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

chet said:
Assuming your calc is correct (i used the Wolfram calc to get a p-value of .0236 for similar numbers), this is what BP would use as a marketing opportunity. CD12 results in a significant reduction in mortality but the result is not quite statistically significant.  There's nothing competing in this slot and the world would benefit from leronlimab being approved.  

Personally, I see two outcomes as being overwhelmingly more likely than others:  

1) CD12 shows leronlimab sig reduces mortality in a statistically sig way; and 

2) CD12 show leronlimab sig reduces mortality but p-value is above .05.  

I know the drug works but is NP capable of designing a trial to showcase the drug's capability.
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They usually use the language 'trending towards statistical significance'.  It just means that if the study had more people it would have eventually reached a p-value of less than .05.

 
BassNBrew said:
Can you please elaborate on why you know the drug works?
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Most of the anectodal evidence supports the fact that it's working.  A big clue would be the mid-term peak when they recommended continuance of the trial without adjusting the primary endpoint.  The trial gets shut down if there is zero or low efficacy.

 
Chaz McNulty said:
They usually use the language 'trending towards statistical significance'.  It just means that if the study had more people it would have eventually reached a p-value of less than .05.
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Does NP have enough clout with the FDA to get them to say that it's trending?  

 
chet said:
Does NP have enough clout with the FDA to get them to say that it's trending?  
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I am hoping it doesn't come to this.  I am really hoping at this point that every decision is science based and NP is not involved.  It's obvious that everyone in BP roots against NP.  The guy bumbles all over the place, but might have won the lottery by unknowingly purchasing a drug with multiple indications.

 
Chaz McNulty said:
I am hoping it doesn't come to this.  I am really hoping at this point that every decision is science based and NP is not involved.  It's obvious that everyone in BP roots against NP.  The guy bumbles all over the place, but might have won the lottery by unknowingly purchasing a drug with multiple indications.
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With the standard of care improving and the willingness of some doctors to keep terminal patients on life support, it could be close.  The latter being the reason the DSMC asked to look at 42-day data as well.

 
Charlie Harper said:
I went back and using the 18% mortality rate from this tweet we get 23 control deaths and 64 LL deaths and we get a p-value of 0.156. So obviously the shorts picked studies that wouldn't meet statistical significance.

I get just barely over at p value of 0.053.

I used THIS calculator for both values. So if 87 is the final death number we have to hope the control group mortality is at 30% vs 18%. Also any extra deaths likely decreases the chances of LL having statistical significance. 

Definitely looks like a slim window.
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I think I found out the reason for the difference in p-values.  Your calculator uses CHI square and the Wolfram calc likely uses z-test.  Anyone know which one's appropriate here?

 
chet said:
I think I found out the reason for the difference in p-values.  Your calculator uses CHI square and the Wolfram calc likely uses z-test.  Anyone know which one's appropriate here?
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I believe chi square is a two tailed test which would make the Wolfram calculator more appropriate.

 
Using the Wolfram calc, and assuming 87 total deaths, the maximum number of deaths the drug arm could handle while achieving statistical significance is 51.  That outcome return a p-value of 0.0407.  The control arm mortality rate in that case would be 27.7% which seems very possible in the severe/critical cohort.

Here's a link.

 
I'm tempted to buy right now but I keep coming back to Michael "NasdaqSoonCome" Mulholland's stock sell.  He liquidated everything right before trial results.  Mulholland would not have sold that amount of stock if he believed trial results were going to be good.

CytoDyn chose the members of the DSMB.  That must mean that Nader was given the results of the interim analysis, is that correct?

 
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Don Hutson said:
I'm tempted to buy right now but I keep coming back to Michael "NasdaqSoonCome" Mulholland's stock sell.  He liquidated everything right before trial results.  Mulholland would not have sold that amount of stock if he believed trial results were going to be good.

CytoDyn choose the members of the DSMB.  That must mean that Nader was given the results of the interim analysis, is that correct?
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They chose the members of the DMSB?  Where’d you hear that?

 
Don Hutson said:
I'm tempted to buy right now but I keep coming back to Michael "NasdaqSoonCome" Mulholland's stock sell.  He liquidated everything right before trial results.  Mulholland would not have sold that amount of stock if he believed trial results were going to be good.

