I've seen Caddyshack at least 50X and I don't drink martinis, so maybe I'll just continue trying to provide relevant info. No idea what you think is wrong with a post correcting someone who was completely wrong, but now I know why lions eat their young.
You completely whiffed on statistical significance and now you're going to double down telling me I'm wrong about saying the interim analysis at 50% enrollment by the data safety monitoring board, whose primary focus is ensuring patient safety, was about clinical efficacy? Good luck with that. There are usually three possible outcomes from a DSMB review: i) evaluation of safety in the treatment arm vs. the placebo arm, with termination of the trial if excess adverse events in the treatment arm; ii) termination of the trial if the clinical outcome, to that point, is overwhelmingly positive, and iii) stopping the trial early due to "futility" i.e., it's obvious there is unlikely to be significant efficacy.
Because there isn't any clear demonstration of efficacy. I could generate a positive safety profile in lots of patients with a placebo.
covid-19tracker.milkeninstitute.org
Well more news out. DSMB recommendations for Leronlimab vs. Regeneron show Leronlimab better. Regeneron was advised not to use Regeneron cocktail told to stop using any further high flow oxygen and mechanical ventilation patients into their clinical trial. Something not said and not an exclusion criteria in the Leronlimab trial. That leaves only Leronlimab for severe critical population in a clinical trial. Numbers why don’t you check again about the DSMB. The first look at the severe / critical trial was at 149 patients and that was a safety look. The second look at 195, at 50 % of the 390 designed enrollment , was an efficacy look , with recommendations to take another look at 293 patients . Are you really trying to tell me that wasn’t an efficacy recommendation ? I will ask you the same question I asked Cheese, why do you think they asked for another look at 293 before the full 390 designed to complete the trial? How often does the DSMB recommend another look before the complete trial is over instead of telling the company to add more patients or change their endpoint to succeed in their trial? Like they have done for the other Covid companies trying therapeutics, where they advised to stop the trial for futility, being unsafe, or not going to meet endpoint u less they change the trial !
It could be because efficacy data is trending in the right direction. It could also be because it's trending in the opposite direction, because more interim looks are better given situation of the world / changing treatment paradigms, because the company wanted to add another look despite however it's messaged, because DSMB get paid to do these so perhaps they recommended another one and company said yes, etc. Could be million things.
There is a DMSB for every trial, so nobody has compared the Regeneron antibody cocktail vs. Leronlimab. Leronlimab may end up being safer for seriously ill, hospitalized patients, but we don't know that yet (the Regeneron trial was put on "hold" in patients on ventilators or with high flow O2, not stopped, so we don't know if it will continue). And trials at an interim point are occasionally asked by DMSB's to look at a further interim point downstream before the endpoint - neither you nor I "know" why they did that in Leronlimab's case (only the DSMB is unblinded to the data).
That is my point. Only the DSMB has seen the actual data . You cannot come out and say their recommendation to exclude on high flow oxygen and ventilators and halting for safety concerns is good news for Regeneron cocktail and boast that it will be better than all the others. I will agree with you that it will be better than most of the others that have failed in their trials but definitely not better than Leronlimab which trial was not stopped for safety nor for efficacy and no one was excluded. I know randomized trials are the gold standard and Cytodyn completed one on M2M and is ongoing on S/C but the reason the FDA approves the trials is because Leronlimab was given by EIND to about 60-65 patients in really bad shape and it got most off of echmo, patients on kidney dialysis and really sick people with very few deaths.
What I am saying specifically is we all want the same thing numbers. We all pray... well maybe not all ... that the scientific field will once again give us that miracle type drug or therapeutic... please understand this was not intended to offend you or any of our brilliant in the med / sci world. I don’t claim to know anywhere near what those trained and educated do. I would think perhaps 95% of the world’s population even the highly educated don’t truly realize the difficulty nor the walls which have prevented more success. I think sometime as interesting and hopeful the information is it lends itself to getting up false hopes. Here’s another issue raised in Europe again regarding masks. Germany and Spain are 95% in lock step with face coverings yet their numbers are as bad as ours and perhaps worse. Several of the TOP virologists working on Covid are skeptical again as to actually what the masks do or don’t do? They may help but perhaps it really does not matter. Keep the info coming and of course our Rutgers football sports news. Did not mean to cause another uproar...
