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

[unckeyherb]

pre-open at 5.51

 

[Don Hutson]

shorty dude said 4-6 weeks after unblinding.

While the finished paper/study might take 4-6 weeks to produce, Whyatt said topline results would come out quickly if the results were good.  So far, they have chosen to release safety data and not any efficacy data.  The results are obviously marginally good at best.  But we knew going in that it was going to be difficult to hit a home run in the M2M trial.  There are a lot of deaths in the S/C trial so it will be far easier to show efficacy.

 

[pecorino]

So predictions on what happens tomorrow with the stock price. Let’s hear them....

Looks like it’ll open higher. I’ll predict a repeat of a decent gain (say to $5.65) and then a slow walk down to close marginally lower at $5.35

 

[Jayrok]

https://t.co/A2GsatyUL3?amp=1 - Bruce Patterson contributed to the article.

Can a Tiny Protein be the key to reopening the world?

It goes on to describe how immune system works.  Here are some excerpts:

RANTES is a specialized Chemokine that acts as a ‘magnet protein’ recruiting and directing leukocytes (white blood cells) in the immune response. When the immune system is in balance (homeostasis), the system is an efficient alien cell killing machine. In a portion of the population, however, external forces such as a virus can destabilize the immune system. When this occurs, the immune system can become hyperactive attacking both viral and healthy cells in a phenomenon called cytokine release syndrome or cytokine storm syndrome (CRS/CSS).

It goes on to mention how research by Cytodyn and IncellDx (Dr. Patterson) focused on the RANTES protein.  Then more stuff on the trials and last week's safety results.  

OUTSTANDING SAFETY PROFILE -  The Leronlimab treatment arm in the Phase 2 trial experienced a nearly absurd 58.4% reduction severe adverse events (SAEs) compared to the placebo arm. (21.4% or 6 SAEs in 28 Patients in the placebo arm versus only 8.9% or 5 SAEs in 56 Patients in the Leronlimab arm.) This is difficult to put into context. Doing nothing created 2.4 times the SAEs than patients receiving Leronlimab.

MEASURING THE MOA - Patients treated with Leronlimab under the FDA’s EIND program experienced reversed hyperimmune activation, inflammation, and immunosuppression. In addition, the resulting RANTES modulation was also responsible for reductions in COVID-19 plasma virus. The effect was like an anti-viral drug, but the actual operation was a control mechanism placed on the human immune system.

TREATMENT TRIFECTA - Modulating RANTES with Leronlimab restored the immune system to homeostasis and decreased the viral burden. The result is a COVID-19 trifecta. Leronlimab was shown, through IncellDx’s testing protocol, to (1) calm the Cytokine Storm, (2) return the immune system to homeostasis, and (3) reduce the viral load.

IS THERE HOPE? - So, does a tiny protein no larger than 7.8 kilodynes hold the key to reopening the world? Infection and antibody testing will be helpful in building public confidence, but not sufficient to completely allay public anxiety. Vaccination will have the most effect on public confidence. Unfortunately, any vaccines are still at least 6-12 months away. The ultimate anxiety around Covid-19 is severity and the risk of death, particularly for citizens in the most vulnerable population groups. A laboratory test and treatment option that, in advance, can be used to identify, protect, and possibly direct how to treat this vulnerable population can significantly bridge the public confidence gap between where the world is today, and where it can be with a successful vaccine. Understanding the role of the tiny RANTES protein and Leronlimab (which modulates its activity) in the treatment of COVID-19 could mean that a diagnosis is no longer a death sentence.

A nice article that basically puts some of the technical clinical jargon into more layman's terms about how LL does a nice job of calming the storm, returning the immune system to normal and reduces the viral load.  And that a diagnosis of Covid may not mean a death sentence for s/c patients.  

 

[arrow1]

melting up....

 

[The Ref]

Hi all -

good to see the passion going in here still.  I’m on vacation and had to step away from the day to day, hour to hour tracking.

i don’t think it’s overly strange scheduling a presser Later in the week To announce/discuss results.  Guess we will find out soon enough.

GL to all.

 

[ex-ghost]

Hell of a run up this morning. So far. $5.73, up 6%

 

[Charlie Harper]

Looks like a conference call on Thursday to provide updates on the m/m and severe trials. Doesn’t say anything about providing results. 

They really know how to dangle that carrot each week. 

 

[fantasycurse42]

Comprehensive update 

 

[stbugs]

 That was a good one.  Props.

