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I know here in Bahrain few Philippines. I could ask to call them. Anyone has a tel number of the relevant hospital?
Misiu143, your analytical approach to all the various drugs in question is extremely great. You clearly point out in a very practical way all the advantages and disadvantages regarding the treatment of Covid.
You are a great help for people, like me, who are not educated in medical science.
Look at the profile of this company in Brazil;
Innovative
Medium size set up for growth
14% government owned which is good for fighting Covid
I my opinion, this is the company which CYDY will take as a partner. Nader gets rid of shit BP. Very clever draw.
I agree. I observe for 20 years. When Clay Trader appears on the scene the shorters not far. He is the bad omen.
The guy who is asking the questions is quite strange in my opinion. He is asking about costs. He is asking about days of hospitalisation. He hasnt yet got that Remdestodeath doest rescue any life but LL does. Maybe he would ask differently if his mother or daughter would be on the death-bed.
82% not good enough? Remdestodeath so much better? What about the other approved rubbish? FDA is a joke or a criminal gang?
FDA = Fight Defeat Adversery of big pharma
You will wonder but Hungary will be first.
Great. Thank you. We know the great contributors on this board.
We all know who are the contributors, the fence-sitters, the paid bashers for shorters and BP, the NP- haters, those ones who know everything better.
I hope Nader contacts this mr. Siegel and informs him first hand.
The prime minister of Hungary is the underdog in EU. He gives a shit on Brussels bureaucrats. He approved against EMA 2 Chinese and 1 Russian vaccine. Hungary is in top 5 worst in covid deaths. So, he needs solutions not blabla.
I send to his ministry by a friend 2 weeks ago a full set of info about LL. Few days later Nader reported that he was contacted by Hungary.
I have the same feeling.
This man is great. He got the right thinking.
I hope Philippines and Hungary buy all avaiable vials and FDA get finally grilled by Congress why they didn't act.
This is an excellent speech and 1000% true. The only thing missing is that silencing came by the money power of BP.BP make huge money by vaccines.
Very good paper. Thank you. Make aways:
1) known and applied for 35 years
2) leads faster to useful results
3) USA and Europe open these trials
4) planning sophisticated
5) evaluation a real science and tricky
6) need good will from regulators
I am sure this is a NO GO for small biotecs like cydy. That's the reason they were talking constantly with FAUCI clan. The evaluation is in no way done in just days or few weeks. This is a difficult task if FDA would be objective which I believe they are not. If they get any EUA within 2 months then we have the confirmation that all is a foolish and corrupted game.
But the fact seems to me that if this kind of trial is equally accepted by FDA no one would then ever made a trial with fixed endpoints. Something is very fishy in this game for a very long time.
So what now?
If ONE can do an adaptive study and changes everything along he learns, why we didn't do? Why we are not doing now so?
The adaptive study makes a lot of sense to me but this could have made also us brining the winner. "Learning by doing". Not stupid, but then all others are stupid.
FDA allows this and evaluate results in the same manner as from those who stupidly didn't do like this?
Like on the "Farm of Animals". Some pigs are more similar to other pigs.
Of course, they will come back and try us to 1.75 or so but only with their own borrowed or naked shares. No long is selling anymore. Who wanted to sell, sold already. No food for shorts.
Sale dried totally up and is like a Wadi in the dessert of Sahara. One small spark for buying and this goes up 2 $ in no time. Shorts are sitting on a barrel full with dynamite.
One can watch the gaming of the shorters in a relaxed way. Very low turn over makes it easy for shorter in cooperation with their complices (market makers)controlling and capping the share price. There are no sellers anymore. Only the shorters and the wash trades of the MM. Business as usual. Many bombs in the pipeline and if one ignites very soon the game will significantly change. 31 Mio shares short.
Shorters will run for the exists.
I think the idea to replace Nader comes from BP as Nader will not sell for just 10$. Getting for us a new CEO gives them a better and a new chance in this buying game.
