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***OFFICIAL CYDY/Leronlimab Thread***


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This is another fail like CD10 for which the company has never released data. CD12 is clearly a fail and they are not releasing data here either. If data were positive NP would be letting you know in big bold letters.

Just another manipulation through vague wording that makes no sense. Stall tactic why NP tries to buy time to come up with something to keep people in. I would guess that long haulers is going to be that next big talking point.

It still grinds me I fell for this side show carnival pitch. I remember the video conference that had NP, Patterson and Alazari all present and saying things that God was smiling down on us because of what LL can do.

Unless the SEC should ever decide to step in I can still see NP luring in people. And there probably is still money to be made playing pump and dump. But it is not a stock to be in if you are a true long.

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Yes, go ahead FC42

I closed.  Cydy operation mountain house completed.

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

This PR pretty much confirms it didn't hit. 

I think NP doesn't have the pull to get this through without statistical significance. 

I don't know if there's precedent set, but CYDY might get caught in purgatory where it's kept open as an eIND just as a method of last resort. 

I think I'll cut my shares again.

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42 minutes ago, Moonlight said:

This is another fail like CD10 for which the company has never released data. CD12 is clearly a fail and they are not releasing data here either. If data were positive NP would be letting you know in big bold letters.

Just another manipulation through vague wording that makes no sense. Stall tactic why NP tries to buy time to come up with something to keep people in. I would guess that long haulers is going to be that next big talking point.

It still grinds me I fell for this side show carnival pitch. I remember the video conference that had NP, Patterson and Alazari all present and saying things that God was smiling down on us because of what LL can do.

Unless the SEC should ever decide to step in I can still see NP luring in people. And there probably is still money to be made playing pump and dump. But it is not a stock to be in if you are a true long.

I know you are really jaded but it's not clearly a fail if the FDA has not pulled the OLE or eIND.

Trust me, I'm juggling both arguments in my mind here but I don't think anything is clear.

I feel like they are probably close, perhaps more data comes in from the OLE patients that puts them over the edge. I really don't believe it's game over yet or we would know that.

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48 minutes ago, Moonlight said:

This is another fail like CD10 for which the company has never released data. CD12 is clearly a fail and they are not releasing data here either. If data were positive NP would be letting you know in big bold letters.

Just another manipulation through vague wording that makes no sense. Stall tactic why NP tries to buy time to come up with something to keep people in. I would guess that long haulers is going to be that next big talking point.

It still grinds me I fell for this side show carnival pitch. I remember the video conference that had NP, Patterson and Alazari all present and saying things that God was smiling down on us because of what LL can do.

Unless the SEC should ever decide to step in I can still see NP luring in people. And there probably is still money to be made playing pump and dump. But it is not a stock to be in if you are a true long.

Somebody on yahoo said the language about “in discussions with fda etc” was the same from a PR for cd10 back in September. 
 

"CytoDyn will also provide an update on the ongoing discussions with the FDA and the U.K. Medicines & Healthcare product Regulatory Agency (MHRA) for leronlimab as a treatment for COVID-19." - Sept 10

Edited by Capella
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I'm worn out on this ride, I will say that much.  

Put a lot of time into staying updated, most of that time is obviously just wasted time as nothing happens.

Then when you do get a PR, its murky and makes you question what you are doing here.

I dont trust NP but I still trust the Doctors that have been advocating it.   Its possible though, they just didn't design the most efficient trial to showcase its strengths and are now in purgatory again.

If its close, will the FDA trust Cytodyn enough to want to work with them?  That answer is a struggle for me, I don't know that they would... Cytodyn needs a partner here I think

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Here's something I heard earlier today.  The ongoing FDA discussions could be CYDY asking for full approval instead of EUA because they showed the drugs works for mild/moderate in CD10.  A full approval would allow for off-label use whereas an EUA would not. The FDA does not have ongoing discussions with companies whose drugs fail.  Also telling is that OLE and EINDs continue.  Another point is that the data was unblinded earlier--we don't know exactly when.  He would have had to announce a bad trial if that were the case.  

All in all, it was supremely stupid to issue that PR but I've come to expect that. 

