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***OFFICIAL CYDY/Leronlimab Thread*** (7 Viewers)

lakerstan said:
Could it be this?

https://www.fiercepharma.com/manufacturing/az-lilly-amgen-and-more-score-justice-department-nod-for-monoclonal-antibody-scale-up

"Eli Lilly, AstraZeneca, Roche's Genentech unit, Amgen, GlaxoSmithKline and Lilly partner AbCellera can now share manufacturing information that could help speed up coronavirus antibody production, thanks to a business review letter from the Justice Department's antitrust division."

""The demand for monoclonal antibodies targeting COVID-19 is likely to exceed what any one firm could produce on its own," the DOJ said in its letter. "Moreover, waiting until regulators approve specific treatments before scaling up manufacturing might delay access to these potentially life-saving medicines by many months, which adversely could affect the nation’s efforts to fight COVID-19."

I'm not smart enough to know if this is noteworthy:  

"Notably absent from the collaboration project was Regeneron. The Tarrytown, New York-headquartered biotech first pushed its antibody cocktail, dubbed REGN-COV2, into clinical trials in June. The treatment was created by selecting hundreds of neutralizing antibodies against SARS-CoV-2 from a mouse model and humans who recovered from the virus. The company ultimately settled on two of the most potent antibodies, pairing them to prevent a viral mutation from evading treatment. 

In July, Regeneron signed a $450 million deal with the Trump administration to supply 1.6 million doses of its antibody cocktail, possibly by summer's end, the company said." 
Click to expand...


I don't see anything in that article that's says they will have a results ready trial in the next week or two.  I see BP scrambling to get into the mix.  Eli Lily is working on a phase 1 trial--phase 1 is for safety and not efficacy.

Meanwhile, Eli Lilly started dosing COVID-19 patients in a phase 1 trial of its AbCellera-partnered antibody therapy last month. The companies said they expected results by the end of June, but that trial data hasn't yet appeared. 
Click to expand...

 
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chet said:
With the administration talking about monoclonal antibody companies releasing results, has anyone bothered to look at what others will be releasing results over the next week or two?  What companies could Fauci and Trump be referring to?
Click to expand...
EVLO enrolling patients for a phase 2 study in this.  Stock is currently in a circuit halt up but seems they are still months behind CYDY.

https://clinicaltrials.gov/ct2/show/NCT04488575?term=nct04488575&draw=2&rank=1

 
fantasycurse42 said:
I apologize. Trying to put all our thoughts into one clear organized and coherent post was too much to ask as we collectively have 7 figures on the line, my bad. Now if you'll excuse me, I have to put a collared shirt over my Beastie Boys tank top to host a virtual meeting. 
Click to expand...
:lmao:

 
chet said:
Link please
Click to expand...
Drugmakers refuse to attend White House meeting after Trump issues executive orders on costs

https://www.politico.com/news/2020/07/27/drugmakers-trump-meeting-canceled-382847

A White House meeting with top pharmaceutical executives that President Donald Trump promised for Tuesday is off, five industry sources familiar with discussions told POLITICO. Three said the drug-pricing discussion was canceled because the major drug lobbies, reeling from Friday’s cluster of executive orders on the topic, refused to send any members.

Drugmakers and Trump were slated to discuss an executive order, signed Friday but not yet released, that would order health officials to release a plan linking Medicare payments for certain medicines to lower costs paid abroad. The provision, known as a most-favored-nations rule, has been lambasted by the drug industry and some patient groups that say it would curb innovation and reduce drug access.

Trump said Friday that drugmakers would have a month to present a better option to the rule.

The drug lobbies PhRMA and BIO were reluctant to send representatives from their member companies — many of them multibillion-dollar manufacturers of the world’s best-selling medicines and vaccines — after conflicting reports last week about whether the White House would include the rule and little information to date about what the new rule would look like, three people familiar with the discussions said.

Several pharmaceutical companies believed that the most-favored nations rule had been dropped ahead of the Friday afternoon announcement. The hours before Trump’s drug pricing event were a “chaotic” back-and-forth that even left some of his health officials surprised, sources told POLITICO Friday.

