What's new
Fantasy Football - Footballguys Forums

This is a sample guest message. Register a free account today to become a member! Once signed in, you'll be able to participate on this site by adding your own topics and posts, as well as connect with other members through your own private inbox!

***OFFICIAL CYDY/Leronlimab Thread*** (7 Viewers)

Dwayne Hoover said:
Patterson should get published at some point relatively soon.  Even if FDA gives them a phase 3, that's news worthy and may give a small bump.
Click to expand...
I don't believe Patterson's paper being published will do anything to the SP at this point.  And if they get phase 3, which is most likely, I have feeling the SP will continue to bleed south.  Just my opinion, but anything short of EUA for M/M, we keep falling.  

 
Question, is it possible the NASDAQ gets denied since they are now under the $4 mark? Not trying to be negative but the drop seems like very unlucky timing. Or can they still overturn it even if is under the $4 mark?

Tiffany Shapiro

No, they addressed that not the last call but the call before. What they may lack in share price they can make up in assets.

Aaron Gillman

Tiffany Shapiro

 okay that’s good. I just remember seeing NASDAQ requirements listing a $4 share price was one of the req’s. And I didn’t know how flexible was that.

David A. Petrocelli

Not all NASDAQ markets require the $4 min too

Martin Lee

$3 price is the minimum

 
cosjobs said:
Question, is it possible the NASDAQ gets denied since they are now under the $4 mark? Not trying to be negative but the drop seems like very unlucky timing. Or can they still overturn it even if is under the $4 mark?

Tiffany Shapiro

No, they addressed that not the last call but the call before. What they may lack in share price they can make up in assets.

Aaron Gillman

Tiffany Shapiro

 okay that’s good. I just remember seeing NASDAQ requirements listing a $4 share price was one of the req’s. And I didn’t know how flexible was that.

David A. Petrocelli

Not all NASDAQ markets require the $4 min too

Martin Lee

$3 price is the minimum
Click to expand...
If they meet some other requirements, the SP can be 3 or even 2 dollars.  

 
Capella said:
What changed is they had good results and nobody cared. Good science doesn’t mean anything unless you can get people to know about it. 
Click to expand...
Interim analysis of S/C is the next thing that should stop the bleeding and the science is looking good. The FDA can't ignore success there with the safety profile of LL. They could but then we'd know Big Pharma has them by the balls.

I don't get the panic. The science is good whether the price was $4.xx or $3.xx. We've always been waiting for EUA since the initial press release didn't bump stock price. The FDA can still grant EUA for m/m...it's only been a few days. Patience.

 
Last edited by a moderator:
Jayrok said:
I don't believe Patterson's paper being published will do anything to the SP at this point.  And if they get phase 3, which is most likely, I have feeling the SP will continue to bleed south.  Just my opinion, but anything short of EUA for M/M, we keep falling.  
Click to expand...
Being peer reviewed and validated by outside experts is still really important. Not to mention the attention that it should get by others in the medical community who are not on board yet.

At this point, one of the biggest issues I see is that it's the same people over and over talking about this stock.  Any expanded attention in the medical community is critical.

 
Charlie Harper said:
Interim analysis of S/C is the next thing that should stop the bleeding and the science is looking good. The FDA can't ignore success there with the safety profile of LL. They could but then we'd know Big Pharma has them by the balls.

I don't get the panic. The science is good whether the price was $4.xx or $3.xx. We've always been waiting for EUA since the initial press release didn't bump stock price. The FDA can still grant EUA for m/m...it's only been a few days. Patience.
Click to expand...
Did they say in the call how many patients they still lack for qualifying for the interim analysis?  

 
Dwayne Hoover said:
Being peer reviewed and validated by outside experts is still really important. Not to mention the attention that it should get by others in the medical community who are not on board yet.

At this point, one of the biggest issues I see is that it's the same people over and over talking about this stock.  Any expanded attention in the medical community is critical.
Click to expand...
I agree with you last sentence. They need to move away from Dr. Yo and towards some people that can actually reach others.  

Being peer reviewed is awesome and I do believe he'll be published.  I just think at this point, the market is focused on actual news.  There may be a bump if published.  It'll quickly be shorted back down absent FDA news.  We all know this.  Or news from any of the other countries NP said he's submitted the TLine report to.  

FDA approval or use in other countries that show success is the only thing covid-related that's going to jump start this stock.  I long for the day that this gets going and out of reach of the people shorting it.  Yes, they can still short if on NAZ, but if the drug improves patient care and gets going... they will move on to other targets.  

