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***OFFICIAL CYDY/Leronlimab Thread*** (2 Viewers)

Don Hutson said:
We aren't/weren't going to have a placebo arm either.  Our Mexican trial was going have to 3 arms:

1. leronlimab

2. remdevsivir

3. leronlimab + remdesivir
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Maybe they didn't have this trial because POTUS didn't allow Mexico to have remdesivir.  

 
[icon] said:
.... To keep Americans out of Mexico? :lol:  
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On a related note, I think tourism in America is going to take a VERY long time to recover. Why would any foreigner even think about coming here now or even if (hopefully when) we get this under control at any point in the next 1-2 years?

 
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fantasycurse42 said:
Pretend a whale has a lot of shares, in example someone like Chet owns 1mm shares, he has a cost basis of $1 and the price is $5.20. Chet is still bullish but looking to take a little risk off, so he decides he wants to recoup his initial investment of $1mm. With a ticker only trading 7-8mm a day, it will be difficult for him to put a limit order in for his 200k shares where the current price is, so he may put a limit order in to sell any shares at say 10-20 cents below the current ask (all the way down to $5). The price moves down and some buyers who were waiting now take advantage 10-20 cents below, driving the price back up.

It can work the same way if someone like that was looking to increase shares.
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Certainly a possible scenario, but in that case the person loses around $40,000 just for convenience.  Could have happened.

But why also could it not be the activity of a short seller looking to profit off the weakness in a trading day of low volume?  

I understand your scenario is possible, but I get the impression several of you guys are saying it's not reasonable to consider that move yesterday the action of a large short trade.  Why?  I'm not labeling all drops in price the action of evil shorters!  Really just point it out when there's an anomaly in volume vs drop in price and a rapid gain again.  If someone were looking to liquidate, the fact that the share price jumps back up quickly shows that there's a strong appetite for the stock at a higher price than it ultimately goes down to.  If they were trying to sell the shares in blocks over a period of an hour they'd likely gain tens of thousands of dollars more, than selling them all at once.  That's why I consider that scenario less likely than a short sale.

 
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https://www.nytimes.com/reuters/2020/07/23/us/23reuters-health-coronavirus-pharmaceuticals.html

U.S. Clears Way for Drugmakers to Share COVID Antibody Capacity

By Reuters

July 23, 2020

(Reuters) - The U.S. Department of Justice on Thursday said it will not stand in the way of efforts by companies, including Eli Lilly and Co and Amgen Inc, to share information to help scale up capacity to manufacture antibody treatments for COVID-19, the disease caused by the new coronavirus.

In a letter to Lilly, Amgen, AbCellera Biologics, AstraZeneca Plc, Roche Holding's Genentech unit and GlaxoSmithKline Plc, the DOJ said demand for monoclonal antibodies targeting COVID-19 is likely to exceed what one firm could produce on its own.

The drugmakers are in various stages of developing experimental monoclonal antibodies - manufactured proteins designed to bind to a targeted cell, neutralize it and mark it for destruction by the immune system - for treatment, or even prevention, of COVID-19. Monoclonal antibodies are among the most common type of biotech medicines, used for cancer, rheumatoid arthritis and many other conditions.

The DOJ did not include Regeneron Pharmaceuticals Inc, which expects to have definitive trial results for its dual-antibody treatment by late summer or early fall. The Department of Health and Human Services in June awarded Regeneron a $450 million contract and the company has cleared the way for U.S. manufacturing of its antibody cocktail by moving production of its other products to a plant in Ireland.

"Waiting until regulators approve specific treatments before scaling up manufacturing might delay access to these potentially life-saving medicines by many months," the agency said in its letter.

The DOJ said the companies have committed not to exchange information related to the prices of any monoclonal antibodies that are eventually shown to be safe and effective and approved for use.
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How good does the efficacy trial result need to be to get FDA approval on an emergency basis?

It's my understanding that if the FDA does approve leronlimab, then it can be used more freely by doctors to treat other diseases, greatly increasing demand for the product if it shows potential in other areas.

So I'm curious what is "good enough" vs a placebo, with respect to efficacy results, to get emergency approval by the FDA for unmet medical need (or any other pathway to approval quickly).

 
adonis said:
How good does the efficacy trial result need to be to get FDA approval on an emergency basis?

It's my understanding that if the FDA does approve leronlimab, then it can be used more freely by doctors to treat other diseases, greatly increasing demand for the product if it shows potential in other areas.

