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

Also, someone asked Dr. Yo if he listened to the call-

1. So we know it works.  But now we need the p-values and all the stats to know how much does it work.  I think for FDA to really consider EUA, the p-values have to be incredible.
2.  I am not sure people asking the questions have any idea how research and the FDA works.

 
Capella said:
So I don’t know anything about the science but my main takeaway is that I don’t think we are going back to $2-3 per share and there’s very little chance I’ll lose money here. I think by EOY we’ll be in the 9-12 range as a baseline. 
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I’d say I do feel much better about at least holding the 5’s at this point until the full PR, could see 1-2 higher.

 
Another conference call summary from the Yahoo Board:

Summary done by Taz:

30July 2020--Today’s Investor Community Conference: Meeting Minutes.
These are my raw notes folks, if I’ve made any error please help keep me honest.
Dr. Nader, Scott Kelly, Lelazari
Warning about forward looking statements, basically do your due diligence and know there is always uncertainties and expectations.
First, and most important update on M/M trial. Toughest population to prove.
Dr. Kelly: COVID, therapeutics are the best solution. Referenced how hydroxycholorquine is terrible. Remsidivir 15 to 11 days, doesn’t quite work. Mechanical ventilation alone doesn’t work. Decasmethazone, immune-suppression can cause more harm than good.
We believe Leronlimab can decrease the viral load of the COVID. As of today, we do have positive results… data is still in progress.
Scored. Fever. Body ache. Breathing. Cough.
2nd NEWS (national early warning score) degree of illness that requires critical care intervention. This indication was met, breathing, body temp, heart rate, blood rate. Day 3,7 and 14… all good.
3rd Leron arm beats placebo arm.
Hope to have the top line report within 10 days. SAE 64% less than placebo.
Jay Lelazari: SAEs reduced is a big big success. This is the CRITICAL End Point.
Dr. Kelly: We need multiple therapeutics … we need multiple vaccines. We are not worried about competition. 43% population will not take vaccine, until known risks more clear.
CD12: Positive anecdotal, 60 patients in C/S population … went very well.
The meeting will be held on: 8/30, with results due sometimes next week.
M/M, M/S, S/C 3 cats… can we effect the mortality rate, we believe will have the most effect on.
Every piece of data coming available, is showing more and more confident.
BLA finalized tomorrow submission on Monday. Monotherapy submission very soon as well.
All other indiciations, Dr. Kelly, MS & Alhemzhiers, NASH… making minor changes to enhance enrollment. 11 commitments have come through already.
1st patient to be injected in September, since now it has been administered on animals, which went very well. TRYING NOT TO DILLUTE, working on that very hard.
Mike: Our submission Uplisting package, continued review… 6 week process. Might get a response next week. Next few weeks, we’ll be completing 10K… 3rd of August. Fingers crossed.
Q/As:
Will there be PR covering all the efficacy end points? Yes, coming soon.
CD12 patients? Total of 165 CD12 patients enrolled
MS information: Leronlimab, we hope to get it in the future. Animal studies did do very well.
Dr. Alex: Familiar with Leron, tried to get for few patients suffering from COVID, making it available would be great. Why isn’t out yet? GLD sucks. 2000 drug companies saying they “have it”, FDA has their work cut out for them. There are shameless people who make it tougher. Big companies may be able to providing it in a more expedited form process. Us, small guys, it is tougher to push through. Patience! Leron is excellent! We do need to WH, FDA gave us 16 EINDS, they are working with us. They have even given us the pass on the anecdotal aspect. They have not done that for any other company.
Roger (Independent Investor): Mexico? They want to use combination. Dr. Nader asked them to put on hold. Just excited about approval here in U.S. first. Mexico wants to do combo, we are not for that currently.
Mary: Wonderful preliminary results, plans on federal funding like BARDA? We are not focusing on that currently. The 25M as of late puts us at ease. The moment we get approval we will have government support.
Robert: FDA contact? They are very solid, organization. Our contact is a lady, she communicates with us, knows head of FDA very well. All comm is documented, the process is in work.
How rapidly with CD10 cleared from bodies comparing Leron & placebo. Day 3 – day 0 is major improvement. Top line will provide the clear results. It is very good though.
Barbara: 8 years old, diagnosed with lymphoma, what studies conducted? Several patients have been CCR5 negative. We have not had a positive patient yet.
Donald: With all indications possible, are separate patents required. Yes, we are covering that exclusive 12 years on using Leron. For both domestic & international.
Blake: Vials, why has it dropped from 5M to 1.2M, Samsung still in the deal? AGC projection? Samsung did get booked. We were hoping to get funding in a non-dilutive fashion. Samsung executive very close to me 1.2M still available for us. AGC, facility a new one… we can get some there when it comes to manufacturing. Funding, we believe will help us.
Mike: President mentioned “getting a shot… coming home from.” We cannot comment if he is talking about us. 4 or 5 papers of Dr. Yang or Dr. Otto, when to expect them. 3 papers hopeful, soon.
Dr. Nader last comment: “We cannot sleep these days, we are so excited with all the excellent results and pathway we are paving!”