 
Have to believe that some other country is going to give this a shot too.  There should be a trial started in one of these countries NP is targeting, should help a little.

Have no expectation of a short term home run, just a couple of singles to stop the bleeding is good.

 
Last edited by a moderator:
BassNBrew said:
In at $3.55, out at $3.71.  It's like a pinky bandaid on battle ax wound.
Click to expand...
Out at 3.53, still out.  I'm sure I picked the absolute minimum to sell at.  The chances of me selling at a random point in the day and having that be the minimum hovers around 95%.

 
Charlie Harper said:
Why are you selling if you held this long? Truly curious.
Click to expand...
Why not? : https://www.dropbox.com/s/m8vl0knvh7meq90/CYDY_1mo.jpg?dl=0

It's pretty clear the CD10 topline results are going to miss primary endpoint...

So, can you blame someone to not want to stay aboard the Biotech Titanic and be entertained by another month or three of NP and company tripping over their own ##### under the hope that the Severe trial results come back with a statistically significant hit on a primary endpoint so we can get this show on the road? 

Because that's a pretty hard sell right now.... 

 
Last edited by a moderator:
Charlie Harper said:
Why are you selling if you held this long? Truly curious.
Click to expand...
Why hold?  Market sentiment is king and the sentiment is not good.  Most of these bio plays don't work out and I walk away with a 35k profit at the level I sold.  It ain't all bad to ring the register.

 
Oh my.  Just read a few of the yahoo comments.  Not sure if i should laugh or cry.

One guy sent an email to Trump's new Rona advisor.  Below is a snippet.

"From my perspective, COVID-19 is an emergency situation that is occurring, and “facilitating patient access as soon as possible” means CytoDyn’s EUA request should be acted on and leronlimab should be approved immediately. My parents are in their 90's, and I'm no spring chicken. There is only one right choice. Anything else would cost time and lives and be illogical, unethical, and immoral."

His underlings who screen his emails will get a good laugh before sending it to the trash bin.

 
ILUVBEER99 said:
Oh my.  Just read a few of the yahoo comments.  Not sure if i should laugh or cry.

One guy sent an email to Trump's new Rona advisor.  Below is a snippet.

"From my perspective, COVID-19 is an emergency situation that is occurring, and “facilitating patient access as soon as possible” means CytoDyn’s EUA request should be acted on and leronlimab should be approved immediately. My parents are in their 90's, and I'm no spring chicken. There is only one right choice. Anything else would cost time and lives and be illogical, unethical, and immoral."

His underlings who screen his emails will get a good laugh before sending it to the trash bin.
Click to expand...
My favorite there is the people posting THANKS FOR THE CHEAP SHARES SHORTIES while secretly crying that they’re down 45%

 
ILUVBEER99 said:
Oh my.  Just read a few of the yahoo comments.  Not sure if i should laugh or cry.

One guy sent an email to Trump's new Rona advisor.  Below is a snippet.

"From my perspective, COVID-19 is an emergency situation that is occurring, and “facilitating patient access as soon as possible” means CytoDyn’s EUA request should be acted on and leronlimab should be approved immediately. My parents are in their 90's, and I'm no spring chicken. There is only one right choice. Anything else would cost time and lives and be illogical, unethical, and immoral."

His underlings who screen his emails will get a good laugh before sending it to the trash bin.
Click to expand...
Take two hydrochorlinquine, chase it with some bleach, and call me in the morning.

 
This is a well written synopsis of the phase 2 results.  

The purpose of this email is to update you and to provide the exciting results of the clinical trials which have been submitted to the FDA. A number of experts believe that Leronlimab should be approved by the FDA for emergency use authorization. I wanted to make you aware of these developments, which are beyond significant for both the economy and health of the country. I encourage you to share this good news with your colleagues.
 
MILD to MODERATE COVID-19 PATIENT GROUP
 
Leronlimab was involved in a Phase 2 (FDA) trial to assess the safety and efficacy of Leronlimab to treat mild to moderate (M/M) cases of COVID-19. A few points related to mild to moderate COVID-19 patients.

  1. M/M COVID-19 patients are generally defined as having less severe clinical symptoms (low grade fever, cough, discomfort) with no evidence of pneumonia and not requiring admission to ICU.
  2. Numerous clinical trials and studies have attempted to assess drug interventions in M/M patients. It is considered the hardest patient population in which to test a medication as most patients in this class recover on their own. No drug intervention to date has been able to show statistically significant efficacy for this patient group. This includes Remdesivir which is the only FDA approved treatment and only for a small sliver of COVID-19 patients.
  3. A treatment for M/M COVID-19 patients is very important as all severe/critical COVID-19 patients first begin as M/M and progress to severe/critical patients placing tremendous strains on the healthcare system and incur very costly inpatient hospital expenses. A drug demonstrating efficacy in this patient group has the potential to save substantial healthcare dollars through avoided hospital admissions.
 