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6 minutes ago, Dwayne Hoover said:

I'm worn out on this ride, I will say that much.  

Put a lot of time into staying updated, most of that time is obviously just wasted time as nothing happens.

Then when you do get a PR, its murky and makes you question what you are doing here.

I dont trust NP but I still trust the Doctors that have been advocating it.   Its possible though, they just didn't design the most efficient trial to showcase its strengths and are now in purgatory again.

If its close, will the FDA trust Cytodyn enough to want to work with them?  That answer is a struggle for me, I don't know that they would... Cytodyn needs a partner here I think

Yea now that I’ve been out of it today I’m not sure I’m getting back in. Lot of lost time following this crap. We’ll see. I just don’t trust the company at all. 

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2 minutes ago, chet said:

Here's something I heard earlier today.  The ongoing FDA discussions could be CYDY asking for full approval instead of EUA because they showed the drugs works for mild/moderate in CD10.  A full approval would allow for off-label use whereas an EUA would not. The FDA does not have ongoing discussions with companies whose drugs fail.  Also telling is that OLE and EINDs continue.  Another point is that the data was unblinded earlier--we don't know exactly when.  He would have had to announce a bad trial if that were the case.  

All in all, it was supremely stupid to issue that PR but I've come to expect that. 

How do we know the fda is having conversations? Just because Nader put it in a PR? If the fda said no thanks they aren’t going to come out and announce it. 
 

We truly don’t even know if the OLE and EINDs are being used. We assume they are but as far as I know there isn’t any proof. 
 

I’m just tired of the deception and incompetence. 

Edited by Capella
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4 minutes ago, chet said:

.  

All in all, it was supremely stupid to issue that PR but I've come to expect that. 

If its proving to be a warning sign, Im glad he did.

Current stock price doesnt matter to me, the end goal is all that matters.  That PR seems to be saying its a murky situation though, that's the current read I have and if it really is, then I need to sell more shares.

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11 minutes ago, Capella said:

How do we know the fda is having conversations? Just because Nader put it in a PR? If the fda said no thanks they aren’t going to come out and announce it. 
 

We truly don’t even know if the OLE and EINDs are being used. We assume they are but as far as I know there isn’t any proof. 
 

I’m just tired of the deception and incompetence. 

I talked to two people today who have been investors for years.  They both own several million shares and have met NP many times.  I said the only way the item about ongoing discussions with the FDA could be negative is if NP is lying about it.  Neither of them thinks highly of him but they both said there's no way he's stupid enough to lie about that.  Lie in a material way on an official PR?  I just don't think it's possible.

 

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1 minute ago, chet said:

I talked to two people today who have been investors for years.  They both own several million shares and have met NP many times.  I said the only way the item about ongoing discussions with the FDA could be negative is if NP is lying about it.  Neither of them thinks highly of him but they both said there's no way he's stupid enough to lie about that.  Lie in a material way on an official PR?  I just don't think it's possible.

 

They are definitely having conversations, the big question is do they already know the data is borderline

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1 minute ago, chet said:

I talked to two people today who have been investors for years.  They both own several million shares and have met NP many times.  I said the only way the item about ongoing discussions with the FDA could be negative is if NP is lying about it.  Neither of them thinks highly of him but they both said there's no way he's stupid enough to lie about that.  Lie in a material way on an official PR?  I just don't think it's possible.

 

Ok that’s true but maybe he’s not lying but just omitting truth. Yes we are in discussions but we haven’t heard from the fda for 3 weeks or whatever. 
 

What was the point of the PR? He absolutely HAD to know what that would do to the share price. 

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Just now, Dwayne Hoover said:

They are definitely having conversations, the big question is do they already know the data is borderline

Or do they know it's fantastic?

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Just now, Capella said:

Ok that’s true but maybe he’s not lying but just omitting truth. Yes we are in discussions but we haven’t heard from the fda for 3 weeks or whatever. 
 

What was the point of the PR? He absolutely HAD to know what that would do to the share price. 

I've stopped trying to interpret what he does, and to a lesser extent Scott Kelly.  I will say that he probably thought it would help the stock but he has no experience in the stock market and isn't qualified to make those determinations.  