CytoDyn choose the members of the DSMB.  That must mean that Nader was given the results of the interim analysis, is that correct?
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Didn’t he have to initiate that sell back in November or something?

 
chet said:
They chose the members of the DMSB?  Where’d you hear that?
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It's been talked about a lot here and on the CYDY message boards.  I thought it sounded strange, too.  I would have thought that the FDA appointed people.

 
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Don Hutson said:
It's been talked about a lot here and on the CYDY message boards.  I thought it sounded strange, too.  I would have thought that the FDA appointed people.
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I don't think they chose the committee.  Not sure but that would be very strange.  It's more like a lie the shorts would say to diminish the importance of the message from the DMSB.

 
chet said:
I don't think they chose the committee.  Not sure but that would be very strange.  It's more like a lie the shorts would say to diminish the importance of the message from the DMSB.
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This quote comes from the first google search result:  "In general, the DSMB voting members are appointed by the clinical trial sponsor or by the Principal Investigator."

 
Dave RL said:
I believe that is true. There are requirements for them not to be associated with the sponsor I believe.
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A DSMC member can't be financially associated with the sponsor like being a stockholder.  Andy Harris is on the DSMC of RLF-100's trial and he and Dr Javitt worked together at Johns Hopkins and are close friends.  But Harris doesn't own any RLFTF stock, so he is allowed to be on the DSMC.

 
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Don Hutson said:
A DSMC member can't be financially associated with the sponsor like being a stockholder.  Andy Harris is on the DSMC of RLF-100's trial and he and Dr Javitt worked together at Johns Hopkins and are close friends.  But Harris doesn't own any RLFTF stock, so he is allowed to be on the DSMC.
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Would they have the results from the DSMC once the trial ends?  Or do they have to wait for all the results at the same time?

 
Chaz McNulty said:
Would they have the results from the DSMC once the trial ends?  Or do they have to wait for all the results at the same time?
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Hospitals send results to Amarex.  Amarex sends results to CytoDyn.  CytoDyn hired Amarex to process the trial.

 
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A couple of weeks ago, a few weeks and 31 patients were added to RLFTF's trial.  Investors didn't like it but going from 165 patients to 196 patients was good.  Their trial is now supposed to conclude on Jan 21st.  I wonder if the FDA added a few weeks to the trial so that it would finish at about the same time as leronlimab and lenzilumab?  Maybe the FDA wanted to look at the data from all of the severe/critical trials at the same time?  Putting in equal investments into HGEN, RLFTF, and CYDY would have a lower risk than investing in just one.

 
Don Hutson said:
Mulholland submitted the planned stock sell on November 12.  CytoDyn released the pr on the DSMC's interim analysis recommendation on October 20th.
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It seems like we all agree this is going to be close.

Could be as simple that Mulholland just wanted to lock in this money rather than chance it.  Even if he thought they had a slight edge, he may elect to sure up the money now.  Doesn't seem that far fetched, its not like all the insiders bailed.  

 
Mulholland also still stands to make a great deal of money if this thing takes off too.  It's not like he is totally out.

I don't like what he did but I'm not convinced it means anything entirely negative either.

I didn't think Cytodyn had that much insight into where exactly they stood in the review anyway.  Am I wrong about that?  All the data is still blinded at that point.  

 
Don Hutson said:
A couple of weeks ago, a few weeks and 31 patients were added to RLFTF's trial.  Investors didn't like it but going from 165 patients to 196 patients was good.  Their trial is now supposed to conclude on Jan 21st.  I wonder if the FDA added a few weeks to the trial so that it would finish at about the same time as leronlimab and lenzilumab?  Maybe the FDA wanted to look at the data from all of the severe/critical trials at the same time?  Putting in equal investments into HGEN, RLFTF, and CYDY would have a lower risk than investing in just one.
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No idea on this but don't forget that CYDY bypassed the 75% review. I know in HGEN's case this was the point where they added more patients.   Seems like a slightly risky move by Cytodyn there but they must be fairly confident 

 
Don Hutson said:
The data of the first 195 patients was unblinded to the DSMC during the interim analysis.
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But not to CYDY.  They would have had to take a penalty to see the data and they chose not too.  I'm just wondering if that data is immediately handed over as soon as the last trial patient reaches the 28 day mark.  That would conclude the trial.

