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Jesus Predicts His Betrayal St John 13

(Psalm 41:1-13; Matthew 26:17-25; Mark 14:12-21; Luke 22:7-13)

 

This is a mural 57 x 63 Judas is sitting in the 2ed seat of honor as the CFO of the group and totally trusted by all the other 11 disciples right behind Jesus. John in the top seat asks Jesus who it will be? He leans back (verse 26) Simon Peter (bottom left) is in the lowest seat which I am sure ticked him off as he points at John to asking and find out more. Over 100 pictures I researched usually have Judas in the back as if he was not trusted and Simon Peter next to Jesus. Read the text since they were in a backward C configuration on the floor not a traditional table.

  

I am not speaking about all of you; I know whom I have chosen. But this is to fulfill the Scripture: ‘The one who eats bread with Me has lifted up his heel against Me. 19 I am telling you now before it happens, so that when it comes to pass, you will believe that I am He. 20 Truly, truly, I tell you, whoever receives the one I send receives Me, and whoever receives Me receives the One who sent Me.”

 

21 After Jesus had said this, He became troubled in spirit and testified, “Truly, truly, I tell you, one of you will betray Me.”

 

22 The disciples began to look at one another, perplexed as to which of them He meant. 23 One of His disciples, the one whom Jesus loved, was reclining at His side. 24 So Simon Peter motioned to him to ask Jesus which one He was talking about. 25 Leaning back against Jesus, he asked, “Lord, who is it?”

 

26Jesus answered, “It is the one to whom I give this piece of bread after I have dipped it.” Then He dipped the piece of bread and gave it to Judas son of Simon Iscariot. 27 And when Judas had taken the piece of bread, Satan entered into him.

 

Then Jesus said to Judas, “What you are about to do, do quickly.”

ue to system problems I was unable to upload this series of images until today.

 

On the 4th & 5th October 2016, leading international thinkers in the areas of Data, Predictive Models, Technology and Decision making gathered at the RDS, Dublin, for Predict 2016. The speakers, many of whom I managed to photograph, discussed the latest progress in Predictive Modelling and its future – from Data to Software and Hardware technology, plus Predictive Modelling methods and the best examples of Data-driven Decision-making.

 

The organisers kindly invited me to the Predict event at the RDS. In case your are interested I used a Sony A7RM2 coupled with a Sony 29-135 full frame lens. The lens does attract a lot of attention which allows me to to have interesting interesting people … volunteers, students from Brazil, photographers etc.

Symposium: Predicting Walking Ability

Following Lower Limb Amputation (C21A)

Oceanside D

Jason Kahle, MSMS, CPO, FAAOP

Jason Highsmith, PhD, DPT, CP, FAAOP

Kenton Kaufman, PhD, PE

Hans Schaepper, PhD (c), MS Div, CPO, Department Chair,

Loma Linda University

In today’s Healthcare climate, it is crucial to understand the evidence available to determine which characteristics prevent walking candidacy and prosthetic fitting criteria. There are many characteristics such as age, level, etiology, cognitive ability and pre-amputation characteristics which have been identified, and are backed by evidence to form population conclusions. This presentation will help provide the US and international prosthetic professional an understanding of evidence support regarding provision of prosthetic care, for all viable amputee candidates. The purpose of this symposium is to educate the clinician regarding existing high quality evidence to support prosthetic candidacy.

Grandma Predicts A Happy Thanksgiving - Wax Fortune Telling Tarot Card Reading Gypsy Swami Grand Mother Prognostication Booth at Coney Island - Brooklyn New York City 6/20/2010 vintage gypsies Grandma 's Predictions 2010 NYC

Les prédictions technologies, médias, télécommunications de Deloitte Canada à Montréal ont eu lieu le 19 janvier 2011

Vlad Lata, Chief Technology Officer and Co-Founder, KONUX, delivers a technical review on 22 February 2018 at the 6th International Railway Summit.

