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***OFFICIAL CYDY/Leronlimab Thread*** (5 Viewers)

djmich said:
Honestly...thats my interpretation.  They are already stretched too thin, Mexico was a fallback.
Click to expand...
I agree with this. Lots going on with the FDA trials and trying to get approval.  If/when this happens, the team shouldn't need to get involved with other country trials where LL is part of some cocktail.  I'd think some countries would be happy to order vials of the drug without long trials.   But who knows. 

 
"Question about the magnitude of the results.  What can you tell us?"

"In regards to NEWS, I said that we have very positive results and we have seen great improvement in day 3,7,14.  The magnitude will be better than remdesivir which has 11 vs 15."

 
He reiterated "Great" improvement in day 3, 7, and 14.  When asked about the magnitude of the positive results. 

 
confirmed they're the only once a week subcutaneous injections, in reference to Trump mentioning that.

Second question was whether there were any updates on publications.  Many publications out there, but no updates.  Nader says there are 3 papers, Otto Yang, Nich something, and another guy,...doens't have an idea on why Bruce Patterson paper is taking this long.

 
Is Trump talking about us when he says you can go into the hospital and get a shot...?  

We don't know.  We hope he is aware.

NP asked his team if there are any other drugs in trial that can be administered in a shot (no IV).  I thought I heard the reply as no, they don't believe there is another drug that can be delivered in a shot.  Or at least that they know of. 

Did I hear that right?  

 
Walking Boot said:
It's the second most annoying thing my autocorrect does, turning regular words into compound words at random. First most-annoying is that it randomly adds "n't" to verbs like 'could' or 'should' or 'was', which means a third of my texts have the exact opposite meaning. I really wish I knew how to fix it.
Click to expand...
So ducking obnoxious. 

 
"Elaborate on question earlier about an initial press release."

"Next week we'll be reporting on CD-12, safety look.  Also hopefully top-line report for CD-10 completed within 10 days.  Immediately announce and publish.  We want to publish all deatils.  Most of our doctors have patients in this trial will be on that paper."

Editorial: This guy is impossible at setting clear dates or timelines.  

 
Bob Sacamano said:
The words people are looking for are, "Statistically significant", Nader
Click to expand...
Yah, using those words would be nice, provide clarity.

Thing is though, the sample sizes are there, you cant simultaneously have great results and not be statistically significant.  Because otherwise the result would, I think the scientific word is, suck.

 
adonis said:
"Elaborate on question earlier about an initial press release."

"Next week we'll be reporting on CD-12, safety look.  Also hopefully top-line report for CD-10 completed within 10 days.  Immediately announce and publish.  We want to publish all deatils.  Most of our doctors have patients in this trial will be on that paper."

Editorial: This guy is impossible at setting clear dates or timelines.  
Click to expand...
Yes to that. So frustrating.

 
Jayrok said:
Is Trump talking about us when he says you can go into the hospital and get a shot...?  

We don't know.  We hope he is aware.

NP asked his team if there are any other drugs in trial that can be administered in a shot (no IV).  I thought I heard the reply as no, they don't believe there is another drug that can be delivered in a shot.  Or at least that they know of. 

Did I hear that right?  
Click to expand...
Yup. But they didn't sound too sure TBH.

 
Otis said:
Where we at?  
Click to expand...
Same place we were at before.  

Excited about results.  Should have m/m efficacy in 10 days.  Possible Nasdaq uplist mid-August.  Happy with sever results and will release safety results (didn't catch when, I thought it was in that 10 day time span too).  

Still not rich and sticking out the wild swings in stock price. 

 
https://investorshangout.com/post/view?id=5844805

Rough notes from call:

07-30-2020 CYDY Investor Con Call

NP:
CD10, M2M
Difficult to show improvement of any drug
No one has received better than placebo results

SK:
Potential therapies in COVID-19
Believes therapeutics will be best for COVID until vaccine
M2M – NEJM 7/23/2020
Hydroxycloroquine +/- others did not improve

M2S – NEJM
REM shortened from 15 to 11 days
No clear effect on mortality or viral load

Sanofi & Regeneral
IL-6 – couldn’t help them

Roche
Actemera, IL-6 – failed to beat placebo

Dexamethadone
Shows so benefit, but is an immunosuppresent
M2M – may cause more harm than good

+++++

NP:
Results
CD10
Positive efficacy results in CD10
Data is still being evaluated
PE – clinical improvement scored in 4 categories
Seen improvement in D3 from D0 in LERO

