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***OFFICIAL CYDY/Leronlimab Thread***


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12 minutes ago, BassNBrew said:

Dude, The trial failed.

So why hasn't the FDA rescinded the OLE and eIND approvals? Think for yourself and stop parroting the #shortmafia.

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8 minutes ago, chet said:

So why hasn't the FDA rescinded the OLE and eIND approvals? Think for yourself and stop parroting the #shortmafia.

Because saline and water aren’t harmful. 

 Obviously it’s safe and doesn’t pose a risk to patients. It has not proven to be statistically effective in two different studies. More data is needed to determine if it is an effective treatment. Probably why the FDA has rescinded any thing. Also there’s nothing else that can be recommended right now that is a effective eind will get pulled if hgen’s trial is successful. 

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From YMB:

Quote

"I watched NP’s interview with Dr Been last night and I would like to share more thoughts with my fellow investors here. Firstly, let me disclaim that I have worked for three of the top 10 Global Big Pharma companies since 2005, so my perspectives may have a potential bias from BP and should be taken with a grain of salt. Having taken care of that, here are my thoughts and free advice to CYDY management team. (Three parts: 1. How to interpret the CD12 data so far; 2. What could have been done better; 3. Strategies for moving forward.) 
1. How to interpret the current data. Overall the primary endpoint did not reach statistical significance and there is no sugarcoating for that. However, it is not because the drug didn’t work, it’s mainly due to the small sample size. We may think 394 is a big number (at least for a small biotech like CYDY), but Gilead, Regeneron, Lilly, etc. all did trials in thousand of patients. And the three vaccines approved for EUA all had tested tens of thousands of people. There is power in numbers, and statistical power depends on both the effects of the drug and the sample size. Larger sample size means larger statistical power to detect the drug effect. If CD12 had over 1000 total patients, we probably wouldn’t need to slice and dice the data as much as we do now to show the drug works. 
2. What could have been done better. Given that CYDY is a small biotech with <20 employees and never had revenue, it is unfair to expect them to do more than what they have done. However, it is equally unfair to conspire that FDA and BP would intentionally impede the progress of this company. The FDA reviewers are dealing with hundreds of companies and they are very ethical professionals. They need to protect the public health and cannot play favor to either big or small companies. If the data is insufficient, they cannot give exceptions just because the small companies have less resources. Therefore, it could have been very helpful for CYDY if they actually had partnered with a reputable big pharma company with enormous resources to do the trials faster with larger sample size. At one point, I heard that they were talking to 11 companies, but nothing happened for reasons that I don’t know. So that’s a missed golden opportunity. (Think about BioNtech partnership with Pfizer: how did they end up being the first COVID vaccine granted EUA?) Later phase clinical development is a game of huge resources and professional experiences, which unfortunately is what small biotech lacks. 
3. Moving forward strategies. I have to praise NP for his vision, passion, perseverance, stubbornness and boldness, and undoubtedly Pro-140/Leronlimab wouldn’t get to where it is today without him! However, as it entered late phase development with so many potential indications in COVID, HIV, cancer, GvHD, Nash, etc., it has become evident that he is overwhelmed. He doesn’t have background or experiences in getting a drug pass the finish line, and his personality may not have helped in dealing with other stakeholders (eg. Dr Bruce Patterson) and regulatory agencies. (His comments on “hundreds of billions of dollars for each indication” are totally laughable and cast doubt for the credibility of everything else he says.) Therefore, I think he should be humble and let people with the appropriate knowledge and experiences do the talking. And better yet, let them work on the clinical development plans. Each indication warrants a very thoughtful and specific development plan. And because of the huge demands of resources in both money and human sense, they SHOULD seek partnership with big pharma with deals to share development cost and future profits. It is very common for small biotech to bring drugs from discovery to human trials (up to phase 2 studies) and then either sold to or partner with big pharma simply because it’s a game that they cannot afford. With so many potential indications, every month of delay in getting regulatory approval could mean loss of millions of dollars revenue, not to mention that the patients who could have been helped early May due before the drug is available to them. Even though Leronlimab could reach peak annual sales of over 10 billion dollars with many indications, it would be zero revenue without getting regulatory approval for a single indication. Therefore, PLEASE go talk to some reputable BIG PHARMA companies and get a reasonable deal! 
In the meanwhile, with the promising data at hand, they should also reach out to government funding (OWS, NIH, etc.) as well as charitable foundations such as Bill and Melinda Gates Foundation to seek financial support. There are tons of free money available because the pandemic has impacted everybody. 
Lastly, I am playing Sunday “CMO” consultants on because I am an investor of CYDY and a believer of Leronlimab. So, I welcome constructive criticism and comments, but please no trash talks!" 

