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

Dr. Jay reiterating significant results in day 3.  He believes LL shows positive impact in both M/M and S/C cases.  Said he was surprised at the feedback they received last week when they released safety results for M/M.  If I heard that right.

 
Jayrok said:
Dr. Jay reiterating significant results in day 3.  He believes LL shows positive impact in both M/M and S/C cases.  Said he was surprised at the feedback they received last week when they released safety results for M/M.  If I heard that right.
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This sounds like a secondary endpoint - they had a few with multiple check-in times. The primary endpoint was a singular 14 day evaluation point. Hope I'm wrong with my interpretation. Also depends on the "primary endpoint good results" part above. If they are good AND significant, that's great. If they are "good" but not significant, that's ... well ... not good.

 
What were the 3 statements from Kelly?

1. Can we prevent M/M patients from getting worse

2. Can we prevent M/S patients from needing oxygen?  

3. Can't remember the third.  Something like can we... in severe/critical patients.  

So far they believe the drug is working and will help the patient population.  

 
Polish Hammer said:
This sounds like a secondary endpoint - they had a few with multiple check-in times. The primary endpoint was a singular 14 day evaluation point. Hope I'm wrong with my interpretation. Also depends on the "primary endpoint good results" part above. If they are good AND significant, that's great. If they are "good" but not significant, that's ... well ... not good.
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I think he did mention "excellent top line results" but didn't elaborate. Who knows though.

 
NASDAQ update: submission package still being reviewed.  

"Important to understand it's a 6 week process, as such we'd expect a comment letter back next week.  Then going forward over following 2-3 weeks, other items for discussion take place, including their review of our 10-k which will be filed no later than Aug 14th.  Maybe the 3rd week of august would be one to circle to see where we are at that time."

Nader asks if 3rd week of august we'd uplist, the answer was waffling saying we're working towards that.

 
PR will be released with these discussed results.  Uh oh...  hopefully they'll be better received than the M/M safety numbers.

 
"Nader is there going to be a press release mentioning the efficacy endpoints you just mentioned previously?"

"Absolutely...these are strong results...we can't wait to put out a press release, but we want to wait to get all the results.  All the physicians involved in this study are going to be involved in a major publication after the topline results are released.  Should be very quick."

 
adonis said:
NASDAQ update: submission package still being reviewed.  

"Important to understand it's a 6 week process, as such we'd expect a comment letter back next week.  Then going forward over following 2-3 weeks, other items for discussion take place, including their review of our 10-k which will be filed no later than Aug 14th.  Maybe the 3rd week of august would be one to circle to see where we are at that time."

Nader asks if 3rd week of august we'd uplist, the answer was waffling saying we're working towards that.
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Comment letter from NASDAQ (identifying things they need/questions) is a week 3 activity iirc, so that makes sense.

 
From a FB post...  can someone please interpret. ty

not use to seeing a reduction in SAEs in clinical trials... surprising clinically severe reduction in M/M patients. Day 3 - similar to EIND - started at day 3 - similar to what we've seen in other critical and mild patients day3 impressive vs day14.

Didn't think it would work in early or moderate phase - more in hyper inflammation. but CD10 m/m don't require 02, what cd10 study showing going to be broadly therapeutic in m/m patients... need to quickly take look cd12 and see where we are

 
"Could you provide an update on how many CD12 patients."

"More than 161, close to 165...do interim analysis at 195 and if results are good, see if FDA responds."

"You said previously there could be interim analysis on 50 patients..."

"So when i said 50, I was hopign we'd do 50, but i was slapped around by regulatory team.  To do interim analysis, we'd have to ask FDA to change to 50 from 195"

 
Encouraging content in this call, imo.  Tomorrow SP will be interesting, especially if a quick PR is released and the subsequent hit piece(s). 

Personally I'm looking to add in the coming days.  I think good news is coming in the next 2 weeks.  

 
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Jayrok said:
Encouraging content in this call, imo.  Tomorrow SP will be interesting, especially after the PR is released and the subsequent hit piece(s). 

Personally I'm looking to add in the coming days.  I think good news is coming in the next 2 weeks.  
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Not sure what PR will be released, as NP seems to indicate no PR until all results are done.  Topline's not done either, but i'm sure some news will come from this.

 
Jayrok said:
Encouraging content in this call, imo.  Tomorrow SP will be interesting, especially after the PR is released and the subsequent hit piece(s). 

Personally I'm looking to add in the coming days.  I think good news is coming in the next 2 weeks.  
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I'm maxed out at a cost basis of $5.94 so this call has solidified me to keep 100% of my self-managed portfolio in CYDY. 

 
adonis said:
Not sure what PR will be released, as NP seems to indicate no PR until all results are done.  Topline's not done either, but i'm sure some news will come from this.
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Hmm.  I thought I heard he was going to release a PR that mentions what was discussed today.  Like the last safety top line stuff.  

I'd much rather they not send out a PR until all results are done.  

 
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Jayrok said:
Did I double post?  Don't see it.  I'm talking about a PR in the morning or tomorrow from Cytodyn with the results discussed in this call today.  
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I don't see the double post now (maybe I was seeing things).  Either way, it was a failed attempt at a joke about CYDY updating PRs  :bag:  

 
Jayrok said:
Hmm.  I thought I heard he was going to release a PR that mentions what was discussed today.  Like the last safety top line stuff.  

I'd much rather they not send out a PR until all results are done.  
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I may be surprised, but I heard "yes, we will..." and then he hedged, as far as I understood.  The question was seeking a quick PR release, and Nader said he's definitely going to make a press release, and then added a few conditions on the end after saying he was definitely going to release it.  Feel free to correct me if anyone else heard differently.

 
Steeler said:
I don't see the double post now (maybe I was seeing things).  Either way, it was a failed attempt at a joke about CYDY updating PRs  :bag:  
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Yeah I hope they hold any PR from release until they have all results.  I just thought I heard him say a PR will be sent that outlines the positive data they told us today.  Hope they don't do that.

 
adonis said:
I may be surprised, but I heard "yes, we will..." and then he hedged, as far as I understood.  The question was seeking a quick PR release, and Nader said he's definitely going to make a press release, and then added a few conditions on the end after saying he was definitely going to release it.  Feel free to correct me if anyone else heard differently.
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that's what I heard as well.

 
Mexico trial is on hold because they wanted to do a combo therapy trial, so Nader said no and put it on hold. Lol

 
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he mentioned a PR that would cover all efficacy end points so seemed to backtrack from immediate PR but hard to know as it was explained

 
adonis said:
"Nader is there going to be a press release mentioning the efficacy endpoints you just mentioned previously?"

"Absolutely...these are strong results...we can't wait to put out a press release, but we want to wait to get all the results.  All the physicians involved in this study are going to be involved in a major publication after the topline results are released.  Should be very quick."
Click to expand...


adonis said:
I may be surprised, but I heard "yes, we will..." and then he hedged, as far as I understood.  The question was seeking a quick PR release, and Nader said he's definitely going to make a press release, and then added a few conditions on the end after saying he was definitely going to release it.  Feel free to correct me if anyone else heard differently.
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"Absolutely...these are strong results...we can't wait to put out a press release, but we want to wait to get all the results."

I took this comment as they're going to release a PR mentioning the endpoints he went over today.  But then the last sentence may mean "but, we're going to wait to get all the results." 

So hopefully there is no PR tomorrow that does not contain all results.  Wait and spring it all together. 

 
What's the good of adding 45 minutes for questions if half the time is spent on inane questions?

I'd like a prosecutor to screen these calls and ask followups :).

 
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