Care to explain why these other bio-companies splash news everywhere when a rat lives 3 hours longer than the control group and but spins in circles for those last three hours or a liter of their drug in a petri dish left in an oven overnight gives an indication of reduce COVID?  NP hasn't been shy about early calls previously.  

Is it possible that CYDY has no insight into the patient data?  

Do you actually know how long they wait to splash news? Also, isn’t a result about a lab test easier to say X is effective in killing CV 19 than to make sure you’ve got every T crossed and i dotted when going for FDA approval? They also splashed the safety stuff within 2 days of unblinding. I’d think that when trying to get FDA approval you are going to be a bit more careful than a lab test of a rat pre-phase 1.

Again, you guys have no idea how long that company waited to announce because unlike NP they don’t have conference call after conference call promising something ambiguous.

 

[stbugs]

While the finished paper/study might take 4-6 weeks to produce, Whyatt said topline results would come out quickly if the results were good.  So far, they have chosen to release safety data and not any efficacy data.  The results are obviously marginally good at best.  But we knew going in that it was going to be difficult to hit a home run in the M2M trial.  There are a lot of deaths in the S/C trial so it will be far easier to show efficacy.

Look, I know you want the price to go down since you are out, but you are 100% wrong in making that assumption.

You and I know nothing about the results and again you are taking the word of a known short as gospel and making a huge assumption. You could right, you could be wrong. Stop trying to be a word of reason when you are making your own assumption.

 

[Sand]

I just hate conference calls 

So you hate my life.  I swear I live most of my life on these things.

 

[stbugs]

So you hate my life.  I swear I live most of my life on these things.

Hah, not that I like them, but I was referring to the incessant amount of calls that NP likes to have. They’d be way better off just reporting results when done and accurate and filling out paperwork than planning and having these dumb calls that just give more ammo to shorts.

 

[Zegras11]

Hah, not that I like them, but I was referring to the incessant amount of calls that NP likes to have. They’d be way better off just reporting results when done and accurate and filling out paperwork than planning and having these dumb calls that just give more ammo to shorts.

I think NP feels a huge obligation to those that have been long for many years.

 

[Capella]

Extremely low volume again today. There is no movement on this. 

 

[Don Hutson]

There is chatter on the message boards that Trump's visit today to the Fujifilm plant is because of leronlimab.  Fujifilm made leronlimab in the past and would be an obvious choice to make it again if they were going to seriously ramp up production.  They are speculating that Nader hasn't let the cat out of the bag because he didn't want to upstage Trump.  It is possible that they asked for the review of the S/C data last week and didn't tell us.  Obviously, message board speculation is often flimsy.  Trump is scheduled to participate in a Coronavirus briefing at the Fujifilm plant at 3:30pm today.

 

[⚡DEADHEAD⚡]

Hah, not that I like them, but I was referring to the incessant amount of calls that NP likes to have. They’d be way better off just reporting results when done and accurate and filling out paperwork than planning and having these dumb calls that just give more ammo to shorts.

Dude likes to hear himself talk. I can't figure out why.

 

[Chaz McNulty]

There is chatter on the message boards that Trump's visit today to the Fujifilm plant is because of leronlimab.  Fujifilm made leronlimab in the past and would be an obvious choice to make it again if they were going to seriously ramp up production.  They are speculating that Nader hasn't let the cat out of the bag because he didn't want to upstage Trump.  It is possible that they asked for the review of the S/C data last week and didn't tell us.  Obviously, message board speculation is often flimsy.  Trump is scheduled to participate in a Coronavirus briefing at the Fujifilm plant at 3:30pm today.

I think this is wishful thinking.  But it would be awesome.

 

[fantasycurse42]

The camera maker? I’m sorry, I’m not buying into this. I’m unfortunately not a lottery winner.

 

[⚡DEADHEAD⚡]

There is chatter on the message boards that Trump's visit today to the Fujifilm plant is because of leronlimab.  Fujifilm made leronlimab in the past and would be an obvious choice to make it again if they were going to seriously ramp up production.  They are speculating that Nader hasn't let the cat out of the bag because he didn't want to upstage Trump.  It is possible that they asked for the review of the S/C data last week and didn't tell us.  Obviously, message board speculation is often flimsy.  Trump is scheduled to participate in a Coronavirus briefing at the Fujifilm plant at 3:30pm today.

From InvestorHangout:

There is a mention of Fuji in this old 10-k from 2016. Looks like they have produced Leronlimab (PRO 140) in the past.