 

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The drip will start for real tomorrow after the CC.  Is anyone going to be really surprised if it's eventually back down in the $1.80 - $2.25 range again?

That may be the time to trade it again if it does get there.  I think there a long few months ahead, who knows what is going on with HIV

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24 minutes ago, BassNBrew said:

Because saline and water aren’t harmful. 

 Obviously it’s safe and doesn’t pose a risk to patients. It has not proven to be statistically effective in two different studies. More data is needed to determine if it is an effective treatment. Probably why the FDA has rescinded any thing. Also there’s nothing else that can be recommended right now that is a effective eind will get pulled if hgen’s trial is successful. 

Why do you keep repeating this lie?

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1 minute ago, chet said:

Why do you keep repeating this lie?

It's true Chet.  It showed some promise but the number of patients were too low to matter.

We all agree that there is power in numbers but this company does not have the resources to get the big trial that it will need.

They cannot do it on their own.  NP very well could run this into the ground much lower.

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Just now, Dwayne Hoover said:

It's true Chet.  It showed some promise but the number of patients were too low to matter.

We all agree that there is power in numbers but this company does not have the resources to get the big trial that it will need.

They cannot do it on their own.  NP very well could run this into the ground much lower.

They reached statistical significance in CD10 in the secondary endpoint using NEWS2 to measure patient recovery.  So it's not correct to say that it has never reached SS.  This trial showed significant value in the critical space but the number of patients was too low in mortality but it did show 6-days less hospital stay in a SS way.  

Look, I am not trying to force anyone to stay long.  I just don't want lies and distortions to go unchallenged.  

NP is a clown and needs to be replaced but the drug works and will get an EUA IMO.

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1 minute ago, chet said:

They reached statistical significance in CD10 in the secondary endpoint using NEWS2 to measure patient recovery.

IDK Chet, they didn't even think this was worthwhile enough to try a phase 3.  Phase 2 as an exploratory trial may have had something positive to take away but since it never went any further, I don't disagree that it's a failure at this point.

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33 minutes ago, BassNBrew said:

Because saline and water aren’t harmful. 

 Obviously it’s safe and doesn’t pose a risk to patients. It has not proven to be statistically effective in two different studies. More data is needed to determine if it is an effective treatment. Probably why the FDA has rescinded any thing. Also there’s nothing else that can be recommended right now that is a effective eind will get pulled if hgen’s trial is successful. 

Saline and water don't stop the HIV virus for multiple years.  We do know that the drug is effective against HIV.  

I honestly believe that if this drug was in another companies (competent) hands that it would probably be approved by now.  NP and crew cannot get anything right and make bad decisions at every turn.  

The gamble, to me, is the drug good enough to overcome this incompetence?

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1 minute ago, Dwayne Hoover said:

IDK Chet, they didn't even think this was worthwhile enough to try a phase 3.  Phase 2 as an exploratory trial may have had something positive to take away but since it never went any further, I don't disagree that it's a failure at this point.

This is the only decision the company has made that I agreed with.  They are on a limited budget, and I don't think it was worthwhile to go after the m/m group.

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31 minutes ago, chet said:

Why do you keep repeating this lie?

Because it’s not a lie. 

In a study the small, I can probably find numerous subsets where it apparently works. I can probably also find numerous subsets where the patients grew more hair on their balls using LL. 

