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This_Guy

***OFFICIAL CYDY/Leronlimab Thread***

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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?

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Just now, stbugs said:

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?

"Sometime this year"

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Over 210 patients right now 

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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.

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Just now, Bob Sacamano said:

"Sometime this year"

SMH. Limit order already set for $4. Hopefully it doesn’t tank too early.

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Just now, Bob Sacamano said:

Over 210 patients right now 

That’s well above the count for “interim” results, right?

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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.

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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.

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5 minutes ago, stbugs said:

That’s well above the count for “interim” results, right?

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.

 

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22 minutes ago, 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...

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.

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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.

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18 minutes ago, stbugs said:

SMH. Limit order already set for $4. Hopefully it doesn’t tank too early.

I would be shocked if this hits. 

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3 minutes ago, Dwayne Hoover said:

I wasn't expecting much and Im still bummed out.  There was nothing announced to be excited about.

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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3 minutes ago, 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?

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.

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We are so screwed.  At least it hasn't been as big of a hose job as ETHE.

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So what's preventing CYDY from pivoting back to compassionate use?

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43 minutes ago, eaganwildcats said:

I would be shocked if this hits. 

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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3 minutes ago, 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.

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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1 minute ago, 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.

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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3 minutes ago, Dwayne Hoover said:

https://twitter.com/adamfeuerstein/status/1306341325273534466

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

 

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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4 minutes ago, Dwayne Hoover said:

https://twitter.com/adamfeuerstein/status/1306341325273534466

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

 

He's not wrong on a lot of this.  

This stock tanks tomorrow.  I am usually pretty positive, but I think 3.60 open and a close around 3.00-3.10.  

I'm just mad at myself because I had a feeling this call was not going to be good and I was too chicken #### to sell at 4.10 today.  Can't blame anyone but me.

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8 minutes ago, 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.

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.

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2 minutes ago, 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.

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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2 minutes ago, 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."

I honestly don't think there is malice or intentional fraud.  NP is just incompetent.

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27 minutes ago, 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.

 

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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1 minute ago, Golf Guy 69 said:

Wow, you all are crazy.  It was a no news call.  Nothing has changed for the most part.

Except we were told by NP that they hadn't filed for an EUA, and that the advice given by both the MHRA and FDA was that they weren't interested in approving a drug for emergency use for a mild-moderate population, or on the results from a mild-moderate population.

Could this NOT have been determined by a $#$%@# phone call at some point, oh, I don't know, over the past two months?  I'll supply a script.

"Hey Guys, it'd your buddy NP over at Cytodyn.  We're working with a drug that has had good success against Covid in the mild to moderate population.  Is there any chance that even good data in this group could lead to emergency use authorization?  Oh...no?  Ok, thanks."

Bam.  Months of investors hopes being strung along gone.

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1 minute ago, Dwayne Hoover said:

I didn't hear what you did here.  Can you expand on this?  Aren't we still expecting interim results in October?

Interim results should be available, but results ready for release in October?  No confidence.  FDA approval based on resubmission? Don't have a timeline.  Uplisting?  Extremely unlikely. All dominoes that will fall in sequence, but not closely after each other.  Many months of delay still ahead.

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1 minute ago, adonis said:

Except we were told by NP that they hadn't filed for an EUA, and that the advice given by both the MHRA and FDA was that they weren't interested in approving a drug for emergency use for a mild-moderate population, or on the results from a mild-moderate population.

Could this NOT have been determined by a $#$%@# phone call at some point, oh, I don't know, over the past two months?  I'll supply a script.

"Hey Guys, it'd your buddy NP over at Cytodyn.  We're working with a drug that has had good success against Covid in the mild to moderate population.  Is there any chance that even good data in this group could lead to emergency use authorization?  Oh...no?  Ok, thanks."

Bam.  Months of investors hopes being strung along gone.

I get you but where we differ is months of hope.  I never considered EUA realistic.

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Just hoping I can get out at $3.75 tomorrow.  This stock will be in the 2s in no time and you can kiss the NASDAQ good bye.

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1 minute ago, adonis said:

Interim results should be available, but results ready for release in October?  No confidence.  FDA approval based on resubmission? Don't have a timeline.  Uplisting?  Extremely unlikely. All dominoes that will fall in sequence, but not closely after each other.  Many months of delay still ahead.

Part of me wants them to fill the trial and not do interim but there is a problem with that too.  Their primary endpoint is mortality (at least right now it is) and I'm not sure that adding more patients is going to help them to hit that endpoint.  If they wait, I believe they may also have to change the endpoint.

