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The other pathetic drug companies pick and choose their patients and their end points and they still can't prove any use. Cytodyn says "give us your sickest, weakest patients, people with 1 foot in the grave, and we will improve their outcomes". And still the corrupt FDA won't approve our drug. Unreal
Boston, you are so right. Our severe/critical trial had just filled a few days before my wife was intubated. Pretty sure the EIND would not have been granted if that trial was still recruiting patients.
Yes, Forum Communications owns a ton of newspapers and also the ABC TV affiliate in Fargo.
Thanks. I agree, any good publicity can only help the cause.
To all who read my letter, especially the commenters as I always appreciate the kind words. You must know, it was extremely painful writing the letter and reliving the dark moments we experienced back in mid-December. I only did it with the hopes it might get some attention for our drug. All we need is one media person or politician with the guts to put some pressure on the FDA. To that end, I ask that you please spread it around the internet if you feel as I do, that our drug can and will help people if simply given the chance. Thanks.
I apologize as well. I lost my cool there, just getting sick of people taking shots at Dr. P.
He and Dr. Kelly really went out of their way to help my wife, so I defend them whenever necessary.
A PLEA TO THE FDA
You watch the ambulance pull out of the small town hospital emergency bay with your wife of 34 years, having just chatted for a few moments as the crew prepared her for the 100 mile ride to a large hospital, better able to handle the possibility that her lung function may continue to deteriorate. It would not be a surprise at this point. You've already watched her deteriorate over the last few days, not wanting to believe what you were seeing with your own eyes. It was not a pleasant chat, what with a Bipap mask force feeding 15 litres of oxygen per minute to her. Even at that rate, the crew is struggling to keep her oxygen saturation at 90, the magic number. You cry, even though she begs you not too. She is obviously scared. You tell her not to give up. And they whisk her away. No use following the ambulance. There's no visitation whatsoever at the Covid ICU unit where she's headed. Your mind is racing. You fear you many never see your mate again. The thought devastates you. You do your best to contact friends and family. It's a battle to hold back the tears with every call, a battle you usually lose. Her lungs continue to lose the fight with Covid and her own immune system. Just one day later you get the call. They need to intubate her. You feel sick. Again, a short conversation, this time on the phone, through the woosh of the Bipap. The topic remains unspoken but you both realize this could be your final conversation....ever. You exchange "I love you's", and off she goes into a drug induced coma. The emotional pain you are feeling is nearly unbearable. Once intubated, her chances of survival have dropped to 33-50%. And many that do survive are forever dependant on a ventilator, a result of the damage their lungs have sustained. Many wind up in long term care facilities. A few are lucky enough to have a loved one willing and able to keep them home and deal with the ventilator. You get daily phone updates from her doctors. The rest of the time you pray the phone does not ring, for fear it will be THE CALL. The call you dread, the call that will change your life forever.
This nightmare that my wife and I lived through is being experienced by thousands of our fellow Americans every day. But it doesn't have to be that way. There is a drug that has proven to help people that are in the very situation that my wife was in....intubated and in critical condition. Leronlimab is a monoclonal antibody owned by an American company called Cytodyn. It has yet to be approved for Covid19 treatment by our FDA. In a recent phase 3 trial, Leronlimab reduced mortality in this group by 82%. This drug has saved the lives of countless Covid patients with one foot already in the grave, and numerous medical papers have been published documenting as much. Use of Leronlimab has resulted in zero serious adverse events in this trial and numerous previous trials. And yet, our FDA sits on its hands while our fellow Americans are dying each and every day. There is not enough Leronlimab available to treat the entire world, and while our FDA fiddles, other countries are looking into acquiring quantities of Leronlimab for their citizens. Will the FDA be held accountable if this drug winds up saving lives in the Philippines, Brazil, Canada, the U.K.....instead of the United States?
My wife is one of the lucky ones. I was able to get Leronlimab for her under the FDA's paperwork laden Emergency Investigational New Drug procedure. She was not expected to survive. But she did. Not only that, she was also able to wean off the ventilator. She is home now, working to regain her strength and happy to be alive.
During the EIND process, FDA employees told my wife's doctor that they were not sure Leronlimab would benefit her, but they were confident that it would not harm her. Is there any reason, therefore, not to make this drug available to American patients and doctors? RIGHT NOW! What is the FDA waiting for?
