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***OFFICIAL CYDY/Leronlimab Thread*** (9 Viewers)

[icon] said:
Mornin! Would love a bit more info on HGEN and your targets with NASDAQ / Buyout. Still holding about half my position on this. Half considering adding if there's tangible hope of uplift/buyout.
 

I know they got OWS money right? 
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I have a pretty big position in HGEN now, thanks to averaging down. They have a checkered past with Pharmabro involved, but all I see now is experienced and competent leadership and good hiring. They are highly institutional / insider owned. They received financing from JPM.

Their big drug has been in development for years to address Cytokine Storms. The have a partnership with Gilead going back before Covid. Their drug Phase 3 trial for Covid is > 50% enrolled, should fill in a month. Now NIH has chosen their drug to study with Gilead’s Remdesivir. Gilead is struggling right now.

My speculation, with clinical success of their trials, Gilead buys HGEN.  Price - mid to high teens. If successful, this drug is commercialized 4Q2020 under EUA.

I’m not an investment advisor, do your own DD. 

 
I like how they have been sending out positive presser after bought pump video and the stock has been straight down.

Now they release a board member is leaving and the stock is up 10%+ in Germany.

 
Whyatt said:
I have a pretty big position in HGEN now, thanks to averaging down. They have a checkered past with Pharmabro involved, but all I see now is experienced and competent leadership and good hiring. They are highly institutional / insider owned. They received financing from JPM.

Their big drug has been in development for years to address Cytokine Storms. The have a partnership with Gilead going back before Covid. Their drug Phase 3 trial for Covid is > 50% enrolled, should fill in a month. Now NIH has chosen their drug to study with Gilead’s Remdesivir. Gilead is struggling right now.

My speculation, with clinical success of their trials, Gilead buys HGEN.  Price - mid to high teens. If successful, this drug is commercialized 4Q2020 under EUA.

I’m not an investment advisor, do your own DD. 
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Great synopsis. Thanks for sharing :thumbup:

 
Charlie Harper said:
Takes time for full analysis.

So back to the original question:

What do you make of the Phase 2 results? 

Truly interested in your thoughts.
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You weren’t asking me, but the phase II results were negative. Failure to meet the primary endpoint, while meeting select secondary endpoints is largely a negative trial. Any positive secondary endpoints are nothing but hypothesis generating. 

 
I feel a lot better today than I did yesterday.  They submitted to UK overnight.  

https://www.cytodyn.com/investors/news-events/press-releases/detail/462/cytodyn-requests-fast-track-approval-for-covid-19  Reviewed within 36-72 hours.  People are claiming that means answer in 36-72, but I think that its just reviewed.  Might be some questions to answer, some back and forth, some logistics, so maybe won't have that answer this week.  Still, it puts pressure on FDA, IMO. 

S/C trial enrollment up to 182.  Getting closer to being able to start looking at interim data. 

Stock is up in Germany.

I think we get an answer by Friday from the corrupt ### government whether they feel like saving lives or not.

 
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pmedina said:
You weren’t asking me, but the phase II results were negative. Failure to meet the primary endpoint, while meeting select secondary endpoints is largely a negative trial. Any positive secondary endpoints are nothing but hypothesis generating. 
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If CYDY was a failure, what do you call Remdesivir's trail results? One trial stopped early due to increased adverse events and the other where the primary endpoint was CHANGED mid trial to find a statistically significant result?

That's what keeps bringing me back to LL.

 
[icon] said:
While these guys have proven to defy logic over and over, I'm going to ASSUME they performed a "full analysis" before submitting the data to the FDA. It would be insane not to. 

They've supposedly submitted to the FDA already, correct? 
 

So why haven't WE seen the data? 
Occam's Razor screams the answer. 
 
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Fair point.

Could be they know the info will be used by AF for another hit piece and impact stock price as they uplist. So why not just submit to regulatory agencies first and get their decision, before releasing complete data to the public? 

Either way we'll see in 48-72 hours with UK if it's good enough. Works for me.

 
Steeler said:
You no longer sound like a guy who is trying to provide an alternate perspective - you sound like a guy that wants to pound his chest about being right.  What's your reason for quoting this post "for posterity"?  So you can come back and rub salt in his wounds if the stock price continues to plummet?  It's not a good look.
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I think he came in a little to early to brag.  Especially considering that many have already made a bunch of money off this and it is still at 300% of the SP of when he first started to disparage it.

This could be his Ron DeSantis 'waxing poetic' moment.

 
Charlie Harper said:
If CYDY was a failure, what do you call Remdesivir's trail results? One trial stopped early due to increased adverse events and the other where the primary endpoint was CHANGED mid trial to find a statistically significant result?

