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TNTLAMB

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  1. Another vote for the train we have flown to Rome and left the bulk of our luggage with the departure hotel moved into smaller carry-ons making thinks much easier. Frankly we have found it much more enjoyable to do any touring after the cruise.
  2. I hesitate to comment anytime Politics is involved as no matter what is said or by who, its wrong to someone and the fireworks start. So let me start by saying I have set up, run and designed literally dozens of vaccine trials and reviewed hundreds more protocols. Basic protocols never change based on a particular set of circumstances In the cases of vaccines those protocols are not only determined by local (national) regulatory boards but also by an International board overseen by the WHO. Once a medication is ready for human trials The first step is to define your cohort. This is a statistical process in order to get large sample results from a a smaller sample which in effect gives better results. This is called a container certain age groups may be left out, gender may be adjusted (n need to test a birth control pill on men) The container is large enough and defined enough to eliminate sample bias. the subjects are define in a the same way. There are essentially 3 phases to every study each phase increasing the numbers of subjects in each. The studies are NOT conducted by a regulatory agency OR the drug manufacturer (Though both track) Studies are done by CRO (contract research Organizations, and always by several different groups (though all may be contracted by the same CRO.) Gawd help any trial that has a difference in results by different testers. There is some Serious explaining to do. More than one study has been terminated or started over with new cohort definitions When phase 3 studies are completed that data verfies and tested by and yet another independent group, the drug is submitted to the FDA for approval YET anothr independent group of Physician specialists in the area reviews the data and votes yea or Nay and submits their recommendations to the FDA. The drug then receives market approval based on the cohort. The FDA also has the option to grant compassionate approval or early access (based on the data and review committee) to folks outside the initial container. (you will see on TV Commercials :for patients 12 to 65 for example. That doesn't mean only folks 12 to 65 can take the drug) Once the Drug is taken to market a whole new series of studies kick in. I'll spare you that detail A word about Phase 3 trials. The proctor of the study recieves an update on every patient enrolled on a set schedule (that time may vary) EVERY adverse event is reported immediatly an adverse event may range from a sudden ingrown toe nail to death. The proctor then has options note it or act on it. If they don't know exactly what to do the study is halted until they do know. I have NEVER seen a trial EVER that at somepoint has NOT been halted. The Covid study is no exception. The only difference is The press is intrested in this one. So what does this have to do with Covid and Warp speed? The differenc between this study and a normal stdy is this study has gone to the top of the waiting list. The study protocol (including the contianers) was considered and approve before any other waiting trial. This save anywher efrom 1 year to 3 years. When the competed studies are turned over for approval, againthe waiting period is waived and IMMEDIATE action will be taken. In 1992, the U.S. passed the Prescription Drug User Fee Act (PDUFA), which allows the FDA to collect fees from companies to expedite the drug-approval process. Even that has been waived. The approval committees are evaluating data as it comes. Mostly put the Red tape along the way is being eliminated but nothing else is. The protocol for a vaccine BTW is 889 pages long so compressing it into one post is difficult forgive me for leaving some stuff out. There are two difference though It is entirely possible that at least 2 of the vaccines could have fallen into the Abbreviated New Drug Application (ANDA) for approval requiring NO clinical trials or at most additional efficacy data, meaning we could have had them months ago as all they were was a variation of existing vaccines. (no testing of this years flu jab has happen for example) Of course the Public wouldn't have stood for that as the antivaxers have been very active and the politicians even more so. The other difference is the FDA ADDED a step. trump an and others, including industry were pissed (excuse my French) but of course we were unable to explain it in light of all the new Social media Qualified Immunologist. They clamped on a 2 month waiting period after the Phase 3 trials were completed before the approval process can start. They are going to explain that on the 22nd. Who know maybe its something that should have been done all along. Yes most age groups have been considered (portionally on users) NO, at risk groups have not been purposely excluded for any reason other than defining a consistent cohort. That's not to say they haven't been evaluated for suitability for vaccines. this one isn't that special. Anyway, hope this is helpful. (Excuse any sarcasm you come across I really try to avoid it lol)
  3. I would not worry about that a lot. The Covid 19 vaccine is very similar to that of your annual flushot not only in how its made, but in how it works. It will never be like a measles or small pox vaccine. nor will this "thing" ever go away like smallpox. herd immunity will never happen (if did, the common cold would be rare) These types of vaccines are not inoculations. While they may not ever totally prevent you from getting the disease they can and do prevent the viral load from growing to the point of making you seriously ill. As far as new strains its important to note Influenza vaccines, also known as flu shots or flu jabs, are vaccines that protect against infection by influenza viruses. New versions of the vaccines are developed twice a year, as the influenza virus rapidly changes. It will be much the same with Covid. There is an occasional miss (ie Swine flu) but that is rare.
