Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
lol, you ok man….
You seem emotional… everything ok at home?
Lol
How about Dr. Phil? Is good at getting to emotional fragility….
Well I know you can’t read my mind. You’re having a tough enough time comprehending a text….
Go back and read it again, pretty self explanatory….
You seem emotionally attached to your position. Get a puppy, it may help.
Thought you might be interested…. Dr. Been has a 3 part youtube video on dr.’s suing FDA over ivermectin. The FDA’s defense is mind blowing. Judge really pins down the FDA about what they said. Do they have the right to tell doctors what to prescribe? Their defense is hilarious!! Must watch….
Just follow your “holy than thou” government. “good boy”….
I mean you spent hours and hours writing posts about Nader and how bad he was and he should be gone! Yet you thought Leronlimab was saline??? So we needed a better CEO to sell SALINE!!!! No credibility….
Because they stop the injections at the third and fourth week of a four week trial. Take a guess at what point the drug lost its effectiveness to render it a failed trial. (Pssst the third and fourth week)).Ask yourself who didn’t approve a four week injection trial. (The FDA). What was the problem with four injections? We KNOW there were no harmful side effects from the HIV trial. So why the heck did they limit it to 2 injections?? THEN when the data is looked at , the drug out performed SOC in the first 2 weeks and the third and fourth week dropped like a rock. What was the FDA’s-response?? Your cherry picking???? The drug failed the trial!! The CEO points out the good data in first two weeks (with injections). So what’s wrong with a CEO pointing out the results of trial?So what?? It was good data!!What was the threat of the drug being approved?? The FDA sees the CEO point at good data in first 2weeks and the poor data in last two weeks because they stopped the injections.. THEN the FDA puts out a “hit piece letter”?? WHY DID THE FDA feel it necessary to write an unprecedented “hit piece letter???The drug failed the trial!! What was the FDA and (ahem) “big Pharma afraid” of??The FDA had Zero interest in the first two weeks of the trial. Hmmmm, wonder why? Nothing to see here, nothing to see here……
What’s also is incredible was the reaction by the FDA after Nader pointed out the efficacy of the drug in critical patients. Zero interest in the first 2 weeks of the trial. WHY? The FDA said it was cherry picking the data. But the efficacy dropped HUGELY after first 2 weeks. Wonder why….The FDA gave it the thumbs down in the cd12 trial (incidentally by jacking with the trial itself, with denying injections the last 2 weeks in a 4 week trial and oh “surprise surprise”, the patients got worse in the last 2 weeks and the trial failed BECAUSE of these 2 weeks.The safety record had already been proven in HIV trials, hmmmm very odd wouldn’t you say to deny the injections for week three and week four of the trial. Nevertheless the trial had failed so the drug would not be approved for covid 19 PERIOD! So why the need for the hit piece letter?? Is the FDA in charge of protecting investors?? What did the hit piece accomplish and why the need? What harm could the drug do if it had already failed trial and the FDA had spoken. That hit piece letter tells me everything I need to know. Look at the FDA’s response to different medications including NAC,Hydroxychlorquin and ivermectin. I personally know people who used these medications and responded well. Was it the drug or was it just the person getting better on there own. I guess you could say the same thing about remdesiver and vaccines.The FDA wanted to mandate the vaccines.!! So if there was a viable therapeutic it would not have been possible.
Any chance LL could be marketed as a supplement like NMN and NAC. Oh wait, the FDA is “trying” to help big Pharma “take out” those supplements too….by calling a once approved supplement a “pharmaceutical” and shouldn’t be sold over the counter. You see, big Pharma wants a piece of a “huge money maker” NMN and NAC. Ahhh the FDA and big Pharma march hand and hand together!! (or pick any other part of the anatomy). Hey, the FDA would never do anything corrupt. Just like our “clean as a whistle blower” FBI….
Nice post!!
I agree, it does avoid Nader. The reason I said didn’t matter who CEO was. At all!!Is Nader a weasel and a crook? We will find out. Was he the reason LL didn’t get approved? Nope….