So I do expect results in early October but think they will need to be an absolute home run (and that concerns me)

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This really should have been uplisted over a month ago.  I now have no confidence this will happen anytime soon.

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1 minute ago, Golf Guy 69 said:

I get you but where we differ is months of hope.  I never considered EUA realistic.

If Gilead repackages chewing gum it would have a EUA in hours.

Edited by BassNBrew
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2 minutes ago, BassNBrew said:

Just hoping I can get out at $3.75 tomorrow.  This stock will be in the 2s in no time and you can kiss the NASDAQ good bye.

Good luck.  Alot of longs are really pissed.  Why did he have a CC.  Why not just a press release on Friday saying that they will need a phase 3.  The company has no idea how to present information.

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4 minutes ago, Chaz McNulty said:

That was a small positive.  Crossing the blood brain barrier is a big positive, but the whole thing was just so overwhelmingly deflated by the realization that what we have been waiting on for weeks, was never even filed.  

Pathetic. 

And as frustrated as I am, as mad as I am at myself for screwing this up at almost every turn, I still think it could have a bright future.  Am I delusional?

Edited by Caesar

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38 minutes ago, Caesar said:

That was a small positive.  Crossing the blood brain barrier is a big positive, but the whole thing was just so overwhelmingly deflated by the realization that what we have been waiting on for weeks, was never even filed.  

Pathetic. 

And as frustrated as I am, as mad as I am at myself for screwing this up at almost every turn, I still think it could have a bright future.  Am I delusional?

We might.  But right now incompetence is beating science.

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1 hour ago, Chaz McNulty said:

Good luck.  Alot of longs are really pissed.  Why did he have a CC.  Why not just a press release on Friday saying that they will need a phase 3.  The company has no idea how to present information.

I didn't mind the CC.  It got all the information out there, with the spin they wanted, but it was a whole lot of bad news really.  The bad news being almost NOTHING they were hoping for in the short term has panned out and it turns out the direction they've been going in for months has been pointless.  It was good to get it out, and I appreciate a CC more than a press release.

Either way, I'd likely be frustrated, but as an investor, hearing them go through the CC, I feel I have a more clear picture of what has happened, where we are, and what the next steps are.  I just don't like the picture of what's been going on the past several months.

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1 hour ago, Caesar said:

And as frustrated as I am, as mad as I am at myself for screwing this up at almost every turn, I still think it could have a bright future.  Am I delusional?

Depending on your timeframe, from what I hear it's still a promising drug.  

However, we're primarily still hearing that from folks with ties to Cytodyn, or with anecdotal evidence.  We have some good results from m/m, but until more is known on the Covid front, it's a big question mark.  FDA approval seems reasonably likely, so odds are it's worth at least where we are now, on that alone.  But that still may be 4 months out, or more.

The good news is there's upside.  But the upside is a ways off too.  Just a lot of waiting to be done, and I'm gonna guess shorts will pick off those who don't want to wait, and others who don't want to wait to cash out when they invested at fraction of the current price may not wanna wait either.

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3 minutes ago, adonis said:

Depending on your timeframe, from what I hear it's still a promising drug.  

However, we're primarily still hearing that from folks with ties to Cytodyn, or with anecdotal evidence.  We have some good results from m/m, but until more is known on the Covid front, it's a big question mark.  FDA approval seems reasonably likely, so odds are it's worth at least where we are now, on that alone.  But that still may be 4 months out, or more.

The good news is there's upside.  But the upside is a ways off too.  Just a lot of waiting to be done, and I'm gonna guess shorts will pick off those who don't want to wait, and others who don't want to wait to cash out when they invested at fraction of the current price may not wanna wait either.

Agreed.  I had to do a bit of mindless work, so I had time to cool off a bit.  I don't want to say I was emotional about the stock, but more about not taking the action I felt was right.  Now, I do think it is going to drop, but there are still a few catalysts out there in the next month or two that should stop it from dropping too far.  Maybe 2.80 is the low?

I will sell tomorrow, about 75%, but I hope to be back in with more shares at a lower cps than I have today.  If you can't get to $10, I'll try to take it a buck at a time.  lol

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5 minutes ago, adonis said:

So...any bets on how low it goes tomorrow? $2.30?

A lot of people will sell to buy in lower.  I could see this going to $2.80 before bouncing up to $3.20.

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7 minutes ago, Chaz McNulty said:

A lot of people will sell to buy in lower.  I could see this going to $2.80 before bouncing up to $3.20.

This is about how I see it going as well. 

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