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***OFFICIAL CYDY/Leronlimab Thread***


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3 minutes ago, stbugs said:

That’s not what I mean, it was up more earlier. I didn’t say sell now just that it might be a good day. I just remember the rosy projections before any vaccine efficacy new was out was close to the premarket price. If you don’t care, no problem just letting people know what I remember. Make your own call. I don’t own any.

Yea I’ve said the returns on these have been significantly diminished but I sure don’t think 23 is the floor. It’s not going to a 150 or anything though 

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Yes, go ahead FC42

I closed.  Cydy operation mountain house completed.

Told my wife I was about to buy some more and she said that’s what I’ll get to keep in the divorce proceedings 😂😂😭😭😤

43 minutes ago, BassNBrew said:

Great news.  How long do you think until they get approved?

From what I’m reading they apply this week and it should be a few weeks after that - so sometime in April. 

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HGEN results are good but remember their drug only works for patients with elevated GMCSF which is about 15-20% of severe/critical.  This is not a category killer.

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2 minutes ago, chet said:

HGEN results are good but remember their drug only works for patients with elevated GMCSF which is about 15-20% of severe/critical.  This is not a category killer.

It’s almost certainly getting an approval off these results — all that matters for the stock purposes. They’ll have revenue coming in. 

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2 minutes ago, chet said:

HGEN results are good but remember their drug only works for patients with elevated GMCSF which is about 15-20% of severe/critical.  This is not a category killer.

If they get an EUA, other countries will be interested as well.  This seems like a good buying opp but I have higher expectations

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1 minute ago, Capella said:

It’s almost certainly getting an approval off these results — all that matters for the stock purposes. They’ll have revenue coming in. 

I agree and that's why i own the stock.

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21 minutes ago, Dwayne Hoover said:

If they get an EUA, other countries will be interested as well.  This seems like a good buying opp but I have higher expectations

In all seriousness I think your expectations are unrealistic if 84% two hours after news isn’t good enough for you.   

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2 minutes ago, Chaz McNulty said:

😂

Is it the his words or the dancing banana that have you so incensed? 

I'm not sure what triggered it.  A simple response to my first post, would have been. Yes, Dwayne, I think $21.75 is a good buying opportunity premarket.  Luckily I followed my instinct despite what was believed to be disappointment.

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2 minutes ago, Dwayne Hoover said:

I'm not sure what triggered it.  A simple response to my first post, would have been. Yes, Dwayne, I think $21.75 is a good buying opportunity premarket.  Luckily I followed my instinct despite what was believed to be disappointment.

You said to me “it’s fine to be disappointed” 45 minutes before the market even opened lol. Cut it out with the innocent doe stuff. 

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Also I had a point in here somewhere.

What i was also trying to convey pre coffee but was not as eloquent is that those that bought in the teens put out a lot of risk when they could have just bought at $21.50 this morning and got a good pop

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1 minute ago, dkp993 said:

Fascinating stuff fellas.  Can we get 2 more pages of it please. 

I mean we can keep discussing how much money everybody has lost in cydy if you prefer 

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Just now, Capella said:

I mean we can keep discussing how much money everybody has lost in cydy if you prefer 

Yes please x 1000 over this

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I wonder if the HGEN stock price gets the big increase upon an EAU?  I realize the stock price has gone up a ton today, but they were already at the $23 level in February with no news.

I guess we will see what kind of action we get throughout the week.  I think this should be $35 plus with a succesful Covid trial, and an imminent EUA approval.  Especially considering the extremely low float.

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6 minutes ago, Chaz McNulty said:

I wonder if the HGEN stock price gets the big increase upon an EAU?  I realize the stock price has gone up a ton today, but they were already at the $23 level in February with no news.

I guess we will see what kind of action we get throughout the week.  I think this should be $35 plus with a succesful Covid trial, and an imminent EUA approval.  Especially considering the extremely low float.

I would think the big increase would be the EUA. 73M shares traded so far today so there’s a lot of eyeballs on it now so should be a good lead-up imo. I think one day last week there was less than 1M traded. 

