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***OFFICIAL CYDY/Leronlimab Thread*** (1 Viewer)

adonis said:
Better questions on this call.
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They were.  The last caller made a good point to include the ease of administration for LL in mild patients in the write-up.  Visit Dr. office and receive a shot.  No IV.  Good point about Remdesivir not being a viable option for this patient population.  

 
Jayrok said:
They were.  The last caller made a good point to include the ease of administration for LL in mild patients in the write-up.  Visit Dr. office and receive a shot.  No IV.  Good point about Remdesivir not being a viable option for this patient population.  
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Also made explicit the assumption most had that these patients were not in the hospital or on oxygen.

Again, reinforces the promise of the drug that it showed statistically significant results with the NEWS2 in this population, which would be the most difficult population to show improvements in with so many of the patients getting better on their own rapidly with or without the drug.  Only harder population would just be a mild population.  I'd have been curious to know the mild to moderate ratio of patients in the study.  The more mild-heavy the study, the more impressive the results become.  

 
Notes from another board:

4:04 Mulholland opens. He introduces everyone. He reminds everyone that boiler plate warnings exists and goes into it with the same gravitas of a seasoned statesman or telemarketer I can't tell which. The important thing is everyone is reminded investing comes with risks. 

4:06 A wild Nader appears. 

-FDA asked for EUA based on CD 10 data. 

-Clinical Results Getting Significance is important. Phase 3 endpoint determined from Phase 2 results. Primary endpoint, Clinical Significant, we had clinical significance. GOOD NEWS: Secondary endpoint we achieved NEWS2 50% in Leronlimab versus 20% placebo. Reducing serious events over 2.5 times because of Leronlimab preventing complications. 70% of SAEs in placebo, so without Leronlimab things get worse. 

-Phase 3 chance of hitting primary if NEWS, and number of patients. We would go for 75 to 80 patients. Safety has already been demonstrated thanks to HIV patients.  

4:13 Doctor Kelly very encouraged. Objective evidence. Physiological parameters. Randomized, doubled blinded placebo control study. Mild to Moderate 81%. 20 million infections out there. NEWS2 objective way of snapshotting who is at risk over time. 

4:15 Doctor Lazari hard to imagine to have a better study. Immunomodulator. We would see biggest bang for our buck in severe cases. To get this result in moderate, healthier group, is good. Reduced symptoms, also when should this drug should be used.  

(Quick note: my investment partner has a medical background and says this is good and this is a good call so far.) 

Lazari believes we have the first working drug for COVID. 

4:18 Nader CD 12 195 interim analysis. Moves to HIV, 49 patients only using Leronlimab. Good results from them. We are getting academic notice. We asked Scott Kelly to get top people in the various fields we are looking at for. These scientists will be on the website stating they support our drug. 

4:21 Kelly lists off rooster of our Science Advisory Board. Additional physicians coming on board for transplants, cancer, COVID.  

(Quick Note: Unlike other CCs Adam Feuerstein has chickened out and not Tweeted any lies at this time 4:23pm EST 8/12/2020) 

Onboarding scientists have nice credentials including time spent at NIH. Kelly sounds very excited about these people. 

Q&A 

HC Wainwright: Congratulations on data placebo group number typical? Kelly points out we don't have much mild to moderate data out there, we are looking at symptoms.  

Lazari off the top rope states the importance NEWS2 and why we would get an approval. Kelly drop kicks with the point that NEWS2 is objective. 

Nader states top line sent, wants guidance and open to meeting for emergency use. 

Mulholand reads questions.  

One patient died after study. 50 year old female with substance history. High score in terms of risk. 33 days after day 0, not related to drug. COD not sent to company. 

Major media and big pharma waiting in the wings. So where are we with media response. Nader states top line sent to media, and pharma groups who asked for it. Transfer of information happening right now. 

Question about COVID or Leronlimab outside of Primary and Secondary. Wants to know about wealth of data collected. Clinical outcome submitted. Blood work not submitted, data from blood work not as dramatic in the mild/moderate population. Learning where we best fit in during treatment time. Before or After oxygen needed, after minimal symptoms. Ideal treatment time being deterimined. 

NASDAQ update comment letter not yet received. 10K to be filed with SEC. 10k and audited data an important part of that. 

Projected revenue. Never commented on future revenues, Doctor Lazari, distribution networks up and ready.  

Nader if we do get approval, how many vials. Potential is 2.5 billion in sales based on previously stated comments. 

Why is Patterson not on advisory board? Patterson's lab used at one time. Patterson's lab isn't being used at this time. 