BIO, the lobby representing many small biotechnology companies developing therapies, has said that the most-favored-nations rule would hit its members the hardest. Many make the type of physician-administered medicines, such as expensive cancer and arthritis infusions, that would be affected.

"There are discussions taking place to determine the best way to work with the administration on this issue over the coming weeks," said an industry source.

"The White House has been more than accommodating in attempts to schedule this meeting," a White House official said on background.

A PhRMA spokesperson painted the White House talks as a distraction. "The president’s plan to import policies from socialized health care systems abroad is disrupting our work [on Covid-19 therapies] and diverting our focus away from those life-saving efforts," the spokesperson said. "We remain willing to discuss ways to lower costs for patients at the pharmacy counter. However, we remain steadfastly opposed to policies that would allow foreign governments to set prices for medicines in the United States."

Inside Health Policy first reported that the meeting was canceled. The White House did not immediately respond to request for comment.

The favored nations rule has rankled conservative groups along with the industry and patient organizations. The president on Friday left the door open for alternative options, saying that if drugmakers can present a better plan “we may not need to implement the fourth executive order, a very tough order.”
Click to expand...

 
Thought this was a reasonable post on yahoo just now:

The following positive development would not suprise me:
a) Leronlimab (LL) show positive results (more positive than any other monoclonal antibody)
b) behind the scenes several big pharma players will negotiate contracts for production of LL
c) because of the global scale cytodyn can afford to give these manufacturers a good share of the revenue. This way BP is happy and cydy too.
d) cydy will have more than enough money for other potential applications of LL.
e) share price will rocket.
Click to expand...
 
  • Smile
Reactions: JAA
fantasycurse42 said:
I apologize. Trying to put all our thoughts into one clear organized and coherent post was too much to ask as we collectively have 7 figures on the line, my bad. Now if you'll excuse me, I have to put a collared shirt over my Beastie Boys tank top to host a virtual meeting. 
Click to expand...
I have a telehealth appointment in 20 minutes and just put a uniform top on while still rocking my basketball shorts. :bag:  

 
It's unusual that NP has gone this long without a paid press release or trying to manage shareholder emotions/reactions/expectations.

 
Does anyone know the number of severe-criticals they plan to submit for the safety check?

I've been playing around with the binomial calculator to determine what outcomes will be statistically significant when both placebo and drug have the same number of deaths.  

Assuming a submission of 99-patients (33 placebo and 66 drug), 10 deaths in each returns a p-value of 0.04862 which is barely significant.  11 deaths in each returns 0.3813.  9 deaths in each returns 0.06123.  Although morbid, the more deaths, the higher the chance of achieving statistical significance.  

Obviously, if the placebo returns more deaths than drug, the numbers get significant very quickly.  9 deaths in placebo and 8 in drug returns 0.04135.  16 deaths in placebo and 14 in drug returns 0.003328.

 
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There is no such thing as barely significant. It’s like being a little pregnant. Either the results are significant or they are not. 

 
pecorino said:
There is no such thing as barely significant. It’s like being a little pregnant. Either the results are significant or they are not. 
Click to expand...
Is there such a thing as highly significant, because I hear that phrase used a lot.  And you can't be "highly pregnant".

 
chet said:
Does anyone know the number of severe-criticals they plan to submit for the safety check?

I've been playing around with the binomial calculator to determine what outcomes will be statistically significant when both placebo and drug have the same number of deaths.  

Assuming a submission of 99-patients (33 placebo and 66 drug), 10 deaths in each returns a p-value of 0.04862 which is barely significant.  11 deaths in each returns 0.3813.  9 deaths in each returns 0.06123.  Although morbid, the more deaths, the higher the chance of achieving statistical significance.  

Obviously, if the placebo returns more deaths than drug, the numbers get significant very quickly.  9 deaths in placebo and 8 in drug returns 0.04135.  16 deaths in placebo and 14 in drug returns 0.003328.
Click to expand...
I'm back! 