So I'm curious what is "good enough" vs a placebo, with respect to efficacy results, to get emergency approval by the FDA for unmet medical need (or any other pathway to approval quickly).
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I honestly think the low bar has been set by Remdemisvir.  If they pass the primary outcome then I believe it is a slam dunk.  If they fail the primary but are really strong on almost all the secondary, then it's tough to say.  This could happen and it could still be a better treatment than Rem.

 
Chaz McNulty said:
I honestly think the low bar has been set by Remdemisvir.  If they pass the primary outcome then I believe it is a slam dunk.  If they fail the primary but are really strong on almost all the secondary, then it's tough to say.  This could happen and it could still be a better treatment than Rem.
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Agreed. It would be very hard (as much as it seems like the admin likes them) to stop something that is better and safer.

 
I'm becoming more and more cautiously optimistic. I think it will work better and safer than anything on the market right now; to NP's credit (more so prob bc of Bruce's endorsing) we moved early on the trials, and we're 4-6 weeks away from a lot of positive activity.

Dr. P needs to continue to be a major endorser or we will lose credibility. He is well-respected and if we have positive results that he speaks of, I think that would be game over. Volatility will be scary and suspect some with conviction will be shaken from their shares. 

 
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fantasycurse42 said:
I'm becoming more and more cautiously optimistic. I think it will work better and safer than anything on the market right now; to NP's credit (more so prob bc of Bruce's endorsing) we moved early on the trials, and we're 4-6 weeks away from a lot of positive activity.

Dr. P needs to continue to be a major endorser or we will lose credibility. He is well-respected and if we have positive results that he speaks of, I think that would be game over. Volatility will be scary and suspect some with conviction will be shaken from their shares. 
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Agreed.  And to NP's credit, he's moved the company faster than most other monoclonal's to get in testing and to be strategically at the head of the line for approval for treatment.  He has his stumbles, but he's done a good job positioning the company here - win or lose on this.  They're in an incredibly good position to, with good results, do a world of good and make a world of money.

 
So does anyone have an idea of how the DSMB review of the S/C trial will go down?  Will they announce that they have requested the DSMB to look at the trial?  Will we know within a day or two of their findings or will it take longer?  If the trial isn't stopped and is allowed to continue, will they announce that?  Maybe @Whyatt can help us understand this.

 
Don Hutson said:
So does anyone have an idea of how the DSMB review of the S/C trial will go down?  Will they announce that they have requested the DSMB to look at the trial?  Will we know within a day or two of their findings or will it take longer?  If the trial isn't stopped and is allowed to continue, will they announce that?  Maybe @Whyatt can help us understand this.
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I would liken to understand this as well. All of these things take some time according to my reading, so my expectations have been reset (by myself, not the actual person who should reset them).

From what I understand, continuing the trial is par for the course, especially after just a 25% sample size, stopping due to inefficiency or safety issues with the drug is disaster, and stopping bc it is helping so many people is mansion. 

 
fantasycurse42 said:
I would liken to understand this as well. All of these things take some time according to my reading, so my expectations have been reset (by myself, not the actual person who should reset them).

From what I understand, continuing the trial is par for the course, especially after just a 25% sample size, stopping due to inefficiency or safety issues with the drug is disaster, and stopping bc it is helping so many people is mansion. 
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I wonder how much you have to beat the placebo group by to get them to stop. 

If Placebo is 50% deathrate (25 out of 50) and LL is 33% (33 out of 100), would that be enough?  Is saving 17 lives per 100 enough to make them stop for humanitarian reasons?

 
Chaz McNulty said:
I wonder how much you have to beat the placebo group by to get them to stop. 

If Placebo is 50% deathrate (25 out of 50) and LL is 33% (33 out of 100), would that be enough?  Is saving 17 lives per 100 enough to make them stop for humanitarian reasons?
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Think the DSMC is looking at the first 100 patients.

 
Judge Smails said:
It’s all about the vaccine. 
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I completely disagree with this. Vaccine A) won’t be near 100% effective B) won’t be taken by more than 50-60% of population tops.

Sadly, this #### isn’t going anywhere.

ETA: completely disagree is a little strong. I think other factors beyond vaccine including where infections are accompanied by treatments will be equally important.

 
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fantasycurse42 said:
I completely disagree with this. Vaccine A) won’t be near 100% effective B) won’t be taken by more than 50-60% of population tops.