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FDA recommendations to monoclonal antibody producers.

Quote

Given the serious concerns raised by the emergence of SARS-CoV-2 variants, FDA intends to leverage its emergency authorities under section 564 of the FD&C Act, when appropriate, to foster the development and availability of therapeutics for use during the current public health emergency. When scientifically supported, FDA will streamline the data necessary to support the development of monoclonal antibody products targeting SARS-CoV-2 and also expedite the review of these data.

 

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8.2 mil shares traded in the first 30 minutes. This type of whip saw action is usually a bottom.

Almost 3x the amount of shares traded in any 30-minute period in the last month.
 

Edited by Getzlaf15
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1 minute ago, Getzlaf15 said:

8.2 mil shares traded in the first 30 minutes. This type of whip saw action is usually a bottom.

Almost 3x the amount of shares traded in any 30-minute period in the last month.
 

I show 8.42MM shares traded for the day.  Are you saying only 220k shares have traded in the last 5.5 hours?  That can't be right.

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Just now, chet said:

I show 8.42MM shares traded for the day.  Are you saying only 220k shares have traded in the last 5.5 hours?  That can't be right.

I have about 16.5 shares traded today

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1 minute ago, Getzlaf15 said:

I have about 16.5 shares traded today

Interesting.  Ameritrade is reporting 8.45MM now.  What's your source?

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Just now, chet said:

Interesting.  Ameritrade is reporting 8.45MM now.

I see that on Fidelity also.  But the graph price chart with the volume bar chart at the bottom on Fidelity adds up to 16.5

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17 minutes ago, chet said:

FDA recommendations to monoclonal antibody producers.

Quote

Given the serious concerns raised by the emergence of SARS-CoV-2 variants, FDA intends to leverage its emergency authorities under section 564 of the FD&C Act, when appropriate, to foster the development and availability of therapeutics for use during the current public health emergency. When scientifically supported, FDA will streamline the data necessary to support the development of monoclonal antibody products targeting SARS-CoV-2 and also expedite the review of these data.

A whole lot of drugs ending in "...imab" in Fauci's presentation a few minutes ago.  One notable omission (actually two, for those of us also holding HGEN).

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1 minute ago, SFBayDuck said:

A whole lot of drugs ending in "...imab" in Fauci's presentation a few minutes ago.  One notable omission (actually two, for those of us also holding HGEN).

Which ones did he mention and where are they in development compared to LL?

He probably mentioned Tocilizumab (approved).

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36 minutes ago, chet said:

 Neither of them thinks highly of him but they both said there's no way he's stupid enough to lie about that.  Lie in a material way on an official PR?  I just don't think it's possible.

Didn't he do as much about the Nasdaq uplist application?  Was that ever in an actual PR?

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9 minutes ago, chet said:

Which ones did he mention and where are they in development compared to LL?

He probably mentioned Tocilizumab (approved).

I actually didn't catch which ones he mentioned, just glanced up from my lunch and saw it on the screen.  But there were a handful.  Here's the part of the briefing where he talks about it, but while he keeps referencing "next slide" during the briefing, I can't find a version on YouTube that is actually showing the slides (which they did show on tv).

A quick google search and it looks like bamlanivimab and etesevimab (used together), casirivimab and imdevimab (used together) have EUA. 

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1 hour ago, Capella said:

Yea now that I’ve been out of it today I’m not sure I’m getting back in. Lot of lost time following this crap. We’ll see. I just don’t trust the company at all. 

Who are you? Please return the keys to my Ifriend Capella

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10 minutes ago, BassNBrew said:

Who are you? Please return the keys to my Ifriend Capella

LOL I don’t know why but that PR was my breaking point. I’m sure I’ll be buying back in. 

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2 hours ago, Dwayne Hoover said:

I know you are really jaded but it's not clearly a fail if the FDA has not pulled the OLE or eIND.

Trust me, I'm juggling both arguments in my mind here but I don't think anything is clear.

I feel like they are probably close, perhaps more data comes in from the OLE patients that puts them over the edge. I really don't believe it's game over yet or we would know that.

