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Please explain to me how the placebo effect works on somebody who is heavily sedated and on a ventilator. These people have no freaking idea what is going on in most cases, their doctors and/or loved ones are making the calls.
Thank you Boston, no question about it.
Wouldn't it be something if old man Biden announced the emergency approval of Leronlimab tonight?
Fwiw people, Janet Woodcock got back to me today, saying 'We look carefully at the data from all clinical trials'. To her credit she said she was glad to see my wife has recovered as well.
Have to agree. Even I added some this morning, something I have been avoiding since my average cost is down around 50 cents and it rubs me the wrong way to increase my average cost. But I broke down and did it.
Hey c20. When I was trying to get LL for my wife her doctor had numerous conversations with the FDA about her. The FDA told him they didn't know if Leronlimab would help her but they were quite confidant that it would not harm her, so they gave the OK. As we know, she is alive and well sitting here next to me. The folks who aren't responding to Fauci's standard of care have a good shot at dying. Period. Leronliman has shown moderate efficacy, at the very least, in both trials. Its a crime that these bastards at FDA are jerking us around while people are dying.
I'm not arguing numbers or P values. The fda's and Woodcocks own words indicate that in a pandemic, p values, statistics etc are out the window. Potential efficacy and safety are in play. That's what they said. It's not arguable that our drug showed SOME efficacy in both trials and anecdotal efficacy in the EIND's. Nobody can argue that Leronlimab is not safe. So I ask why is it not made available, at the very least, to people on ventilators who have not responded to the wonderful standard of care pushed by Fauci? People who are on their way to the grave. And we need another 140 patient trial now while people die every day? Are you kidding me? And now this idiot Fauci is hyping a pair of phase 1 and a phase 2b drug to treat covid while we have one ready to go. Again, are we all insane here? This is a freaking outrage.
I personally don't think the stinking corrupt FDA is going to approve us after the 140 new patient trial either. They will have another bullshit excuse not too. If somebody doesn't expose this crap we as shareholders are finished.
My wife's doctor is looking into this right now as per my request. Hopefully he will email Woodcock.
"If there is any potential efficacy and the drug is safe"
That is the FDA's own guidance for covid therapeutics. Does Leronlimab not meet those bullet points? I'm living with the proof that it does, and believe me, covid patients were dropping like flies in the ICU in the rooms surrounding my wife. If anybody hasn't realized by now the bullshit game the FDA is playing with us you gotta be freaking blind.
I just emailed the doctor who got Leronlimab for my wife and explained what is happening. I asked him to email Janet Woodcock and ask her to reconsider. Hopefully he may do it.
I also got a canned response from Dan Vergano at Buzzfeed.
What we really need is somebody in the media with some clout who is willing to expose this stinking FDA for what it is.
One other thing I'll throw out there. The subgroup of patients that I'm particularly riled up about are very critical and have not responded to all the other FDA approved meds. They are intubated and heavily sedated. Meaning, the placebo effect is not an issue. So the FDA wants everybody to believe that dumb luck saved these people rather than our Leronlimab. It's pure bullshit.
Misiu, for what it's worth I just emailed J. Woodcock at FDA regarding my wife's situation. Laid it all out. My wife did not respond to the Dex, Methyl Prednisone, Remdisivir and antibiotics, the 'Standard of Care', as they say, but apparently she did respond to our drug, as have many others.
I personally don't see the harm in granting EUA for Leronlimab at the very least for this subgroup of patients like my wife, most of whom will probably not survive without it. It's just inhumane what is going on here.
The FDA is screwing us, plain and simple, and all the folks that could have been saved, past and future, by our drug. Those bastards had no intention of ever approving Leronlimab for Covid.
Perhaps you'd like a picture of the Leronlimab I was able to procure for my wife under EIND in mid December.
Mohave, had to respond to your post as I totally agree with your take. My wife was on Bipap for 2 days and we were able to visit a bit as they moved her from our small town hospital to the big one in Fargo. She looked to be incredibly uncomfortable with that mask on, shoving high flow oxygen into her face. Thankfully their protocol called for proactive intubation, and when her sats would not hold 90 they opted to intubate her before it was an emergency. Of course, intubation and the sedation that goes along with it has its own issues, but at that point there really isn't much choice. Great post!
