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***OFFICIAL CYDY/Leronlimab Thread***


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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 😂😂😭😭😤

Level of worry increasing.  Went from pretty calm two days ago to getting agitated.

Literally what a difference a day makes in my life.

I do not want to be one of those idiots on Yahoo complaining about how the FDA is corrupt  when the trial wasn't designed well.

Think I sell some more shares and be content with what I have

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3 minutes ago, cosjobs said:

Mostly sold out at this point. Its not so much I don't believe in the drug, I'm just tired of it tying up so much of my bankroll when the market seems to be giving money away right now.

For sure. 

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7 minutes ago, BassNBrew said:

It would likely shut the doors on the company.  NP went all in with Covid.

If they don't get an approval, you could be right but I don't agree that a narrow miss means they won't get an approval.  It's harder with someone like NP running the company but there's nothing else for severe/critical.  

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10 minutes ago, Capella said:

Sure but a bad trial design means another trial? With the vaccines pouring out now (and thank god for that) a miss with cd12, even a close one, would seem to shut the door on any positive covid outcome for Cydy. 

I don’t know enough about their finances to have an opinion here. He spent all the money on trials? 

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3 minutes ago, Capella said:

I don’t know enough about their finances to have an opinion here. He spent all the money on trials? 

He bought a bunch of LL from Samsung expecting to sell it within a year.

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1 minute ago, BassNBrew said:

He bought a bunch of LL from Samsung expecting to sell it within a year.

And so if the fda doesn’t approve, it can’t be sold to the Philippines or elsewhere?

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5 minutes ago, Capella said:

I don’t know enough about their finances to have an opinion here. He spent all the money on trials? 

As of the quarter 

ended November 30, 2020, the Company delivered to Samsung purchase orders totaling approximately $116 million related to the manufacture of leronlimab and payments totaling $40 million, with additional payments scheduled to be made throughout calendar 2021 and 2022. As of November 30, 2020, the Company has recorded current liabilities of approximately $44 million and long-term liabilities of $34 million related to inventory manufactured pursuant to the Samsung Agreement. Under the Samsung Agreement, the purchase order is binding and the Company is obligated to pay the full amount of the purchase order, and make specified minimum purchases of leronlimab from Samsung pursuant to forecasted requirements which the Company is required to provide to Samsung. The first forecast scheduled 11 manufacturing batches setting forth the total quantity of commercial grade leronlimab the Company expects to require during calendar year 2020, as of the quarter ended November 30, 2020, all batches were substantially complete. The Company estimates initial 

ramp-up

 costs to manufacture commercial grade leronlimab at scale could total approximately $127 

million, with approximately 

$64 

million payable over the course of calendar year 2020, of which 

$45 

million has been paid as of the date of this filing, approximately 

$37 

million payable during calendar year 2021, and approximately 

$26  million payable in calendar year 2022. Thereafter, the Company will pay Samsung per 15,000L batch according to the pricing terms specified in the Samsung Agreement. The Samsung Agreement has an initial term ending in December 2027 and will be automatically extended for additional 

two-year

 periods unless either party gives notice of termination at least six months prior to the then current term. Either party may terminate the Samsung Agreement in the event of the other party’s insolvency or uncured material breach, and the Company may terminate the agreement in the event of a voluntary or involuntary complete market withdrawal of leronlimab from commercial markets, with one and half year’s prior notice. Neither party may assign the agreement without the consent of the other, except in the event of a sale of all or substantially all of the assets of a party to which the agreement relates.

https://www.cytodyn.com/investors/sec-filings/all-sec-filings/xbrl_doc_only/6207

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Just now, Capella said:

And so if the fda doesn’t approve, it can’t be sold to the Philippines or elsewhere?

You can't be sure they will want it.

I suppose this is where they miss close and have to start another trial, it may still be in demand in another country.

