Old guy

Both files are marked "unavailable"

See below for excerpts of the actual letter. "Based upon limited in-vitro and anecdotal clinical data in case series, chloroquine phosphate and hydroxychloroquine sulfate are currently recommended for treatment of hospitalized COVID-19 patients in several countries, and a number of national guidelines report incorporating recommendations regarding use of chloroquine phosphate or hydroxychloroquine sulfate in the setting of COVID-19." and 1.The SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus; 2.Based on the totality of scientific evidence available to FDA, it is reasonable to believe that chloroquine phosphate and hydroxychloroquine sulfate may be effective in treating COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of chloroquine phosphate and hydroxychloroquine sulfate when used to treat COVID-19 outweigh the known and potential risks of such products; and 3.There is no adequate, approved, and available alternative to the emergency use of chloroquine phosphate and hydroxychloroquine sulfate for the treatment of COVID-19.

You are a lawyer Moytoy, you will understand the problem she has placed herself into.

Where is the link, please?

Now, rgbilliken you are a chemist and a pharmaceutical researcher. Are you also an interpreter of the FDA thinking and intention rationales, or do you have a statement from the FDA saying what you just said?

Lordy! you are full of yourself are you. Tell me please, not yet MD, what branch of medicine are you going into? Of course with the graduation coming soon, you are already accepted to some kind of residency program, correct? What is your choice of medical branches or specialties if you prefer?

Did you read the study? Did it make sense to you? Were controls used in this study? How much of clinical research is, as you call it, "purely observational"? Do you realize that the intent of this brief study is totally unrelated to getting initial approval for use from the FDA? Do you realize that a fast track approval by the FDA was already granted for this use? There is no need to establish all of the parameters you are talking about when all they are looking for is viral load levels. Did the viral load levels go down? Does this mean anything to you in terms of clinical response? Do you need to establish causality for this particular use? What specific kind of causality? Are you referring to a determination the actual interaction mechanism between the drug and the pathogen in this case? Some genome studies may be controlled to the nth degree, but not clinical studies dealing with active disease. Do you realize that complete 100% safety regarding the use of medicines cannot ever be established? Do you think the function of an MD is to read research papers and order drugs without ever seeing or checking patients? Why do MDs check patients regularly while in the hospital? Why are some patients hospitalized and others are not? Is the decision between hospitalization and outpatient therapy established according to rigid and fully defined rules? What is your current level (how far along are you) as a "lowly medical professional in training"?

I am glad you agree the toxicity issues are taken care of already and what you are skeptical about is whether or not the drug will be effective for this use. All I can tell you, is that the FDA gave it a fast track approval for this use and that is beyond your level. It was the FDA that is responsible for approving it for this use, not you. You are free to be as skeptical as you wish.

You are aware that this product was tested extensively when first approved. I do not imagine you know this but here it goes: Normal testing for a pharmaceutical product includes a first stage that determines if the product can be used in humans without dangerous toxicity and whether it shows any kind of effect as expected. Once this passes, it is tested again to determine how much of the product is tolerated by humans again without serious toxicity, all kinds of side effects are documented and recorded. Phase III is the difficult one, the product has to prove to be better than other available product or provide some unique advantage. If all 3 phases are completed, then it is approved. This particular product, has been used extensively for autoimmune disease therapy, against without major problems. Fast track products, fast tracked because of a major medical need or the like, are fully approved without much of this process being completed. However, Hydroxychloroquine has been fully approved via the long process from long ago. The issues with toxicity, and harm have been worked out and found to be OK LONG AGO. All that is needed now is approval for a new use (which has been already granted by the FDA). Also, at this time, everything relating to Covid is being fast tracked. Like it or not this is the way it is. The study I provided the link for does show good response in limiting the virus levels in infected people. It is approved for this use by the FDA and it has been used for many years for different applications. What is it that is hard to understand here? @rgbilliken, OK so you do. You, of course agree that once a drug passes the full FDA approval it does not need to pass it again, or don't you? This is all basic regulatory stuff. Once the licensing agency says it is OK to use, that is all there is to it. I assume you are not a lawyer also and involved in litigation over drug use and abuse and or side effects and toxicity. This is a different animal all together, and something that will eventually have to be settled in court. But that comes later.

I have given my credentials before several times, can you give yours? What kind of a scientist are you?

Did you happen to see or, help us Lord, even read the article I linked? Assuming you missed the link for some reason, here it goes again. https://www.sciencedirect.com/science/article/pii/S0924857920300996 This is a controlled test study. Pleas read it, at least to the point you understand that it is a controlled test study.

I thought we were going to keep politics out of this discussion. What does it really matter who was right or who was wrong? The important thing is to get this bug under control and to keep the death toll as low as possible. The faster we do this the better it will be for the economy and the people. To make clear what I would love to see happening as soon as possible, it goes like this: I'd love to see people being able to go back to work, and kids go back to school. I would love to see traffic in the street even with rush hours and all of that. I would love to go to my favorite restaurants and enjoy a nice steak and potatoes in some form. I would still love to see the Bills ending the A10 tournament and going into the Dance, this year if at all possible. I would love to see the shows I had bought tickets for and refused a refund for when cancelled, choosing instead to give the money as a donation. I would love to be able to shake hands with my friends, and to go to Church with no fear of exposure. However this is achieved, it is fine with me. Let's get first things first instead of letting this sink into a universe of hate, recrimination, and blame finding. Let's put this episode in the rearview mirror.

Well guys and gilrs, not all is dark and threatening in this world. I just got a copy of an article to be published by Elsenvier, which, despite its small size, shows a good reduction of the virus load in Covid-19 patients treated with Hydroxychloroquine. They also tested combination therapy with Hydroxychloroquine and Azithromycin (a commonly use URI antibiotic derived from Erythromycin) that shows a much greater reduction of the viral load in these patients. The link to the article's PDF is here: https://www.sciencedirect.com/science/article/pii/S0924857920300996 The central concept is (as is the case in most infections) that the lower the viral load the body has to fight, the easier it is for the body to bring it under control and heal. This is good enough to treat people actively with this combination of meds and should help reduce the death toll significantly. This is a real study with controls, and even if it is small it is a proper study with very good results. There is light out coming into the tunnel for a change, we MAY be coming close to the other end. As a word of caution, there are patients that arrive for care in a very advanced stage, many of these patients may die despite all therapeutic intervention attempted. Do not pop the bubbly yet, but it might be nice if you put your bottle in the fridge. We may be getting closer to controlling this bug. Again this here is a proper study with very promising results. Remember there are no guarantees in health care, people die despite all attempts to achieve the opposite outcome. However, this looks good, at least to me, as of now. AnkielBreakers. This is a nice attempt, based upon your estimates and compromises of data picked from a field full of unknowns. You may or may not be correct, but this will depend upon a large number of factors. When it is all said and done, the total of dead bodies counted and confirmed to have died of this disease will tell the real story. You all know my estimate. The article linked above may help in keeping the death toll a lot lower than that. It is wait and see now.

We will see, it would be great if he can play reasonably well and be active with the team.

At this time I think we need pictures from TJs' pole dancers in the East side to distract people away from this mess. Small video clips from the Soprano's showing the talent pool at Barabim's might do it as well.