To our Food and Drug Administration, I pray that you approve this drug and make a survival story like ours possible for thousands of our fellow Americans. Please do your job!
Mark S, Jamestown ND
A letter I posted on Facebook. Please share.
Don't worry Misiu, if it WAS Remdisivir, you can be sure it'll get covered up. Am I cynical? Yes. Disgusted? Yes.
Thank you bballs
Along those lines, it's important to note what FDA employees told my wife's doctor when they approved her EIND.
WE DON'T KNOW FOR SURE IT WILL HELP HER BUT WE ARE CONFIDANT IT (Leronlimab) WILL NOT HARM HER.
This is directly from her doctor.
What is this stinking agency waiting for?
The shorts don't want to save lives, they just want to make money. Karma is a bitch, that's all I can say to them misiu
She was hospitalized in Fargo. The flight was a dedicated jet with ventilator and full staff of medical people for her. The helicopter they have here does not hold enough fuel to make 500 miles. The access to Leronlimab was still uncertain so I was coming up with a plan B for her, as Fauci's wonderful SOC was failing her. Point is some folks WOULD try and figure out a path to the Philippines or Brazil if necessary.
For the record, when my wife was spiraling downward every day and recently intubated, my back up plan if the FDA didn't allow us Leronlimab under EIND was a $31000 plane ride for her to the middle of Nebraska where the hospital promised me she could get RLF-100 under expanded access. They were administering a trial.That's not the Philippines but still, 31 grand is nothing to sneeze at. Desperate people do these things for loved ones.
There is literally nobody in the media willing to take on the FDA, in my opinion. Reason. They are all members of the same corrupt club. Congress as well. So anybody that thinks the FDA is afraid of some media figure or Senator is kidding themselves. The Congress is bought off by lobbyists just like the FDA. We gotta go to other countries.
"Rosen, a globally recognized law firm".
As per news item on TD AM. If you gotta announce you're globally recognized, I got news for you. You're NOT globally recognized. AMBULANCE CHASER !!
I don't mean to put a damper on this, but all the successful EIND's in the US, including my dear wife, has gotten us nowhere. Most doctors will not vouch for an unapproved drug used outside of a trial, even if it appears to have helped the patient. I can't even get a local radio host in Fargo interested in my wife's unbelievable survival story so I can get us some PR. I'm not sure how some success in a far off land is going to help us, UNLESS we can sell a boatload of Leronlimab to them. That changes everything.
Potential testimony before the Senate....
Senator- uh madam, why did you fail to approve this drug, Leronlimab, which would have saved thousands of lives had you acted prudently?
Woodcock- well Senator, we knew the drug would help people but those pip squeak shareholders and a few doctors were antagonizing us here at the FDA, and we needed to put them in their place. The hell with the dead.
Totally agree. Good results there will be huge. As far as antagonizing the FDA, I have news for everybody. The stinking FDA is supposed to work for US, citizens of the United States. That includes the thousands of poor folks lying in ICU's right now being kept alive by a ventilator while a drug that can help them is being slow rolled by these corrupt bastards. SCREW THEM!! They need to be exposed. Whether we can find a brave media person to do it is another story.
I agree. Why should we need to do additional trials with people dying left and right? We have enough efficacy plus safety data. This is getting more ridiculous by the day.
You're right Misiu, im probably jumping the gun. We see a pulmonologist end of April so we shall see what's up.
Now wait just a minute! How do you know the Dexamethasone didn't miraculously kick in a day or two after the Leronlimab sub-cue was administered? Im quite sure that'll be the take of the Fauci-Woodcock kabal.
The FDA is trying to run out the clock on us. By the time all these millions of trials they're pushing us into are done covid with be a thing of the past and the folks that could've been saved will be dead and buried. Anybody who thinks this agency has the health and welfare of Americans as its main goal is delusional.
Diesel what makes you think the FDA will do the right thing without being pushed somehow? Their past non action on our drug indicates a willingness to suppress it.
Im not sure how we gonna accomplish this without getting some media on board. I emailed Siegel and Sapphire at fox as well as our local TV networks in Fargo. Nobody gives a damn yet. We certainly can't count on the corrupt FDA to do the right thing.
That's right. If the FDA had acted on our EIND results coupled with the drugs safety profile, they would have saved thousands of lives.
If these numbers were released by one of the FDA big pharma favorites, we all know the FDA hacks would be scrambling to get to the microphones right now.