 
Bluto Blutarsky said:
Also, someone asked Dr. Yo if he listened to the call-

1. So we know it works.  But now we need the p-values and all the stats to know how much does it work.  I think for FDA to really consider EUA, the p-values have to be incredible.
2.  I am not sure people asking the questions have any idea how research and the FDA works.
Click to expand...
Where are you seeing this?

 
Bluto Blutarsky said:
Also, someone asked Dr. Yo if he listened to the call-

1. So we know it works.  But now we need the p-values and all the stats to know how much does it work.  I think for FDA to really consider EUA, the p-values have to be incredible.
2.  I am not sure people asking the questions have any idea how research and the FDA works.
Click to expand...
Didn’t they grant the useless remdesevir (no idea how it’s spelled) and hydro 

 
I don't think the bid/ask price now means anything.  First indication will be the opening in Germany tonight at 2:30am EST (I think).

 
Chaz McNulty said:
For the s/c trial, are they just looking at safety data on Monday?
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I believe they're looking at overall results - safety included. 

They'll look to see outcomes of folks on the drug vs the control group, and if it's clear that leronlimab has a better outcome, they can stop the trial and give all control patients leronlimab.  

They could also stop the trial if it's clear leronlimab is harmful when compared to the control group, and then they'd switch leronlimab folks to standare care I believe.  Would be a major blow.

They can let the trial continue if it's anywhere inbetween those two.

Obviously, we'd be hoping for the first circumstance.

 
adonis said:
NP is enthusiastic, and he's rarely measured. 

He said some results were "good" and the news2 or whatever results were "very good" with what came across on the phone as a wink, a nod, a foot stomp, and a grunt.  He did everything he could to convey good results, without outright saying it.  However, he wasn't willing or able to state that the results were significant.  That's what it boils down to.  They made the case that the results they're seeing are better than anyone elses out there right now, but they came up short in saying the differences between leronlimab groups and the placebo were statistically significant.  However, he strongly hinted that was the case in at least one secondary endpoint category.
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So I guess this begs the question. After today are you happy you got out yesterday or disappointed?

 
Overall I think the call was a clear positive, the most clear positive call I've ever attended.

- They're days away from submitting to the FDA in preparation for a Type A meeting. 
- We're less than two weeks away from top line results from the m/m trial, with strong hints/claims that the results were positive in several key areas.
- Funding isn't an issue for at least a year with the new loan 
 

Overall, exceeded my expectation.  If prices stay reasonable, I'll be adding to my position.

 
dkp993 said:
So I guess this begs the question. After today are you happy you got out yesterday or disappointed?
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Disappointed I sold yesterday as if I'd just held on, I'd have 100% of my position instead of the 70% I bought back at open today.  I'll be looking to add back the 30% over the next few days if possible.

My actions lately are proof of the following:

"The stock market is a device for transferring money from the impatient to the patient." - Warren Buffett
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adonis said:
Disappointed I sold yesterday as if I'd just held on, I'd have 100% of my position instead of the 70% I bought back at open today.  I'll be looking to add back the 30% over the next few days if possible.
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Major props to you for recognizing a mistake and not being stubborn about it. Hi have taking the opposite approach before and missed out on some good stocks

 
BassNBrew said:
Major props to you for recognizing a mistake and not being stubborn about it. Hi have taking the opposite approach before and missed out on some good stocks
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The lesson I've been doing my best not to learn is that i'm not smart enough, or informed enough to time the market.  I'm hard headed, but I think it'll stick this time (and the incredible earnings report AAPL had after I sold the last of my shares last week :) ).

 
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adonis said:
The lesson I've been doing my best not to learn is that i'm not smart enough, or informed enough to time the market.  I'm hard headed, but I think it'll stick this time (and the incredible earnings report AAPL had after I sold the last of my shares last week :) ).
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You can’t win them all. I see guys regretting selling apple but failing to mention they bought lvgo or se and still made a killing. Most of us can’t own everything. Also can’t expect to bat 1000 when the pros often are whiffing 

 
Read an article today that quoted Fauci speaking about vaccines.  Said the vaccine had to be safe and ideally reduce the rate 50%.  Said 60+% would be better.  Does this way of thinking also carry over to therapeutics?  

 
chet said:
I don't think the bid/ask price now means anything.  First indication will be the opening in Germany tonight at 2:30am EST (I think).
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Other than day traders (bass n brew > hi!) who even are the sellers tomorrow? If you’ve been holding this long why would you get out after that call?

