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***OFFICIAL CYDY/Leronlimab Thread*** (3 Viewers)

ETA. the more I think about it, why on gods earth would they not take DSMC suggestion of adding the 42 day endpoint?  
My take on this is that since they filled the trial, they were thinking they would achieve statistical significance at 28 days and it would be irrelevant.  This would have let them unblind earlier as well.

Perhaps there was a change of heart at the last minute

 
CD12 is an adaptive design trial so there is a good chance they can include the 42 day stats if they can be calculated.

 
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My take on this is that since they filled the trial, they were thinking they would achieve statistical significance at 28 days and it would be irrelevant.  This would have let them unblind earlier as well.

Perhaps there was a change of heart at the last minute
Correct. That was NP's rationale to skip the interim analysis at 75%. 

NP was the one that said data would be unblinded last week.  

He's the guy with the insider knowledge trying to keep the stock price afloat. 

I think he's learned enough to watch what he says. So I'm certain they have the unblinded data now (RLFTF enrolled 5 days later and already has data). 

Best case scenario: Statistically insignificant, but trending towards. So right now they're working behind the scenes to setup new trial parameters to dangle to stock holders. 

Worst case: Not even close. Drugs is a bust.

The one thing for sure is that home run statistically significant result is definitely out the window. 

 
Correct. That was NP's rationale to skip the interim analysis at 75%. 

NP was the one that said data would be unblinded last week.  

He's the guy with the insider knowledge trying to keep the stock price afloat. 

I think he's learned enough to watch what he says. So I'm certain they have the unblinded data now (RLFTF enrolled 5 days later and already has data). 

Best case scenario: Statistically insignificant, but trending towards. So right now they're working behind the scenes to setup new trial parameters to dangle to stock holders. 

Worst case: Not even close. Drugs is a bust.

The one thing for sure is that home run statistically significant result is definitely out the window. 
Best case is 42 day was added and it’s statistically significant.  This would explain the timing and the thinking that he didn’t take that recommendation was really just assumptions by everyone here-deserved by the way.

 
Best case is 42 day was added and it’s statistically significant.  This would explain the timing and the thinking that he didn’t take that recommendation was really just assumptions by everyone here-deserved by the way.
???

IIRC NP said it himself that they didn't take the interim analysis and 42 day mortality that comes with it. 

 
???

IIRC NP said it himself that they didn't take the interim analysis and 42 day mortality that comes with it. 
As was mentioned earlier, its an adaptive trial, so its possible that the 42 day endpoint may be added.  The mortality rate from 28 to 42 days skyrockets and it is possible that this is where LL reaches statistical significance.  

 
Eli Lilly (LLY) – The drugmaker received emergency use authorization from the Food and Drug Administration for its combination antibody therapy used to treat Covid-19 patients. Data from a late-stage trial showed that the treatment cut the risk of hospitalization and death by 70%.

 
As was mentioned earlier, its an adaptive trial, so its possible that the 42 day endpoint may be added.  The mortality rate from 28 to 42 days skyrockets and it is possible that this is where LL reaches statistical significance.  
We'll see. I just find it hard to believe that NP wouldn't dangle this carrot if that were the case. 

 
I believe these two drugs were the ones who's medical codes were added to the system in December along with Leronlimab 

 
It's not for treatment of those hospitalized with covid. So Lilly drug isn't a direct competitor to CYDY.

The study was done in nursing homes AFTER covid was detected in a resident. Then it went on to see if staff or other residents contracted COVID. 

 
It's not for treatment of those hospitalized with covid. So Lilly drug isn't a direct competitor to CYDY.

The study was done in nursing homes AFTER covid was detected in a resident. Then it went on to see if staff or other residents contracted COVID. 
Pretty pertinent info here.

 
Today looks like it was a good day trading day.  Missed the opportunity when it was lower.  Thought about it but didn't want to put anymore money towards it.

Current level of frustration with NP is starting to build again but you should never take your eyes off chances to make some bucks

 
It's not for treatment of those hospitalized with covid. So Lilly drug isn't a direct competitor to CYDY.