Some blowhard talks about being weak in marketing and media. Nader states he doesn't write PR, we run them by lawyers. We can't puff our news. We have to be a company that can uplist by being professional. 

Question about papers. Nader stated we are hoping to submitted. Others being reviewed. These are paper of physicians. Group of people working on 5 different publications. 

DSMV efficacy or safety. Only safety looked at, interim note done yet. 

How many went onto 02 from both testing populations. 50% venting need in Leronlimab. Only 2 one from each no need to report. 

Approval in other countries happen without the FDA? There are countries that want the top line report sent to them. We are pursuing these countries and own regulatory body. 

O2 data 84% didn't need it on leronlimab, placebo 79% delta of 5%. So no reporting cause meh. 

EUA approval question on time. Nader finally won't give a timeline that he can't answer. So we will have to wait and see. But once they know we will know. 

Type A meeting submitted a week ago so 30 days to hear. 

195 enrollment 175. Nader states learning not to give guesses. We are hopefull to get it done soon. 

Important Note: Nader is actually realizing not to overpromise it seems. Wild stuff. 

EUA question about phase 2 approval before phase 3. Remdesivir. Still phase 3 has to be done. Nader has no idea if FDA will approve. If phase 3 we go to moderate patients. 

Question about Webcast for DATA. Then some blah blah blah stuff. 

Overall good stuff. 
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Major media and big pharma waiting in the wings. So where are we with media response. Nader states top line sent to media, and pharma groups who asked for it. Transfer of information happening right now. 
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This is interesting to me and I wish they would have commented more on it.  NP says top line sent to media... What media?  is that media Proactive video?  Is it Dr. Yo or Dr. Been?  Because those are the only people that have shown any interest in interviewing NP or Dr. Patterson.  And Proactive gets paid to interview NP. 

Seems with news like this someone would be on somewhere other than Youtube podcast shows like randypanties.  CNN, Fox... CNBC?  We have a drug that is useful in combating Covid19.  Excellent p-value in NEWS2 parameters.  Shown to calm cytokine storm and bring viral load to zero.  Dr. Yo will be interested to talk about it I suppose.  

 
I dont understand the M-M Phase 3 trial size being the same. 

First, we hopefully have interim and then final S-C results and its a moot point...in which case who cares.

But, if in some scenario the Phase 3 of M-M becomes important why do you want to be flailing around on the whims of a small sample size in a population where we already know it is harder to symptom measure changes due to M-M nature. 

 
djmich said:
I dont understand the M-M Phase 3 trial size being the same. 

First, we hopefully have interim and then final S-C results and its a moot point...in which case who cares.

But, if in some scenario the Phase 3 of M-M becomes important why do you want to be flailing around on the whims of a small sample size in a population where we already know it is harder to symptom measure changes due to M-M nature. 
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Because they can't fill a large trial in a timely manner. See: Waiting On S-C To Finish Enrolling, We're Still

 
Bob Sacamano said:
Because they can't fill a large trial in a timely manner. See: Waiting On S-C To Finish Enrolling, We're Still
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I get that, but as I was trying to point out...if Phase 3 M-M is important (meaning S-C failed), then having a non statistically significant results because the trial size is too small would be the death nail in CYDY Covid coffin.  I don't think thats the place to #### around.

This is where honestly they should partner up with BP vs throw themselves under the bus.

I'd like to add some more back tomorrow, only got 5k more at EOD today, hopefully price stays down. 

 
Jayrok said:
This is interesting to me and I wish they would have commented more on it.  NP says top line sent to media... What media?  is that media Proactive video?  Is it Dr. Yo or Dr. Been?  Because those are the only people that have shown any interest in interviewing NP or Dr. Patterson.  And Proactive gets paid to interview NP. 

Seems with news like this someone would be on somewhere other than Youtube podcast shows like randypanties.  CNN, Fox... CNBC?  We have a drug that is useful in combating Covid19.  Excellent p-value in NEWS2 parameters.  Shown to calm cytokine storm and bring viral load to zero.  Dr. Yo will be interested to talk about it I suppose.  
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He seemed to infer it was sent to major media outlets, I think he said major media.  Certainly wasn't talking about proactive.

I'm sure they sent it to all the sources you named, not holding my breath that any of them will report on it though.  I feel like the media will take their cue from the FDA on this one.   The media aren't necessarily experts in understanding the data on this press release either, not sure how much of a chance they will take on it or Cytodyn in general.

CNBC seems especially averse to even mentioning an OTC stock which was why Sara Eisen's tweet last week was so remarkable.  Not expecting anything from that crew unless someone can get Sara to tweet something again. 