SE – “news 2” national early warning score
Degree of illness of pt, will they need critical care intervention going forward or not
4 parameters
Seen good improvement in all Day 3, 7, 14

SE – pts who needed oxygen and ventilators
LERO beats placebo

Still evaluating data
There are 48 components in cytokine panel

Don’t want to rush

Hope to have top-line report within 10 days or so

SAE LERO 64% lower than placebo

Regeneron will be using SAE as their EP for their study

++++

JL:
Mixed results that SAEs (when published) engendered (presumably with stock price)
SAEs are the very events we want to see reduced
Appears to be a clinically significant reduction
Significant results at Day 3, very compatible with EIND program
EIND saw very rapid reductions at Day 3

Surprising result from CD10 – didn’t think it would work in early viral phase or early immunological phase, but expected good results in later immunological phase
CD10 are even early in the progression of the virus
CD10 – will be broadly effective early in the disease progression

Need to look at CD12 and see where we are

+++++

SK: Landscape of COVID
Need multiple therapeutics and vaccine
We are not worried if there are other therapeutics or vaccines
Antibodies might be transient
Pts will wait for safety data on vaccines
43% of respondents will take effective vaccine
50-70% effective vaccine = victory

Hope LERO will be part of the solution

++++

NP
CD12
DSMC – organized as of today, meeting is set
Monday, Aug 3rd
Results due sometime during the next week

CD10
Top line report should be ready within 10 days or so
They will give us better data next week

+++++

SK:
M2M
M2S
S2C

+++++

JL:
Encouraged since the outset, every piece of data is pointing more and more that this is going to work.
The sooner we get to CD12, the better.

+++++

NP:
BLA
Meeting A will be submitted to FDA Monday or Tuesday
Will be submitting all of MONO to FDA as well (hopefully that perhaps MONO will be evaluated as well)

+++++
SK:
MS, ALZ
Preparing protocols

NASH
Will make some minor changes to protocol re: enrollment

Advisory Board
11 commitments
More updates soon

+++++
NP:
Hope 1st pt injected in NASH in September

Financing:
Net $25M raise
Less than 3M shares “I believe”

NASDAQ:
MM:
Submision pckg under review
6 week process
Expect comment letter back next week
Next 2-3 week, other items for discussion
Review of 10k, which will be filed not later than 14th Aug

3rd week of Aug “to see where we are at that time”
“Fingers crossed” “prepared to do so”

++++++

Q&A

Ye Chen, HCW
Q: PR regarding EP’s
A: Absolutely
Results are very strong
Want to get all the efficacy data
All the drs who were involved in this study, they will be part of a publication

Q: Update on pts in CD12
A: more than 161, should be close to 165
Will be doing safety look
JL suggested if we can do interim analysis earlier if possible

Q: Interim at 50 vs. 195
A: Interim is not going to happen at 50.

+++++

Lori H, PI
Q:

+++++

Mark
Q: Lost his mother, father had heart attack from COVID. Brother has MS. Losing his ability to walk.
A: Hope to get approved for COVID soon.
Positive results in MS animal study
Definitely will start MS study this year. That is his intention.

+++++

Dr. Alex K.
Q: Tried to get it to some of his pts, who suffered from COVID. LL has much higher efficacy that any thing else, especially compared to e.g. REM. How did they get approved? Why is FDA blocking so much? What is the constraint to get knowledge / publicity / FDA support?
A:
2,000 drug companies say they have the ‘miracle drug’, FDA’s job is hard
FDA doesn’t have our data yet
Good news: LERO has excellent results

FDA is very clear. Do the studies.

+++++

Ernie Moody
Q: HIV pts taking LERO, none got COVID?
A: Not one single pt who is taking LERO has gotten COVID, as the SAE would have to be reported.
Has no merit for approval.

+++++

Roger M., PI
Q: MX trial?
A: They want to do a study in combo.
NP said to put on hold.
CD10 and CD12 – should be able to get info to FDA
MX was moving too slowly.

+++++

Laurie H., PI
Q: Federal funding?
A: We are working on those things.
NP told the team to not make an urgent matter
Team is small and trying to get bigger
NP believes when they get approval from FDA, all of those doors open immediately

+++++

Robert R., PI
Q: Good contact at FDA? Do you share some of the results before application is completed? Good repore at FDA?
A: FDA has rigid rules and regulations.
President and CEO of Amarex communicates with FDA
Every communication is e-mail format
Under their laws and regulations

+++++

Robert S., PI
Q: How rapidly pts in CD10 cleared virus in the bodies and vs. placebo?
A: Have only announced today
Score = indicator of improvement
SE, oxygen and ventilator report
Can’t say anything until they have legal and regulatory support

+++++

Barbara W.
Q: 8yr old T-Cell lymphoma, large tumor in chest
A: Screened several pts for lymphoma, but all so far have been CCR5 negative
Haven’t shown animal or other studies for children vis-à-vis cancer yet.