Watching Level2- activities, a blind can see the criminals at work. I am more than ever sure the price will rocket in an unbelievable way in the days to come. The spring is coiled. We need just 3 to 4 mio share turnover and the shorts are dead. No one is selling anymore except the shorters. Stay relaxed and know what you own.
No doubt Nader has his big deficiencies but we know him after 5 years. A new CEO is for us shareholders a bigger risk. Nader has passion and will not sell us off. Go Nader go!!
Yes. You are right and I was wrong! Thank you for the correction.
Whoever pays 45% of the yearly budget of FDA, owns FDA. To say say something different is far away from real life.
This is totally irrelevant for an approval.
Nader doesn't have to pass a language course or the Mr. Universum competition. And FDA is not his supervisory board or a main shareholder to qualify the results of the company.
The drug is top class with respect to all relevant parameters for approval.
Name me one single argument against approval? Just one!! In my opinion for matters of deaths pvalue doesn't count when clinical results are phantastically. Yes, p-value counts for irresponsible bureaucrats.
I agree with the critical views on Nader but also on the rest of team. They are in one boat. But when it comes to approval of drug I disagree completely and want to make clear to all readers, so far not yet convinced:
1) drug is without doubts proven to be 100% safe. No risk but possibility to huge life wins.
2) drug showed its excellent efficiency, especially for critical patients below 65 but in my opinion to all other groups as well.
3) drug is manufactured and available. Producer is Samsung which is best of class.
What else is missing? Nothing!! These are the facts whether Nader is performing or not in your opinion.
That's a phase2 only?
Good or bad?? Both could be BIG!
Didn't we learn the lessons of CD10 and CD12? A low number of arms is a high risk to match the necessary p-value. Excellent clinical results do not win against a low p-value. FDA gives a sh.t what helps the sick people, but what satisfies bureaucrats statistics.
So who is now telling us to lower the number of arms? Is FDA manoeuvring us into the next big disaster "excellent results with getting no approval"?
Is it not better to focus and get enough resource to pass finally one trial successful and get a BLA? CD10 and 12 failed due to too low several arms. HIV combo phase 3 was very successful, but management has still not explained what went wrong (I don't believe the story around occupancy test)with BLA. More than 2 years and no end in sight?
A very nice letter from a poster on Yahoo. Very straight to the point and very important and correct:
Dear Dr. Pourhassan,
As an investor in Cytodyn and a supporter of the company and the drug Leronlimab, I respectfully request that you revise the most recent press release. The headline states “...Expected Regulatory Filings...”, while in the body of the release it says “Management will update stockholders on the Company’s recent COVID-19 related filings.......”
From this press release, it is impossible to determine whether the filings in the US, Canada and the UK are “expected” as the headline states, or if they have already been filed, as is stated in the body of the PR.
This is an extremely important point that is left to interpretation by this release. It is exactly this type of laxity in corporate communications that gets continually exploited by short sellers who like to attack the stock price. As a loyal shareholder who is tired of having to defend a great company and a great drug due to miscommunication, I implore you to both revise this PR and to take more care in public communications of all types going forward. Thank you for your consideration.
These guys are too smart to write a crystal clear press release. If they work in the same confusing way as they write their press releases then who wonders where we are.
Big arm numbers are for risk mitigation. With small numbers any bad luck is mitigated. I don't need to be a doctor to understand such basic for trials.
If I am in a position where FDA is not in love with me, I have to be with each critical parameter on the safe side. We just learned again: p-value is a ko- criteria. Like it or not, higher numbers creates home runs.
Concentrate money and brainpower. Trials with 50, 200, 400 are just not good enough to secure p-value. We are blaming bad luck, we should blame non existing risk management in place securing our homeruns for a great molecule.
P-value is for science, beaucrats and commercial contracts. If we deal with deaths, I doubt it should be a ko criteria.
As written before, 2895 COVID trials. 5% of them mean 145 trial under scrutinization. Just imagine you apply for a job, and there are 145 candidates on the first shortlist (2895 applicants). Your CV must offer something special to become visible among 145 and to get under the best 10 if you are still weak, as you have not passed the minimum of minimum experience (145 equal in terms of years of experience). What is the chance to become among the best 5 who will be invited for a face to face interview?