I would not be surprised to hear continued crickets from our corrupt FDA. We know who buys and sells them. Unless we can get some actual big media to run with our numbers. That might shame the bastards into an approval.
The Gold Standard? Yeah, they've approved 3 drugs that essentially do not work. And the head hack of the FDA made a fool of himself crowing about the plasma on a much awaited prime time news conference. They're doing a bang up job down there, just like all of D.C.
Maybe you missed all this Grip, but many of our Leronlimab patients, such as my wife, were already on a ventilator and headed for the big sleep when our drug pulled them back from the grave. Did you miss all that?
Yes we are gonna request an antibody test. Thanks Misiu !
Saxxie. I asked Dr. Kelly a few months back if he thought my wife may be protected from long haulers syndrome by the 2 Leronlimab doses she got. He was unsure. FWIW, 3 1/2 months after getting covid, she does not seem to be suffering from the brain fog or cognitive problems many are reporting, although fatigue is an issue. I would expect that to be the case after being hospitalized for 2 months and on a vent for 43 days though, and it's improving day by day.
Rock, Misiu, anybody else out there know if being dosed with Leronlimab has any effect on being vaccinated for covid in the future?
The question of whether my wife should be vaccinated now has come up and whether the LL has any bearing on it.
Call me greedy but I'm hoping for a pullback near 2 bucks
C20, can you imagine the situation we are in right now? Here is a tiny company with no revenue going to the FDA and begging for a shot at helping the sickest of the sick, in the middle of a freaking pandemic, and our dandy FDA sits on it's hands. How many drug companies have the guts to go after patients who are barely hanging on by a thread on life support anyway? Are they lining for that task or are they cherry picking patients? We are not cherry picking patients like these other outfits. We are simply trying to help dreadfully sick people with zero options. But still the FDA can't or won't get it right. Its sickening really.
Yes c20, I just sent my 3rd letter to Miss J. Woodcock of FDA regarding the EIND process and how cumbersome and time consuming it is, and the sad fact is, not all doctors are even willing to do the legwork or put the time in. If we got even targeted approval for the most critical our drug would be able to help far more people.
It seems to me the other monoclonal antibodies that were approved and hyped by the FDA, the ones that had to be given as early as possible and before the patient needed supplemental oxygen, reduced hospitalization by just a few percentage points. I think one of them was made by Lilly or Pfizer. In addition, they weren't tested long enough to know of their side effects, yet in a pandemic, these were approved by our wonderful FDA. And let's not forget that hack from the FDA crowing about the plasma that night in prime time. It's all bullshit people.
C20, to be fair, many of these doctors have not even heard of Leronlimab, and that was the case with my wife's doctor. He started from scratch, did the research, made numerous calls to the FDA, convinced the higher ups that LL would not harm my wife, etc. The obstacles are unreal. Again, that's why we need the drug approved. It gives us instant credibility with the medical people.
Maverick. My experience with the EIND for my wife confirms what the doctor is saying. The process took a number of days and many phone calls on my part, no big deal for me truthfully. But not only does the doctor have to be on board he/she has to convince his bosses and the hospitals research department that this is a viable strategy for the patient. And even though my wife's doc was on board, it took me days of badgering him and the hospitals chief medical officer to make this happen. On top of that Dr.s Pourhassan and Kelly devoted a good amount of time as well. And even though the FDA supposedly streamlined the process right after my wife got her LL, im sure it's still a hassle for all involved. This is why it is CRIMINAL that the FDA refuses to approve our drug, at the very least for the critical intubated patients. Most of these folks are dying, and the 'lucky' ones make it but wind up on a ventilator forever. This is a CRIME.
Thanks c20. Truth is she is doing remarkably well. Home for about a month now and she gets stronger and needs me less every day. She's gained almost 10 of the 30 lbs she lost back. Her lungs are healing it seems, the cough she left the hospital with is gone and her shortness of breath is improving.
She got 2 doses of LL, on Dec 24 and 31. I inquired about her needing a 3rd dose in late Jan. but the doctor pointed at her breathing on her own and then pointed to the spot where the ventilator used to stand next to her bed. He said if she still has significant inflammation in her lungs there's no way she'd be breathing on her own, so we didn't ask Dr. Kelly about a third dose.
Hey little voice, may be i missed it but did you ever explain how the placebo effect works on a person in a medically induced coma, such as most of the successful Leronlimab recipients??