Or you could say the FDA new that LL did perform much better than SOC for first and second week! That they limited the doses to 2 weeks instead of the four week dosage we requested. Well obviously the effectiveness dropped off the last two weeks and cd12 failed. In the “hit piece” letter from the FDA (unsigned) they didn’t say the data Nader quoted was wrong 78% and 82% better than SOC for week one and two. They said it was “cherry picked”! Ok, you could say that. But after seeing the data after the first two weeks and zero dosage the last two weeks do you think the FDA might be excited that there might be something to cd12 and want to dig a little deeper?? They were not the slightest bit interested. The first two weeks was so troubling and possible impede the future “vaccine” mandates so a “Hit Piece” letter was necessary. Can’t prove it, but makes sense to me. The trial was over. LL failed. Again why did the FDA feel so threatened that a hit piece letter would be necessary.
Bottom line… FDA is corrupt. Everything She stated is a fact. Wouldn’t have mattered who the CEO was period. The FDA wanted to fight pandemic with vaccines. So if Musk, Bezos and Gates had tried to get LL over the finish line it wouldn’t have happened. The huge “tip off” that the FDA was corrupt was the hit piece letter. Now from the information I have received the FDA had only written a letter like this once. So tell me, what did the FDA think was going to happen after ND spoke about the effectiveness of LL from week one 78% better after week one against SOC and 82% better after week two. What was the threat to the FDA that they felt the need to write a letter. Did they write it to help unsuspecting investors? Not their job. Did they write ite because they thought the drug might somehow be approved? No way it failed… So again without a new trial what and how was LL a threat??
CYDY did!! Who in there right mind would set up a trial where the medication was only used for half of it. Oh yeah, the great data came out for cd12 showing 78% better against SOC in first week and 82% better than SOC for severe to critical patients. DSMC saw this data and said carry on. The third and fourth week dropped significantly which caused the trial to fail. Now what in the heck could have caused that???? Oh yeah, the stopped administering the drug for the third and fourth week!! WELL WHAT DO YOU KNOW???? The reaction from the FDA was telling?? No speedy new trial. No EUA. JUST a hit piece letter which in the last paragraph said they would work with CYDY in the future on more covid-19 trials, I mean LMFAO!! Oh, now I remember cydy and Nader sabotaged their own trial.....the FDA would never do something corrupt. Imo
None of these analyses met statistical significance because the freaking FDA sabotaged the trial with only allowing 2 doses when 4 doses was requested from CYDY. You are absolutely right the trial failed. But who in the world would want a trial where you stop using the medication for half the trial?? Oh yeah, Nader sabotaged his own trial, yea that makes since. The FDA said no to 4 doses, why?? The medication has been used for years without any serious side effect for HIV. So again, what was the purpose of only allowing to doses. Can’t prove this but I have a good idea. BP is in the pocket of the FDA no doubt. The FDA has approved drugs with much less “statistical significance” for BP...hmmm another theory I can’t prove is the FDA wanted to mandate vaccines which BP wanted hands down. (Remember vaccines for everyone, therapeutics only for the sick). a viable therapeutic would have put a wrench into the mandates. Imo
Homerun! Perfectly stated.
That’s wrong..... they asked for four doses and the FDA said no. Simple as that. There was plenty of data to show from the HIV trials that there were no SAE’s from LL. So you have to ask yourself why the FDA would not allow 4 doses and why the DSMC kept quiet after they looked at data after two weeks. All the DSMC said was you can continue trial. LL was 78% better than SOC after week one and 82% better than SOC after week 2. Don’t you think with just that data the DSMC would say more than you can continue with trial with zero doses? Doesn’t pass the smell test. Psst.... it’s not that hard to put the pieces together. The FDA wanted to push Vaccines and did not want a viable therapeutic. Ergo, sabotage the trial....
