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

This is quite the preamble.  Right now it seems to me that they are putting out 4 prominent doctors to say Leronlimab works prior to Nader having to announce FDA and MHRA not impressed.  Interesting to see

 
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Bringing out the big guns commenting from a physician perspective about experiences with leronlimab and updates on publications.  Questions have been asked about why they've been quiet, but now they're going out there and vouching for the drug.  Seems compelling.

Still nothing to do with the details of the company, just belief in the drug which for most of us hasn't been too much in question.

 
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adonis said:
Bringing out the big guns commenting from a physician perspective about experiences with leronlimab and updates on publications.  Questions have been asked about why they've been quiet, but now they're going out there and vouching for the drug.  Seems compelling.
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Third doctor was very compelling.

 
I don't know, I dont think this is gonna play well.  We've all heard the anecdotal already.

This CC seems like a mistake to have so for, hope I'm wrong but bad news probably coming to make it even worse

 
Dwayne Hoover said:
I don't know, I dont think this is gonna play well.  We've all heard the anecdotal already.

This CC seems like a mistake to have so for, hope I'm wrong but bad news probably coming to make it even worse
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Shot down on getting EUA in both countries.  They want to see S/C results.  No surprise there.

 
Dwayne Hoover said:
I don't know, I dont think this is gonna play well.  We've all heard the anecdotal already.

This CC seems like a mistake to have so for, hope I'm wrong but bad news probably coming to make it even worse
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Have never heard from the last two doctors before like this

 
So yes, what we're hearing right now is a significant delay in terms of FDA approval or approval in UK.  Months most likely.  Uplisting coming soon, and doubtful will be further delays.

 
Well, the AF hit piece just writes itself at this point.  Still optimistic about the long-term options here, but short term will be brutal :)

 
adonis said:
Well, the AF hit piece just writes itself at this point.  Still optimistic about the long-term options here, but short term will be brutal :)
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Unfortunately yes, its gonna bomb in the short term.

Like you,  I wasn't counting on EUA before the severe critical trial finished but I think a lot of people were buying on that hope.

 
Oof, definitely going to drop soon.

Uplisting will have review of application completed next week.  They don't sound optimistic to be honest. 

 
Sounds like I should have dumped it all at $5 and just assumed it would dump to sub $3 at some point. Did they give an update on S/C and when that could happen?

 
Cytodyn now has 21 employees and plans to hire a few more.  Of course, they need an additional $100 million in shares to give them.  Makes complete sense.

 
This is a terrible call.

Honestly, they were in a bind to how to deliver the news of no immediate EUA, bad news is bad news no matter the format .  They probably thought it would be better to deliver the news over the phone than in a press release but this call has been a massive waste of time.

 
And if the price of stock falls, chance of uplisting goes away.  We're back to waiting for results for s/c for anything else.  It's all talk until then, and likely lower stock prices.

All we have is an upset NP on the call.

 
stbugs said:
That’s well above the count for “interim” results, right?
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Yes, but in the back of my mind, I'm always going to be worried that if they only deliver interim results, they wont be rewarded even if they are good.

They are going to be held to the highest of standards and these interim results will need to be nothing short of a home run.  Basically put the FDA in a position where they don't have a choice, not sure they will be that good.

 
eaganwildcats said:
Also sounds like that last doctor is now on the payroll unless I missed something. Not sure that's a good thing or not...
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He is the doctor that is credited with single-handedly getting patients to enter the trials when enrollment had come to a standstill.  Him being a buddy of Scott Kelly and now getting hired calls into question his motivations.

 
They remind me of a guy who works for me whose wheels spin a lot, does a lot of work, but at the end of the day ended up going down many rabbit trails that he shouldn't have.

I intervene a lot to keep him on track and can usually short-circuit his low probability rabbit trails, based on experience and knowledge of the industry and technology.

This company seems to have spent a lot of energy trying to get EUA approval for the mild-moderate results in a situation where this shouldn't have been pursued because it wasn't what the FDA was looking for.  With better oversight and leadership, they should've been focused on s/c studies all along.  Sure, it's nice to be able to say that you're the only ones out there with good results in the m/m group, but there COULD be a reason other companies aren't spending a ton of time there because it's not where the FDA is caring about.

A better leader would've short circuited these rabbit trails and focused them more on what was the highest threshold for success.  It's fine to have pursued other options, but they now seem, based on feedback from FDA and UK's equivalent, to have been pointless endeavors, paired with uplisting based on increased stock prices, based on the hope of early approval, and where are we now?  Still with a product with good science behind it, imo, but we have ridden down several rabbit holes with NP for now.

Sadly, I'm locked into the shares for a while as i'm unwilling to take a big loss with some drops otherwise...oh well.

 
Dwayne Hoover said:
I wasn't expecting much and Im still bummed out.  There was nothing announced to be excited about.
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Still waiting on S/C results, and lowered probability on the uplisting option.  

What I'm most discouraged about is that the FDA and MHRA had no intention of greenlighting a drug for EUA for mild/moderate populations, which means the exercise has been pointless.  How could they be unaware of this, spending all this time and blowing so much smoke about it, while all the while had they known enough about what the FDA was looking for they'd have known there was basically no shot.

