshore.  If there p-value is below .05, they should be shouting that out to the world.

[Don Hutson 1,804]

1 minute ago, Chaz McNulty said:

This came from the CDC, not CYDY (CYDY reported it as the reason they were being delayed).  The cat fight is between BP and the CDC.  Weird, because he seems like he's one of the experts on Rantes and CCR5.

That is assuming what Nader said is accurate when he threw Bruce under the bus.  Bruce didn't specify the target of his tweet.

[Harris 613]

I've just sold everything. I didn't end up making a ton of money on this and it was just a stressful rollercoaster in the end. I should have sold much, much higher when it was around $5-6. It was really hard to sell at $2.80 here as I wanted to believe in this stock but everything lately tells me there's nothing good on the horizon. 

It's really a shame because I got into this for HIV and breast cancer treatments in January. I wish they never got into the whole COVID thing because it's become their downfall in a way.

[Chaz McNulty 838]

1 minute ago, Don Hutson said:

That is assuming what Nader said is accurate when he threw Bruce under the bus.  Bruce didn't specify the target of his tweet.

I don't think he would outright lie when the information is out there.  I am suspect that they will ever be granted approval for anything.  whether it's written instructions on needle packaging, we want to see safety in 700mg's not 350mg's, or BP (one of the scientific leaders in Rantes) has screwed up the CCR5 receprot occupancy test, despite doing it properly for several other big pharma companies in the past.  

The drug has proven safe and shown efficacy in the HIV population for years.  This does not seem to matter.

[Chaz McNulty 838]

I have been in this long, so I will hold until I see the CD12 results.  There is no way they would try and hold them to a p-value of .005.  I think that's nonsense.

[Sputnikv8 491]

Last person remember to shut off the lights on their way out.  

[Don Hutson 1,804]

1 minute ago, Chaz McNulty said:

I have been in this long, so I will hold until I see the CD12 results.  There is no way they would try and hold them to a p-value of .005.  I think that's nonsense.

It might be how they normally do things.  They don't usually want to stop a trial before it is completed.  So it makes sense that the p value would have to be much better than .05 to end a trial with the interim analysis.  But we are in desperate times so I don't think anyone knows.

[Chaz McNulty 838]

1 hour ago, Don Hutson said:

Below is a link to Investors Hangout where someone made p value charts.  He seems more credible than the other people trying to do p values.  To get a p value less than .05, the LL arm would have 23 deaths and the placebo arm would have 22 deaths.  That would produce a p value of .03447.  However, some people on the boards are saying that a p value of .05 will not be good enough to have the trial stopped for efficacy.  They are saying a p value lower than .005 will be necessary.  To achieve a p value lower than .005, the LL arm would have 20 deaths and the placebo arm would have 25 deaths.  This would result in a p value of 0.00349.  Obviously, we are in unique times and no excellent treatment exists so what p value will be necessary is anyone's guess.

https://investorshangout.com/post/view?id=5914267

Do you really believe that Don?

[Don Hutson 1,804]

1 minute ago, Chaz McNulty said:

Do you really believe that Don?

I'm just the messenger.  I have no idea.

[Chaz McNulty 838]

1 minute ago, Don Hutson said:

It might be how they normally do things.  They don't usually want to stop a trial before it is completed.  So it makes sense that the p value would have to be much better than .05 to end a trial with the interim analysis.  But we are in desperate times so I don't think anyone knows.

We are talking about a primary endpoint of death.  It's nonsense to think you would need to hit anything close to .005.  That's just doomsayers talking.

[Chaz McNulty 838]

Just now, Don Hutson said:

I'm just the messenger.  I have no idea.

You are, but you get to decide which messages you bring to the board.  I like that you argue from the other side, but I think a p-value of .005 is a load.  I would have left that one on the other boards.

[Don Hutson 1,804]

1 minute ago, Chaz McNulty said:

You are, but you get to decide which messages you bring to the board.  I like that you argue from the other side, but I think a p-value of .005 is a load.  I would have left that one on the other boards.

Multiple people have said it.  It didn't come from Shorts.  It came from Longs who know far more on the subject than you or I.  You have absolutely zero idea of what p value is necessary.

[artemus 2]

Here's a link to yesterday's call: https://edge.media-server.com/mmc/p/oofoxd3c

Edited October 1, 2020 by artemus

[Chaz McNulty 838]

1 minute ago, Don Hutson said:

Multiple people have said it.  It didn't come from Shorts.  It came from Longs who know far more on the subject than you or I.  You have absolutely zero idea of what p value is necessary.

I heard from Joe at the market that they need a p-value of .00003.

[Caesar 1,157]

7 minutes ago, Don Hutson said:

Multiple people have said it.  It didn't come from Shorts.  It came from Longs who know far more on the subject than you or I.  You have absolutely zero idea of what p value is necessary.

I have to agree with Don on this one as far as the source.  Way better information there than YMB or IHUB.  

While I think .005 is a load as well, I think the point they are trying to make is that best case would be .05 and worst case would be .005.  They then gave the required numbers to reach both, and if it falls somewhere in the middle, then we have a pretty good idea where it needs to be.

Again, with the FDA, who the hell knows what they will require?  If they show a 20-30% reduction in deaths, it seems like a no-brainer to save 20000+ people, give or take.  But again, with the FDA, wtf knows?

[artemus 2]

6 minutes ago, Caesar said:

I have to agree with Don on this one as far as the source.  Way better information there than YMB or IHUB.  