+++++

Donald P.
Q: Separate patents required for various indications?
A: Yes, we are working on those.
Also patent for composition for LERO
No one can use for any indication, LERO b/c of the “composition of materials” patent.

SK: All new indications, updating patent portfolio

++++++

Blake L.
Q: Regeneron PE related to SAE. Did change take place mid-trial or original EP?
A: NP we haven’t done P3, SE’s are just as important as PE’s. But we will make case for approval at this time
If “unmet medical need”, then could get approval

SK: We put in SAEs in our PR. Then found out about Regeneron.

Q: Production Samsung numbers. 5M vials, then down to 1.2M vials, now down to 1.1M vials and Samsung possibly being booked. Production we don’t know about? AGC production volume?
A:
NP changed the numbers as we get the numbers from them. Samsung got booked. WE couldn’t book them. Samsung has done the 1.1M vial production
500k vials this year
600k vials this year
Several billion in sales this year if approved.

AGC – has another facility they are starting, which is exciting.

As soon as CYDY gets approval from FDA, should get gov’t money

Might not get more than 100k vials from AGC this year. As of right now, 100k is good to go.

+++++

Robert Frist
Q: By day 14, decrease or eliminate the viral load?
A: Cannot answer at this time.
SK: What separates us is increase the CD8 population.
If P3 is required, what would it look like?
A: Don’t know, can’t guess.
Do pts who die from Flu, do they develop cytokine storm?
SK: Believe there might be the same component, but we don’t know yet.
Decrease tumor necrosis issue?

++++++

Chuck Grey
Q: No question

++++++

Jim Roberts
Q: 28.5M, are their conditions based on results in current trials.
A: No clinical or regulatory performance milestones / hurdles.
More details in upcoming 8k
Basically mirrors march 31 note

++++++

Deno Ramsey
Q: Positive results, magnitude of the effect?
A: Magnitude will be in topline results
“NEWS” – Very positive results in that regard” Day 3, 7, 14
NP thinks it will be much stronger than REM (mentioned 15 to 11 days)

++++++

???
Q: Trump, therapeutic, shot – referring to LERO
A:
SK – most are IV infusions, like REM
Certainly hope Pres is aware
We are only sub-Q

Q: 4-5 papers, Yang, Patterson … any updates?
A:
3 papers, hoping for update next week
Dr BP – no idea why it is taking so long
Not counting on this one (BP)

++++++

Mark Kramer
Q: PR reiterating info from today’s call
A:
Next week will report on CD12, safety
Hopefully have CD10 results announced AND published within 10 days
Most of Drs in our trials will be on the paper

+++++++

NP
COVID trials are going very well
Our M2M is better results than other companies have published so far

Cancer is still going forward
HIV having Type A meeting to discuss COMBO and MONO

Don’t have to pay back loan for at least 6 months, then due in full for 2 years

Read More: https://investorshangout.com/post/view?id=5844805#ixzz6TiMkjvQL

 
So was it a good result? I’m drinking beer standing in a lake reveling over the monster that is Amazon. Still holding a lot of shares. We good?

 
I get wanting to be thorough and find every positive data point you can to put in front of the FDA. But damn, if your endpoint results are that good, do you spend another 2 weeks parsing out every data point before you move forward?

 
adonis said:
"Question about the magnitude of the results.  What can you tell us?"

"In regards to NEWS, I said that we have very positive results and we have seen great improvement in day 3,7,14.  The magnitude will be better than remdesivir which has 11 vs 15."
Click to expand...
I'm going to reiterate, I think they are focusing on secondary endpoints in all of this talk about days 3, 7, 14. Below I copy/pasted their secondary endpoints since the primary only says day 14. If this is what they are hanging their hat on, and missed significance on the primary, I don't think the medical community will receive the news positively.

  • Time to clinical resolution (TTCR) [ Time Frame: Day 14 ]
  • Change from baseline in National Early Warning Score 2 (NEWS2) [ Time Frame: Days 3, 7, and 14 ]

    This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). Higher scores mean a worse outcome.