Sadly, this #### isn’t going anywhere.

ETA: completely disagree is a little strong. I think other factors beyond vaccine including where infections are accompanied by treatments will be equally important.
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Then foreigners just won't be coming here, even after they're allowed.

Back to our hero: volume super low today.

 
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kevzilla said:
Then foreigners just won't be coming here, even after they're allowed.

Back to our hero: volume super low today.
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Hence my opinion that tourism in this country will suffer for a long time. Anecdotal, but most family/friends in or around NYC say the city is disgusting right now. 

 
fantasycurse42 said:
Hence my opinion that tourism in this country will suffer for a long time. Anecdotal, but most family/friends in or around NYC say the city is disgusting right now. 
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Showing homes in Boise this afternoon to a couple that owns a condo in Manhattan.  His work said WFH in March.  They went to Sun Valley, ID for two months and worked from there.

 
Getzlaf15 said:
Showing homes in Boise this afternoon to a couple that owns a condo in Manhattan.  His work said WFH in March.  They went to Sun Valley, ID for two months and worked from there.
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They’d sell that condo in Manhattan right now if they knew they wouldn’t take a bath on it. Prob the worst real estate market in the country right now... Who would want to buy there right now? At some point, you’re going to see price drops coming aggressively in Manhattan.

 
Getzlaf15 said:
Showing homes in Boise this afternoon to a couple that owns a condo in Manhattan.  His work said WFH in March.  They went to Sun Valley, ID for two months and worked from there.
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Can you PLEASE stop doing this.  We're full up and what was once a great place to live is getting less so.  Maybe you're just making a play to list my house.  I regret writing that nice summary of Boise for you all those years ago before you moved here :).

 
Chaz McNulty said:
I wonder how much you have to beat the placebo group by to get them to stop. 

If Placebo is 50% deathrate (25 out of 50) and LL is 33% (33 out of 100), would that be enough?  Is saving 17 lives per 100 enough to make them stop for humanitarian reasons?
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You'd have to do statistics wizardry to figure out the level of significance.

 
siffoin said:
Can you PLEASE stop doing this.  We're full up and what was once a great place to live is getting less so.  Maybe you're just making a play to list my house.  I regret writing that nice summary of Boise for you all those years ago before you moved here :).
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❤️

That was 10 years ago this month.

 
fantasycurse42 said:
They’d sell that condo in Manhattan right now if they knew they wouldn’t take a bath on it. Prob the worst real estate market in the country right now... Who would want to buy there right now? At some point, you’re going to see price drops coming aggressively in Manhattan.
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He mentioned taking a bath, but he said he did extremely well on the sale before this one.

 
siffoin said:
Can you PLEASE stop doing this.  We're full up and what was once a great place to live is getting less so.  Maybe you're just making a play to list my house.  I regret writing that nice summary of Boise for you all those years ago before you moved here :).
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I'll be in Boise on the 8th of Aug.  I'll waive to you all as I make my way to Yellowstone.  

Two nights in Donnelly, ID at my aunt/uncles lakehouse and then we'll spend one night in Sandpoint after a full day at Glacier.  

Back to stonks.

 
Getzlaf15 said:
He mentioned taking a bath, but he said he did extremely well on the sale before this one.
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There is so much money in the NYC real estate, that while this exodus is a disaster for them, it's a boon for places like where you are. Accompanied by nobody wanting to be there, companies are realizing they don't need 5 floors of office space either sending more people away, that hurts retail/commercial, and a mayor who is completely incompetent that the Gov is demanding he clean some of this #### up (reminiscent of the 1980s I remember from my earliest days); it's a ####### disaster right now. And our money goes sooooo much further elsewhere.

I believe at some point when the NYC market starts recovering in volume, prices will fall, but maybe in the 10-20% range, speculators will backstop it. I actually intend on being one of them and buying a 2br condo. Intention is to AirBNB it out during the fall/winter/spring and stay there when I'm in NYC for work or during the summer when we head north. This is more 2022 thinking though. 

