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***OFFICIAL CYDY/Leronlimab Thread*** (6 Viewers)

fantasycurse42 said:
I've done this, and I've put about $5k in my pocket, if it goes to zero, I'll still have $5k. That doesn't change the fact that I have $40k of very real money still floating out there. I personally don't want to give that back, nor do I think anyone else wants to let go of nice gains. 

I'm not trying to be a #### here, but I just went back and read a few pages of unorganized incoherent mumbo jumbo... I'm asking for everyone to put together their thoughts in an organized manor so I can add it up and come up with probabilities, it's beneficial for us to decide what type of risk makes sense here. It's a good exercise to run through in an organized fashion. 
You need to cash out more stock. You're way too worried.

 
Polish Hammer said:
"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 kind of lean that this is where we are at with the mild to moderate but it would still be enough to warrant a phase 3 trial.

 
Capella said:
How are there still message boards that look like that? 
Seems like a big opportunity for someone to create a good message board for finance.

Yahoo's format is fine, they literally have too many yahoos though.

A site with a little moderation and a good format would go a long way.

 
When in doubt, I always go back to the Doctors.  They are the only thing that keep me in it.

Bruce Patterson is on record saying,  more than once i believe, that "within 14 days the viral load was zero". Since I'm sure he is not making that up.  Isn't that something that should help the mild to moderate trial?

 
So we've been seemingly range bound for nearly a month. Granted, volume has dropped way off. But if you look back, it sat at .30 for a long period of time, then up to 1.00, then up to 3.00, now it this 4.50 - 6.50 range. I could see this settling in at this level until we have real news. That could be through a Phase 3 imo.

 
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.
This is spot on.  I agree a strike out is fully possible.  Of the data we can draw on right now we have safety data from the current trial that looked quite good with respect to SAEs.  Those were not insignificant numbers.  The early study was promising.  The odds are still pretty good (IMO).  I continue to hold knowing this is likely a binary outcome.

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”. 
Or, like Remdesivir, have a great marketing arm to change the endpoint and then claim victory.

 
Picked up some shares towards the end of the day at 5.35.  Previously bought some at $5.45.  Filling back in what I sold at the beginning of the week for $5.75.

 
Two 100k share purchases after hours and another 15.5k share purchase, all under 5.4.

Unusual times.

 
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Quite a few people seem to be wandering into the CYDY discussion thread that apparently don't want CYDY discussion.

We're on a holding pattern until news, so discussion is what is going to fill this thing up.  If that's not your jam and you just want news then put in a google news alert for CYDY and be done with it.

 
Two 100k share purchases after hours and another 15.5k share purchase, all under 5.4.

Unusual times.
I don't think those are after hours trades--I think it's the market makers doing an adjustment.  I don't think OTCBB is allowed to trade pre- or post- market.

 
'Member WORLD SURVEILLANCE GROUP INC"? I think it was formerly known as Globetel and bought into it on a buddy's recomendation back in the 'aughts. Simply speaking, "lighter than air" blimps serving  supporting locales lacking Internet...or world surveillance. IIRC, it was covered in the Hub.  Didn't end up so well.  Wonder if it's worthless yet?

 
Two 100k share purchases after hours and another 15.5k share purchase, all under 5.4.

Unusual times.
I don't think those are after hours trades--I think it's the market makers doing an adjustment.  I don't think OTCBB is allowed to trade pre- or post- market.
Thanks for the info.  Is there any good reason why someone would be doing that on some days and not on others?  Does it indicate anything?

I've been watching closely for weeks and only saw it happen once before (yesterday) although I've seen a few times where 100k shares were bought/sold during the trading day.  

 
fantasycurse42 said:
I'm keeping a list, let's all contribute:

- Didn't meet endpoint goal, other positive data though

- Coupling with severe from interim

- Bad results

- Stalling for severe

- Trump is fully onboard with Leronlimab being the savior and he doesn't want to upstage him

Let's keep going. We need a comprehensive list and then we need to analyze it to come to the most logical conclusion. 
There are several things you're not including:

  • Dr. Otto Yang spoke positively about the drug.
  • Dr. Patterson claims ZERO viral load after 14 days.
  • Signed a distribution agreement.
  • Signed a manufacturing agreement.
  • Submitted to register the drug under the name "Immunovance." (IIRC)
  • Advisory board members consist of seemingly well regarded individuals (I am putting a lot of faith into this, probably more than I should)
  • To a far lesser extent, Dr. Been, Dr. Yo, Dr. Drew exposure, as immature or "un-Dr." like as they are.
There's more.