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15 minutes ago, Dwayne Hoover said:

IDK Chet, they didn't even think this was worthwhile enough to try a phase 3.  Phase 2 as an exploratory trial may have had something positive to take away but since it never went any further, I don't disagree that it's a failure at this point.

It was actually remarkable they were able to show SS in a small trial where most of the patients get better on their own.  After the trial, they decided to focus their resources on CD12.  That's not admitting failure--it's making a business decision based on information gleaned since the trial started. As people continue to spread the lie that the trial was a failure, uninformed people will believe it.  Nader makes enough mistakes which provide plenty of ammo to the shorts--please don't contribute to the problem by spreading lies and distortions.

We have learned so much about COVID since April when both trials started.  In hindsight, both were poorly designed.  Great post over at iHub which addresses many of the points made by others.  

 

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I’m holding on to my few thousand shares.  Got most at .29 and .63 with a few hundred at 4.13.  Took some profit already.  @chet brought me in and Chet will lead me out.  If it crashes and burns I’ll look at it like a rough weekend at the tables.  
 

Still have faith (maybe blind and stupid faith) in the drug and that the FDA will come through.  

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57 minutes ago, chet said:

Why do you keep repeating this lie?

Cause it hasn't unless you believe CYDY cherry picked data on small sample sizes.

You can believe in the drug, but with the vaccines will a new trial with MORE patients fill and finish in time for all this to matter? That's the true question you need to ask yourself if you want to be in bed with NP.

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We have no idea where the HIV BLA stands or what the holdup is.  That's more concerning if you ask me..

There are already other competitors getting drugs to market.

The next few months are going to be rough I think.

If it dips into the $1.60 range at some point and there hasn't been any truly bad news, may be tempted to trade it again. Until then, not gonna spend much time on this

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I admire the loyalty of many of you in this thread.  I got out of the stock a while ago and made a little profit--but I could not handle the lack of transparency or the lack of professionalism by the companies management or leadership.  We literally have had potentially the worlds biggest medical situation for a century--and a medical company was literally completely unable to capitalize on it in any meaningful way.   Like I said before--I'm rooting for the stock and im rooting for you guys--but I wish some of you guys would have sold earlier and just left the door open to get back into the stock if things change.  The bummer is that now the price is soo low that getting out makes less sense. If this goes back to anywhere near the $5-6 level without any real change in their management--I'd encourage you guys to evaluate your positions and maybe reduce your exposure.   The opportunity cost of holding this stock for the past few months has been fairly significant. 

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Just now, jvdesigns2002 said:

I admire the loyalty of many of you in this thread.  I got out of the stock a while ago and made a little profit--but I could not handle the lack of transparency or the lack of professionalism by the companies management or leadership.  We literally have had potentially the worlds biggest medical situation for a century--and a medical company was literally completely unable to capitalize on it in any meaningful way.   Like I said before--I'm rooting for the stock and im rooting for you guys--but I wish some of you guys would have sold earlier and just left the door open to get back into the stock if things change.  The bummer is that now the price is soo low that getting out makes less sense. If this goes back to anywhere near the $5-6 level without any real change in their management--I'd encourage you guys to evaluate your positions and maybe reduce your exposure.   The opportunity cost of holding this stock for the past few months has been fairly significant. 

Thanks Captain Obvious. 

 

:lol:

 

 

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7 minutes ago, ChiefD said:

Thanks Captain Obvious. 

 

:lol:

 

 

Apparently it's not very obvious. I've said very similar quotes months ago about the fact that even if LL is a good drug--that the management's lack of professionalism will cap the upside of the company. Bad management can absolutely derail a good product--whereas good management can actually make a viable business out of a bad product.   Lots of people have held onto this stock for too long even though "the obvious" stuff that i just mentioned has been "obvious' for a while.   Even if good news were to come out regarding the drug--I'm relatively confident that Nader would find a way to somehow ruin that and fail to capitalize on it.   