While I think .005 is a load as well, I think the point they are trying to make is that best case would be .05 and worst case would be .005.  They then gave the required numbers to reach both, and if it falls somewhere in the middle, then we have a pretty good idea where it needs to be.

Again, with the FDA, who the hell knows what they will require?  If they show a 20-30% reduction in deaths, it seems like a no-brainer to save 20000+ people, give or take.  But again, with the FDA, wtf knows?

The only time .005 was mentioned was that it was the penalty that comes if you unblind early.  For statistical significance, which still remains the goal for the CD12 study, it's still 0.05.

[Don Hutson 1,804]

9 minutes ago, artemus said:

The only time .005 was mentioned was that it was the penalty that comes if you unblind early.  For statistical significance, which still remains the goal for the CD12 study, it's still 0.05.

The .005 we are talking about came from the message boards, not from CytoDyn.  Under normal circumstances, a p value of .005 might be what is needed to end a trial early in the interim analysis.  But we aren't in normal circumstances so nobody knows.  I think Caesar summarized it well with:

15 minutes ago, Caesar said:

I think the point they are trying to make is that best case would be .05 and worst case would be .005. 

 

Edited October 1, 2020 by Don Hutson

[Don Hutson 1,804]

I'm back in.  I bought at $2.77.

Edited October 1, 2020 by Don Hutson

[FreeBaGeL 8,820]

39 minutes ago, artemus said:

The only time .005 was mentioned was that it was the penalty that comes if you unblind early.  For statistical significance, which still remains the goal for the CD12 study, it's still 0.05.

He was talking about the number to end the trial early, not the number required for statistical significance at the end.

For ending the trial early it's all purely 100% guesswork.  It could be .05 (unlikely) or .005 or anything in between.  I think the basic point is that to end a trial early the results at the half way mark have to be really over the moon good, not just statistically significant.

[Caesar 1,157]

24 minutes ago, Don Hutson said:

I'm back in.  I bought at $2.77.

  you got my shares.  

I reduced.  I'm willing to take a hit right now because if they get approval, the PPS will become somewhat irrelevant long term.  I'm now down to a comfortable position I can afford to just wait it out. 

I'm not looking to buy back in unless it trickles down under 2 while we wait.  Even then, I am not sure I will make the move. 

[Dwayne Hoover 365]

2 hours ago, Jayrok said:

This is from another board:

FWIW

I understood this part but I thought that once he added the control group that the paper would be accepted.

If I understand correctly, the paper has now been rejected for a different reason?  Im confused though because there has been talk about HIV things that I thought were unrelated. 

Am I the only one having a problem following this?

[Chaz McNulty 838]

1 minute ago, Dwayne Hoover said:

I understood this part but I thought that once he added the control group that the paper would be accepted.

If I understand correctly, the paper has now been rejected for a different reason?  Im confused though because there has been talk about HIV things that I thought were unrelated. 

Am I the only one having a problem following this?

I think the HIV thing is to do with LL as a monotherapy and approval getting pushed back.  This seems to be the reason.

[Dwayne Hoover 365]

1 hour ago, Chaz McNulty said:

If there p-value is below .05, they should be shouting that out to the world.

How will they know this?  My understanding is they aren't going to see any of the data (unless the trial is halted).  Am I wrong?

Edited October 1, 2020 by Dwayne Hoover

[Chaz McNulty 838]

33 minutes ago, Don Hutson said:

I'm back in.  I bought at $2.77.

It usually goes up on Friday's, so you can probably make a quick buck too.  

[Chaz McNulty 838]

Just now, Dwayne Hoover said:

How will they know this?  My understanding is they aren't going to see any of the data.  Am I wrong?

No idea.  Aren't they the ones that have to go through the data and present it to the CDC?

[Dwayne Hoover 365]

7 minutes ago, Chaz McNulty said:

No idea.  Aren't they the ones that have to go through the data and present it to the CDC? 

My understanding is that they don't see any data unless trial is halted.

Other than that, they have to make the decision to unblind it, which they will be penalized for in the p value.  

If that is the case, it would be extremely risky to unblind

 

Edited October 1, 2020 by Dwayne Hoover

[artemus 2]

5 minutes ago, Dwayne Hoover said:

My understanding is that they don't see any data unless trial is halted.

Other than that, they have to make the decision to unblind it, which they will be penalized for in the p value.  

If that is the case, it would be extremely risky to unblind

That's what I understand as well.  Only 1 person on the review board sees the results.

[Chaz McNulty 838]

44 minutes ago, Dwayne Hoover said:

My understanding is that they don't see any data unless trial is halted.

Other than that, they have to make the decision to unblind it, which they will be penalized for in the p value.  

If that is the case, it would be extremely risky to unblind

 

They must know what the penalty is beforehand.  I have heard that they need .045 to reach statistical significance.  Maybe that accounts for a .005 penalty?  If this is the case, then they should definitely unblind.  With 45 deaths, I don't think there is any combination of deaths between placebo and LL that put them around .045.

They really need to get information out to other countries.

[Dwayne Hoover 365]

Just now, Chaz McNulty said:

They must know what the penalty is beforehand.  I have heard that they need .045 to reach statistical significance.  Maybe that accounts for a .005 penalty?  If this is the case, then they should definitely unblind.  With 45 deaths, I don't think there is any combination of deaths between placebo and LL that put them around .045.

They really need to get information out to other countries.

What if the unblinding isn't helpful data?

[Chaz McNulty 838]

12 minutes ago, Dwayne Hoover said:

What if the unblinding isn't helpful data?

Then we know 3 months sooner that this was a dog.