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Posted On: 03/02/2021 6:52:55 AM
Post# of 148908
It would be my honor some day to sit down with all of you (minus the obvious d-bags on most of our ignore lists) over multiple 4L bottles of Chateauneuf du Pape and walk you through a tutorial on cooking a delicious steak in a poorly outfitted hotel room kitchen.
It's a masters level course that covers such topics as:
Is that too much butter? (No, it's not enough butter.)
Is the wine for cooking or drinking? (Any wine is "cooking" wine if you drink it while you're cooking)
Why two filets? (Because some dumbass decided that while you'd definitely want 20oz of ribeye at bare minimum you'd rarely want more than 8oz of filet. I rarely condone murder but whoever made that choice for us should be murdered. Buy two and eat a real amount of steak fer christsakes. Hashtag Murder)
Have you ever tried pork butt? (I SAID NO BUTT STUFF)
But on to Leron...
Calstang brought up CRMD and their complete response letter due to manufacturing concerns. It obviously happens sometimes, as we all know. I had a few shares take a beating from that decision. But in our case I think we're, luckily, in an advantageous position due to our BLA delays.
We've already had a full, in-depth review of our manufacturing, safety, and efficacy when it comes to HIV. That puts us in a different starting place for this EUA than if we'd never gotten that far. Imagine having to convince the FDA that a CCR5 blocker was capable of dropping mortality rates AND they'd never seen any information regarding safety or efficacy or manufacturing before.
Obviously we had/have a few things of our own to shore up so the FDA can tick all eleven thousand anal retentive boxes and approve us for HIV, but if there's anything positive to be gained from this experience it's that the FDA knows a LOT more about Leronlimab and Cytodyn than they normally would as they decide whether or not to give us an EUA or full approval, partial indications (like just severe, or just critical), or possibly even (like in the UK or Canada) throw in an HIV approval at the same time. That last one is a super long, long, long, long, shot but I'm nothing if not long (and strong, and down to get the friction on).
So fellas...
Let's all stop to smell a (two) filet mignon cooking today. Enjoy a glass or bottle of reasonably priced red wine (until we're rich and can drink ridiculously priced bottles for the fun of it) or any other beverage or meat substitute you choose. And as one of the world's greatest authors said about investing in CYDY recently:
"So be sure when you step, step with care and great tact. And remember that life's a Great Balancing Act. Just never forget to be dexterous and deft. And never mix up your right foot with your left.
And will you succeed? Yes! You will, indeed!
(98 and 3/4 percent guaranteed.)"
It's a masters level course that covers such topics as:
Is that too much butter? (No, it's not enough butter.)
Is the wine for cooking or drinking? (Any wine is "cooking" wine if you drink it while you're cooking)
Why two filets? (Because some dumbass decided that while you'd definitely want 20oz of ribeye at bare minimum you'd rarely want more than 8oz of filet. I rarely condone murder but whoever made that choice for us should be murdered. Buy two and eat a real amount of steak fer christsakes. Hashtag Murder)
Have you ever tried pork butt? (I SAID NO BUTT STUFF)
But on to Leron...
Calstang brought up CRMD and their complete response letter due to manufacturing concerns. It obviously happens sometimes, as we all know. I had a few shares take a beating from that decision. But in our case I think we're, luckily, in an advantageous position due to our BLA delays.
We've already had a full, in-depth review of our manufacturing, safety, and efficacy when it comes to HIV. That puts us in a different starting place for this EUA than if we'd never gotten that far. Imagine having to convince the FDA that a CCR5 blocker was capable of dropping mortality rates AND they'd never seen any information regarding safety or efficacy or manufacturing before.
Obviously we had/have a few things of our own to shore up so the FDA can tick all eleven thousand anal retentive boxes and approve us for HIV, but if there's anything positive to be gained from this experience it's that the FDA knows a LOT more about Leronlimab and Cytodyn than they normally would as they decide whether or not to give us an EUA or full approval, partial indications (like just severe, or just critical), or possibly even (like in the UK or Canada) throw in an HIV approval at the same time. That last one is a super long, long, long, long, shot but I'm nothing if not long (and strong, and down to get the friction on).
So fellas...
Let's all stop to smell a (two) filet mignon cooking today. Enjoy a glass or bottle of reasonably priced red wine (until we're rich and can drink ridiculously priced bottles for the fun of it) or any other beverage or meat substitute you choose. And as one of the world's greatest authors said about investing in CYDY recently:
"So be sure when you step, step with care and great tact. And remember that life's a Great Balancing Act. Just never forget to be dexterous and deft. And never mix up your right foot with your left.
And will you succeed? Yes! You will, indeed!
(98 and 3/4 percent guaranteed.)"
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