We have developed and validated a current good manufacturing practice (“cGMP”) process to manufacture PRO 140, through a single contract manufacturer, FUJIFILM Diosynth Biotechnologies U.S.A., Inc. This contract manufacturer previously produced multi-Kg scale bulk batches of PRO 140 under cGMP for our Phase 2 clinical studies and is capable of producing sufficient quantities of PRO 140 for all the clinical studies required prior to submitting a BLA to the FDA. In addition, we have undertaken certain comparability studies which supported the use of previously manufactured amounts of PRO 140 in current and planned clinical studies. This process has been completed and all PRO 140 drug substance can be used in our clinical trials.
 

 

[⚡DEADHEAD⚡]

Interesting theory. But production capacity to support clinical trials is not enough; need industrial-scale manufacturing capacity.

 

[ex-ghost]

Fun. A little interesting rumor. Let's go!

 

[Capella]

Well that would really be something but can’t say I see that happening. I guess anything is within the realm but if so why aren’t insiders buying this morning? If somebody as big as the president were about to announce this multiple people would know and buys would be coming in left and right. 

 

[fantasycurse42]

These people are nuts  He doesn’t want to upstage Trump, are they serious:

 Employees at FUJIFILM are working on key elements of a potential vaccine, from the drug maker Novavax. Novavax was awarded $1.6 billion under Operation Warp Speed--the U.S. government's program to mass-produce an effective treatment.

 

[fantasycurse42]

Maybe, just maybe, he’s heading there bc theyre working on Novavax related products? They did just give them $1.6B.

No, he’s going there for Leronlimab.

 

[Capella]

Maybe, just maybe, he’s heading there bc theyre working on Novavax related products? They did just give them $1.6B.

No, he’s going there for Leronlimab.

I still say there is no chance leronlimab has been mentioned in his presence. 

 

[⚡DEADHEAD⚡]

NP has been outspoken about Trump's immigration policies. If it ever comes to it, a WH vetting might not be favorable for NP.

 

[fantasycurse42]

I still say there is no chance leronlimab has been mentioned in his presence. 

Close to zero. The only reason I don't say completely zero is because it has been mentioned a few times on this OAN thing that he supposedly loves.

 

[BassNBrew]

Bought some Fuji to mitigate some downside.

 

[FreeBaGeL]

Look, I know you want the price to go down since you are out, but you are 100% wrong in making that assumption.

You and I know nothing about the results and again you are taking the word of a known short as gospel and making a huge assumption. You could right, you could be wrong. Stop trying to be a word of reason when you are making your own assumption.

Cav's daughter isn't a short and she said the same thing, that they have top line results by now.

I am as invested in this as anyone but I'd be lying if I said I wasn't getting concerned.  This is a company that has rushed to get out info about every tiny shred of potential good news for the last 6 months as soon as they have it.  I find it a little hard to believe that given what we've seen these guys have their hands on obviously good top line results and aren't telling us.

I'm not selling any shares.  There are enough theories out there with reasons they could be holding back good results for me to hold for a hail marry, but being realistic by far the most likely reason they aren't saying anything is because the results aren't good enough to say anything about, and they're trying to stall until they get secondary endpoints or S/C results with hopefully something good.

Mostly though I'm holding because I've said all along this stock is a home run or bust for me.  I know we're not supposed to get emotionally invested in the stock market but I've set this money aside as something I'm willing to be emotional with.  Ultimately watching this thing go to $20 while I'm sitting on the sidelines would hurt a lot more than watching it go back to a buck while I'm holding.

 

[Capella]

Cav's daughter isn't a short and she said the same thing, that they have top line results by now.

I am as invested in this as anyone but I'd be lying if I said I wasn't getting concerned.  This is a company that has rushed to get out info about every tiny shred of potential good news for the last 6 months as soon as they have it.  I find it a little hard to believe that given what we've seen these guys have their hands on obviously good top line results and aren't telling us.

I'm not selling any shares.  There are enough theories out there with reasons they could be holding back good results for me to hold for a hail marry, but being realistic by far the most likely reason they aren't saying anything is because the results aren't good enough to say anything about, and they're trying to stall until they get secondary endpoints or S/C results with hopefully something good.

Mostly though I'm holding because I've said all along this stock is a home run or bust for me.  I know we're not supposed to get emotionally invested in the stock market but I've set this money aside as something I'm willing to be emotional with.  Ultimately watching this thing go to $20 while I'm sitting on the sidelines would hurt a lot more than watching it go back to a buck while I'm holding.

I agree with all of this but you could also say that if they know it’s a grand slam they can wait a few days to get everything in a line. 

 

[⚡DEADHEAD⚡]

Cav's daughter isn't a short and she said the same thing, that they have top line results by now.