I do not know a lot about OLE or eIND lets get that out. But my impression is that neither means a drug is getting FDA approval. A question to be asked is how many and which people have been using LL through OLE or eIND? 

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2 hours ago, Dwayne Hoover said:

I know you are really jaded but it's not clearly a fail if the FDA has not pulled the OLE or eIND.

Trust me, I'm juggling both arguments in my mind here but I don't think anything is clear.

I feel like they are probably close, perhaps more data comes in from the OLE patients that puts them over the edge. I really don't believe it's game over yet or we would know that.

I get more jaded with each day. I mean the company was just successfully sued for unjust enrichment of mgt, the CFO is selling mucho shares just before data is supposed to be released, NP while claiming that he will obtain financing without dilution gets high interest financing that ends up in stock conversion and further dilution. Since I have been involved with CYDY I can not think of anything they have successfully accomplished.

What happened to the BLA for HIV? They again have not released why it was rejected or what needs to be fixed. 

Funny thing I would be scared to short the stock. It has such an ability of attracting new investors and raising SP through vague PRs and promotions hinting at new uses or markets in new countries.

And on the very odd chance it has something that works its getting passed by other companies able to design and complete trials that demonstrate efficacy.

There are just so many other choices out there that seem safer to me.

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1 minute ago, Moonlight said:

I get more jaded with each day. I mean the company was just successfully sued for unjust enrichment of mgt, the CFO is selling mucho shares just before data is supposed to be released, NP while claiming that he will obtain financing without dilution gets high interest financing that ends up in stock conversion and further dilution. Since I have been involved with CYDY I can not think of anything they have successfully accomplished.

What happened to the BLA for HIV? They again have not released why it was rejected or what needs to be fixed. 

Funny thing I would be scared to short the stock. It has such an ability of attracting new investors and raising SP through vague PRs and promotions hinting at new uses or markets in new countries.

And on the very odd chance it has something that works its getting passed by other companies able to design and complete trials that demonstrate efficacy.

There are just so many other choices out there that seem safer to me.

HGEN is just as risky but for different reasons.  Both could get approved, one could get approved, neither could get approved.  I'm hedging my bet a little and just making sure I have some of both.

Nothing about HGEN's trials have been screaming success though. There has been multiple endpoint changes and changes to trial size.  Did they get it right in the end?  Its a guess.  The drug seems to have its own issues. At the end of the day, I'm far from convinced it's better than leronlimab and this is more important than the CEO IMO.

I like the connections though and the CEO does carry himself better (if you ever hear from him at all)

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5 minutes ago, Dwayne Hoover said:

HGEN is just as risky but for different reasons.  Both could get approved, one could get approved, neither could get approved.  I'm hedging my bet a little and just making sure I have some of both.

Nothing about HGEN's trials have been screaming success though. There has been multiple endpoint changes and changes to trial size.  Did they get it right in the end?  Its a guess.  The drug seems to have its own issues. At the end of the day, I'm far from convinced it's better than leronlimab and this is more important than the CEO IMO.

I like the connections though and the CEO does carry himself better (if you ever hear from him at all)

I have no idea which drug is better but I sure as hell know which ceo is better. 

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36 minutes ago, Moonlight said:

I do not know a lot about OLE or eIND lets get that out. But my impression is that neither means a drug is getting FDA approval. A question to be asked is how many and which people have been using LL through OLE or eIND? 

Its not a slam dunk but if you just check out how the FDA describes OLE on its site, it definitely gives the impression that approval is a strong possibility

"They are typically used when the controlled trial has ended and treatment is continued so that the subjects and the controls may continue to receive the benefits of the investigational drug until marketing approval is obtained."

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/treatment-use-investigational-drugs

This is still a strong argument in Cytodyn's favor.  When you completely dismiss Cytodyn, you are completely dismissing this and I dont think that's right

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1 hour ago, Capella said:

LOL I don’t know why but that PR was my breaking point. I’m sure I’ll be buying back in. 