I don't think they would get it before the conclusion of the trial without taking a penalty.

 
Chaz McNulty said:
But not to CYDY.  They would have had to take a penalty to see the data and they chose not too.  I'm just wondering if that data is immediately handed over as soon as the last trial patient reaches the 28 day mark.  That would conclude the trial.

I don't think they would get it before the conclusion of the trial without taking a penalty.
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Officially, you are probably right.  Unofficially, the chances are good that the DSMC gave Nader results.  Nader got to appoint the members of the DSMC.  Nader likely appointed at least one person who was going to tell him results.

 
Don Hutson said:
Officially, you are probably right.  Unofficially, the chances are good that the DSMC gave Nader results.  Nader got to appoint the members of the DSMC.  Nader likely appointed at least one person who was going to tell him results.
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This system is set up to be completely corrupt.

 
Dwayne Hoover said:
Mulholland also still stands to make a great deal of money if this thing takes off too.  It's not like he is totally out.

I don't like what he did but I'm not convinced it means anything entirely negative either.

I didn't think Cytodyn had that much insight into where exactly they stood in the review anyway.  Am I wrong about that?  All the data is still blinded at that point.  
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I'm sure they can all award themselves plenty of additional shares.  It makes sense for them to sell early.  If this trail fails they got rich, if it's a success and the stock goes to $20 everyone is fine with mgmt lining their pockets with more shares.

 
Dwayne Hoover said:
Mulholland also still stands to make a great deal of money if this thing takes off too.  It's not like he is totally out.

I don't like what he did but I'm not convinced it means anything entirely negative either.

I didn't think Cytodyn had that much insight into where exactly they stood in the review anyway.  Am I wrong about that?  All the data is still blinded at that point.  
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Could you imagine working for a maniac like NP?  He fires people like he's ordering dinner.  It's not out of the realm of possibility that MM's wife forced him to take some money off of the table because of the volatility of NP and the SP.

And I highly doubt MM has any insight into the CD12 trial.  He's the hired help with no expertise in science.

 
The share price doesn't suggest a lot of confidence right now but perhaps this is the darkness before the dawn.

In my handicapping, I had the share price moving upward as we got close to approval.   Thought there would be a lot of short covering as well as general retail buying.  Maybe that still happens but today was a downer for sure.

 
I have buy order in at 4.70

It won't get me back to where I was, but it will get me back in a little bit.  Let's see if it falls that far today.

 
If it's close and perhaps Cytodyn doesn't quite get there with the p value they need, is anyone confident that the FDA would still give EUA?

I feel like a BP would get the benefit of the doubt but not sure they would trust Cytodyn enough to deliver here. Feels to me like Cytodyn will have to overwhelmingly prove benefit to get any approval.

 
Dwayne Hoover said:
If it's close and perhaps Cytodyn doesn't quite get there with the p value they need, is anyone confident that the FDA would still give EUA?

I feel like a BP would get the benefit of the doubt but not sure they would trust Cytodyn enough to deliver here. Feels to me like Cytodyn will have to overwhelmingly prove benefit to get any approval.
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Really depends on Biden appointments.

 
Dwayne Hoover said:
If it's close and perhaps Cytodyn doesn't quite get there with the p value they need, is anyone confident that the FDA would still give EUA?

I feel like a BP would get the benefit of the doubt but not sure they would trust Cytodyn enough to deliver here. Feels to me like Cytodyn will have to overwhelmingly prove benefit to get any approval.
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I don't believe they get the benefit of the doubt.  I really think we are looking at a 50/50 prospect right now. 

 
Caesar said:
I don't believe they get the benefit of the doubt.  I really think we are looking at a 50/50 prospect right now. 
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I'm good with 50/50.  Great pot odds.  If you bought in for 5K at $3.00 share price, you are risking 5K to make around 35K  (with stock price of $21) on a coin flip.

 
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