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Chuckles,
Your shorty report looks timely. They are going after us now.
I don’t think that goes back far enough. The real question is can anyone produce his birth certificate?
Has anyone found his kindergarten records yet?
The FDA is restricting the dosage on the cancer trial as well.
I predict I will be a billionaire.
He only needs to be right once.
How many times have you predicted that?
The HIV trial was a failure?
3. No trial to date has successfully shown that the drug actually works or should be approved.
LOL
I agree. NP is making it harder than it should be.
3X,
If nothing else you are tenacious in your positions.
It will be interesting to see how this story ultimately plays out. Either you will be the prophet that everyone one should have listened to or the the crazy guy along the road to success.
GLTU/A
Like the HGEN board?
All stock message boards are buried with FUD.
Fair points.
3X
If the previous CEO of CYDY was good, why didn’t he get the BLA approved? Is it a possibility in your mind that CYDY is not playing on a level playing field?
What other stock message board is buried in FUD like this one? Is that FUD the result of NP and the CRO or evidence of the poor condition of the field we find ourselves on?
Why is our CRO not credible?
3X
I’m having a hard time getting my head around what you could put on a BLA application that would make the FDA mad. Did he include some editorial comment about their mothers wearing army boots?
NP did something with BLA that pissed off FDA.
And it is the same reduced dosage game they (FDA) are currently playing in our cancer trial.
I’ve see the results my friend has experienced in the trial.
Those with eyes will see and ears will hear.
The patients in trail may disagree with that perspective. They were given a death sentence and Leronlimab has given them a second shot at life.
They want to up the dosage because results aren't optimal. That is obvious. CytoDyn always has excuses. Nothing is ever their fault.
Misiu143
The FDA has clearly been playing this dosage game with HIV, CD12, and cancer. Even IF there was adverse side effects to Leronlimab, these patients are dying. Without Leronlimab these patients will experience the worst SAE possible - death.
When you contrast the dosage restrictions on Leronlimab (with no side effects) with the pump patients with as much Remdesivir as you want (with lots of side effects), you are just left wondering how can this be?
To say that Leronlimab has failed its trials is like saying Babe Ruth was a failure because you have redefined a home run as a ball hit over 1,000 feet. If you play with the rules enough, anything can be defined as a failure.
DDDD,
Even at the lower dosage the drug is clearly working.
The FDA is playing games with dosage in the cancer trial like they did in CD12 and HIV. The fact that the drug is achieving the results it is with the equivalent of one hand tied behind its back is a testament to the power of Leronlimab.
(Response attempt #4)
Misiu143,
That is the exact situation. The fact that the FDA can offer no rational for the lower dosage, leaves Dr. Jay and the patients in the trial dumbfounded.
3X,
I agree with you on the HIV BLA. My guess is it was a poor quality application. No excuse for that.
LLL
3X,
At least a portion of my intel comes from having a friend in the cancer trial. In that example Dr. Jay has been trying to get the FDA to increase the dosage for close to a year. The FDA has continued to say NO in spite of no side affects. One has to wonder why they would refuse the request of the medical team running the trial.
The dosage issue is similar to the constraint they put on CD12. As a result we saw the mortality reduction of 82% at 14 days tapper off to 24% (still better than any approved drug) at 28 days. You then add the DSMC recommendation to not change the primary end point and suggested looking at 42 day mortality (with no change in dosage), it feels like they were trying to make the trial fail.
Also, look at the hospital LOS of CD12. It blows all of the other drugs away. So, just because LOS was not selected as a primary end point, we can’t approve a drug that is clearly superior to the current standard of care?
I could go on but you know the story as well as I do.
Just as an aside, I also live in the Vancouver area (I think you do as well). My guess is there is a good chance we know each other or at a minimum share common friends.
Thanks for helping CYDY get this far by being an early supporter.
LLL
3X,
6 months ago I was with you on management m. However, the more we learn about the trials and the FDA, I don’t think it would matter who was running CYDY. There are clearly a lot of powerful players that don’t want to see Leronlimab approved for anything.
I’m actually coming over to the view that NP is exactly the leader we need right now. He is driven and doesn’t give up. Considering the strong head winds we are facing, his strengths are what we need (at least until we get to our first approval).
I think NP is bringing more to the party than you are willing to acknowledge.
The video is so bad they have already taken it down.
That was pathetic.
Misiu143
I just wanted to let you know how much I appreciate your knowledge and tenacity. I hope I have the opportunity to meet you in person at one of our CYDY celebrations.
You have been a real inspiration on this long, difficult journey.
LOL
That’s right and I bought more shares today!
Mr. White said we now have a storage unit full of cash from the buyers of Leronlimab. He predicts demand to stay strong!
Since the trials were run by physicians instead of scientists, I don’t think this is true. My high school science teacher told me Leronlimab works.
The trials indicate that leronlimab is no more effective than saline.
Is it safe to say Leronlimab is no longer considered saline?
It seems that we have moved on from that to physicians are not scientists.
I’m just trying to keep up with the current thinking on the efficacy of Leronlimab and the people doing trials and publishing peer reviewed papers.
Leronlimab will receive FDA approval for many indications....soon.
Leronlimab will not receive FDA approval...ever.
Hilarious!
Thanks for the laugh.
FAKE!
This letter has already been taken down on Reddit.
Evil Rabbit
I totally agree!
Can you provide a link that supports your opinion?
Maybe we should write Angela Lewis a check for $500 to cover her “losses” on CYDY. That would save her years of delay and certainly exceed the $0.50 she would receive from any class action lawsuit.
CTMedic,
Thanks for the response.
So are you saying RO is a real issue and not just the FDA slow walking the BLA?
Just to add to B52T38’s question, it was my understanding that other countries don’t require RO for approval.
Is that true?
That is unreal. I keep thinking the short interest can’t go much higher.
6/30/2020 we were only at 10M shares.
3X,
To use your condo paint job analogy, if you want the other owners to hire a different painter, give us some options to support. Otherwise CYDY Painting, Inc. is going to get hired to paint the outside of the buildings.
People are predisposed to support SOMETHING. You continue to preach for a null value. Your posts will continue to fall on deaf ears until you give shareholders something to support. We all know NP is less than perfect, but he is all we have at this time.
You are a vocal critic but not an effective problem solver.
LLL
3X
Since you feel the only path to success for CYDY is with a new CRO and CEO, perhaps you could share your thoughts on qualified organizations and individuals to fill those roles.
Less armchair quarterbacking and more detail would be appreciated.
But 1% is still 1,000,000 people. CYDY doesn’t have enough inventory to even supply that many patients.
99% of Filipinos simply can't afford it.