  4. They aren't shortening the trials. The FDA for reasons they won't state (but would practically guarantee are political in some measure including perceived public pressure) have added 2 mos of "observation" following the completion of Phase 3 trials before the manufacturers can apply for compassionate use approval (ie impacted populations which is what China and the USSR are doing) I don't know that I have ever seen that. In fact I have seen both early access and compassionate use permits near the end of phase one and not uncommonly during phase 2) I can understand early access as adverse event reporting is different but I will be very interested in the October 22 meeting when the FDA gets to explain to the manufacturers why they changed the rules. A phase 4 trial is an aftermarket trial somehow there has been a step added. Funny how it covers a lame duck congress but that's apolitical statement which I generally avoid making.
  5. Russias is intresting its a two jab deal They are using two vectors Jab One is Ad26. Jab2 is Ad5. There real data isn't available so its hard to know if they know something or simply could decide which way to go so went both. Chinas is Ad5. Your articles are right on. Most think of T-cells in regards to HIV and forget the mitigation of Bcells. Its interesting you bring up the subject because this is exactly why I distrust Fauci. Way back when he made call based on Primate research which doesn't apply as well as he thinks (pigs, Chinese hamsters and even horses are better choices in regards to immune system research) He chose to go with a new class of drugs called assembly inhibitors. The theory was those compounds bind to HIV-1 capsid proteins and prevent them from assembling into the HIV capsid, the inner structure of the virus that houses viral RNA, enzymes, and other key viral components. These compounds do not stop new viruses from assembling, they cause them to form with defective capsids, which cannot then infect new cells. the combination of drugs that comprise HAART (Highly active antiretroviral therapy) can interact with other drugs and weaken the effect of the “cocktail,” thus allowing resistant strains of HIV to emerge. The HIV vaccine trial your links refer to was abruptly halted when researchers found that the vaccine promoted rather than prevented, HIV infection. Researchers in Molecular Genetics in France and our own NIH knew how the vaccine could have enhanced HIV infection I was convinced at the time Fauci didn't know the difference between a bacteria and a virus. Did he learn anything beween then and now? https://www.niaid.nih.gov/research/anthony-s-fauci-md i'm not convinced. He states: "Our approach over the past several years has been to delineate the role of persistent viral reservoirs in the pathogenesis of HIV infection and to explore and develop novel therapeutic strategies aimed at achieving sustained virologic remission in infected individuals in the absence of ART." He still doesn't get it. Hes trying to kill the virus. His approach to COVID is exactly the same as his approach to HIV. Pharma long ago moved beyond all of that and realized it wasn't the damn virus, overly simplified it was what the virus did to the immune system. Some real progress was made. But again it came from Pharma. Canada was the first to jump on board and made HAART available. In fact British Columbia Made HAART Free for all. These medications may also be called antiretroviral drugs (ART), antiretrovirals (ARVs), or anti-HIV drugs. The availability of HAART means that HIV is manageable through lifelong treatment. I dare say the HIV Crises and approach has had more effect on modern medicine that most would like to admit. Immunotherapy, precision medicine etc all came from that research. Just about all recent cancer treatment comes from that work. Were it up to Fauci we would have seen a rise in HIV that made the 80's look like nothing. He is taking the same damn approach to Covid. I'm not convinced yet Those side effects warned in your article are not unexpected in fact quite the opposite. I would trust Pharma over Fauci any day. Keep in mind though I'm long retired so is just opinion, and really want to be cruising again
  6. I suspect without seeing the "Specific Data" the Russians get it. Their Vaccine like Pfizers is based on known technology which has been used succesfully for over 30 years. Overly simplified they simply attach RNA from the virus to an agent to update the immune system. its exactly the same methodology used to create the seasonal flu vaccine which is made every year with different RNA based on a "best guess" of whats going to be out there. We could have had should have had a vaccine months ago. The technology exists. (Personally I think its a result of the anti vaccine folk getting political again, but thats ONLY my opinion) IF enough people take the vaccine basically what happens is a herd immunity is created. The problem in the US and much of the world is we are looking to Immunologists for a solution that we already have. What we are failing to do is listen to another Specialty- Rheumatology. The Cov-idiots are