 
Capella said:
Other than day traders (bass n brew > hi!) who even are the sellers tomorrow? If you’ve been holding this long why would you get out after that call?
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Biggest trading day of the year and I’ll be on the Appalachian trail with no service all weekend. Will be wondering if I’m rich all weekend 

 
BassNBrew said:
Biggest trading day of the year and I’ll be on the Appalachian trail with no service all weekend. Will be wondering if I’m rich all weekend 
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I’ll be drinking hard at the lake again. Sitting in front of a big fire about 15 feet from the lake with a big restaurant type cooler of beer, family and friends. F ckin A type of day and post 4pm numbers loving it. Livin the dream. Have fun on the mountain!

 
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Charlie Harper said:
NP seemed measured audio wise. Didn't see video.
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Completely agree. Way less cavalier than he has been, and he deferred to others who held the expertise (and ability to explain) on certain topics. I'm hopeful he's been coached a bit. Good for him. Shows some growth. 

I know there's a backstory on how's he's been given the keys to the castle. I've got some theories but my research has not borne fruit yet.

 
Capella said:
Other than day traders (bass n brew > hi!) who even are the sellers tomorrow? If you’ve been holding this long why would you get out after that call?
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I think you underestimated shareholders ability to find the negative in everything. I have seen it the past week where the price just continues to trickle down due to no news.  People trying to analyze every word uttered and written/changed in the last PR. 
 

I get it. That’s kinda how you get an edge, but at some point, it’s simply futile. 
 

I plan to ride the wave of initial euphoria after the call and when it teeters off next week, I will buy my shares back as many people grow impatient or find some article about NP saying he voted for Walter Mondale or something. 
 

Good chance I’m wrong, but I’m not selling until I’ve locked in sone profits, so that’s the chance I’m willing to take. 

 
From the Yahoo Message Board:

Here’s a transcript from about minute 7 to 13. NP and JL.

NP
As of today, we do have positive efficacy results in our CD-10, and the data is still being evaluated to find more positive aspects. In regards to our primary endpoint, clinical improvement was scored in four categories: fever, body ache, difficulty to breathe, and cough. We have seen improvement in Day 3 vs. Day 0 in Leronlimab arm as compared to placebo arm. So that is the first major positive result for us. A very important secondary endpoint is called NEWS2, which is an upgrade version of NEWS. N-E-W-S stands for National Early Warning Score. NEWS2 assesses the degree of illness that points out to any need for critical care intervention. Very, very crucial parameter.

So again, this indicator is to determine the degree of illness of patients: whether the patient will be needing critical care intervention by assessing the following parameters: breathing, oxygen saturation, body temperature, blood pressure, and heart rate. In regard to this very crucial parameter, we have seen good improvement in Leronlimab arm compared to placebo arm in all evaluated days, which is Day 3, Day 7, and Day 14. We are so delighted with this result.

8.50
Thirdly, though, of another secondary endpoint, is in regards to patients who needed oxygen use and mechanical ventilators. Leronlimab arm beat the placebo arm.

As of today, we are still evaluating a mountain of information to put in our exciting topline report and present to the FDA as soon as that is possible. Please note: there are 48 components to cytokine storm panel and 3 immunological parameters for Day 0, 3, 7, and 14 that needs evaluation. And the last thing we want to do is to rush and miss any positive parameters. We hope to have the topline report within ten days or so.

Now, what we just explained does not even touch on the number of the SAE events that occurred in this study, a very important parameter. As previously announced, SAEs in Leronlimab arm was 64% less than in placebo. Regeneron just announced that they will be using the number of SAE events as a primary endpoint in their study. In this regard, I would like to ask Dr. J Lalezari, who’s best known as patient advocate, to elaborate on these SAEs that we reported. Dr. J Lalezari, please.

10.20
JL
Thank you, Nader. And hello, everybody. I was surprised last week by the mixed results that the -- what appeared to be a clinically significant reduction in SAEs engendered [?] These are the critical endpoints. They are not endpoints that we’re used to seeing because we’re not used to seeing a reduction of SAEs in clinical studies. I have been PI [Principal Investigator] in about 300 studies and I have never seen that before. But SAEs are medically-significant events: life, death, and intubation. And these are the, I think, the very events that we would want to see reduced. And what I think is surprising is the -- what appears to be a very clinically significant reduction in such an early mild to moderate population.

I would also comment that the -- what Nader just said about the significant results at Day 3, as early as Day 3, that that is very compatible with what we saw during the Emergency IND program that first encouraged us to believe the drug was working -- where we saw very rapid reductions in IL-6 and increases in CD8 that started at Day 3. So I’m -- I think the early results we’re seeing in this study are compatible with what we’ve seen in a more severe population. If the result was only significant out at Day 14, I’d be much more suspicious of it. But it is compatible with what we’ve seen in other patients.