How do we know FDA is corrupt?? One word.....Remdesiver which by the way is still under EUA. Hmmmm wonder why?? Not enough data?? How many people do you think have had the remdesiver shot. I can guarantee it’s a lot. (that would be a pretty good trial for full approval would it not?). Is that not enough to make a determination for “normal” approval and not EUA?? What about our precious vaccines?? Has there not been enough jabs to be granted “normal approval” instead of EUA. Why do you think these drugs, after all the data that is easy to attain are still under EUA. Hmmmmm, maybe BP doesn’t want to be accountable for adverse side effects and wouldn’t dare take the risks of lawsuits associated with their drug Remdesiver and various vaccines. Why doesn’t the FDA give “normal approval” with “ALL” the ”DATA” that is available from the millions of doses administered of the vaccines and Remdesiver. Ponder that one...
Guess you didn’t read the attached letter of misiu143’s post. THREE doctors just said in plain English the exact opposite of your post. Oh wait, I guess your right!! Not one “SINGLE” doctor went on the record about LL saving lives, in this case “THREE” doctors went on the record saying LL saved lives. So technically you are correct sir.....
Close.....FDA sabotaged trial with only approving two doses which lead to the failure of LL meeting any COV clinical trial endpoints.
Yep, it showed no clinical benefit. Yep, that’s why it failed. Pretty easy to see that. Left out something very important. CYDY requested 4 doses over 4 weeks. Good Ol’ FDA said nope 2 doses. CYDY said ok, how about the trial two weeks then? Good Ol’ FDA said nope 4 weeks. So how is that going to help the trial results!! Pssst........it wouldn’t!! So why would the Good Ol’ FDA do that?? Plenty of prior data to show no SAE’s with LL. So WHY just 2 doses over a 4 week period?? The only logical conclusion was they didn’t want the trial to succeed! Well it didn’t succeed and LL failed the trial. Sorry guys, said the FDA. Then something happened they didn’t expect, the trial showed great results in the first two weeks against SOC and the CEO pointed it out. (call it cherry picking) who cares. The drug failed the trial and CEO talks about good data in the trial. Where is the threat! The statement that NP made was not going to change anything. The FDA somehow felt it was necessary to write a “hit piece”, “rebuke”, “statement” about a drug that was no threat to the public, and a CEO talking about data within a trial. That seems very odd to me. That first sentence in the letter was strange. FDA: “ Due to significant public interest we are writing this “hit piece”.REALLY?? How many people knew about LL much less read a PR by them?? The FDA did say it WOULD help CYDY with future trials using previous trial data. You mean the trial data that NP pointed out!! All very weird to say the least unless the conclusion was the FDA didn’t want to use a therapeutic to fight this pandemic. They wanted vaccines! LL would have been a problem....
And LL is Saline. Why does someone post about a CEO when they think LL is Saline????? Very odd….I mean every CEO is a scam guy if they are pushing SALINE. If 13d had won would LL miraculously become a viable therapeutic??? Say it now, is Leronlimab a viable therapeutic or not? You said on earlier post that it is Saline. If that is the case, who gives two cents who is the CEO…
Looks like Andrew Left had some visitors last night.... search warrant.
Ok, let’s say EVERYTHING in your last paragraph is true!! Was that talk about LL from CEO going to somehow get the drug approved?? NO WAY!! IT FAILED THE TRIAL!! Should the SEC/DOJ be hot on the trail!! Sure if NADER is guilty!! Where the strange part occurs is the FDA feeling threatened by that PR and the need to respond. WHY?? A CEO points out data within a trial (right or wrong) and the FDA feels it’s necessary to respond?? What is the threat?? The drug failed the trial!! Not going to be granted EUA!! They say they wrote the “hit piece” due to “significant public interest”? BS!! Seriously, how many people knew about LL?? How many people follow a small start up Biotech company on the OTC? How many people read PR’s from a start up Biotech company on the OTC??? NOT MANY!! So even the reason for the “hit piece” is suspicious at best... In my opinion which cannot be proved at this time, the only reason to set up a failure in CD12 and to write a “hit piece” letter right before things were getting rolling in the Philippines was to kill this drug. So why kill the drug?? Easy, FDA wanted to push vaccines and a viable therapeutic would get in the way. Been saying this quite a bit and low and behold someone posted a video from project veritas with a former FDA higher up talking about vaccines!! Hmmmmmmmmm