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38 minutes ago, Capella said:

I would think the big increase would be the EUA. 73M shares traded so far today so there’s a lot of eyeballs on it now so should be a good lead-up imo. I think one day last week there was less than 1M traded. 

EUA in USA and other countries getting on board should help for a bump in the coming weeks.

Short window so far this morning to get in and out though.  I unloaded some of my shares at $24 just to get some cash off this.  Still have half my shares and some $17.50 calls for 5/21 that I would like to see jump more.

Feel like some good media exposure could help the situation too

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The news on the website started out so promising.

Quote

VANCOUVER, Washington, March 29, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the Republic of the Philippines, Department of Health, Food and Drug Administration (“Philippines FDA”) has approved the use of leronlimab... 

But then the crusher.

Quote

to treat a COVID-19 patient under Compassionate Special Permit (“CSP”) pursuant to FDA Order No. 2016-005.

This sounds similar to an EIND.

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1 hour ago, Chaz McNulty said:

The news on the website started out so promising.

But then the crusher.

This sounds similar to an EIND.

If they save the patient, the Philippines might approve another patient for treatment!

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This new PR seems like really good news.  I know it’s not an endpoint that they were going for but decreasing mortality by 84%, even if it’s in a smaller subset of patients, seems impactful to me.  Whatever, We’ll probably open in the red today.

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11 minutes ago, Capella said:

Ok so that seems good - why is it coming out now and not two weeks ago?

THIS was the two weeks later we’ve been waiting for!!!

 

:headbang:

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7 minutes ago, Capella said:

Ok so that seems good - why is it coming out now and not two weeks ago?

Because it's a bunch of BS.  If LL reduces death by 82% at 14 days but only 6% at day 28, then one could easily say that use of LL between day 15 and 28 increasing the relative likelihood of death by almost 1400%.

Note that's not actually true because the data has been sliced so many different way and Cody refuses to release actually full data for any of their trails.  The 82% is based on 62 patients and the 6% on 309 which might include severe.  When you look at their numbers for day 28 result you get the following caveats with no number of patients..."when use with common Covid treatments in critically ill and less than 65 yo" and "used in addition to dexamethasone in the critically ill population ≤ 65 years old".  

So if you have 62 critically ill, how many were less than 65 yo?  Should be a split of 41 getting LL and 20 getting the placebo for the full population.  Best I can tell is that critical case split is 12%/82% based on under 70 yo and 70 yo and over.    Giving the benefit of the doubt to LL lets use 20 percent.  Based on that, these numbers being touted for under 65 years old are based on 8 LL patients and 4 placebo patients based on an expected distribution.  Cytodyn felt like they didn't get a fair shake on the young/old distribution so lets use 9 and 5.

Running with that, lets say 3 placebo patients died (60%) and 4 LL patients died (44%).  There's your 16% reduction in mortality.

 

 

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31 minutes ago, Dwayne Hoover said:

How many patients died in this window?

Notice you never get the full numbers, just the improvement in critical FSU football players who graduated in 4 years and didn't spend a night in jail.

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10 minutes ago, BassNBrew said:

Notice you never get the full numbers, just the improvement in critical FSU football players who graduated in 4 years and didn't spend a night in jail.

So zero?

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25 minutes ago, BassNBrew said:

Because it's a bunch of BS.  If LL reduces death by 82% at 14 days but only 6% at day 28, then one could easily say that use of LL between day 15 and 28 increasing the relative likelihood of death by almost 1400%.

Note that's not actually true because the data has been sliced so many different way and Cody refuses to release actually full data for any of their trails.  The 82% is based on 62 patients and the 6% on 309 which might include severe.  When you look at their numbers for day 28 result you get the following caveats with no number of patients..."when use with common Covid treatments in critically ill and less than 65 yo" and "used in addition to dexamethasone in the critically ill population ≤ 65 years old".  