I am as invested in this as anyone but I'd be lying if I said I wasn't getting concerned.  This is a company that has rushed to get out info about every tiny shred of potential good news for the last 6 months as soon as they have it.  I find it a little hard to believe that given what we've seen these guys have their hands on obviously good top line results and aren't telling us.

I'm not selling any shares.  There are enough theories out there with reasons they could be holding back good results for me to hold for a hail marry, but being realistic by far the most likely reason they aren't saying anything is because the results aren't good enough to say anything about, and they're trying to stall until they get secondary endpoints or S/C results with hopefully something good.

Mostly though I'm holding because I've said all along this stock is a home run or bust for me.  I know we're not supposed to get emotionally invested in the stock market but I've set this money aside as something I'm willing to be emotional with.  Ultimately watching this thing go to $20 while I'm sitting on the sidelines would hurt a lot more than watching it go back to a buck while I'm holding.

I am hopeful the new advisory board members are doing their jobs and essentially telling NP that the old way of doing things was unbecoming of a company seeking NASDAQ uplisting and it's time for NP to follow their lead. That means the findings of this study is perhaps the most significant event in this company's history and the report had better be bullet proof.

A person can hope...

 

[fantasycurse42]

I agree with most of what has been said. My fear is NP is an incompetent moron and if he had good news, nothing on Earth would hold him from getting it out. The delay is very concerning, and if he tries stalling on Thursday, at the point I have to think about becoming a seller. 

Meh, who am I kidding, I'm not selling... I'm going down in a big ball of flames. 

 

[Zegras11]

I agree with most of what has been said. My fear is NP is an incompetent moron and if he had good news, nothing on Earth would hold him from getting it out. The delay is very concerning, and if he tries stalling on Thursday, at the point I have to think about becoming a seller. 

Meh, who am I kidding, I'm not selling... I'm going down in a big ball of flames. 

I think the biggest bang for the buc is to not announce anything until the day it's up listed.   A lot of people can not buy OTC stocks 

 

[fantasycurse42]

I think the biggest bank for the buc is to not announce anything until the day it's up listed.   A lot of people can not buy OTC stocks 

Could be months, and if results are good for the drug, they need some publicity... The easiest way to get publicity is to publish results showing efficacy. 

 

[fantasycurse42]

Looks like it’ll open higher. I’ll predict a repeat of a decent gain (say to $5.65) and then a slow walk down to close marginally lower at $5.35

Nice call. 

 

[Don Hutson]

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=157178805

CYDY ticker just on Fox Business news with JNJ, ABT, PFE, HOLX and others with headline "Developing COVID-19 Therapies/Vaccines/Tests"

 

[⚡DEADHEAD⚡]

I think the biggest bang for the buc is to not announce anything until the day it's up listed.   A lot of people can not buy OTC stocks 

I'm not as confident uplisting is in the cards or a lock. Am I missing something?

 

[The Tahitian Facemask]

Biotech Stock Catalyst and FDA Calendar
 

Search on Covid for a listing of what’s in the pipeline.

 

[stbugs]

Cav's daughter isn't a short and she said the same thing, that they have top line results by now.

I am as invested in this as anyone but I'd be lying if I said I wasn't getting concerned.  This is a company that has rushed to get out info about every tiny shred of potential good news for the last 6 months as soon as they have it.  I find it a little hard to believe that given what we've seen these guys have their hands on obviously good top line results and aren't telling us.

I'm not selling any shares.  There are enough theories out there with reasons they could be holding back good results for me to hold for a hail marry, but being realistic by far the most likely reason they aren't saying anything is because the results aren't good enough to say anything about, and they're trying to stall until they get secondary endpoints or S/C results with hopefully something good.

Mostly though I'm holding because I've said all along this stock is a home run or bust for me.  I know we're not supposed to get emotionally invested in the stock market but I've set this money aside as something I'm willing to be emotional with.  Ultimately watching this thing go to $20 while I'm sitting on the sidelines would hurt a lot more than watching it go back to a buck while I'm holding.

Whyatt came out and said it was 4-6 weeks for results. Somehow morphed into top line results could leak out in 3 days. As @Capella said, knowing results isn’t the same as reporting them. I’m sorry, but you’ve got app these hurdles with trials and I find it hard to believe that companies going for actual FDA approval are just throwing numbers out without spending the time to review them and certify them. SAEs are simple numbers so seeing that is not surprising.