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4 minutes ago, jvdesigns2002 said:

Apparently it's not very obvious. I've said very similar quotes months ago about the fact that even if LL is a good drug--that the management's lack of professionalism will cap the upside of the company. Bad management can absolutely derail a good product--whereas good management can actually make a viable business out of a bad product.   Lots of people have held onto this stock for too long even though "the obvious" stuff that i just mentioned has been "obvious' for a while.   Even if good news were to come out regarding the drug--I'm relatively confident that Nader would find a way to somehow ruin that and fail to capitalize on it.   

There have also been some good runs in between so its not just about holding for too long.  

Even though this last round is not looking good, was still able to profit from it

Buy low, sell high.   Even if you bought in the 2.20 range a few months back, you still get out today with some decent return, not too mention if you exited when it was in the $6 range

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2 minutes ago, Dwayne Hoover said:

The HIV BLA is not even in the realm of being finished.  This was something he initimated was a slam dunk for revenue.

Just get all your money out of this, its done.

Hmmm.  According to the Yahoo boards, this call is going swimmingly!

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2 minutes ago, Dwayne Hoover said:

 

I know you were joking but they are doing exactly what you are saying, they think this call is going great

I really get a kick out of them.  Some of the pumpers and bashers are quite funny.  It is getting harder and harder to scroll through for actual info though.

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2 minutes ago, Chaz McNulty said:

I really get a kick out of them.  Some of the pumpers and bashers are quite funny.  It is getting harder and harder to scroll through for actual info though.

Man that thoughtful investor loser typing today that it was a “data anomaly” made my blood boil. Mainly because so many people hang on his every word. That guy is worse than any shorter. 

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26 minutes ago, Capella said:

Man that thoughtful investor loser typing today that it was a “data anomaly” made my blood boil. Mainly because so many people hang on his every word. That guy is worse than any shorter. 

Thoughtful Investing 5 minutes ago

Webcast: Substantively very good. Expert explanations were clear. NP explanations not always clear. He should stick to addressing company strategy, which is very good, and let doctors answer questions about the trials and trial results.

Picked up 38k shares today. Webcast confirmed it was a very good move.

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The memes on WSB are fantastic. 

As for FBG, I'm glad you can't post that stuff. If I could ask for an exception, this thread would be the one. Because the outhouse that doesn't moon would be so symbolic of the leadership of this company (:stillholding:).

:banned:

 

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22 minutes ago, dkp993 said:

Anyone here who listened to the call today want to provide some thoughts?  TIA

From some yahoo user: 

Folks, I have taken notes for the last couple of these and decided to do so again today. This is not an editorial nor my thoughts. Rather, I am recording what I understand them to say as they say it. I welcome clarifications about things I missed or misunderstood:

The call started at 3:02 Central. Listen only mode. Mike Mulholland, CFO, is the first speaker.

Mulholland started. Nader Pourhassan (NP), CMO Scott Kelly, Dr. Rahman, the Director of the Mt. Sinai Lung Transplant Institute joined. He then issued standard language about forward looking statements. Prepared comments will be followed by questions. He turned it over to NP.

NO—on 15 April 2020 we injected the first patient in CD 12. 3 agencies are working with us and have suggested the final path to approval for Leronlimab. Less than one year is very short for this type of development. The most important message from CD12 is that Leronlimab works as an immunomodulator. Statistically significant secondary inputs and superiority to other drugs.

Method of action (MOA) not specific to COVID. Works in HIV where we hit primary end points. We hope for that approval by the end of the year. We hope for COVID EUA before then.

We are grateful to US FDA for allowing us to extend the trial and, ultimately, extend a BLA for actual full approval. We believe COVID sales will be ongoing for a very long time. He then asked Scott Kelly to comment on big pharma results for COVID.

Kelly addressed the COVID 19 competitive landscape.

- Remdesiver is approved but does not demonstrate mortality improvement, particularly for critical.
- Blood plasma has been scaled back to only be used early in the illness.
- A number of other drugs have also proved to not be successful, including Merck’s molecule.