Pretty sure it was 100. I'll have to double check. 

 
pecorino said:
There is no such thing as barely significant. It’s like being a little pregnant. Either the results are significant or they are not. 
Click to expand...
So why did Fauci use the term "trending" when remdesivir returned a p-value of 0.06 or 0.07.  I have also heard that to end the study early, the p-value will likely have to be far below 0.05.  

 
pecorino said:
There is no such thing as barely significant. It’s like being a little pregnant. Either the results are significant or they are not. 
Click to expand...
From a statistician's perspective, this is correct. From the perspective of a medical clinician, this is incorrect. I can tell you firsthand that if you have something just under 0.05 many docs will say "yes, you met statistical significance, but just barely." They will - on the whole - put MUCH more credence (read: "blind faith") into something that is below 0.01. However, in the case of COVID where there aren't tons of proven options to deal with it, I think getting below 0.05 on a meaningful endpoint has the potential to be a windfall in terms of acceptance/usage.

 
Can't find it, but I'm fairly certain the number was 100 for the DSMC, think NP said it on a call iirc. I absolutely heard that number. 

 
chet said:
So why did Fauci use the term "trending" when remdesivir returned a p-value of 0.06 or 0.07.  I have also heard that to end the study early, the p-value will likely have to be far below 0.05.  
Click to expand...
"Trending towards significance" is something that salespeople will sometimes say, and doctors don't like to hear (at least in my line of work). What it can mean is that the study may have been underpowered, and had there been more patients accepted into the study with similar results over time it could have crossed the line to significance. I think technically it means that while the study results may have been favorable, the confidence interval was so wide that it crossed over the line of benefit/no-benefit. Going off of memory, so hopefully I got that right.

 
fantasycurse42 said:
Can't find it, but I'm fairly certain the number was 100 for the DSMC, think NP said it on a call iirc. I absolutely heard that number. 
Click to expand...
The number is dependent on when they ask for the review.  Nader said they had 127 patients enrolled during his July 3rd interview with DrBeen.  It is a 28 day trial so I think the number will be larger than 100 unless they asked for the review last week.  If they asked for the review today, it'd likely be about 120.

 
Don Hutson said:
The number is dependent on when they ask for the review.  Nader said they had 127 patients enrolled during his July 3rd interview with DrBeen.  It is a 28 day trial so I think the number will be larger than 100 unless they asked for the review last week.  If they asked for the review today, it'd likely be about 120.
Click to expand...
I believe last update we had we were at 153 patients.

 
Polish Hammer said:
From a statistician's perspective, this is correct. From the perspective of a medical clinician, this is incorrect. I can tell you firsthand that if you have something just under 0.05 many docs will say "yes, you met statistical significance, but just barely." They will - on the whole - put MUCH more credence (read: "blind faith") into something that is below 0.01. However, in the case of COVID where there aren't tons of proven options to deal with it, I think getting below 0.05 on a meaningful endpoint has the potential to be a windfall in terms of acceptance/usage.
Click to expand...
The difference between .049999999 and .05000000001 isn't sufficient to justify a binary "significant" or "non-significant" conclusion.  It's an analog world, and .05 is an arbitrary line drawn (ok, not completely arbitrary, but the .05000000 nature is).  There is a difference between .04999 and .0000001 in terms of the strength of the conclusions, and the "significance".

 
chet said:
Does anyone know the number of severe-criticals they plan to submit for the safety check?

I've been playing around with the binomial calculator to determine what outcomes will be statistically significant when both placebo and drug have the same number of deaths.  

Assuming a submission of 99-patients (33 placebo and 66 drug), 10 deaths in each returns a p-value of 0.04862 which is barely significant.  11 deaths in each returns 0.3813.  9 deaths in each returns 0.06123.  Although morbid, the more deaths, the higher the chance of achieving statistical significance.  

Obviously, if the placebo returns more deaths than drug, the numbers get significant very quickly.  9 deaths in placebo and 8 in drug returns 0.04135.  16 deaths in placebo and 14 in drug returns 0.003328.
Click to expand...
You're saying that 99 patients with 9 deaths in each returns .06123.  Is this a linear scale?  If we double the numbers - 198 with 18 deaths in each, would we get the same p-value?