 
Bob Sacamano said:
Make sure they know to double the population sign.
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The teenagers are too cool to take this trip with us.  They are going to stay home and watch the cat.***





***We gave them this 'job' two weeks ago and in equal parts impressed/disappointed, they did what only teens with my DNA would do and threw a bit of a party.  During Covid.  Where one of their buddies barfed all over our bathroom.   Not the kids bathroom, not  the guest bathroom, no....this ambitious lad went to the far corner of our house to puke up his vanilla vodka.  So the Malaise teens are NOT going to watch the cat without a chaperone.**




**The chaperone is my amigo Sosa who probably wouldn't care if they smoked all teh weed and drank all my booze so long as they shared with him and bought him fast food.

 
fantasycurse42 said:
There is so much money in the NYC real estate, that while this exodus is a disaster for them, it's a boon for places like where you are. Accompanied by nobody wanting to be there, companies are realizing they don't need 5 floors of office space either sending more people away, that hurts retail/commercial, and a mayor who is completely incompetent that the Gov is demanding he clean some of this #### up (reminiscent of the 1980s I remember from my earliest days); it's a ####### disaster right now. And our money goes sooooo much further elsewhere.

I believe at some point when the NYC market starts recovering in volume, prices will fall, but maybe in the 10-20% range, speculators will backstop it. I actually intend on being one of them and buying a 2br condo. Intention is to AirBNB it out during the fall/winter/spring and stay there when I'm in NYC for work or during the summer when we head north. This is more 2022 thinking though. 
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I thought you couldn't do AirBnB in NYC?  

 
Man this is boring. I didn’t invest a bunch of money into some shady OTC stock with a trumpian CEO and no published results just to see it move back and forth 2 percentage points a day. 

 
Chaz McNulty said:
I wonder how much you have to beat the placebo group by to get them to stop. 

If Placebo is 50% deathrate (25 out of 50) and LL is 33% (33 out of 100), would that be enough?  Is saving 17 lives per 100 enough to make them stop for humanitarian reasons?
Click to expand...
Yes.  That scenario returns a p-value of 0.0249.

 
siffoin said:
Can you PLEASE stop doing this.  We're full up and what was once a great place to live is getting less so.  Maybe you're just making a play to list my house.  I regret writing that nice summary of Boise for you all those years ago before you moved here :).
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Where exactly in Boise? Sounds like a nice place, maybe I should sell my home in SoCal and move there.  

 
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chet said:
Yes.  That scenario returns a p-value of 0.0249.
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Chet you’ve been awful quite with your thoughts on this the past few weeks.  How are you feeling about the PR and the limited results being released?  Are you a bullish as you’ve always been or are you starting to get nervous?  Thanks as always.  

 
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CYDY is within a few pennies of the low if anyone is looking to add. 

its also within 16 cents of the high if you're looking to grab profits.

Yawn

 
Interesting post by Thoughtful Investing on Yahoo Finance:

Thoughtful Investing6 hours ago
It sounds like Trump is zeroed in on Leronlimab just waiting for the gold standard final placebo controlled m/m results. Someone else pointed out to me that he said on Fox News last night:

"therapeutics I think are going to be fantastic, frankly I'd like to have that first [before vaccines] because you can go into the hospital give somebody a shot, or do whatever you have to do, and they'd get better right away but we are doing very well therapeutically" https://www.youtube.com/watch?v=YWx0rm0AgJE at about 22.21.

Where did he get "give somebody a shot"? None of the other therapeutics that I have heard about result in someone getting better from just a shot. 

Maybe he is just not being precise with this language but I don't think so. FDA is intimately aware of leronlimab's promise. Why? FDA has seen the HIV BLA filings, the 60 Covid 19 eIND's they granted and, as a result of the eIND patient dramatic results, FDA had conversations with Cytodyn about the m/m and s/c study design. 

The President wants and likely feel he needs leronlimab to allow people to go back to work normally, shop normally, travel normally, go to the office normally to get the economy growing back to full capacity if he is to be re-elected. So he is all over COVID 19 treatment progress now. So is Dr. Fauci. 

They are surely communicating with FDA to stay abreast of the latest developments including leronlimab. Thus, it is clear that Mr. Trump is well aware of leronlimab's promise and how close it is to receiving approval. Hence the reference to a "shot" to "get better right away". If the m/m trial efficacy results demonstrate anywhere close to the efficacy implied by the safety data, emergency use of leronlimab will be approved by FDA as soon as they finish reading the trial results.
Click to expand...

 
chet said:
Interesting post by Thoughtful Investing on Yahoo Finance:
Click to expand...
Man that’s a reach, and I’m big on cydy.

I've read him daily, and he has said similar before, speculating that him starting his task force again was to talk about leronlimab.  Several of his thoughts or hopes haven’t planned out, but I still appreciate his thoughts.

 
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