 
'Member WORLD SURVEILLANCE GROUP INC"? I think it was formerly known as Globetel and bought into it on a buddy's recomendation back in the 'aughts. Simply speaking, "lighter than air" blimps serving  supporting locales lacking Internet...or world surveillance. IIRC, it was covered in the Hub.  Didn't end up so well.  Wonder if it's worthless yet?
Uh, sir, this is a Wendy’s.

 
There are several things you're not including:

  • Dr. Otto Yang spoke positively about the drug.
  • Dr. Patterson claims ZERO viral load after 14 days.
  • Signed a distribution agreement.
  • Signed a manufacturing agreement.
  • Submitted to register the drug under the name "Immunovance." (IIRC)
  • Advisory board members consist of seemingly well regarded individuals (I am putting a lot of faith into this, probably more than I should)
  • To a far lesser extent, Dr. Been, Dr. Yo, Dr. Drew exposure, as immature or "un-Dr." like as they are.
There's more.
I would add:

NP waiting for short attach to release all the positive data.  In the process, bankrupting all of his enemies.

 
I would at least like to hear that the Mexico trial is moving forward. Not sure what happened there.  NP seemed to think Mexico dropped the ball and didn't tell them that they didn't have what they needed to get it started.  Cytodyn dropped the ball by not following up to make sure that they did.  Either way, there hasn't been any recent updates and still seems to be in limbo.

A Mexico trial is at least a good backup to have while we figure out what is going on with the FDA in the USA.  Its quite possible it could get approved in Mexico first which would not be a bad thing IMO.

Think we need a better explanation on what is happening on this front.

 
I would at least like to hear that the Mexico trial is moving forward. Not sure what happened there.  NP seemed to think Mexico dropped the ball and didn't tell them that they didn't have what they needed to get it started.  Cytodyn dropped the ball by not following up to make sure that they did.  Either way, there hasn't been any recent updates and still seems to be in limbo.

A Mexico trial is at least a good backup to have while we figure out what is going on with the FDA in the USA.  Its quite possible it could get approved in Mexico first which would not be a bad thing IMO.

Think we need a better explanation on what is happening on this front.
NP probably dropped the ball.  He talks as if things are ongoing when he hasn't started them yet.  Look at the uplisting.  3 weeks before Nasdaq he was talking about the NYSE as if he had already put the paperwork in.  

He means to get to everything, but he shouldn't act as if something is in process when it hasn't really been started.

 
I would at least like to hear that the Mexico trial is moving forward. Not sure what happened there.  NP seemed to think Mexico dropped the ball and didn't tell them that they didn't have what they needed to get it started.  Cytodyn dropped the ball by not following up to make sure that they did.  Either way, there hasn't been any recent updates and still seems to be in limbo.

A Mexico trial is at least a good backup to have while we figure out what is going on with the FDA in the USA.  Its quite possible it could get approved in Mexico first which would not be a bad thing IMO.

Think we need a better explanation on what is happening on this front.
What I think is that we are a small fish in a big pond regarding Mexico and that there are other bigger players that are in the forefront there. That our communication to Mexico wasn't missed by them suggests to me that perhaps we weren't at the top of their list. You know when NP was first talking about Mexico way back I was thinking that we were being sought out and in an esteemed position with them. Hoped this was the case because, if we only needed to do a 25 person trial and could include the compassionate use data to supplement, that was easy street to me. 

Its coming to be a realization with me the small pieces of information we have about CYDY and its competence are like Rorschach tests and you make your own interpretation of them based on what you want to see. 

 
What I think is that we are a small fish in a big pond regarding Mexico and that there are other bigger players that are in the forefront there. That our communication to Mexico wasn't missed by them suggests to me that perhaps we weren't at the top of their list. You know when NP was first talking about Mexico way back I was thinking that we were being sought out and in an esteemed position with them. Hoped this was the case because, if we only needed to do a 25 person trial and could include the compassionate use data to supplement, that was easy street to me. 

Its coming to be a realization with me the small pieces of information we have about CYDY and its competence are like Rorschach tests and you make your own interpretation of them based on what you want to see. 
If the efficacy results are good, Mexico won't have any delays.

 
There are things that Trump has lied about for sure, this isn't one of them.
I heard you the first time.

If you think we should be investing our money in hydroxy as opposed to LL, please give your reasons why. Right now the FDA, UK and WHO consider hydroxy as not good science for co-vid.

 
I don’t know if he’s lying or just dumb or spoiler both, but he’s definitely wrong. 
Nope, he said it has been shown to help which studies have shown as true.  I don't believe it is the answer by any means but that doesn't mean he is lying.  