 

© 2018 IRITS Events Ltd. Photo: Richard Hadley

The technology of Predictive Analysis in Healthcare is a forefront contender aimed at bringing forth a technological utopia. Many Predictive Analysis Tools & Techniques are used to gain useful insights from the data, those such as Data Mining, Machine Learning & Artificial Intelligence are used for analyzing the data and make future predictions based on how well the data is analyzed.

 

The Healthcare Industry is surrounded by Predictive Analysis Examples such as determining which type of diseases are patients risk to suffer from. These Predictive Analytics Examples in Healthcare are an indicative of how effective Predictive Analytics has been in such a complex domain. On the other hand Predictive Analysis using Machine Learning can predict how likely a person can be affected by a particular illness. The model used for Machine Learning uses a patient records database to make predictions by determining the symptoms exhibited by the patient.

 

Predictive Analysis models using Big Data are designed exclusively to capitalize on the large repositories of Data available and improve their accuracy on predicting the right outcome.

 

Predictive Analytics using AI calls for a more advanced, accurate and efficient way of achieving better data virtualization, integration and quality.

 

To build your own Advanced Healthcare based Predictive Analytics Software Solutions, visit our site at: www.osplabs.com/healthcare-predictive-analytics/

Predicting the future of e-cigs and vaping in 2016, it is almost impossible to point out anything positive. This situation is mainly brought about by the fact that: the vast majority of vapers have shifted their focus towards overly enjoying their new found freedom from tobacco, sharing...

 

www.ichorliquid.co.uk/blogger/vapers-bliss/

ADME & Predictive Toxicology, Nanomedicine, Barcelona 2013

The photo was taken by : Sharon Powell Mangum

Contact for work : nguyenhuuthang.vpbq@outlook.com

Photo uploaded on July 26, 2017

Url facebook : www.facebook.com/sharon.p.mangum/posts/10209441875711590

Not copy image !

  

Themes: Art / Origin: Arts of North America / Genre: Pop Art / Characteristic: Diptychs, Doubles / Authenticity / Provenance: Original / Artists types: Professional artists / Mounting: On Panel / Photo color tint: Color / Artistic trend: English Painting / Period: Contemporary / Number of items: 1

Predicting a spooky future: Greek independent feature film 'Ο Χειμώνας' (The Winter) by Konstantinos Koutsoliotas

We predict the next book by @anya1anya is about #ds106. Design her some cover art.

 

Based on the original cover of Virginia Woolf's essay, A Room of One's Own drawn by Virginia Bell.

 

gforsythe.ca/ds106-as-an-act-of-feminism/

ADME & Predictive Toxicology, Nanomedicine, Barcelona 2013

Because of predicted historic and catastrophic flooding on the Ohio River, everything changes for the AQS quilt show in Paducah, KY, this week. The Julian Carroll Convention Center and the Paducah Expo Center are threatened with flooding and will not be accessible or the show since the flood wall has been closed. Events have been moved but the show will go on...

 

Pavilion - corner of 4th Street and Executive Boulevard - will now house the Best of Show, Category Winning Quilts, and Bed Quilts

 

Expo Center Vendors now move to Circuit City for The Alliance for American Quilts Display. Convention Center Vendors now move to Office Max for The Pilgrim/Roy 2012 Challenge Display & AQS Lancaster 2011 Winners. These are located in the Kentucky Oaks Mall Vicinity - 3470 James Sanders Boulevard.

 

Pavilion Vendors will relocate to First Baptist Church - 2890 Broadway - along with Workshops/Classes, Lectures, All Star Review, Wall Quilt Category Exhibit and Stitched Premier

 

The National Quilt Museum - 215 Jefferson Street - No change in scheduled events.

Additional Events: YoYo Ladies • Live Auction • Silent Auction

 

AQS Food Tent - 2nd Street & Monroe - Farmers Market Parking Lot across from National Quilt Museum

 

Vendors on Kentucky - 200 Kentucky Avenue - Finkel Building & Hurt Book Sale (No change.)