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3 minutes ago, BassNBrew said:

As of the quarter 

ended November 30, 2020, the Company delivered to Samsung purchase orders totaling approximately $116 million related to the manufacture of leronlimab and payments totaling $40 million, with additional payments scheduled to be made throughout calendar 2021 and 2022. As of November 30, 2020, the Company has recorded current liabilities of approximately $44 million and long-term liabilities of $34 million related to inventory manufactured pursuant to the Samsung Agreement. Under the Samsung Agreement, the purchase order is binding and the Company is obligated to pay the full amount of the purchase order, and make specified minimum purchases of leronlimab from Samsung pursuant to forecasted requirements which the Company is required to provide to Samsung. The first forecast scheduled 11 manufacturing batches setting forth the total quantity of commercial grade leronlimab the Company expects to require during calendar year 2020, as of the quarter ended November 30, 2020, all batches were substantially complete. rl_doc_only/6207

Do you think NP pulls a Dirk Diggler on Samsung?

https://www.youtube.com/watch?v=9oziRZ0K1yQ

 

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We will see if you guys are right, hopefully soon. I'm on Chet's side though as I've looked at the drug and the MOA and have a pretty good idea what it's going to be able to do. 

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So I haven't been following this probably nearly as close as I should be given what I have invested, but are there any reasonable scenarios out there for why NP would have good data from the trial results and still not have shared them at this point?

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1 minute ago, FreeBaGeL said:

So I haven't been following this probably nearly as close as I should be given what I have invested, but are there any reasonable scenarios out there for why NP would have good data from the trial results and still not have shared them at this point?

Of course.  It takes time.

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11 minutes ago, FreeBaGeL said:

So I haven't been following this probably nearly as close as I should be given what I have invested, but are there any reasonable scenarios out there for why NP would have good data from the trial results and still not have shared them at this point?

Could be waiting to finalize eua with fda.  Top line Results without approval results wouldn’t look great.  
 

ETA it would give more fodder for shorts

Edited by unckeyherb
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6 minutes ago, unckeyherb said:

Could be waiting to finalize eua with fda.  Top line Results without approval results wouldn’t look great.  
 

meta it would give more fodder for shorts

Damn you

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4 minutes ago, unckeyherb said:

Could be waiting to finalize eua with fda.  Top line Results without approval results wouldn’t look great.  
 

meta it would give more fodder for shorts

If top line report shows statistical significance, it will still look great.

Now perhaps the FDA doesn't want them blowing the lid on this until they comb through it themselves. I am inclined to believe this as a possibility but have no idea.

There could also be some wrangling for a different endpoint (42 days) that does favor them.  Definitely possible.

There could be something happening behind the scenes to get all ducks in a row for delivery logistics that they want to firm up before releasing info.  

Its also at least remotely possible that someone is negotiating with them for a buyout.  

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1 minute ago, Dwayne Hoover said:

If top line report shows statistical significance, it will still look great.

Now perhaps the FDA doesn't want them blowing the lid on this until they comb through it themselves. I am inclined to believe this as a possibility but have no idea.

There could also be some wrangling for a different endpoint (42 days) that does favor them.  Definitely possible.

There could be something happening behind the scenes to get all ducks in a row for delivery logistics that they want to firm up before releasing info.  

Its also at least remotely possible that someone is negotiating with them for a buyout.  

they could also be data mining to find SOMETHING that could be positively spun (dangling carrot) due to the trial missing its endpoint and/or not having statsig.

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All I know is I don't really know, but I've made a calculated bet and investment based on digging the facts out of all this crap/stuff and right or wrong I'm not second guessing myself. NP has flaws but the real question is: is LL good enough to overcome them. My opinion is it is.

(just re-read this. Too many is's 😂)

Edited by Dave RL
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4 minutes ago, Dwayne Hoover said:

If top line report shows statistical significance, it will still look great.

Now perhaps the FDA doesn't want them blowing the lid on this until they comb through it themselves. I am inclined to believe this as a possibility but have no idea.

There could also be some wrangling for a different endpoint (42 days) that does favor them.  Definitely possible.

There could be something happening behind the scenes to get all ducks in a row for delivery logistics that they want to firm up before releasing info.  

Its also at least remotely possible that someone is negotiating with them for a buyout.  

https://m.youtube.com/watch?v=Npr9Svl47q8

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2 minutes ago, unckeyherb said:

they could also be data mining to find SOMETHING that could be positively spun (dangling carrot) due to the trial missing its endpoint and/or not having statsig.