I know I’ve said this before but just for the stress reduction, I’m glad I’ve been out for a while. Made way more than I would have ever expected back when we started on something I would have never known about without Chet. It also helps that most of my reinvestments have been gang busters the past half year or so. I was down 4% today, which is a lot, but I’m way less stressed about it than I was with CYDY because almost all of it is hold for 5 years because I know they’re good companies and most are growing solidly. This company has been a big ball of stress after that bear raid. Before that it was all rainbows and unicorns.

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6 hours ago, Dwayne Hoover said:

Its not a slam dunk but if you just check out how the FDA describes OLE on its site, it definitely gives the impression that approval is a strong possibility

"They are typically used when the controlled trial has ended and treatment is continued so that the subjects and the controls may continue to receive the benefits of the investigational drug until marketing approval is obtained."

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/treatment-use-investigational-drugs

This is still a strong argument in Cytodyn's favor.  When you completely dismiss Cytodyn, you are completely dismissing this and I dont think that's right

It is my understanding that OLEs are not uncommon but usually built into clinical trial protocols to provide an option for participants to continue using the drug after the trial ends. This could occur if the participant was of the belief that the drug was of benefit and wanted to continue. I would think that this would occur more for chronic conditions than acute. Conditions such as diabetes, cholesterol etc. The OLE would permit access to the drug until it ever became available in the market.

Again I'm no expert and will yield the floor to someone with superior knowledge. That being said the OLE may have been available to CD 12 participants without any data analysis as long as the drug was determined to be safe. LL has previously had an excellent rating for safety. 

But being available for OLE doesn't mean LL is being used by any participants. First, they would have to believe it was beneficial and two believe there was a need or advantage to continuing using the drug. We do not know if any CD 12 participants continued use after the trial completed and are unlikely to know based on what the company has disclosed information. 

I see the distinct possibility that when CYDY says it has been granted OLE that it was built into the trial protocol from the beginning and there should be caution as to thinking that this a sign that the FDA  will be approving. I haven't read the trial protocol so I cant say what was in it.

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7 hours ago, Dwayne Hoover said:

HGEN is just as risky but for different reasons.  Both could get approved, one could get approved, neither could get approved.  I'm hedging my bet a little and just making sure I have some of both.

Nothing about HGEN's trials have been screaming success though. There has been multiple endpoint changes and changes to trial size.  Did they get it right in the end?  Its a guess.  The drug seems to have its own issues. At the end of the day, I'm far from convinced it's better than leronlimab and this is more important than the CEO IMO.

I like the connections though and the CEO does carry himself better (if you ever hear from him at all)

I do not know if HGEN will be approved but it seems a stronger bet based on its government and Big Pharma connections. Mayo Clinic supports it as well.

And as it relates to covid HGEN is less risky. Simply because CYDY failed on CD12. Reading the PR I cant come to any other conclusion. NP stalling with mumbo-jumbo about meeting with regulators and needing to keep things confidential. Allows him to possibly say that delays in approval are to due to the regulators and not the company and no one has data to say otherwise.

CYDY SP went down a lot after CD10 failed and it took many months to come back.

Anyway this is a CYDY board and I'm going to take a hiatus, not my intent to get into conflict. But I did like being part of the CYDY gang, it was an exciting time. But now I feel like the older brother who knows his sister is marrying the wrong fellow.

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28 minutes ago, Moonlight said:

 

Again I'm no expert and will yield the floor to someone with superior knowledge. That being said the OLE may have been available to CD 12 participants without any data analysis as long as the drug was determined to be safe. LL has previously had an excellent rating for safety. 

 

A couple of things here. 

CD12 participants in this case means trial sites.  These would be NEW patients that fit the criteria that the doctors at those sites can administer it too. 

Secondly, I do think the data from these patients will be taken into consideration.  Especially if things are close.  This is my opinion only.

The one thing I don't know is how many of these are actively being used.  That does make me question it a bit because I've never heard about any specific new patient anecdotals that have received this and I know NP loves his anecdotals. 

 

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16 minutes ago, Moonlight said:

 

 Simply because CYDY failed on CD12. Reading the PR I cant come to any other conclusion. NP stalling with mumbo-jumbo about meeting with regulators and needing to keep things confidential. Allows him to possibly say that delays in approval are to due to the regulators and not the company and no one has data to say otherwise.