Dexamethasone is part of the standard of care (SOC). 22.9% died in that group, and 25.7% in the placebo group. Higher numbers in the critical group. It is recommended for the critical, but not mild to moderate, populations.

IL 6 inhibitors. Trials taken together have mostly not shown a mortality benefit. 4000 patients, but the trial was not blinded.

Dexamethasone is about 30% effective, but what about the other 70%? What about co-morbidities? Leronlimab has been used safely in those groups.

NP speaking again. He introduced the Mount Sinai doctor. Harish(?) then said that in critical populations risk reduction for Leronlimab is phenomenally better than with any other medicine. Works better than dexamethasone. He also believes it works for long haulers.

Next was Dr. Rahman. He acknowledged that we did not hit the appropriate p value for the primary endpoints. He said we did, however, see a consistent benefit. Trial was designed in March/April of last year when we didn’t really understand the illness. 24% decrease in mortality for the critically ill. 6 day decreased hospital stays is statistically significant. Better results for hospital discharge.

NP talking again. Quotes several doctors who believe the result is strong enough for EUA while we continue the trial. They are working on the EUA. Will continue the 140 patients at the same trial sites.

Putting out all of the trial data widely.

Phillipines FDA. Chiral is ready to file their version of an emergency order. That should happen maybe as soon as today. 48 hours to review. That would start sales immediately, even if only to a small number of patients. They will keep us updated.

Brazil. We are reaching out to them and will keep everyone updated.

Critical ill 24% mortality population. For the entire population, we are putting out the results. We are very thankful to the FDA for being able to go forward with the protocol for the additional 140 patients, which should be quick since we have trial sites.

MHRA will accept the data from the extension study. We do not know about the 46 patients we have already added.

Health Canada. We do not know when or if we can sell there.

We have also talked to the European authorities.

10 patients have survived 11 months with Stage IV cancer (what type?). Those result are excellent. One of the other doctors then joined NP and said CYDY will ultimately be an oncology company. Dr. Rahman agreed, too.

NASH and long haulers. Dr Kelly chimed in with “very exciting news in regards to both of these projects.” NASH is phase 2 with 60 patients for 14 weeks with weekly doses. That trial is 30% filled and we should have results in early Q4. Long haulers is a huge potential population. Our study is a 50 patient study. Trial started March 1 and is 50% filled. Trying to correlate subjective complaints with bio-markers. Patients get weekly doses for 8 weeks.

NP again—we are not getting away from HIV. We are hoping to have approval by the end of the year, but we don’t have enough information.

They then moved to Q&A. I will stop here. I hope this was helpful.

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Dr. Bream rewrote the PR. This is how it could have been:

Bream (ER MD) rewrote PR. Wow 

Fellow shareholders,

I took the liberty of re-writing Cytodyn's press release from Friday.  Note, this took me 23 minutes to do.  Seriously.

Vancuover, Washington – CytoDyn (“the company”) is pleased to release the analysis of its CD-12 trial.  
Due to an over-enrollment of patients greater than 65-years-old in the leronlimab arm, a modified intention-to-treat (mITT) analysis was performed to standardize the data.  The mITT analysis of CD-12 yielded the following statistically significant results of primary and secondary endpoints:

1) When leronlimab was used in additional to “commonly used COVID-19 treatments” a clear benefit was seen in the primary endpoint of all-cause mortality at day 28 with an absolute risk reduction of death of 6.5% with a relative risk reduction of death of 28.1% (N = 309, p = .0319).  

2) When leronlimab was used in combination with dexamethasone, a clear benefit was seen in the primary endpoint of all-cause mortality at day 28 with an absolute risk reduction of death of 5.7% with a relative risk reduction of 26.2% (N=233, p=.055)

3) The mean length in hospital stay was decreased by 5.5 days in the critically ill population (p = .005)

4) Mortality status at day 28 when leronlimab was used in addition to “commonly used COVID-19 treatments” in the critically ill population with an age < 65 showed a clear mortality benefit with an absolute risk reduction of death of 20.9% with a relative risk reduction of death of 73% (N=40, p=.03)

5) Mortality status at day 28 when leronlimab was used in addition to dexamethasone in the critically ill population showed a clear mortality benefit with an absolute risk reduction of death of 6.5% and a relative risk reduction of death of 23.5% (N=35, p=.04)

6) Length of hospital stay in critically ill patients < 65-years-old showed a clear benefit with a reduction of 6.8 days (N=44, p=.006)

In addition, there were no safety signals seen in the leronlimab group versus placebo.