 
I've come to a conclusion about Thursday:

1) NP will repackage the same #### he shoveled before.

2) The big announcement will be that the safety committee is currently reviewing the data and Cytodyn will have access to it within 1-2 weeks.

The guy's best trait is dangling the carrot and kicking the can down the road. I believe number 2 is how he'll do it. In this scenario, I see share price sub $4. He kicks the can, they continue working on the uplisting, keeping the SP over the $3 that they mentioned was critical. He gives himself enough rope to get to the middle of August in an attempt to uplist. 

 
fantasycurse42 said:
I've come to a conclusion about Thursday:

1) NP will repackage the same #### he shoveled before.

2) The big announcement will be that the safety committee is currently reviewing the data and Cytodyn will have access to it within 1-2 weeks.

The guy's best trait is dangling the carrot and kicking the can down the road. I believe number 2 is how he'll do it. In this scenario, I see share price sub $4. He kicks the can, they continue working on the uplisting, keeping the SP over the $3 that they mentioned was critical. He gives himself enough rope to get to the middle of August in an attempt to uplist. 
Click to expand...
I don't see the point in focusing on uplisting when you are working on a drug that could potentially save lives. As said before, he needs to give two ####s less about the stock price if this is serious.  

I'm close to taking my 20K profit and walking away (wishing I did this when it was 43K).  I know they're "excited" about the results, but there wasn't much movement after releasing safety results and it has been radio silence since.  I'll wait to hear what he says this Thursday, if it is more of the same, stock price will stay stagnant.  

 
chet said:
So why did Fauci use the term "trending" when remdesivir returned a p-value of 0.06 or 0.07.  I have also heard that to end the study early, the p-value will likely have to be far below 0.05.  
Click to expand...
Trending is used when they can’t say significant. Companies do this a lot for secondary endpoints to try and influence prescribing behavior. It means it was not statistically significant. You can argue it was clinically significant if you’d like, but it didn’t meet the statistical threshold. 

 
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bshell27 said:
I don't see the point in focusing on uplisting when you are working on a drug that could potentially save lives. As said before, he needs to give two ####s less about the stock price if this is serious.  

I'm close to taking my 20K profit and walking away (wishing I did this when it was 43K).  I know they're "excited" about the results, but there wasn't much movement after releasing safety results and it has been radio silence since.  I'll wait to hear what he says this Thursday, if it is more of the same, stock price will stay stagnant.  
Click to expand...
Here is why I come to this as the most logical conclusion (I think there are obviously bullish conclusions too, but this would be the favorite if I was placing odds):

We mostly agree, if he was sitting on amazing data, we'd know by now... At least I think we mostly agree on this point. While a good amount of investors are eyeing Covid, NP is also thinking about the future of Cytodyn. Getting listed on the Nasdaq gives them more credibility, so even if LL is a flop for CV19, he is thinking about that for the future. He needs SP to hold the line at a certain threshold or this won't happen. 

 
adonis said:
The difference between .049999999 and .05000000001 isn't sufficient to justify a binary "significant" or "non-significant" conclusion.  It's an analog world, and .05 is an arbitrary line drawn (ok, not completely arbitrary, but the .05000000 nature is).  There is a difference between .04999 and .0000001 in terms of the strength of the conclusions, and the "significance".
Click to expand...
I feel like we are saying the same thing.

 
fantasycurse42 said:
Here is why I come to this as the most logical conclusion (I think there are obviously bullish conclusions too, but this would be the favorite if I was placing odds):

We mostly agree, if he was sitting on amazing data, we'd know by now... At least I think we mostly agree on this point. While a good amount of investors are eyeing Covid, NP is also thinking about the future of Cytodyn. Getting listed on the Nasdaq gives them more credibility, so even if LL is a flop for CV19, he is thinking about that for the future. He needs SP to hold the line at a certain threshold or this won't happen. 
Click to expand...
Man, when you are given time you come up with all kinds of scenarios. Now NP doesn’t care about CV and is just trying to get up-listed.

I can only imagine what Lord of the Flies type situation I’d see if you had to wait a month for some news.