The study was done in nursing homes AFTER covid was detected in a resident. Then it went on to see if staff or other residents contracted COVID. 
It’s a direct competitor the way vaccines are a competitor. I hate to turn it into a pure investment discussion but you can think of it as this, like vaccines, should decrease the total addressable market of CYDY. That’s the easiest way to think about the stock impact. It’s still needed but it cuts down the potential. 

 
It’s a direct competitor the way vaccines are a competitor. I hate to turn it into a pure investment discussion but you can think of it as this, like vaccines, should decrease the total addressable market of CYDY. That’s the easiest way to think about the stock impact. It’s still needed but it cuts down the potential. 
CYDY's biggest hurdle right now is just being legitimized.  If they are slotted as a later stage Covid drug, that's more than good enough at this stage.

There will be more things to work on down the line but they need revenue.

Once legitimized in the USA, other countries will certainly open up for them too.

I believe it's a $20 stock if they just get EUA for COVID at all.  Not really worried that it can't be used for mild to moderate at this point.   

 
CYDY's biggest hurdle right now is just being legitimized.  If they are slotted as a later stage Covid drug, that's more than good enough at this stage.

There will be more things to work on down the line but they need revenue.

Once legitimized in the USA, other countries will certainly open up for them too.

I believe it's a $20 stock if they just get EUA for COVID at all.  Not really worried that it can't be used for mild to moderate at this point.   
I agree.  Everything comes down to this.  If they cannot get some sort of EUA, then all is lost.  We have already seen the incompetence in getting anything else moved forward.  LL may be a great HIV, NASH, Cancer drug, but this company is not capable of bringing anything to market.  That's why they need Covid to legitimize themselves.  If approved, the rest will come a lot easier.

 
I agree.  Everything comes down to this.  If they cannot get some sort of EUA, then all is lost.  We have already seen the incompetence in getting anything else moved forward.  LL may be a great HIV, NASH, Cancer drug, but this company is not capable of bringing anything to market.  That's why they need Covid to legitimize themselves.  If approved, the rest will come a lot easier.
They also will certainly be a good candidate for a buyout if any kind of approval comes from Covid.

 
Losing your nerve with this?
Not really.  IMO the two most likely (and third isn't close) CD12 outcomes are statistical sig and a narrow miss. I just don't see something like RLTLF'S outcome where the drug arm had a higher mortality rate than placebo.  The question is what happens if there's a narrow miss--think p-value 0.06 or 0.07.  I know the shorts will pound the table that it failed etc but if that happens, it's because of bad trial design IMO.  End point should be 42 days and they should only treat patients with elevated rantes.  Sure, that's most severe/critical patients but not all.  

 
Not really.  IMO the two most likely (and third isn't close) CD12 outcomes are statistical sig and a narrow miss. I just don't see something like RLTLF'S outcome where the drug arm had a higher mortality rate than placebo.  The question is what happens if there's a narrow miss--think p-value 0.06 or 0.07.  I know the shorts will pound the table that it failed etc but if that happens, it's because of bad trial design IMO.  End point should be 42 days and they should only treat patients with elevated rantes.  Sure, that's most severe/critical patients but not all.  
Problem is if they miss and have to start again, that means no compassionate use and probably will take 2 years to fill a new trial with all the other treatment options available and the vaccine starting to make an impact.  Given the committed purchase orders, I suspect they will go under.

 
Not really.  IMO the two most likely (and third isn't close) CD12 outcomes are statistical sig and a narrow miss. I just don't see something like RLTLF'S outcome where the drug arm had a higher mortality rate than placebo.  The question is what happens if there's a narrow miss--think p-value 0.06 or 0.07.  I know the shorts will pound the table that it failed etc but if that happens, it's because of bad trial design IMO.  End point should be 42 days and they should only treat patients with elevated rantes.  Sure, that's most severe/critical patients but not all.  
Sure but a bad trial design means another trial? With the vaccines pouring out now (and thank god for that) a miss with cd12, even a close one, would seem to shut the door on any positive covid outcome for Cydy. 

 
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Sure but a bad trial design means another trial? With the vaccines pouring out now (and thank god for that) a miss with cd12, even a close one would seem to shut the door on any positive covid outcome for Cydy. 
It would likely shut the doors on the company.  NP went all in with Covid.

 

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