That's what keeps bringing me back to LL.
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I don’t know about Rem. I just can tell you from a scientific standpoint (I worked in clinical trials at a NCI cancer center and now for a Pharma company), we would consider LL a negative trial.

Now we may take the secondary endpoint that was positive and continue to study, but that is another issue. 

 
pmedina said:
I don’t know about Rem. I just can tell you from a scientific standpoint (I worked in clinical trials at a NCI cancer center and now for a Pharma company), we would consider LL a negative trial.

Now we may take the secondary endpoint that was positive and continue to study, but that is another issue. 
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Yeah, it's not great when you don't hit your primary as that is your best guess pre-trial as to what will show effect.  

However, you can still get good results from a secondary that outweigh the disappointment of missing the primary in that you show a statistically significant impact on a secondary endpoint that has major clinical significance/impact.  In that case, you'd be pretty pleased with the results, and just tailor your Phase 3 trial to focus more on the population that seems to be helped by the drug.  Symptom score >4, primary NEWS2 3 day improvement, and I'd say you have a near lock, based on the results of the Phase 2, for a successful primary endpoing Phase 3 trial, even with only 100 patients.

 
I finally tapped out, selling my last few hundred shares. Which, to those of you still invested should be a Godsend. I wish you all the best with it, but I can't continue to be on this downward spiral.

That being said, thanks again @chet, for bringing this up, it's been a fun ride. 

 
I haven't given up complete hope for fda approval this week or next week.  We are in a pandemic.  There is currently no great option for a Covid therapeutic.  The FDA needs to give some approvals soon if these drugs are going to be available this winter.  Leronlimab being proven 1000% safe makes it an great choice for a faster than normal approval.

 
Don Hutson said:
I haven't given up complete hope for fda approval this week or next week.  We are in a pandemic.  There is currently no great option for a Covid therapeutic.  The FDA needs to give some approvals soon if these drugs are going to be available this winter.  Leronlimab being proven 1000% safe makes it an great choice for a faster than normal approval.
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I understand given how political things are that it may not be approved but that would be truly wild to me given that it has been demonstrated safe and at least works to some degree and we are of course in a global pandemic killing 1000+ with no end in sight. 

 
Where is @chet  

Do they have the capital to uplist?  I'm hearing they are strapped for cash.  Also, I am holding thinking they won't let this dip below $3 as they cannot up list, right?    

 
From the PR:

We are very appreciative of Dave’s enumerable contributions to our Company.

The bolded is, in fact, a word. It means that Dave's contributions can definitely be counted. I suspect the intended praise was stronger than that, and the word they were going for was 'innumerable'.

Going to assume the new communications ace was either asleep or on quite a bender when this was posted at 2:44 AM (per the CYDY website, who knows).

Still holding, in case there was some confusion. But henceforth, CYDY management will be known as The Gang That Couldn't Shoot Straight.

 
Dwayne Hoover said:
Wishful thinking but could the preprint finally be published tomorrow morning?  I sound like a yahoo right now, which I really try not to do but its an off the wall guess
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Patterson finally getting published is a strong possibility.  Another possibility is that Yo and Patterson are stockholders who want to stop the stock price bleed out.  I wonder if Dr Drew is a stockholder?  I hope so.  His audience is large.  There will be people who listen on Thursday who will buy CYDY stock on Friday.

 
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Taken from yahoo board. If this quote is accurate it doesn’t sound good for our little drug. 
 

“Unfortunately CYDY have zero chance of getting an EUA approval. This has been confirmed by FDA in its recent decision to reject EUA for plasma. The direct quote from NIH as follows:

“The three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,” Dr. Lane said. 

Given Leron was P2, only 56 patients treated, no medical journals and sponsorship, it’s a fait accompli that FDA will reject any EUA application.”

 
kevzilla said:
From the PR:

We are very appreciative of Dave’s enumerable contributions to our Company.

The bolded is, in fact, a word. It means that Dave's contributions can definitely be counted. I suspect the intended praise was stronger than that, and the word they were going for was 'innumerable'.

Going to assume the new communications ace was either asleep or on quite a bender when this was posted at 2:44 AM (per the CYDY website, who knows).

Still holding, in case there was some confusion. But henceforth, CYDY management will be known as The Gang That Couldn't Shoot Straight.
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Board members voluntarily leaving at a time when they're supposed to uplist and gave a game changer of a drug isn't good. If the CFO leaves at any point I'm putting in an immediate sell.

 
SouthJersey said:
Board members voluntarily leaving at a time when they're supposed to uplist and gave a game changer of a drug isn't good. If the CFO leaves at any point I'm putting in an immediate sell.
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Sure, CFO troubles are auto-sell. But this guy has his own tech company (which trades on NASDAQ, btw) and his plate may just be too full. But it will be "Board members DEFECTING!" by this afternoon.

 
kevzilla said:
Sure, CFO troubles are auto-sell. But this guy has his own tech company (which trades on NASDAQ, btw) and his plate may just be too full. But it will be "Board members DEFECTING!" by this afternoon.
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Maybe the guy is busy and feels like his multi-million dollar investment is in good shape to grow like crazy.  Could spin this either way.