Anyways, back to CYDY

 
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Has this been discussed before:

http://ddn-news.com/index.php?newsarticle=13639 (September 2019)

VANCOUVER, Wash.—Biotechnology company CytoDyn Inc. is moving into the commercial space with the announcement of an exclusive licensing agreement with IncellDX to sell non-commercial grade quantities of PA-14 or PRO 140 (humanized PA-14) for use in developing and commercializing immunoassays for quantitative measurement of CCR5 levels on human cells. Per the terms of the agreement, IncellDX will be responsible for all aspects of assay development, regulatory clearance, and PA-14 or PRO 140 labeling, packaging and commercialization. At the end of each month for the duration of the deal, IncellDX will provide CytoDyn with demand forecasts for the two compounds for the upcoming three-month period. Specific financial terms were not disclosed.

“The execution of the definitive agreement with IncellDX marks an important milestone for CytoDyn, as it puts us firmly on pace to generate our first revenues over the course of the next several months,” Dr. Nader Pourhassan, CytoDyn’s president and CEO, said in a press release. “We are thankful to Dr. Patterson for recognizing the value of PA-14 and PRO 140 as a potent and valuable asset as a diagnostic test to measure CCR5 expression on human cells.”

PRO 140 (leronlimab) is an investigational humanized IgG4 monoclonal antibody (mAb) that blocks CCR5. To date, leronlimab has been evaluated in nine clinical trials in more than 800 people, and the U.S. Food and Drug Administration has granted a Fast Track designation for leronlimab in two potential indications: as a combination therapy with highly active antiretroviral therapy (HAART) for HIV-infected patients, and for metastatic triple-negative breast cancer.

“IncellDX is very excited to license the exclusive worldwide diagnostic rights to CytoDyn’s CCR5 antibody that binds to the same site as PRO 140, an exciting therapeutic in trials for HIV and cancer,” stated Dr. Bruce Patterson, founder and CEO of IncellDX. “This agreement fits with our strategy to develop companion diagnostics for powerful new classes of drugs. We expect this new product line will be a major growth driver for IncellDX in the second half of 2019 and beyond.”

As for what made IncellDX stand out as a partner for this work, Pourhassan explains that they have worked together before.

“We have a special diagnostic test that we had IncellDX develop for us that we need in order to commercialize our monotherapy trial. That assay could use our own antibody as a staining,” he says, adding that “IncellDX has done substantial work in the CCR5 space, and they indicated they can purchase our product for other companies they do different projects for. Therefore, as a ‘diagnostic use’ and not therapeutic use, this made a lot of sense for us.”

While the companies are optimistic about leronlimab’s potential as a diagnostic, Pourhassan tells DDNews that as a therapeutic, its market potential is even greater. He notes that some reports estimate a market value of $1 billion to $2 billion for a combination therapy for HIV, and more than $7 billion as a monotherapy.

Beyond HIV, Pourhassan notes that CCR5 antagonists are also being explored in triple-negative breast cancer, colon cancer, nonalcoholic steatohepatitis, multiple sclerosis and graft-versus-host disease.

CCR5 plays a role in all of those diseases to some degree, and as such, offers a new target. In HIV/AIDS, leronlimab masks CCR5, which protects healthy T cells from infection by blocking the predominant HIV (R5) subtype from entering the cells. In addition, leronlimab is a self-injectable, subcutaneous injection—the world’s first such option for HIV, according to CytoDyn. Unlike HAART, it causes no serious side effects or serious adverse events, the company states, and also offers better compliance and a longer half-life. Beyond that, “76 percent of patients have resistance to at least one drug with HAART. There has been no drug resistance in patients identified in patients taking Leronlimab in monotherapy for over four years,” CytoDyn reports on its website.

In cancer, CCR5 is implicated in tumor invasion and metastasis, with increased expression serving as an indicator of disease status in many cancer types. By blocking CCR5, researchers have shown they can reduce tumor metastases in lab and animal models of breast and prostate cancer—and leronlimab reduced human breast cancer metastasis by more than 98 percent in a mouse xenograft model.

There is also support for this receptor as a culprit in graft-versus-host disease. Studies have shown that blocking CCR5 can reduce the impact of acute graft-versus-host disease without significant impact on the engraftment of transplanted bone marrow stem cells.

And CytoDyn is looking into leronlimab’s potential in all of these indications. When asked what the next development step is for PRO 140, Pourhassan says “First, BLA submission and initiate our commercialization of leronlimab for combination therapy [in HIV]. Then we will have revenue to chose which indications we will explore next.”

 
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BP's company makes an assay that he thinks will help measure response to LL. Yes, we knew this.
We knew that he made that assay.  It was news to me that their business relationship went back that far - at least the middle of 2019 - and that there's a deal that basically ties, in some way, the success of leronlimab to the financial success of IncellDX. 