Oh absolutely.  I was trying to give you the most positive spin

There is plenty of negative spin if you want that but will let the shorts do all that talking

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1 minute ago, Dave RL said:

All I know is I don't really know, but I've made a calculated bet and investment based on digging the facts out of all this crap/stuff and right or wrong I'm not second guessing myself. NP has flaws but the real question is: is LL good enough to overcome them. My opinion is it is.

This is totally fair and where I landed two days ago.

I still have plenty of shares either way for what I want to gamble on.  Glad to have trimmed a little more and lock in more gains though

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Just now, Dwayne Hoover said:

If no news tonight, you can buy tomorrow in the $5.10 range

I'm hoping it doesn't gap down to much at opening.  Would love to sell everything at 5.45 and rebuy .25 lower.  

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22 minutes ago, Dwayne Hoover said:

If no news tonight, you can buy tomorrow in the $5.10 range

Some guy on the yahoo board said you all should be prepared for no news this week and no news next week either. The stock will be free by then. 

Edited by Capella
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Sold all I had left today. It’s been a great ride. Thanks Chet and everyone else. Total profit just over $11,000 

Buying a fishing boat this summer using that sweet sweet CYDY money. 

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9 minutes ago, Capella said:

Some guy on the yahoo board said you all should be prepared for no news this week and no news next week either. The stock will be free by then. 

There are so many blowhards on that board.  If people are going to make dumb statements, Id at least like them to put a little thought and give a reasonable reason why they feel that way.

This sounds like another blowhard and I'd take a guess as to who it is but that may seem obsessive

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Dumb question, but if they ever get around to releasing whatever results they have, how will they go about it?  Press Release on their website?  Proactive video?  Conference call?  

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3 minutes ago, unckeyherb said:

Dumb question, but if they ever get around to releasing whatever results they have, how will they go about it?  Press Release on their website?  Proactive video?  Conference call?  

PR Conference Call on a Proactive Video, there will be a commemorative coffee mug as well

Edited by Dave RL
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File these into the moderately good news desk

As we know Eli Lilly received EUA from the FDA today.  From what I can tell, it was joint press releases at about the same time, one direct from Lilly and one from the FDA to announce this.

There was no topline report or anything from Lilly indicating this was coming, it was announced when EUA was granted.

Saw an argument on yahoo today that I'd also like to give some credibility too.  If data was bad, FDA would pull the OLE and that would need to be announced.  Obviously there hasn't been an announcement so can we reasonably say OLE is still a thing.  If so that is likely a good sign

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5 minutes ago, Dwayne Hoover said:

File these into the moderately good news desk

As we know Eli Lilly received EUA from the FDA today.  From what I can tell, it was joint press releases at about the same time, one direct from Lilly and one from the FDA to announce this.

There was no topline report or anything from Lilly indicating this was coming, it was announced when EUA was granted.

Saw an argument on yahoo today that I'd also like to give some credibility too.  If data was bad, FDA would pull the OLE and that would need to be announced.  Obviously there hasn't been an announcement so can we reasonably say OLE is still a thing.  If so that is likely a good sign

Damn you too!

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5 minutes ago, Dwayne Hoover said:

File these into the moderately good news desk

As we know Eli Lilly received EUA from the FDA today.  From what I can tell, it was joint press releases at about the same time, one direct from Lilly and one from the FDA to announce this.

There was no topline report or anything from Lilly indicating this was coming, it was announced when EUA was granted.

Saw an argument on yahoo today that I'd also like to give some credibility too.  If data was bad, FDA would pull the OLE and that would need to be announced.  Obviously there hasn't been an announcement so can we reasonably say OLE is still a thing.  If so that is likely a good sign

Counter argument...Eli Lilly checked off the golf outing and steak dinners a while ago.

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4 hours ago, Dwayne Hoover said:

File these into the moderately good news desk

As we know Eli Lilly received EUA from the FDA today.  From what I can tell, it was joint press releases at about the same time, one direct from Lilly and one from the FDA to announce this.

There was no topline report or anything from Lilly indicating this was coming, it was announced when EUA was granted.

Saw an argument on yahoo today that I'd also like to give some credibility too.  If data was bad, FDA would pull the OLE and that would need to be announced.  Obviously there hasn't been an announcement so can we reasonably say OLE is still a thing.  If so that is likely a good sign

The open label extension is definitely the key sign still. They would have pulled it right away if the drug was useless. 

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