LERONLIMAB PHASE 2 RESULTS
 
CytoDyn, the producer of Leronlimab, submitted its top line results to the FDA on Wednesday and requested Emergency Use Authorization based upon the following Phase 2 results.

  1. Leronlimab is the only drug studied to date to show efficacy in the M/M population.
  2. National Early Warning Score (NEWS2) is a generally accepted objective scale for identifying patients who are at risk for rapid health deterioration and in need of critical care. It was developed in the UK and is a leading scoring system to assess risk in COVID-19 patients.  NEWS2 improvement was measured after 14 treatment days in the M/M trial. 50% of patients treated with Leronlimab showed beneficial improvement in NEWS2 scores at 14 days while only 20% of the placebo patients showed improvement in 14 days (P-value<.0223). This is a 150% increase in the number of patients improving their risk for rapid health deterioration or in need of critical care. This is a profound finding and again, a level of efficacy not shown by any other drug in development for COVID-19. Even more remarkable is the fact that M/M patients are generally on their way to recovery on their own by day 14.
  3. More remarkably, an analysis of the per-protocol population showed a similar statistically significant outcome at day 3 (P-value <.03). This finding shows how rapidly Leronlimab has been show to improve the COVID-19 prognosis.
  4. The Leronlimab treatment arm in the Phase 2 trial experienced a nearly absurd 58.4% reduction severe adverse events (SAEs) compared to the placebo arm. (21.4% or 6 SAEs in 28 Patients in the placebo arm versus only 8.9% or 5 SAEs in 56 Patients in the Leronlimab arm.) This is difficult to put into context. Doing nothing created 2.4 times the SAEs than patients receiving Leronlimab. Leronlimab resulted in a prophylactic effect for AEs and SAEs. This is a testament to its potential for COVID-19 therapy.
 
APPLICATIONS IN OTHER COUNTRIES
 
CytoDyn has submitted information for Leronlimab approval in the UK, Israel, Brazil, and other countries, requesting emergency use authorization based upon Phase 2 results. There is a potential that another country will approve Leronlimab before the FDA.
 
Thank you for your consideration and I encourage you to spread the word about important COVID-19 breakthrough. It should be noted that President Trump has recently hinted about his excitement around therapies versus a vaccine. He mentions taking a shot to treat yourself. Whether coincidence or not, Leronlimab is the only treatment showing efficacy, and by the way, it is a shot.
Click to expand...

 
Last edited by a moderator:
Does anybody know the significance of the S-C trial being in a Phase 2b/3.  My understanding is that if LL met statistically significance on the primary endpoint in Phase 3 that the drug would be approved.  Does that change with this 2b element at all.

Edited to add:  I think that summary Chet posted above is spot on.

 
Last edited by a moderator:
chet said:
It was written by a shareholder who is sending it to people of influence.  He gave permission to copy/paste it.
Click to expand...
Well written and concise/ Also connects the dots and is persuasive. Company should adopt it as its own and do a PR with it.

Needs a good headline. 

 
So I guess they just decided not to release the actual data or whether they hit or missed the primary endpoint?

They hire Trump for PR? "You can't miss endpoints if you never release the data!" :coffee:  

 
Last edited by a moderator:
I can’t imagine a worse press release headline than “CYDY announces clinically significant top-line results... .”  “Clinically significant top-line results” about as close as one can possibly write to “the results were pretty yawn but hey technically speaking they were clinically significant because one dude got a little better.”  

Save the nerdspeak for the 2nd or 3rd paragraph of the press release.  How about something more positive for the regular folks in the headline?

 
You must log in or register to reply here.

Similar threads

wadegarrett
***Official OHIO STATE-MICHIGAN Thread***
40 41 42
Replies
2K
Views
52K
Blue Dot Orange Dot
B
Bob Magaw
*** Official 2011 St. Louis Rams Thread ***
Replies
21
Views
2K
Bob Magaw
Bob Magaw
Couch Potato
Couch Potato 2012 Dynasty Rankings
4 5 6
Replies
293
Views
40K
Spin
Spin

Users who are viewing this thread

Total: 6 (members: 0, guests: 6)
Back
Top