Throwing in my 2 cents, but there's a big difference between 'severe' and 'critical'
The severe patients (resp over 30 and o2 sats less than 93) are still in the stage where most get better on minimal intervention, meaning home oxygen and dexamethasone. Once the condition degrades to critical it's a whole new ballgame.
I should probably start contacting the local media here about my wife's unbelievable and unlikely conquest over severe covid thanks in large part to Leronlimab. Can't hurt our cause, or the cause of the poor souls that can't breathe thanks to the inaction of the FDA.
Does Leronlimab work for severe covid 19? An anecdotal summary regarding my wife, a 70 y/o female with asthma, type 2 diabetes, and high blood pressure.
My wife was intubated on Dec 17. Once she was taken off Bipap and intubated, her chances for survival dropped to the 33-50% range, and many of those survivors wind up forever on the ventilator in long term care facilities.
She received normal standard of care, including antibiotic and steroids (dexamethasone, methyl prednisone) for pneumonia and Remdisivir.
She got her first dose of Leronlimab on Dec 24, her 8th day of intubation. Second dose a week later on Dec 31.
She spent a total of 43 days on a vent, suffering a lung tear and a second bout with pneumonia from the ventilator and a few infections along the way. In spite of all the setback she managed to wean off the vent for good after 43 days, still requiring supplemental oxygen.
Her oxygen needs have steadily dropped, from 4 litres/minute to .5 litre/minute. Her o2 sats on .5 litre have consistently been 96-100. In fact, her oxygen line came off for 4 hours yesterday and she desatted down to an acceptable 90-91. Not even low enough to set off the monitor alarm.
Along the way I've had 2 doctors tell me flat out she should not be among the living.
Every single doctor who's treated her has told me she would require supplemental oxygen probably forever IF she was fortunate enough to get off the vent. Now it looks as if her oxygen needs will be sporadic at most.
She's rehabbing and since I'm willing to do a ton of work in order to get her home as quickly as possible, will probably be returning home next week.
Leronlimab have much to do with all this? I'm convinced it certainly did.
Yeah definitely not normal
But what explains the run up on no news? Rumors?
So what's the consensus here on the run up on no news followed by the pull back on no news.
C20, we appreciate it !
Here she comes again. This is crazy
This is why I don't follow my own advice. If i bought yesterday with intentions of selling in today's premarket I'd be getting my butt kicked
Thanks c20, she's doing pretty well. Doc is pushing to get her off the vent in next week. She's gone as much as 30 hours off vent so far with no issues. Her life, and our life, will improve by about a mile if she can lose that ventilator. She is requiring supplemental oxygen and probably will for awhile, if not forever, but that's a minor hassle compared to dragging a ventilator around with you.
While mortality at 28 days may be the primary endpoint, it's important to realize that not all 390 patients had matching levels of illness. You don't have 390 clones getting Leronlimab or placebo at exactly the same time. Im quite sure all the variables have to be taken into consideration along with the raw numbers.
You could make a living buying this when the market opens and selling it in the pre market next day.
Yeah I could live with that
500 mil would be what, 15 dollar share price or thereabouts?
That may be asking for too much. If it makes 5 I could sell my remaining shares and get about a 4 bagger out of it. I have no problem with that.
Oh man I am so sorry. I can see it happening though. If I told you the number of times there's been 3-4 people scrambling trying to get my wife's Heart rate or blood pressure or o2 sats under control you wouldn't believe it. Covid patients are in a very fragile state for an extended period of time, no question. My condolences.
Same with me. I'm still holding enough shares that it'll be quite a bounty for me if it hits double digits.
Im not sure taking profit in the pre or post market is such a bad strategy, if your intention is to book some profits, which I did yesterday.
I sold 40% of my CYDY at 7.50 and 9.90. I'm happily holding 60% still.
Wife's doing pretty well, thanks for asking. She probably 3 weeks from getting home is my estimate, after a month in the ICU already.
Well I couldn't take it. I sold 2/3 of my shares in the aftermarket for 1.90
Still got some in case it really goes.
We appreciate you looking out for us. You must be quite the humanitarian.
Blah blah blah
And for the record, the word is CAREFUL
Ha ha ha