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***OFFICIAL CYDY/Leronlimab Thread*** (1 Viewer)

Good post from yahoo:

“Just so everyone understands, this was a planned safety check. Many here were under the impression that this could lead to the DSMC halting the trial for overwhelmingly clear benefit. That’s an effectiveness review, not a safety review. 

Although the DSMC also looked at efficacy as part of its safety review, halting for benefit is extremely rare, even when a product is working. The threshold for halting the trial for efficacy is extremely high. There has to be no question of statistical benefit. Unfortunately, when you have a 2:1 placebo controlled trial, getting to clear statistical significance is tough on an early DSMC peak. The numbers just aren’t quite high enough. If you halt the trial, and the FDA determines you needed bigger numbers, there is no going back — the trial is done and you’d have to start over from scratch. Therefore, sticking with the FDA approved protocol, which gives us an interim analysis on the very near future, was the correct approach for the DMC to take.  

I’ve been saying for a while that the mild-to-moderate results are our big play. If we get that indication, we get to offer the world the means to prevent the disease from ever reaching the severe or critical stage. I’m looking forward to the rest of the results for that trial, which look amazing.  

Here is information regarding the role of the DSMC, for anyone who is interested. 

https://www.fda.gov/media/75398/download”

 
Capella said:
Good post from yahoo:

“Just so everyone understands, this was a planned safety check. Many here were under the impression that this could lead to the DSMC halting the trial for overwhelmingly clear benefit. That’s an effectiveness review, not a safety review. 

Although the DSMC also looked at efficacy as part of its safety review, halting for benefit is extremely rare, even when a product is working. The threshold for halting the trial for efficacy is extremely high. There has to be no question of statistical benefit. Unfortunately, when you have a 2:1 placebo controlled trial, getting to clear statistical significance is tough on an early DSMC peak. The numbers just aren’t quite high enough. If you halt the trial, and the FDA determines you needed bigger numbers, there is no going back — the trial is done and you’d have to start over from scratch. Therefore, sticking with the FDA approved protocol, which gives us an interim analysis on the very near future, was the correct approach for the DMC to take.  

I’ve been saying for a while that the mild-to-moderate results are our big play. If we get that indication, we get to offer the world the means to prevent the disease from ever reaching the severe or critical stage. I’m looking forward to the rest of the results for that trial, which look amazing.  

Here is information regarding the role of the DSMC, for anyone who is interested. 

https://www.fda.gov/media/75398/download”
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Thanks, good perspective.  I'm not sure why continuing the trial and also saying holy #### I think we have something here lets start getting it out would also not be an option.  If this person is banking on M-M...eek not going to be easy

 
djmich said:
Thanks, good perspective.  I'm not sure why continuing the trial and also saying holy #### I think we have something here lets start getting it out would also not be an option.  If this person is banking on M-M...eek not going to be easy
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I think the M-M will at least open the door to covid treatment for them, however nothing seems to be easy for these guys. 

 
There is one thing that could still happen which is a minor catalyst and could stop the bleeding at the very least..

Patterson could finally be peer reviewed and published.  

Overdue right?  Assuming Patterson is onto this.

 
At this point, Im thinking its gonna be a phase 3 for mild to moderate, hope Im wrong.  The trial was underpowered and I don't think the efficacy is a given at this point.

 
Dwayne Hoover said:
At this point, Im thinking its gonna be a phase 3 for mild to moderate, hope Im wrong.  The trial was underpowered and I don't think the efficacy is a given at this point.
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So how does this work? Cydy gets the results for m/m, submits them to fda for emergency use and it’s up to the fda to grant it or suggest a phase 3?

 
an independent Data Safety Monitoring Committee (“DSMC”) completed its first safety review of the ongoing Phase 3 clinical trial (CD12) in patients with severe and critical COVID-19 and reported it saw no cause to modify the study. The DSMC reviewed compiled safety data from 149 subjects enrolled in the CD12 trial. The DSMC did not raise any concerns regarding safety and recommended that the trial continue.

The Phase 3 study currently has 169 enrolled patients and the Company will conduct a full interim analysis once 195 patients are enrolled, as provided in the trial’s protocol.
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DSMC saw no cause to modify the study.  This is good news.  I've read they have recommended changing endpoints in some previous trials.  Gild changed an endpoint for Remdesivir.

It seems for this trial, things are on track.  They recommended the trial to continue.  Also good news.  We wanted them to stop it because it's a grand slam, but they could have also stopped it if the drug arm wasn't beating the placebo or SOC.  

Maybe they can only stop the trial at the actual agreed upon interim analysis checkpoint "as provided in the trial's protocol."  We've got 169 but need 195 patients to meet that protocol.  

(a) They didn't stop the trial because the drug isn't working, (b) they saw no reason to modify the study, which suggests that things are on track. No changes to endpoints. (c) Maybe they didn't stop the trial because they couldn't until 195 patients are enrolled and an interim analysis is conducted.  

To me the biggest news may be the DSMC didn't modify the endpoint.  