So if you have 62 critically ill, how many were less than 65 yo?  Should be a split of 41 getting LL and 20 getting the placebo for the full population.  Best I can tell is that critical case split is 12%/82% based on under 70 yo and 70 yo and over.    Giving the benefit of the doubt to LL lets use 20 percent.  Based on that, these numbers being touted for under 65 years old are based on 8 LL patients and 4 placebo patients based on an expected distribution.  Cytodyn felt like they didn't get a fair shake on the young/old distribution so lets use 9 and 5.

Running with that, lets say 3 placebo patients died (60%) and 4 LL patients died (44%).  There's your 16% reduction in mortality.

 

 

They only gave drug at days 0 and 7. To me, it implies they should have been giving more drug to patients at day 14 and 21. 
 

This is good and bad news—the drug works but Nader ####ed up the trial. 

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9 minutes ago, chet said:

They only gave drug at days 0 and 7. To me, it implies they should have been giving more drug to patients at day 14 and 21. 
 

This is good and bad news—the drug works but Nader ####ed up the trial. 

Well we already know he ####ed up the trial. Any chance of fda granting anything off this trial? I can’t imagine. 
 

Waiting 3 more months while Hgen gains steam and the vaccines take over is just a disaster for the company. 

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10 minutes ago, chet said:

They only gave drug at days 0 and 7. To me, it implies they should have been giving more drug to patients at day 14 and 21. 
 

This is good and bad news—the drug works but Nader ####ed up the trial. 

You've got to be kidding me.

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1 minute ago, Capella said:

Well we already know he ####ed up the trial. Any chance of fda granting anything off this trial? I can’t imagine. 
 

Waiting 3 more months while Hgen gains steam and the vaccines take over is just a disaster for the company. 

I can't see it.  There are just not enough people in these various populations.  

What is a shame is that the FDA didn't assist in pumping LL and it's competitors into 1000s of people who were dying when these drugs were known to be safe.

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Just now, Capella said:

Well we already know he ####ed up the trial. Any chance of fda granting anything off this trial? I can’t imagine. 
 

Waiting 3 more months while Hgen gains steam and the vaccines take over is just a disaster for the company. 

HGEN doesn’t compete here other than in the 15-20% who have elevated GMCSF. Because of virus mutations, I don’t think the current set of vaccines will be overly effective in 6 months.  I don’t think COVID is going away but with vaccines and therapeutics, I think it will look like a bad flu season rather than a pandemic. 
 

I think this news strengthens the case for a conditional EUA. 

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1 minute ago, BassNBrew said:

I can't see it.  There are just not enough people in these various populations.  

What is a shame is that the FDA didn't assist in pumping LL and it's competitors into 1000s of people who were dying when these drugs were known to be safe.

Yup. Have to imagine Nader made no friends and has no favors. Still a bad look for the FDA, knowing how safe it is. 

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2 minutes ago, chet said:

HGEN doesn’t compete here other than in the 15-20% who have elevated GMCSF. Because of virus mutations, I don’t think the current set of vaccines will be overly effective in 6 months.  I don’t think COVID is going away but with vaccines and therapeutics, I think it will look like a bad flu season rather than a pandemic. 
 

I think this news strengthens the case for a conditional EUA. 

Report came out yesterday from real world examples that the vaccines neutralize the variants. Covid will still be around but the vaccines are covid killers. 

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18 minutes ago, chet said:

They only gave drug at days 0 and 7. To me, it implies they should have been giving more drug to patients at day 14 and 21. 
 

This is good and bad news—the drug works but Nader ####ed up the trial. 

From the PR:

"The Company believes this data provides an opportunity to expound upon the advice and expertise of our Key Opinion Leaders to optimize the dosing of Leronlimab for further clinical benefit."

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1 minute ago, chet said:

Kidding how?  You’re surprised that Nader could be this incompetent?

I hadn't read that.  I know Nadar is ultimately responsible, but this falls in the laps of the employees responsible for this type of stuff.  That said, there just were enough people getting this drug to figure out the optimum way to administer.

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1 minute ago, Capella said:

Report came out yesterday from real world examples that the vaccines neutralize the variants. Covid will still be around but the vaccines are covid killers. 

Link?  I've heard the opposite FWIW.

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