Also, while his daughter may be in the field, @chet referenced someone with true credentials in clinical trials and it wasn’t a 3 day turnaround. I don’t know much about clinical trials but I’d be shocked if most companies report results 3 days after a trial is unblinded. Maybe they know the results, but verifying the numbers, certifying them and then reporting them is not immediate.

 

[Capella]

Conference call will be about how it’s rantes and not panties imo 

 

[adonis]

Best hope is that before opening tomorrow, wed or thur the full results drop.  If we roll into the conference call with no results beforehand, warning bells will be ringing...the sad, sad news...

 

[Sand]

There is chatter on the message boards that Trump's visit today to the Fujifilm plant is because of leronlimab.  Fujifilm made leronlimab in the past and would be an obvious choice to make it again if they were going to seriously ramp up production.  They are speculating that Nader hasn't let the cat out of the bag because he didn't want to upstage Trump.  It is possible that they asked for the review of the S/C data last week and didn't tell us.  Obviously, message board speculation is often flimsy.  Trump is scheduled to participate in a Coronavirus briefing at the Fujifilm plant at 3:30pm today.

This begs the question - what else COVID related is/could be going on at the Fujifilm plant?  I ask out of pure ignorance.  

Edit:  NM - saw the note about Novavax.

 

[SouthJersey]

Conference call will be about how it’s rantes and not panties imo 

Stock price would go up 10% if NP only said this and just ended the call.

 

[fantasycurse42]

This begs the question - what else COVID related is/could be going on at the Fujifilm plant?  I ask out of pure ignorance.  

Novavax

 

[Don Hutson]

Ranting about Panties

Panting from Rantes

 

[fantasycurse42]

Wasn't there a meeting with the DSMB this week? If so, he doesn't even know anything about the severe arm yet, no? So when he mentions comprehensive (and I think he added that in as fluff) update on Thursday, how the #### can he even know what is involved for that trial? Guy comes off as a huckster to me and my skepticism continues to grow.

Honestly, if we had a CEO with any credibility at all, my confidence would be 3-4x where it is now. 

 

[adonis]

Wasn't there a meeting with the DSMB this week? If so, he doesn't even know anything about the severe arm yet, no? So when he mentions comprehensive (and I think he added that in as fluff) update on Thursday, how the #### can he even know what is involved for that trial? Guy comes off as a huckster to me and my skepticism continues to grow.

Honestly, if we had a CEO with any credibility at all, my confidence would be 3-4x where it is now. 

I'm going to guess "comprehensive" to him means he's not just touching on the m/m results, or the s/s peek, but going to review the state of everything.  All trials, all results, remind us of how many indications there are, HIV potential, cancer potential, next steps for FDA (likely has a date for the meeting to follow-up on the RTF) etc...and open up the floor to questions.

He seems to pride himself that the company is transparent and they answer questions.  I think it may have bothered him that no questions could be asked last week, so he's looking to give folks updates on everything and allow questions in an effort to show transparency and instill confidence.

I'm going to guess a bit part of the plan is to keep the SP above $3-4 for the uplisting, and they have to do that in the fact of uncertainty around results, or even in the face of bad results.  If the results aren't good (no benefit to Covid patients, which is certainly possible), then he'll be making an appeal for the company prospects as a whole to keep people invested, so up listing can take place. 

Again, if the results are good, no pep-talk is necessary.  So, in my opinion, the Trump stuff is a pipe dream.  Just conjecture built on hopes until there are results out to back it up.  Bigger fish out there the admin is focused on, and our desire to hit it big makes us think that they'll notice CYDY.  It all goes back to the results.  Nothing else matters.  A press conference doesn't matter unless there are results or the results are discussed.  We fly with good ones, sink with bad ones.  Nothing else matters.

ETA: FDA approval would matter...but that's about the only thing other than results that would move the needle.  A meeting with FDA to clear hurdles from the RTF, getting pushed ahead, and an approved drug which could then be used off-label would be big. Odds are that gets pimped.

 

[fantasycurse42]

We have 3 trading days to figure this out. Maybe we make a list of everything we know? We need to put all the ingredients in the pot to come up with the best possible hypothesis to what we will hear on Thursday. I believe this is the first call Jacob Lalezari will be present on? He is their interim CM(medical)O and was brought on specifically for Covid related trials

My initial lean is he is stalling and waiting for the severe trial, tbh.

 

[unckeyherb]

Could be months, and if results are good for the drug, they need some publicity... The easiest way to get publicity is to publish results showing efficacy. 

On the call last week, NP said Uplisting was 3 weeks away.  Take that with whatever gauge grain of salt you prefer, but that's what he said.