 
Moonlight said:
NIH monies being used to study effectiveness of LL in prevention of HIV transmission in non-human primates.

This study was briefly mentioned before. This article provides more detail. Interesting to note that it looks at the use of a one-time shot of concentrated LL as the method.

 LL is gaining traction.

https://news.ohsu.edu/2020/08/04/new-injection-could-prevent-hiv-in-nonhuman-primates
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So our gov't is funding a study to see if monkey's can get sexy and not transmit HIV by injecting LL yet a 1000 people a day are biting the dust and you're not allowed to take LL.  

 
Can't wait for the proactive investor video calling the Wall Street Journal evil liars.

So frustrating.  All that being said, there is nothing in that article that we didn't already know, but WSJ > Night King on the credibility metric

 
Last edited by a moderator:
BIG DAY TODAY BOYS!  Gonna be a big call with critical data--or not--but either way, we can be certain to either make (or lose) around 7%.  Let's go!

 
djmich said:
Can't wait for the proactive investor video calling the Wall Street Journal evil liars.

So frustrating.  All that being said, there is nothing in that article that we didn't already know, but WSJ > Night King on the credibility metric
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Tbh I’m kinda happy that their name is in a paper that big. Odds are about the same that people will research them and like what they see with the drug against people selling off based on stuff they already knew. 

 
Capella said:
Tbh I’m kinda happy that their name is in a paper that big. Odds are about the same that people will research them and like what they see with the drug against people selling off based on stuff they already knew. 
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Yah, I thought about that too.  If we were listed on NAS the Robin Hood crowd would see that first graph and salivate.

Either way, I'm resigned to exiting at least half of my position today unless we tank.  Gonna bank profits

 
stbugs said:
What did it say? Behind a paywall. 
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Mainly just hammered home the Nader is a con man thing. Didn’t focus on the actual drug very much, did have some weird slant about fda approval (forget exactly what) and discussed a few shareholders who have hit big on it. 

 
djmich said:
Yah, I thought about that too.  If we were listed on NAS the Robin Hood crowd would see that first graph and salivate.

Either way, I'm resigned to exiting at least half of my position today unless we tank.  Gonna bank profits
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Glad I sold a 1/3 at $6.50. Probably should have sold all not that I don’t believe it could pop but just because I’m really tired of waiting. I’m patient enough to realize trials aren’t TikToks, there is a process you have to follow and you can’t just blurt stuff out without review. I’m more tired of dealing with a stock I don’t want to own long term.

 
Otis said:
BIG DAY TODAY BOYS!  Gonna be a big call with critical data--or not--but either way, we can be certain to either make (or lose) around 7%.  Let's go!
Click to expand...
What call is today? I can’t keep up with this stock. Half the time people say there’s going to be news or a call it’s based on misreading PR or mishearing on a call. 

 
stbugs said:
Oh, I know. Just annoying to have people say there’s a call or deliverable every day.

What’s the next milestone, middle of next week for MM efficacy?
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Sometime in the next 10-14 days the M/M and sometime this month the nasdaq uplisting. 

 
Charlie Harper said:
Did they even give NP a chance to comment? You'd think he'd be all over this.
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Extremely unethical for a journalist to not ask for a comment from a person being hit. I mean we expect that from the dork king or whatever but not from a publication like the WSJ. 

 
Charlie Harper said:
Did they even give NP a chance to comment? You'd think he'd be all over this.
Click to expand...
I cant access the article again (guess I had one freebee).  NP had some comments in there, wasn't sure if they were in direct response to the article or prior comments.

I recall them being 1) The criminal charges of him selling fake Indian goods was baseless 2) Around the changing of timeliness and expectations....he's trying to be transparent.

Again, that was what I remember.  Not a huge confidence booster.

 
Chaz McNulty said:
So in the s/c trial, does the placebo group also get the current standard of care?  Drugs like Dexamethasone.
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I believe they do receive that particular site's SOC.  Could be Dexamethasone, Hydroxychloriquin, Remdesivir(?)... I don't think they're given just a sugar pill and water.  If true then LL is up against the SOC, not just a placebo.  Is there an official SOC for severe and critical patients?  I thought those mentioned above were SOC for mild/moderate.  

 
Chaz McNulty said:
So in the s/c trial, does the placebo group also get the current standard of care?  Drugs like Dexamethasone.
Click to expand...
From the ClinicalTrials.gov site for this study: "Note: Subject who were prescribed (1) hydroxychloroquine or chloroquine with or without azithromycin, (2) Remdesivir, (3) convalescent plasma therapy, or (4) immunomodulatory treatments (including but not limited to sarilumab, clazakizumab, tocilizumab, and anakinra) for the off-label treatment of COVID-19 prior to study enrollment may be included and may continue to receive these agents as part of standard-of-care."

 
I can't believe how much attention this stock gets here. I don't follow the day-to-day that closely, preferring to just trust the saying "Ranties not panties" and stay long and strong.

 
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