I never said the DMSB recommendation for Regeneron to hold on dosing patients on vents and/or under high O2 flow was "good news." I have zero idea why you'd say I said that. The very promising Regeneron (and Lilly) interim clinical data are on mild to moderately ill COVID patients prior to hospitalization. Totally different trials/patients.
Let’s try 1 more time. Why in your opinion would the DSMB ask Cytodyn to take another look at when the trial is 75% enrolled at 293 patients instead of just say wait until trial is over after 390 patients ? It you think that doesn’t strongly infer efficacy and likely when they think statistical significance will be found, then you are being dishonest since the DSMB made the recommendation not the company and hey are the only ones to see the actual data.
There are at least two other reasons to ask for an earlier interim look at the data. First, perhaps there was a hint of some safety problem, although not enough to stop the trial, but the DMSB wanted to get an earlier read in case there was a real safety issue, so they could protect patient safety. Second, it's possible that there was a weak efficacy signal - just enough to keep going (and not stopping the trial), but the DMSB wanted an earlier read before the end, in case that showed clear non-efficacy earlier, so they could stop the trial and not waste the time/effort in finishing it. But neither of us knows why and there could be other reasons.
Thanks for at least answering but you are lost. Leronlimab has had no safety issues in over 1000 patients over multiple years as it was being readied to be approved for AIDS where trials have been completed. There were no safety issues in the 60-70 EIND patients, no safety issues in the M2M completed trial and no safety issues when the first interim look was taken by the DSMB on the severe trial at 149 patients. Leronlimab is the safest drug out there that would treat CoVid and multiple other indications. Your second guess is mind numbing . By telling Cytodyn to continue the trial without changing the endpoint with no changes, and not to add patients but rather let’s look again at 75% enrollment , the most probable explaination if you were being honest, is that the data was showing clinical significance but not statistical significance just yet. The DSMB is taking turns on all of Big Pharma drugs halting trials for safety, Eli Lilly’s , Gilead’s, and now Regeneron for some oxygenated and ventilated patients, as well as stopping trials due to futility for many others, like the arthritis drug , Kevzara. You know which drug has not had any of that happen during its trials , that’s right it’s Leronlimab
@goru7 Just curious but what is your relationship with CYDY? Are you an investor, do you work there, etc.? Your posts seem to carry lot of emotion behind them so I'm curious.
Tried that and other angles already - he's obviously either a rep for them or has a ton of $$ invested with them - they're the only logical explanations...
You are an asshat. Get educated. Read Patterson’s manuscript. Covid is a Rantes disease and Leronlimab blocks it at the CCR5 receptor . But it also decreases viral load and brings your immune system To be in homo Statis and works on its own. Unlike the other drugs that only reduce Ig6 have not proven effective to date. Leronlimab does more.
It was in trials for HIV for years and they realized it might work on Covid. Once the MOA is understood it makes sense logically and scientifically.
https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa1583/5932277 This is a recent paper published by Dr. Yang who treated the EIND patients. Trying to locate Patterson’s link. Here it https://www.medrxiv.org/content/10.1101/2020.05.02.20084673v1
You completely flubbed the discussion of statistical clinical significance the other day, you've been overpromising on leronlimab for months, you seem to think CCR5 is associated with SARS-CoV-2, and now you just butchered this post (it's homeostasis, not "homo Statis" - don't even want to know what that is) and I'm the asshat? Also, that "paper" you keep citing is a preprint from May and hasn't actually been published in reputable scientific journal yet.
I know, I've seen it and we discussed it in the old COVID thread. I'm not going to say the drug isn't going to work, because it might, but the market hypesters are extremely aggressive on this one.
Please advise one doctor that says it has not worked ? Do you own research and figure out how many doctors, including those on the front line , that comment about how it works! If it wasn’t a small company, and if their results were produced by Big Pharma , they would have been approved 2 months ago when the M2M trial was completed. While you are doing your research, find me another company that has gone through 2 double blinded placebo controlled 2:1, controlled trials that has been found safe, and not had their trials halted for safety, or futility like all the others or asked to change their endpoint or modify their trials . Looking forward to what your research reveals, and whether you believe it should be approved for At least EUA !