Ok, question. If the FDA did NOT send “the statement” or as I refer to it “hit piece letter, what happens with the approval of LL? Does it get approved because of “cherry picking the data” by a CEO named Nader? Tell me what was the threat of Nader’s “cherry picking” the data of a subset was to the public?? The drug was not going to be approved for EUA. Why the need for the FDA to put out “the statement,” to protect investors?? Was “the statement” to protect the public from “snake oil salesmen??” Oh yeah, “the statement was put out due to “SIGNIFICANT PUBLIC INTEREST” according to the FDA (yes, significant public interest on a start up biotech’s because a CEO comments on a subset of patients in a trial... ) Got to throw BS flag on all those reasons. So then you have to ask what would make better sense for the FDA to put out “the statement”? I got one (can’t prove but looks awfully suspicious) as misiu stated in earlier post. Dr. L requested 4 doses over 4 weeks. FDA said No. Ask yourself why? The drug had been used for years with no SAE’s so safety is not an issue?? So why not give 4 doses?? Then the FDA approve 2 doses but instead of 2 weeks thay make it 4 weeks. That ain’t going to help the p value. SO WHY?? Safety is not an issue!! So the CEO points out good data in a subset of the first 2 weeks of CD12 and the FDA is threatened and puts out “the statement” as you refer to it. Again LL has failed the trial it has not received EUA the drug is not a threat by Naders statements about a subgroup. Does not add up. My conclusion the FDA had another reason for “the statement”. The drug did have promising data in a subgroup which the FDA saw and didn’t want to touch it. The FDA agreed and said said would help CYDY use data to set up future trials... Doesn’t make sense other than they wanted vaccines not therapeutics and purposely sabotaged every therapeutic that looked promising...
So well said...thx misiu143
Exactly right!! If Nader committed a crime the SEC/DOJ will and should prosecute. We all get that. What everyone seems to gloss over is the FDA’s behavior. Not their job to send a “hit piece” letter. Not their job to protect the public from snake oil salesman. It’s not the FDPOSOSA. (Food,drug,protector of snake oil salesman administration). The CRAZY excuse for the letter by the FDA “DUE TO SIGNIFICANT PUBLIC INTEREST” LMAO!! Little Biotech company who puts out a PR about results within a trial. The drug failed trial!! (which I believe it was set up to fail which I can’t prove). So LL was not approved with an EUA. The drug is a ZERO threat to the public. FDA had nothing to worry about, the drug failed the trial. The CEO points good data within trial (subset of patients). So!! Just because the CEO points out good data with a subset of patients doesn’t mean anything will happen RIGHT?? What was the threat to the FDA or the public?? CEO pointing out good data within trial?? The FDA even said they would use this trial data to help CYDY with future trial set ups. Yea sure, FDA was very helpful with first trial! So why the letter? I can’t prove, but the FDA knows there is good data from the first 2 weeks of cd12 and they didn’t want to pursue it. That was obvious! So the billion dollar question, WHY?? My personal opinion with the FDA, government officials and media were given the marching orders. We are going to fight pandemic with vaccines and try and take out any therapeutic. Could be wrong....
The public knew that CD12 trial failed. Soooooooo LL was not a threat to the public. A CEO points out good data within the trial!! Is a CEO not allowed to point out good data within a trial????? The FDA said THEY would help with setting up a new trial!! Ask yourself, who was the FDA protecting with the hit piece letter? The public was safe from LL, it failed the trial, correct?? Was the public with SIGNIFICANT INTEREST (bullsh#t) in any danger?? Explain to me how that letter protected the public? The public was completely SAFE!! How can the drug hurt anyone when it failed trial and is not approved. Ask yourself again, how many people knew about LL and would read a PR on an OTC company on a failed trial. ITS BS... FDA sabotaged trial with allowing only two doses when the company requested 4 doses. Even with the purposeful sabotage (IMO) of the trial there was very interesting data (a sub group) that did very well. What was the sub group you ask? The sub group that got shots the first two weeks. FDA reaction?? NOT INTERESTED!!! But we will help in future trials!! LMAO... can’t prove it but FDA didn’t want LL to be approved or get an EUA. LL was not the only therapeutic that was poo poooed!! Conclusion, FDA wanted to fight pandemic with vaccines and a viable therapeutic was a hindrance.