I’m almost to the point where I’d sell the rest of what I have just so I don’t have to come in here anymore. The assumptions and theories based on waiting a few days for results is mind boggling.

 
stbugs said:
His hot take isn’t all that much different from the negative theories in here based on waiting until Thursday.
Click to expand...
I don’t think the lack of info is a big deal, truly. It could be something as simple as amarex told them they’d have the results on Tuesday and then the company wanted a day to tighten the PR up. Who knows. Not worth getting bothered over. 
 

What concerns me is the total lack of volume. Less than 4M shares the last 3 days and almost certainly today too. That by far and away bothers me the most but we’ll see I guess. 

 
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stbugs said:
His hot take isn’t all that much different from the negative theories in here based on waiting until Thursday.
Click to expand...
My skepticism all along has been NP.

My fear is he is just kicking the can on Thursday and SP will suffer. It's a legitimate worry knowing the history.

And personally, when I invest, I like reading the bearish theories much more than the bullish theories. Usually we know why we're bullish, the inverse of that is always good for perspective. 

 
Capella said:
Could be waiting to couple them with the severe trial info they are getting. 
Click to expand...


fantasycurse42 said:
We have to dive into why still no efficacy results... can we actually put our brainpower to use?

I’ll start with the most obvious; results are bad and NP doesn’t want price to collapse.

What else we got? There are other reasons, otherwise we’d be lower, so what are they?
Click to expand...
I think this makes sense to me. Want to put best case forward by combining results.

 
fantasycurse42 said:
My skepticism all along has been NP.

My fear is he is just kicking the can on Thursday and SP will suffer. It's a legitimate worry knowing the history.

And personally, when I invest, I like reading the bearish theories much more than the bullish theories. Usually we know why we're bullish, the inverse of that is always good for perspective. 
Click to expand...
Fear is a disease.  Get rid of it or you're doomed for failure.  Though I did hear Leronlimab cures it.

This is NOT an investment.  It is a Grand Slam Home Run or a Strike Out gamble in the stock market.  Odds higher today for the GS than back in December to boot, but the strike out is still within the realm of possibilities.  The chance to be in a position that goes from $.30 - $5.00 is EXTREMELY rare.  Going from $.30-$20+...that's something you might not ever see again.

BP spoke like 10 days ago and it seemed after that people were creaming like a 9th grader invited to the SR Prom.  Was that all BS?  To me the main thing going is why would this guy risk his reputation on an OTC company that no one knows about if the science isn't there - especially when he has seen it in action.

The future of these results are unknown to us right now.  There is no cipher to magically uncover the clues.  Home Run or Strike out.  It's not for everyone.

 
siffoin said:
Fear is a disease.  Get rid of it or you're doomed for failure.  Though I did hear Leronlimab cures it.

This is NOT an investment.  It is a Grand Slam Home Run or a Strike Out gamble in the stock market.  Odds higher today for the GS than back in December to boot, but the strike out is still within the realm of possibilities.  The chance to be in a position that goes from $.30 - $5.00 is EXTREMELY rare.  Going from $.30-$20+...that's something you might not ever see again.

BP spoke like 10 days ago and it seemed after that people were creaming like a 9th grader invited to the SR Prom.  Was that all BS?  To me the main thing going is why would this guy risk his reputation on an OTC company that no one knows about if the science isn't there - especially when he has seen it in action.

The future of these results are unknown to us right now.  There is no cipher to magically uncover the clues.  Home Run or Strike out.  It's not for everyone.
Click to expand...
I ####### love it and when it’s done I want to do it again.  

 
Capella said:
I don’t think the lack of info is a big deal, truly. It could be something as simple as amarex told them they’d have the results on Tuesday and then the company wanted a day to tighten the PR up. Who knows. Not worth getting bothered over. 
 

What concerns me is the total lack of volume. Less than 4M shares the last 3 days and almost certainly today too. That by far and away bothers me the most but we’ll see I guess. 
Click to expand...
It isn’t and the lack of volume isn’t surprising either. Everyone knows we are waiting for the results. It’s really that simple. Seeing as how they’ve had some issues with paperwork and announcing (they had to update a press release with like 5 numbers), I’m not surprised it could take just under two weeks to get to final results. People posting about other trials and they end in September and December. Clinical trials take time. They don’t report next day especially if the numbers could be critical for approval.