And I think what is surprising about what we’re getting from CD-10 is that when we thought the drug was working in severe patients, we didn’t think it was going to work during the early virulogic phase, or even necessarily during the early immunologic -- the middle immunologic -- phase. We thought it was really quite encouraging during the hyper inflammation. But the CD-10 study -- and we thought that when there would be a compassionate use program that the drug would perhaps be indicated for patients who needed oxygen supplemental therapy. But the CD-10 population are patients who are even earlier. These are folks with mild and moderate, almost who don’t require oxygen.
12.40

And so what the CD-10 study is showing, I think, is that Leronlimab is going to be broadly effective, not only in the severe and critical, but also in patients who don’t even yet need oxygen therapy. And the SAE is, while not a primary endpoint, I think is indicative of that kind of activity. So all of this is pointing, I think, to the need to quickly take a look at CD-12 and see where we are. Back to you, Nader.

 
chet said:
You need to refill that fridge.  That's a big fireplace.
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In the morning. Killed a few cases today. 3 families so a lot of drinking early and often. Beautiful day, great stock day. Fireplace is awesome. It’s right on the water. You can duck your head and walk in. Two more days before we have to go home. C’mon LeBron, I need a lake house to retire there.

 
stbugs said:
Not at all. Still going strong. Any and all welcome. Great ####### day. We took two Red Bull tables (these) into the lake. One for our beer, one to put a big cooler on with beer so we didn’t have to go up and down the dock.
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That is epically white trash. And I mean that in a good way. But.....life's too short to drink what you're drinking.

I'll send you some Russian River beer after we hit $15/share. Drank a Pliny for President today. Top 10 beer for me. Cost $17 for a 32oz mason jar, so it'd better be good.

 
⚡DEADHEAD⚡ said:
That is epically white trash. And I mean that in a good way. But.....life's too short to drink what you're drinking.

I'll send you some Russian River beer after we hit $15/share. Drank a Pliny for President today. Top 10 beer for me. Cost $17 for a 32oz mason jar, so it'd better be good.
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I’ve been trying to acquire this beer since it was announced.  I’ll have to stick to my weekly Hop Butcher releases.  Cheers!  

 
I'm having trouble understanding people's optimism about the conference call.  There really wasn't any good news.  Just more delays.  The data results given were vague and meaningless.  I think tomorrow will be red.

 
⚡DEADHEAD⚡ said:
That is epically white trash. And I mean that in a good way. But.....life's too short to drink what you're drinking.

I'll send you some Russian River beer after we hit $15/share. Drank a Pliny for President today. Top 10 beer for me. Cost $17 for a 32oz mason jar, so it'd better be good.
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Sounds good to me. PM me when we hit $15. We aren’t drinking to savor, going for white trash fun, friend’s gorgeous lake house on 10 acres, tons of lake front. Just a glorious day!

 
⚡DEADHEAD⚡ said:
That is epically white trash. And I mean that in a good way. But.....life's too short to drink what you're drinking.

I'll send you some Russian River beer after we hit $15/share. Drank a Pliny for President today. Top 10 beer for me. Cost $17 for a 32oz mason jar, so it'd better be good.
Click to expand...
Oh come on. You can’t have a lake day with that heavy sheeeeeit.

Our man @stbugs is doin’ it right with the yard beer. A full day on the lake and you can still function with a sweet buzz all day.

:headbang:

 
Don Hutson said:
I'm having trouble understanding people's optimism about the conference call.  There really wasn't any good news.  Just more delays.  The data results given were vague and meaningless.  I think tomorrow will be red.
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Not sure I disagree with you besides it will start in the green.

 
⚡DEADHEAD⚡ said:
That is epically white trash. And I mean that in a good way. But.....life's too short to drink what you're drinking.

I'll send you some Russian River beer after we hit $15/share. Drank a Pliny for President today. Top 10 beer for me. Cost $17 for a 32oz mason jar, so it'd better be good.
Click to expand...
I’ll have to drive up and get some this weekend from Russian River 

 
Fyi.  I took a safe position.  I took a lot of profits. 

I played middle ground.  If it runs up, I'm retiring.  If it doesn't, I'm retiring in 5 years or less.

Ty chet for 300k.

At minimum.....to add.

 
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Don Hutson said:
I'm having trouble understanding people's optimism about the conference call.  There really wasn't any good news.  Just more delays.  The data results given were vague and meaningless.  I think tomorrow will be red.
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Both sides seem to think they are ahead right now.  Shorts are gonna harp that they are kicking the can and dragging this out and that if it were good news, we would already have been told.  Longs were generally happy with the call and think Cytodyn is just ensuring all ducks are in a row before releasing good data.

I'm cautiously optimistic.  When in doubt, I replay what the doctors have been saying and there hasn't been anyone that has panned this drug that I know of.  Its generally positive or very positive.

 
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