That's a big flaw imo.  Anyone see things differently?

 
adonis said:
Still waiting on S/C results, and lowered probability on the uplisting option.  

What I'm most discouraged about is that the FDA and MHRA had no intention of greenlighting a drug for EUA for mild/moderate populations, which means the exercise has been pointless.  How could they be unaware of this, spending all this time and blowing so much smoke about it, while all the while had they known enough about what the FDA was looking for they'd have known there was basically no shot.

That's a big flaw imo.  Anyone see things differently?
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I'm with you.  Gilead's biggest strength is have NP as the CEO of CYDY.  He is completely lost, and the worse part about it is that he doesn't understand that he's in over his head.  Atleast then he would hire people that could get things done.

 
stbugs said:
Maybe, maybe not. Honestly, my fault for forgetting the call. At this point, just more stuff I’d rather own. Order’s in for $4 limit. If it doesn’t hit, ride it out.
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The problem as I see it is there was a short term bubble introduced by the tilting at windmills NP has lead lately.  A better use of his time, and company resources, over the past few months would've been a focused approach regarding the S/C trial, enrollment, and results at which point FDA could be consulted and uplisting could follow.

INstead, he took a shotgun approach spreading out resources into mild-moderate studies, EUA in with results in a study the FDA didn't care about, and started the uplisting process with a stock price inflated on the hopes of getting an EUA quickly, or FDA approval.

FDA approval still seems likely down the road for monotherapy, and other indications are promising, but man the timeline for returns has been expanded by months at least.  So for those of us locked in, it'll be end of 2020 at this point before we can start to see some promising results.  You could tell NP knew the situation as he was short, abrupt, and frustrated on the call.

The company is indebted to him to get it this far, but really it needs a steadier hand far more familiar with the process than NP is at the current moment.  However, for a company without an approved drug, they're unlikely to find anyone better to take the helm at this point.

 
adonis said:
The problem as I see it is there was a short term bubble introduced by the tilting at windmills NP has lead lately.  A better use of his time, and company resources, over the past few months would've been a focused approach regarding the S/C trial, enrollment, and results at which point FDA could be consulted and uplisting could follow.

INstead, he took a shotgun approach spreading out resources into mild-moderate studies, EUA in with results in a study the FDA didn't care about, and started the uplisting process with a stock price inflated on the hopes of getting an EUA quickly, or FDA approval.

FDA approval still seems likely down the road for monotherapy, and other indications are promising, but man the timeline for returns has been expanded by months at least.  So for those of us locked in, it'll be end of 2020 at this point before we can start to see some promising results.  You could tell NP knew the situation as he was short, abrupt, and frustrated on the call.

The company is indebted to him to get it this far, but really it needs a steadier hand far more familiar with the process than NP is at the current moment.  However, for a company without an approved drug, they're unlikely to find anyone better to take the helm at this point.
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Disagree on your last sentence.  They don't need a $20M CEO.  They just need competence.  There are a lot of very good people that have been in the industry that would take on a job like this.

 
Dwayne Hoover said:
https://twitter.com/adamfeuerstein/status/1306341325273534466

This joker will not relent.  Why does he hate them so much?  

 
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On this series of tweets, I think he has a point.

NP did admit that no EUA was submitted.  That is not how he promoted it.

I'm a big AF critic, but I think he's not too far off here.  I feel like while NP has meant the best over the past few months, I'm left with just words and a lot of poor decisions and smoke and mirrors in terms of what he's offered in terms of guidance and direction for the company.  I think he should step down and let someone else bring Cytodyn into the next chapter and beyond.

 
Chaz McNulty said:
Disagree on your last sentence.  They don't need a $20M CEO.  They just need competence.  There are a lot of very good people that have been in the industry that would take on a job like this.
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By all means, the board should wish NP the best, thanks for the memories, and bring someone else in if they can find a quality person who can turn this around.

 
adonis said:
On this series of tweets, I think he has a point.

NP did admit that no EUA was submitted.  That is not how he promoted it.

I'm a big AF critic, but I think he's not too far off here.  I feel like while NP has meant the best over the past few months, I'm left with just words and a lot of poor decisions and smoke and mirrors in terms of what he's offered in terms of guidance and direction for the company.  I think he should step down and let someone else bring Cytodyn into the next chapter and beyond.
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The tweet didn't link like I was expecting.

I wanted to call attention to this line in particular

"I've covered a lot of sick and twisted biotech companies in my 20 years on the beat, CytoDyn scrapes the bottom."

 
Dwayne Hoover said:
The tweet didn't link like I was expecting.

I wanted to call attention to this line in particular

"I've covered a lot of sick and twisted biotech companies in my 20 years on the beat, CytoDyn scrapes the bottom."
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I honestly don't think there is malice or intentional fraud.  NP is just incompetent.

 
adonis said:
  So for those of us locked in, it'll be end of 2020 at this point before we can start to see some promising results.  You could tell NP knew the situation as he was short, abrupt, and frustrated on the call.
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I didn't hear what you did here.  Can you expand on this?  Aren't we still expecting interim results in October?

 
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