 

I can't even legitimately argue that NP's track record with PRs that are not clear, will turn out positive.  They don't.

Its the old fool me once, shame on you, fool me twice, shame on me, fool me three times, im an idiot.

I'm really skeptical too.  This PR could be exactly what he says it is and everything will still be fine but he's given me no reason to trust him.  

I'm willing to give a little more rope because I am playing with house money so its not going to kill me , even if went to 0.  That being said, I hate giving the money back too, especially if I'm being flat out duped.  Tough one.

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From Reddit:

Quote

Had a long chat with a college professor who was a former FDA official about Leronlimab. This is not the first time we spoke about Cytodyn, to be clear, he cannot invest in pharma but he provided the following info: If the company is in talks with the FDA, there's a 99 percent chance of approval. Given they have the OLE, that's a telltale sign. Medicare billing codes and EIND are aces in the hole. Chances are the talks are for labeling and that imported drug policies are met. To him it sounds like the FDA is guiding and helping Cytodyn get approved and get it done as quickly as possible. BTW, he reads this board and I asked him to possibly join and chime in, he's going to see if he can do so legally.

 

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Sold 20% this morning at $4.17 to go bargain shopping elsewhere such as Tesla at $633.  Wish I had done the smart thing and unloaded all of this but I just can't quit it.

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22 minutes ago, BassNBrew said:

Sold 20% this morning at $4.17 to go bargain shopping elsewhere such as Tesla at $633.  Wish I had done the smart thing and unloaded all of this but I just can't quit it.

Wow tesla got to 633?? 😔 shoulda been in that 

 

edit; all the way to 619. Dammit

Edited by Capella
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HGEN doing worse than CYDY today.  I'm not celebrating this, I own both.  Day to day shouldn't matter for either, aside from buying low and selling high of course.  Matters more to the day traders for sure.

Anyway, I was gonna make a point here.  HGEN has had no news at all today and it's tanking.  People criticize Nader for being too vocal (myself included) but then Durrant not ever saying anything, is not any better for the current stock price.

I guess its a good buying day if you like HGEN, that's all.

In long run it's just as risky as CYDY though, I absolutely believe it has its own flaws.  Both are still equal in that they are in the VERY speculative category.

Just kind of bugs me that you've got people that think HGEN is far superior to CYDY, they are yin and yang, just different approaches.

Will be lucky if I go 1/2 with these, both getting approvals is a grand slam.  Feel like if you own one, you should probably own the other and give yourself a better chance.

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13 minutes ago, ChiefD said:

I almost pulled the trigger on some more shares at 4.01. Started sweating and hallucinating.

 

Did not buy.

Yea I think we see some 3s in the next week. I’m waiting for that. 

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16 minutes ago, Dwayne Hoover said:

HGEN doing worse than CYDY today.  I'm not celebrating this, I own both.  Day to day shouldn't matter for either, aside from buying low and selling high of course.  Matters more to the day traders for sure.

Anyway, I was gonna make a point here.  HGEN has had no news at all today and it's tanking.  People criticize Nader for being too vocal (myself included) but then Durrant not ever saying anything, is not any better for the current stock price.

I guess its a good buying day if you like HGEN, that's all.

In long run it's just as risky as CYDY though, I absolutely believe it has its own flaws.  Both are still equal in that they are in the VERY speculative category.

Just kind of bugs me that you've got people that think HGEN is far superior to CYDY, they are yin and yang, just different approaches.

Will be lucky if I go 1/2 with these, both getting approvals is a grand slam.  Feel like if you own one, you should probably own the other and give yourself a better chance.

I don’t know why it’s tanking today but the reason people feel way better about it is because it’s on nasdaq and the ceo is seemingly quite good and has connections. 

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Just now, Capella said:

I don’t know why it’s tanking today but the reason people feel way better about it is because it’s on nasdaq and the ceo is seemingly quite good and has connections. 

And he isn't selling fake dream catchers when he's not dumping shares of his own stock.

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