Based on this data, the company looks forward to regulatory talks with the FDA, MHRA, Health Canada, the Philippines, and Brazil as we believe the data supports the use of leronlimab worldwide.  The company will hold a call on Monday March 8th at 4pm ET/1pm PT to discuss these results further.

 

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16 minutes ago, chet said:

Dr. Bream rewrote the PR. This is how it could have been:

Bream (ER MD) rewrote PR. Wow 

Fellow shareholders,

I took the liberty of re-writing Cytodyn's press release from Friday.  Note, this took me 23 minutes to do.  Seriously.

Vancuover, Washington – CytoDyn (“the company”) is pleased to release the analysis of its CD-12 trial.  
Due to an over-enrollment of patients greater than 65-years-old in the leronlimab arm, a modified intention-to-treat (mITT) analysis was performed to standardize the data.  The mITT analysis of CD-12 yielded the following statistically significant results of primary and secondary endpoints:

1) When leronlimab was used in additional to “commonly used COVID-19 treatments” a clear benefit was seen in the primary endpoint of all-cause mortality at day 28 with an absolute risk reduction of death of 6.5% with a relative risk reduction of death of 28.1% (N = 309, p = .0319).  

2) When leronlimab was used in combination with dexamethasone, a clear benefit was seen in the primary endpoint of all-cause mortality at day 28 with an absolute risk reduction of death of 5.7% with a relative risk reduction of 26.2% (N=233, p=.055)

3) The mean length in hospital stay was decreased by 5.5 days in the critically ill population (p = .005)

4) Mortality status at day 28 when leronlimab was used in addition to “commonly used COVID-19 treatments” in the critically ill population with an age < 65 showed a clear mortality benefit with an absolute risk reduction of death of 20.9% with a relative risk reduction of death of 73% (N=40, p=.03)

5) Mortality status at day 28 when leronlimab was used in addition to dexamethasone in the critically ill population showed a clear mortality benefit with an absolute risk reduction of death of 6.5% and a relative risk reduction of death of 23.5% (N=35, p=.04)

6) Length of hospital stay in critically ill patients < 65-years-old showed a clear benefit with a reduction of 6.8 days (N=44, p=.006)

In addition, there were no safety signals seen in the leronlimab group versus placebo.

Based on this data, the company looks forward to regulatory talks with the FDA, MHRA, Health Canada, the Philippines, and Brazil as we believe the data supports the use of leronlimab worldwide.  The company will hold a call on Monday March 8th at 4pm ET/1pm PT to discuss these results further.

 

No mention of failed primary endpoint?  No mention of number of patients in these "stat sig" populations?  

Sure, it looks better but it's just a pump with nothing behind the curtain.

I don't think misleading investors is cool at this point.

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Just now, Steeler said:

@chet

What's the best case scenario for CYDY  if they get COVID EUA in 2021 - stock price goes to ??? 

I think it's probably worth about $15/ share but with short covering and some of the maniacs on Yahoo etc, it could swing higher.

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32 minutes ago, Dwayne Hoover said:

No mention of failed primary endpoint?  No mention of number of patients in these "stat sig" populations?  

Sure, it looks better but it's just a pump with nothing behind the curtain.

I don't think misleading investors is cool at this point.

What are you talking about?  A pump?  JFC these are the results of the trial.  He mentioned the size of every subgroup except #3 and that was probably an oversight.  I can tell you right now that there were 62 patients in the critical arm.  This is in no way a pump.  If you think it is, you have no understanding of what a constitutes a pump.

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