Just find this letter very puzzling.... they note the reason for the letter was due to significant public interest. Soooo, this tiny OTC company running a covid 19 test generated SIGNIFICANT PUBLIC INTEREST?? Got to throw the BS flag on that one. I would dare say it was only a very small portion of the population that new about this drug and the (BIGGIE) new about the trial failure. Also it had to be people that would look up CYDY to see the PR by NADER!! “SIGNIFICANT PUBLIC INTEREST” was the reason for the LETTER! NO WAY!! When they mention Nader speaking about a subset of patients did you notice the big red flag. They didn’t mention how the subset was better. They did not mention the subset did better in first two weeks and a massive drop off in last two weeks? Why? Because the last two weeks did not include doses. They didn’t seem at all interested on pointing that out. To go even further they said we will be happy to help CYDY set up future trials. Psst: Hey FDA it was your “HELP” with forcing us on using 2 doses over the 28 days that lead to its failure. NOPE, way to much crap in this letter. So why the crap. LL failed the trial and there was no chance it would get EUA after trial. Unless a new trial was conducted. They did not want a viable therapeutic like LL or any other effective therapeutic because it would hamper the vaccine push and mandates.
Yes because the FDA has a “protects the public from Snake oil salesman” branch with 50 employees lol!! (authors of the rebuke letter). That rebuke is very suspicious. Did the FDA think with Nader’s Pr of the good data within the trial would somehow over rule the trial failure and LL would be distributed world wide. What threat was LL after the trial failure?? What was the reason for the rebuke?? Oh yeah, it was the vicious emails from the pro LL crowd against the FDA. Yes all these masses of people who were invested in an OTC company of a monoclonal antibody were bombarding the FDA with hurtful emails..... hilarious! Nope, they sabotaged the trial with only 2 doses for 28 days, but unfortunately for them there was data with the 2 doses that looked excellent against SOC for first 2 weeks. So low and behold a rebuke letter to try and squash LL. They wanted to fight virus with vaccines (right or wrong). A viable therapeutic would be a problem for mandates and vaccine push. Simple to see.... Don’t ever forget vaccines for everyone therapeutics just for the sick so I am sure there was zero pushback against vaccines to fight pandemic from BP. People out there seem to think I am an anti vaccines with my statements. Full disclosure, I am fully vaccinated. so how did I come to my conclusion? I just watched the FDA, the powers that be, and the media’s response to other therapeutics. So in my opinion (can’t prove) , the word was out, push vaccines and poo poo any viable therapeutic that is out there.
Your response is telling.... YOUR response was the FDA was allowing a phase 3 trial because the drug was safe. True LL is safe and continuation of the trial would be granted. The point that was made earlier was that the FDA was allowing the continuation of the trial because there was “COMPELLING” data within the trial. Your answer was no they are allowing the phase 3 to continue just because the drug is safe. So the FDA is going to allow people to continue a trial in a life or death situation with no COMPELLING data within previous trial just because the drug is safe, nah... no way
So what your saying is, if a drug is ineffective you can continue the trial because there were no SAE’s. That’s a scary thought especially if it’s a life threatening disease. FDA: Sure, continue with a phase 3 trial even though we know it’s ineffective because the drug can’t hurt you?
Narrative needs to change to Kelly…. All anybody needs to hear.
“Sure is a good thing they had vaccines”, It sure is, that’s why I took the vaccine myself. You keep posting as if You think I am against vaccines. I will try one more time, the FDA IMO purposely sabotage our CD12 trial because they didn’t want to have a Therapeutic of any kind be a hindrance to the vaccine push….. Do you understand?????
NOPE......CYDY knew the fix was in from the FDA and they were trying to appease and charm them. Kiss the ring so to speak. You know the old saying catching more flies with honey than vinegar. Obviously the honey didn’t work. They should have started railing on them hard after the hit piece, the result would have been the same but I am sure they would have felt better about themselves. In my humble opinion the FDA didn’t want this drug to fight pandemic along with other therapeutics. Vaccines is what they wanted...
Nice....