 
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djmich said:
I get that, but as I was trying to point out...if Phase 3 M-M is important (meaning S-C failed), then having a non statistically significant results because the trial size is too small would be the death nail in CYDY Covid coffin.  I don't think thats the place to #### around.

This is where honestly they should partner up with BP vs throw themselves under the bus.

I'd like to add some more back tomorrow, only got 5k more at EOD today, hopefully price stays down.
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Going to go out on a limb and guess tomorrow's Christmas in the djmich household.

 
Was thinking the same as djmich one why messing around with a smaller sample, but I think they are limiting it to patients with a higher score (4+) to ensure the results come back the same as what they saw in Phase 2.  If the phase two results were p = .02, then odds are 98% it did not occur by chance and they can do it again. 
Some here talked about timing of a vaccine.  Friend is working on recruiting for one of the BP Phase 3 studies.  They have to enroll 30k people and this will take some time.  They obviously have the deep pockets which helps.  At best, and this is assumes everything going perfect, they would not have results until mid-November.  I believe it was one initial dose and then an additional one 28 days later and then having to wait a month to see if it worked.  So having a smaller phase 3 for CYDY could still result in having positive news before vaccine news breaks.  Well, except for Vlad, lol.  Once the vaccine is approved, it will be quick to market based on them already producing it in large quantities anticipating a positive FDA response. 

 
adonis said:
Solid conference call, solid results. -10% tomorrow.
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Nah. It is gonna jump to about $15/share because I will be sitting in a car all day unable to do anything about it.

You’re welcome, gents. Enjoy your riches.

 
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Moonlight said:
Does AF do another hit piece? He only tweeted Tuesday.

Guy has a vendetta.
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He went pretty silent quick yesterday though.  No follow ups at all.  

I feel like he has to back off a little at this point, he has stretched the limits the past few days.  Stat has to be concerned about credibilty i would think.  To call it a failure was a huge stretch.

 
Dwayne Hoover said:
He went pretty silent quick yesterday though.  No follow ups at all.  

I feel like he has to back off a little at this point, he has stretched the limits the past few days.  Stat has to be concerned about credibilty i would think.  To call it a failure was a huge stretch.
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Surely he comments today.  Truth has not bridled him yet, why start now?

 
Capella said:
Right. Which means today the blood will be back in the water most likely. 
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 Might be a volatile morning.  Open around 4.60, run up to 4.70 then drop to low 4's. 

 
If I could not look at this stock price for two months, I think that would be really beneficial.

Keeping the faith, it feels like everything is aligned, one small positive catalyst is all that is needed to get this rolling.

 
Dwayne Hoover said:
If I could not look at this stock price for two months, I think that would be really beneficial.
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This is where I need to be.  I need to accept that my shares might be worthless down the road and check in quarterly on news.   The daily grind too much.

 
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Golf Guy 69 said:
Dwayne Hoover said:
If I could not look at this stock price for two months, I think that would be really beneficial.
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This is where I need to be.  I need to accept that my shares might be worthless down the road and check in quarterly on news.   The daily grind too much
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This is basically where I am, at least emotionally.  I do look everyday but I’m not really tied to it.  Unless something crazy stupid happens I have not thoughts of making moves.  I’m in long. 

 
I'm kind of the opposite this week since I took a short term position.  I've had a ThinkorSwim CYDY chart active on my screen all day.

 
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dkp993 said:
This is basically where I am, at least emotionally.  I do look everyday but I’m not really tied to it.  Unless something crazy stupid happens I have not thoughts of making moves.  I’m in long. 
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Exactly. Especially now that there's efficacy from mild to moderate. Set it and forget it.

I get the panic and anxiety prior to results...but we got EXACTLY what we needed. 

STATISTICALLY SIGNIFICANT TRIAL RESULTS.

That erases questions about pump and dump, lack of papers published, broken promises....EVERYTHING. 

If you're still panicking about holding, sell your position until you don't care. Nothing except for stock price going up is gonna make you comfortable.

#notselling #notsleepless

 
I’m holding long but those results the other day were far far better than any of us really seemed to expect and the stock still tanked 15%. That was really an eye-opener. Still, I’d rather lose all my money invested in this than be on the sideline if this ever pops though so I’m holding in. 
 

Btw Remember how confident guys like whatt were that the dead person was on the LL arm and it would tank the results and it ended up having nothing to do with the drug. We had some really dumb talks in here. 

 
Bought some at 4.10.  Seems to be holding a bit, but waiting for a next move.  Just can tell if it will be back up or more down.

Added more at 4.00.  Nothing big, these are short term plays.  

 
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