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Which, if approved for Long-haulers, would segue nicely in treatment for Chronic Fatigue Syndrome.
Leronlimab is safe and offers benefit. It met the very definition of Emergency Use Authorization, of the FDA.
You are absolutely right. These bureaucrats only care where the next buck is coming from. They see their responsibility as maintaining those who butter their bread (as told by Janet herself). They have lost their way.
You post is on point!
You just described how I feel, about this subject, to a tee! Very nice post. Thank you.
My guess is, the data will be locked for the trial that just finished, and the next trial is ready to enroll. Maybe they could have some top line data, but there are too many points, to study, for anything to be complete. I'm afraid to get my hopes up.
That is correct. It is non-news.
Just like Fridays are usually green, Tuesdays are usually red. Weird!
Hey, if Elon can do it . . . .!
Dr Rock,
I have been, sorely, missing your posts. Thank you for this one!
This article is a couple of months old. However, I think may help to explain the Brazilian government's desire to find a solution, to Covid-19, that doesn't involve big pharmaceutical companies. I don't think they will drag their feet on getting the clinical trials moving.
https://www.presstv.com/Detail/2021/04/24/650189/Pfizer-US-pharmaceutical-corporation-COVID-19-vaccine-deal-Latin-America
According to several of the trolls, on different message boards, the 13d group already has the backing they need. They claim that they don't need the backing of retail investors. Therefore, they don't need to share anything with us.
I find that pretty hard to believe.
Thank you, for support!
That should reduce the serious adverse events.
The promising pathways act, is a proposal to use real world evidence as a pathway to conventional FDA approval.
https://www.congress.gov/bill/116th-congress/senate-bill/3872
I just had to post something, to see if this board actually went silent.
Thank you for sharing all of these! I may not sleep well for awhile. The blood clotting in the delta variant is very nasty stuff. The lack of effective therapeutics is going to give the variants the upper hand. I worry for the human race.
As Dequoy reminded me yesterday, most of our Congressional members are recipients of big pharma donations. Everyone is bought and paid for.
Medicare will never pay any part of what they are asking. It is almost impossible to get them to pay for treatments that cost next to nothing.
By then, the government might be broke anyway. They can squeeze only so much blood out a taxpayer.
Ask them.
Perhaps the FDA should have paid more attention to their panel of experts, instead of their meal ticket.
Since Leronlimab met the FDA criteria, by their own definition (do no harm and offer benefit). They should have given the EUA. However, CYDY is not their meal ticket.
They need to step up, and start doing the right thing.
IMO
The more the FDA is in the public eye, the more they lose credibility. They are proving, to the world, that they are only operatives for large pharmaceutical companies. Maybe it will turn out to be a good thing, to be bitch slapped by a subservient government bureaucracy.
In fact, some Amyloid Beta plaques are protective. It may do more harm to remove them.
https://www.sciencedaily.com/releases/2021/04/210415114143.htm#:~:text=One%20of%20the%20characteristic%20hallmarks,beta%20plaques%20in%20the%20brain.&text=The%20research%2C%20which%20was%20published,do%20more%20harm%20than%20good.
Are you trying to illustrate that, if your Covid-19 is treated with Leronlimab, that you won't suffer from Post Acute Covid Syndrome? Very nice. That is a wonderful benefit to the patient!
The FDA has a very hard job. It is difficult to find a safe treatment, that offers benefit to the patient. Apparently, they can only approve treatments that cause harm and offer little benefit. It didn't used to be that way.
I read that. Really scary stuff! Hopefully, we can get Leronlimab to take care of those circulating tumor cells. We need the cancer trails completed.
Easy as can be, for a politician to spend taxpayer money. What bearing does this have for CYDY and Leronlimab? This will not take care of a lot of the mutations.
Unfortunately, I believe you are correct. What a shame.
Spin it how you want. The FDA still stinks of corruption. They even went against their panel of experts, in approving the Biogen drug. This is a total double standard, when compared to the treatment of Cytodyn and Leronlimab. Leronlimab has, at least, shown safety and benefit.
https://arstechnica.com/science/2021/06/a-disgraceful-decision-researchers-blast-fda-for-approving-alzheimers-drug/
It couldn't be more blatant. How long before a Congressional investigation?
Money matters.
Outstanding post! Good research. Thank you for sharing. Leronlimab will change the outlook on HIV.
Leronlimab saves lives and has no serious side effects.
I guess the important thing, to the FDA, is their meal ticket, not the patient.
No double standard there!
Apparently, not every country has rejected it. Apparently, the FDA has never said that won't allow it to start any more trials. So far, your arguments are laughable.
"Focusing on only the most favorable of many subgroup analyses, even if the sub-groups are pre-specified, can lead to overestimating the evidence of benefit, because regardless of a drug’s true efficacy, some analyses are likely to appear favorable by chance when a large number of analyses are conducted."
The paragraph, above, came from their letter about Cytodyn/Leronlimab concerning the Covid-19 trials CD-10 and CD-12.
Apparently, this line of reasoning does not apply to a Biogen and their drug which, potentially, can cause more harm than benefit.
Can you provide a link to where the FDA refuses to let CYDY start any more trials with Leronlimab?
Thank you. I knew you were the man to ask.
This is way over my head.
If it changes the status, in the size of the company, does it change the status of the upcoming 5% proxy battle? It seems that there might be a first shot fired. Rules of engagement?
Welcome back! Respect!
Black-Ops, what is the significance of the statement, "Effective June 1, 2021, the Company no longer meets the definition of a smaller reporting company - From the 8-K"? Does this change the 5% rule? I saw this on Stock twits board. I figured I should ask an expert.
But, according to these guys, if the treatment doesn't damage your liver and kidneys, then it isn't working.
OMG, that is the number one patient, in the world, that needs Leronlimab.
Widespread corruption and politics might just lay waste to modern civilization. I fear for our children!