We know the drug works very good; it has excellent results, but we haven't got enough arms (to pass the p-value criteria). We end up where we ended up: Come again when you got enough experience (arms). The failure is with the candidate, not with the one who selects the candidate.
I learned here many lessons; shouldn't we have got people in CYDY who learned these lessons years ago?
I heard Mrs Woodcrock last year in another interview, I believe it was December when she said "I only believe in Big Pharma as only they have the power and capabilities to prove new drugs".
This is a matter of fact. Definitely to run trials below 400 was a waste of money and time. My view! As I said, I am not knowledgeable in this field.
The question, how many will we need for Loghaulers- Trial? Again a too small number?
I just listened to an interview with Mrs Woodcock. She showed a graph where out of 2895 trials for Covid only 5% were powered and randomized enough to pass the minimum requirements. And I understood her saying that trials with 400 arms just not good enough to deliver results.
Being a greenhorn in pharma I can not understand why we had our trial CD10 with 295 arms and CD12 with 395 arms when 400 is for FDA a "joke" (not powered enough)? I criticized many times that Nader isn't focused but run all and nothing at the same time. Watching this interview today gave me the idea if we would have CD10 with 800 to 1000 arms we would be today approved. And the same with CD12.
If I understood the messages from FDA in the correct way then I conclude that also greenhorns designed these trials. They should have known that 295 and 395 aren't enough. Focus money, focus man- and brainpower and get it done.
Now the question is, will be additional 140 arms in CD16 enough or do we run another joke demonstration! Who knows it?
Quote: We would request the WHO to allow Leronlimab participation in the Solidarity Trial. The World could then evaluate the efficacy of Leronlimab against the best it has to offer the Pandemic.!!!
We would...... Who are we? CYDY? When will CYDY request? How long would it take until results would come out? I guess we talk in the best case about 6 months after enrollment started. Until WHO would consider us to participate in such a trial it would take another 3 months? So we talk about results in a best-case of January 22?
Therapy will be needed maybe until 2024/25.
Would WHO bypass FDA? I can imagine they would do as we see their stand against Remdesivir and others. Would WHO stand up against BP? In this, I have no belief as I believe WHO gets a hell of money (donation = bribery) from BP. Donations make people blind!
Nader hired months ago a PR person. I had the impression she was an apprentice. Maybe my memory is wrong.
My open letter to Mrs Woodcock today:
Dear Mrs Woodcock,
I am 57 and served as a graduated Chemical Engineer for 45 years in the industry. P-Value (we used more the expression "2 sigmas") is very well known in the industry and widely used for reporting results of trial or specifications of warranties. It is an important indicator - no doubt!
In the past, you said that clinical results are more important than p-value, and I fully agree with you if we deal with life and not with machines, then we need a more comprehensive approach than just a narrow view which p-value gives us.
How can you take now in the case of Leronlimab the approach that "p-value matters more than lives"? We are not talking about 1 or 2 (which are also important, of course) but the ten- thousands of lives as all other countries are waiting for FDA- approval.
The results of CD12 are talking for themselves. Over and above, I believe strongly, as shown in CD10 by News 2 results, which FDA irresponsible dismissed and instead of it approved worthless Remdesivir, most of the patients would never "arrive" in the severe condition when given in time Leronlimab. Do the great number of lives you could safe not count? Does the significant reduction of hospitalisation days (in case of Remdesivir 1 day reduction- disagreed by WHO- was enough) not count, not because of money but by indirectly increasing the emergency rooms' capacity?
I send you enclosed an article which I agree with in full content.
May God enlighten you NOW and not hold on to Your LAST DAY accountable for the death you are responsible for by appreciating the p-value more than lives. May no- one of your loved ones around you or even you not desperately need Leronlimab instead of "killing" Remdesivir or less effective Dexamethasone.
It's not yet too late to give a conditional EUA with a following up phase 4. You know all the results, you know Leronlimab is working, why are you not following your conscience? A machine or a robot without AI would decide for p-value, but you should decide for lives.
Yours faithfully