 
What is he allowed to announce on Thursday?  If he comes out and says we met the primary endpoint, will that upset the FDA?  Is hw allowed to announce the total deaths in the severe/critical trial?  If so, is he allowed to say how many were placebo versus drug?

 
chet said:
Is hw allowed to announce the total deaths in the severe/critical trial?  If so, is he allowed to say how many were placebo versus drug?
Click to expand...
I thought no one including CytoDyn would be told any results unless the trial was ended because of being horrible or being phenomenal.  And wouldn't it be the FDA making the announcement if the trial was ended?

 
Capella said:
How are there still message boards that look like that? 
Click to expand...
I've seen several of that guy's posts.  They are ALL the same and he doesn't typically respond to anyone who comments.  As such, I don't think he is delusional.  Just thinks he likes rattling cages and getting peoples hopes up.  

He had one yesterday that said something like "Whelp, that confirms it.  President Trump and the FDA are onboard and approval is soon.  Check out starting 15:23 and just listen."

The link is to Trump's press conference where he said some therapeutics are exciting.  He just assumes it's all about LL.  Or he's just having fun on a random message board.  

I think, except for a few wide-eyed believers, most people just roll their eyes when he posts.  

 
siffoin said:
Fear is a disease.  Get rid of it or you're doomed for failure.  Though I did hear Leronlimab cures it.

This is NOT an investment.  It is a Grand Slam Home Run or a Strike Out gamble in the stock market.  Odds higher today for the GS than back in December to boot, but the strike out is still within the realm of possibilities.  The chance to be in a position that goes from $.30 - $5.00 is EXTREMELY rare.  Going from $.30-$20+...that's something you might not ever see again.

BP spoke like 10 days ago and it seemed after that people were creaming like a 9th grader invited to the SR Prom.  Was that all BS?  To me the main thing going is why would this guy risk his reputation on an OTC company that no one knows about if the science isn't there - especially when he has seen it in action.

The future of these results are unknown to us right now.  There is no cipher to magically uncover the clues.  Home Run or Strike out.  It's not for everyone.
Click to expand...
This should be pinned to the top of every page in this thread. 

 
This room is too small for all of us, we're going stir crazy.  Was much better when we had the run of the stock thread and were able to make life miserable for the non CDiddy citizens there and a few other posts about Gold or fast food chains were allowed and broke things up.

Thinking we should move over to the COVID thread...they won't know what hit them.

 
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Cytodyn on Watch

No new news here but kind of an interesting thought that this is on NASDAQ.com

MRNA, PFE/BNTX COVID-19 Vaccines Move Into Phase 3, CytoDyn On Watch, GNCA To Report Data On Jul.30.

1. CytoDyn to Provide COVID-19 Trial Updates On Jul.30

CytoDyn Inc. (CYDY.OB) is scheduled to host a conference call on July 30, 2020, to provide a comprehensive update on its two trials for COVID-19 patients with mild-to-moderate and severe-to-critical indications.

The company is testing Leronlimab in a phase II trial in mild-to-moderate COVID-19 population and in a phase IIb/III trial in severe and critically ill COVID-19 population.

On July 21, the company announced patient safety data from its over-enrolled COVID-19 phase II trial for mild-to-moderate indications.

CYDY.OB closed Monday's trading at $5.55, up 2.78%.
Click to expand...
:tinfoilhat:

 
chet said:
So why did Fauci use the term "trending" when remdesivir returned a p-value of 0.06 or 0.07.  I have also heard that to end the study early, the p-value will likely have to be far below 0.05.  
Click to expand...
For some studies, the p-value threshold is 1%. Most, though, use 5%. Getting a value of 6% or 7% would probably inspire the company to redo the trial as it was “almost significant” and worth their time and money to try again. Also, some call 5% “significant” and below 1% “strongly significant”. 

 
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