partially correct. Covid isn't a big problem by itself. For most its no worse than a bad cold but for a smaller group its a huge problem. Its not the virus that is causing the deaths and long term problem directly but rather the virus effecting these people immune system causing it to go into over drive and the body literally starts attacking itself. This is called the Koebner effect. An insult to the body wakes up a part of their genetic system causing an acute autoimmune disorder. Some have the genetics most don't. The Koebner effect is also what causes everything from Rheumatoid arthritis to Lupus and a host of other autoimmune disease. Rheumatolgists understand this. Studies in both England and Italy have confirmed this. Patients who are taking immuno suppresents including Biologics (Humira, Enbrel etc), DMARDs (Methotrexate, Hydroxychloroquine, etc) are encourage to keep taking them - even in the US. The effects of Covid on these folks have been much less than expected. The medications used Hydroxychloroquine, Regeneron's cocktail etc have been studied in General population and studies disagree. Heres the problem. It takes weeks if not months for them to work for autoimmune disorders. I'm not sure its realistic to expect different results with someone in ICU. SOOOOO then there is thng of massive steroid doses whih is what Rheumatologists have used for years. (not that the treatment discussion has anything to do with your question) Those meds will NOT work and possibly make things worse if you DON'T have an autoimmune disorder. If we get a vaccine, and people take it, people follow the rules to slow things down etc. we should be cruising soon. With a vaccine, despite the fact I have AA amyloidosis and Psoriatic arthritis, I'll be on the first Cruise I can. I won't go to the buffet (because of the crowds) but I never do anyway. I'll cheat on attendance at the embarkation drills, stay out of the elevators and wash my damn hands till the skin falls off, but will have a great time thoroughly. The short Answer is, It appears the Russians know what they are doing, and the rest are questionable. We are failing to listen to the right Scientists. Fauci should know Better.
  7. Fauci is as the CDC essentially an administrator not a researchers. He's smart, so don't misunderstand. He is evaluating others data. Researchers both academic and NIH doing actual research don't know most of the answers. Only half (if that) of the job is done there are lots of models and theory (and lots of changes to those theories) But its not "science" YET. All of those models need tested, not only by the original researchers but other labs as well. Fauci has only had one other similar situation (HIV) in his career. and he muffed it. Once the science caught up, it got fixed. The vaccine is not being fast tracked. It's going through all the steps. How effective it will be is another matter. Effective in terms of how long it will last. After all it is covid and we are yet to have a vaccine for the common cold which is also covid. I don't have any answers but lots of questions. BTW I worked as lead scientist in the area (NIH) and have several vaccines in my VC.
  8. Correct. However the Original post was referring to"mismanagement" of ship conditions and Princess the worst. Thats not true. The Diamond, Grand and Ruby were hit almost simutaneously and largley dependent on their port schedule. The others list failed to learn the lessons taught and their crews paid for it.
  9. Princess is fronting the Casino offers but they are not paying for them. The casino is a sperate operation (though owned by Carnival Corp) Just as Ocean Casino is a completley differnt company. At one point a couple of years ago Carnival was using Konami's Synchros Managment that has everything wired to the Penny including Players Clubs and Perks.
  10. The five ships with the most confirmed Covid-19 cases were the Wonder, the Grand Princess, the Valor, Royal Caribbean Cruises ' Celebrity Eclipse and Carnival Corp.'s Freedom, according to the data. Covid-19 Hits Cruise-Ship Crews Hard - WSJ
  11. There is more to the story. The entire management team for the Cay was replaced almost 2 years ago as one more attempt. The shh wasn't for you, there were a few who couldn't find the Disney Deal, even though it was closed over a year ago. Remember the island has 100 plus miles of beach
  12. I'm involved (indirectly) As you prolly know the Saudi govt bought 8% of CCL a few months back and is making some demands as they bought a bit early making their "Uber experience" look good.
  13. Its for sale (has been since the fire) and negotiations in process. The impossibility of docking facilities has made it far to expensive. If you are paying attention to the redeployments, you will notice its prolly very close to a done deal as PC moves more assets to Europe and restructuring Alaska as well as turning Caribbean port stops upside down.
  14. highly unlikely you need to worry about this. Rumor is Princes Cays will soon cease to exist. What it will be replaced with (if anything) is anyone's guess.
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