[*]Change from baseline in pulse oxygen saturation (SpO2) [ Time Frame: Days 3, 7, and 14 ]

[*]Change from baseline in the patient's health status on a 7-category ordinal scale [ Time Frame: Days 3, 7, and 14 ]

  • A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities. Lower scores mean a worse outcome.

[*]Incidence of hospitalization [ Time Frame: Day 14 ]

[*]Duration (days) of hospitalization [ Time Frame: Day 14 ]

[*]Incidence of mechanical ventilation supply [ Time Frame: Day 14 ]

[*]Duration (days) of mechanical ventilation supply [ Time Frame: Day 14 ]

[*]Incidence of oxygen use [ Time Frame: Day 14 ]

[*]Duration (days) of oxygen use [ Time Frame: Day 14 ]

[*]Mortality rate [ Time Frame: Day 14 ]

[*]Time to return to normal activity [ Time Frame: Day 14 ]
Click to expand...

 
Jayrok said:
Is Trump talking about us when he says you can go into the hospital and get a shot...?  

We don't know.  We hope he is aware.

NP asked his team if there are any other drugs in trial that can be administered in a shot (no IV).  I thought I heard the reply as no, they don't believe there is another drug that can be delivered in a shot.  Or at least that they know of. 

Did I hear that right?  
Click to expand...
Correct, I heard them say that LL is only drug injected by shot.  It was interesting that Nader said he had no idea if Trump was talking about them and then the doctor said he is not allowed to discuss if Trump was talking about them.

 
NP seems supremely confident in the results. He gave us teasers, but mentioned multiple times to wait for full report. This is a good sign, IMO. 

Conference call was to settle the nerves because everyone worried that topline results didn't get announced sooner.

#notselling #neversold #onlybought #lastbuyat981

 
Jayrok said:
Is Trump talking about us when he says you can go into the hospital and get a shot...?  

We don't know.  We hope he is aware.

NP asked his team if there are any other drugs in trial that can be administered in a shot (no IV).  I thought I heard the reply as no, they don't believe there is another drug that can be delivered in a shot.  Or at least that they know of. 

Did I hear that right?  
Click to expand...
tocilizumab was subcutaneous. But I think it has been discredited?

 
So, still have to take the word of a notorious exaggerator that the results are good enough.

They're good, this seems clear, but he's unwilling to comment on whether they're significant, although he STRONGLY hinted that the NEWS endpoint was significant at 3,7,14 days.  That seems big.

 
bshell27 said:
Same place we were at before.  

Excited about results.  Should have m/m efficacy in 10 days.  Possible Nasdaq uplist mid-August.  Happy with sever results and will release safety results (didn't catch when, I thought it was in that 10 day time span too).  

Still not rich and sticking out the wild swings in stock price. 
Click to expand...
I’d say it’s a pretty good indication that we will see a significant stock jump when the PR comes out. We just don’t know when. 

 
adonis said:
"Elaborate on question earlier about an initial press release."

"Next week we'll be reporting on CD-12, safety look.  Also hopefully top-line report for CD-10 completed within 10 days.  Immediately announce and publish.  We want to publish all deatils.  Most of our doctors have patients in this trial will be on that paper."

Editorial: This guy is impossible at setting clear dates or timelines.  
Click to expand...
Is the spelling error yours or NP's?

 
Bob Sacamano said:
I get wanting to be thorough and find every positive data point you can to put in front of the FDA. But damn, if your endpoint results are that good, do you spend another 2 weeks parsing out every data point before you move forward?
Click to expand...
Don’t they have to? I just assumed they did. 

 
Charlie Harper said:
NP seems supremely confident in the results. He gave us teasers, but mentioned multiple times to wait for full report. This is a good sign, IMO. 
Click to expand...
True, but I'm also pretty sure NP was shocked that the stock price didn't shoot to 15 when they announced the SAE results so hopefully his supreme confidence is more in line with what people are anticipating this time.

 
Polish Hammer said:
I'm going to reiterate, I think they are focusing on secondary endpoints in all of this talk about days 3, 7, 14. Below I copy/pasted their secondary endpoints since the primary only says day 14. If this is what they are hanging their hat on, and missed significance on the primary, I don't think the medical community will receive the news positively.
Click to expand...
Why wouldn’t they? Isn’t anything that can slow this thing down fairly newsy at this point?

 
Capella said:
Why wouldn’t they? Isn’t anything that can slow this thing down fairly newsy at this point?
Click to expand...
Because doctors look at a trial that didn't meet its primary endpoint as a "failed trial" and many will dismiss out of hand any other data pulled from the trial. Now something COVID-related could be different, but that has been my experience. 

 
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