Again, BP is a big part of the lynchpin of why I'm invested and I've always been curious if there was more to his financial ties to Cytodyn than I knew.  This is definitely news to me that the relationship goes back that far, involves licensing leronlimab for use in their assays, and that this partnership lead him to develop the assays he recently released.  You could say that in raising the awareness of leronlimab, he's also marketing for his own assays, which calls into question (a reasonable question) his own financial stake in what he's promoting.

 
We knew that he made that assay.  It was news to me that their business relationship went back that far - at least the middle of 2019 - and that there's a deal that basically ties, in some way, the success of leronlimab to the financial success of IncellDX. 

Again, BP is a big part of the lynchpin of why I'm invested and I've always been curious if there was more to his financial ties to Cytodyn than I knew.  This is definitely news to me that the relationship goes back that far, involves licensing leronlimab for use in their assays, and that this partnership lead him to develop the assays he recently released.  You could say that in raising the awareness of leronlimab, he's also marketing for his own assays, which calls into question (a reasonable question) his own financial stake in what he's promoting.
https://www.youtube.com/watch?v=7bmrAH9rI4U - So the broader the audience for leronlimab, the more of a growth opportunity for IncellDX there is.

Again, it's a conflict of interest in terms of why he's the primary guy pimping leronlimab.  He's personally invested in the financial success of leronlimab.

ETA: Not saying the science isn't there.  What I am saying is that for my story, where BP was central, that logical step is called into question.  To be honest, there's not much solid to stand on if that's shaky ground.  Again, not saying BP is lying, or that his results aren't accurate...I am saying that objectively, one has to admit he's biased.

 
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https://www.youtube.com/watch?v=7bmrAH9rI4U - So the broader the audience for leronlimab, the more of a growth opportunity for IncellDX there is.

Again, it's a conflict of interest in terms of why he's the primary guy pimping leronlimab.  He's personally invested in the financial success of leronlimab.

ETA: Not saying the science isn't there.  What I am saying is that for my story, where BP was central, that logical step is called into question.  To be honest, there's not much solid to stand on if that's shaky ground.  Again, not saying BP is lying, or that his results aren't accurate...I am saying that objectively, one has to admit he's biased.
It was always part of my assessment. 

Does it change your course of action?

 
It was always part of my assessment. 

Does it change your course of action?
Honestly, it's my bad for not having noticed it sooner.  I'd assumed he had a financial stake to some degree, but didn't take the time to research how deep.

Again, it doesn't mean what he's found is false.  The research could be great, the results spot on, and leronlimab the miracle drug.  However, "believing BP" is no longer just trusting a man of science, with a good pedigree, who is saying the drug works...every bit of news so far coming from leronlimab has come from folks with a financial interest in the drug finding a huge market.  That's normal, but study results usually underpin their credibility sufficient that you're not just taking their word for results, for anecdotes.

The whole thing I've said before feels like we're always just around the corner from the next set of results.  From that study result, or that FDA approval, or something else.  The pitches by Nader to keep folks excited, about all the possible indications for basically everything.  It's starting to get a bit much for me.

So yes, it changes my course of action.  Not out entirely, but am pulling back my stake by at least 50% tomorrow I think, barring actual news of actual results.  The fact that this is coming soon is great news and if it comes before tomorrow's opening, I'll be lucky.  Otherwise, i'm cutting my risk here considerably.

 
NP probably dropped the ball.  He talks as if things are ongoing when he hasn't started them yet.  Look at the uplisting.  3 weeks before Nasdaq he was talking about the NYSE as if he had already put the paperwork in.  

He means to get to everything, but he shouldn't act as if something is in process when it hasn't really been started.
I had a friend like this in college.  One time he put his arm in a sling and faked injury so that the professor would give him more time to (start and) finish a report.

i swear if NP shows up to Thursday’s conference call with his arm in a sling I might sell before he says anything!

 
https://www.youtube.com/watch?v=7bmrAH9rI4U - So the broader the audience for leronlimab, the more of a growth opportunity for IncellDX there is.

Again, it's a conflict of interest in terms of why he's the primary guy pimping leronlimab.  He's personally invested in the financial success of leronlimab.

ETA: Not saying the science isn't there.  What I am saying is that for my story, where BP was central, that logical step is called into question.  To be honest, there's not much solid to stand on if that's shaky ground.  Again, not saying BP is lying, or that his results aren't accurate...I am saying that objectively, one has to admit he's biased.
This is the only red flag that i see with Patterson which is why the peer review is so critical.  Need more doctors to validate this.

 

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