 
Capella said:
Taken from yahoo board. If this quote is accurate it doesn’t sound good for our little drug. 
 

“Unfortunately CYDY have zero chance of getting an EUA approval. This has been confirmed by FDA in its recent decision to reject EUA for plasma. The direct quote from NIH as follows:

“The three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,” Dr. Lane said. 

Given Leron was P2, only 56 patients treated, no medical journals and sponsorship, it’s a fait accompli that FDA will reject any EUA application.”
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Of course the stock goes up at the moment.  :lol:

 
Capella said:
Taken from yahoo board. If this quote is accurate it doesn’t sound good for our little drug. 
 

“Unfortunately CYDY have zero chance of getting an EUA approval. This has been confirmed by FDA in its recent decision to reject EUA for plasma. The direct quote from NIH as follows:

“The three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,” Dr. Lane said. 

Given Leron was P2, only 56 patients treated, no medical journals and sponsorship, it’s a fait accompli that FDA will reject any EUA application.”
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I get it, but P2 was a randomized control trial.  And yes, only 56 patients...but still achieved statistical significance on news2 in-spite of the small sample size.  Technically that is more difficult to achieve.

I am guessing no EUA as well, not trying to be polyanish...but facts are facts.

 
djmich said:
I get it, but P2 was a randomized control trial.  And yes, only 56 patients...but still achieved statistical significance on news2 in-spite of the small sample size.  Technically that is more difficult to achieve.

I am guessing no EUA as well, not trying to be polyanish...but facts are facts.
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I was about to post the same thing. Seems like the quote is saying that the phase 2 trial is what they need and that whatever they rejected for EUA was because it hadn’t gone through the randomizes trial.

 
FreeBaGeL said:
There's this weird color showing up next to my CYDY shares it's kind of freaking me out.  Not sure what it's called it's been a long time since I've seen it but it's kind of like if someone took blue and added some yellow to it or something.
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Aquamarine?

 
FreeBaGeL said:
There's this weird color showing up next to my CYDY shares it's kind of freaking me out.  Not sure what it's called it's been a long time since I've seen it but it's kind of like if someone took blue and added some yellow to it or something.
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I've got a shot that will take care of that. You can give it to yourself.  

 
FreeBaGeL said:
There's this weird color showing up next to my CYDY shares it's kind of freaking me out.  Not sure what it's called it's been a long time since I've seen it but it's kind of like if someone took blue and added some yellow to it or something.
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My pavlovian response has trained me to expect a gut punch and much red after glimpsing any green.

 
kevzilla said:
ChiefD said:
Good God, who wrote that?  A 3rd grader?
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Clearly translated into English.
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Translated from English into something else, then back again.

Here is the original....from March 28th.  

So this

As the skyrocketing number of cases stretches city hospitals to the limit, doctors are racing to find out which drugs on the market or in development might help in fighting the infection.
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becomes this

Because the skyrocketing variety of instances stretches metropolis hospitals to the restrict, docs are racing to search out out which medicine in the marketplace or in growth would possibly assist in combating the an infection.
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and this

Of seven critically ill patients who received the drug in New York, two were removed from ventilators and two showed significant improvement.
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becomes this

Of seven critically ailing patients who obtained the drug in New York, two have been faraway from ventilators and two confirmed vital enchancment.
Click to expand...

 
FreeBaGeL said:
There's this weird color showing up next to my CYDY shares it's kind of freaking me out.  Not sure what it's called it's been a long time since I've seen it but it's kind of like if someone took blue and added some yellow to it or something.
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Give it time.

 
I may have to tap out.  All of the above stuff just sounds so crappy.  Feels like vaporware for a while now, not sure how else to describe it...

 
Some news that they’ll start enrolling folks in the UK for the s/c phase 3 trial that’s ongoing, apparently as part of their “fast track approval” request there.  
 

Also requesting BLA for HIV in the Uk within 4 weeks.

Oh, and they indicate they’ve submitted written questions to FDA for their type A meeting which will now be done in writing and responded to by Sept 4th rather than teleconference.

 
adonis said:
Some news that they’ll start enrolling folks in the UK for the s/c phase 3 trial that’s ongoing, apparently as part of their “fast track approval” request there.  
 

Also requesting BLA for HIV in the Uk within 4 weeks.

Oh, and they indicate they’ve submitted written questions to FDA for their type A meeting which will now be done in writing and responded to by Sept 4th rather than teleconference.
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That last sentence is a little "hmmm"....is someone frustrated with the verbal communication.

 
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