 

Carson Four Rivers Center Events - No change in scheduled events.

 

Shuttles Routes revised to include all locations.

Symposium: Predicting Walking Ability

Following Lower Limb Amputation (C21A)

Oceanside D

Jason Kahle, MSMS, CPO, FAAOP

Jason Highsmith, PhD, DPT, CP, FAAOP

Kenton Kaufman, PhD, PE

Hans Schaepper, PhD (c), MS Div, CPO, Department Chair,

Loma Linda University

In today’s Healthcare climate, it is crucial to understand the evidence available to determine which characteristics prevent walking candidacy and prosthetic fitting criteria. There are many characteristics such as age, level, etiology, cognitive ability and pre-amputation characteristics which have been identified, and are backed by evidence to form population conclusions. This presentation will help provide the US and international prosthetic professional an understanding of evidence support regarding provision of prosthetic care, for all viable amputee candidates. The purpose of this symposium is to educate the clinician regarding existing high quality evidence to support prosthetic candidacy.

ADME & Predictive Toxicology, Nanomedicine, Barcelona 2013

We’re not returning to ‘outdated’ predict and provide, says Robert Goodwill MP, Parliamentary under secretary of state for transport, the minister for roads and for cycling, too. He says this in a letter to Transport Xtra Magazine.

 

+++

 

I write following your coverage of the draft National Networks National Policy Statement (“Rethink ‘predict and provide’ roads policy, profession tells DfT” LTT 07 Mar).

  

The Government is not bringing in a programme of large-scale new road building, or working to an outdated “predict and provide” model. The draft National Policy Statement (NPS) very clearly rules this out. Our investment is foremost about improving the existing network, bringing forward schemes to improve the strategic road network where there is a strong justification based on economic benefits and quality of life, taking full account of environmental and social impacts. Almost 40% of the funding over this Parliament and next is for maintenance. Our investment in road improvements sits alongside huge investment that will transform our rail network, support sustainable transport choices and protect the environment, including supporting the uptake of ultra-low emission and electric vehicles.

 

++++

 

The letter Goodwill is referring to was packed with experts telling the Government they’re heading for disaster, if they build more roads. The experts included

transport planners, local authorities, and public transport and environmental lobby groups.

 

The draft NPS, on which consultation closed last week, predicts that road traffic will rise 42% in England between 2010 and 2040. This is the NPS that believes cycle use will drop, so won’t plan for cycling.

 

The Transport Planning Society says the road sections of the document are “one of the weakest policy statements of recent years”.

  

“Parts of the document dismiss key policy elements as simply irrelevant, including demand management and the use of sustainable modes. Land use planning, either to minimise the need to travel, or locate travel generators close to sustainable networks is completely missing.”

  

The Local Government Technical Advisers Group (TAG) calls for the statement to be totally rewritten. “So much is wrong with the starting point for this statement that it would be very damaging for the country and its people without a fresh start. The use of national traffic forecasts to continue (or revive) a policy of predict and provide is seriously flawed. The potential demand for increased travel is possibly true but a predict and provide model, even for trunk roads, is highly undesirable. It is deeply concerning that phrasing of the document belittles the benefits of investment in non-car based modes of transport,” says TAG.

  

The Chartered Institution of Highways and Transportation said: “CIHT does not think the document clearly establishes the need for development of the national networks, particularly on the road network. The potential for modal shift from road to rail for passengers is written off in simplistic terms, taking no account of regional and local variations. It does not address demand management in any detail.”

 

Dorset County Council says: “The outcome [of the NPS] is likely to be increased pressure on local roads, whilst local highway authorities are effectively starved of the funds that will be needed to resolve the resultant urban congestion. We do not think it sensible to devise an NPS that does not include strategies for the 98% of the road network outside Highways Agency control.”

 

On the other hand, motoring groups have welcomed the NPS. The RAC Foundation says it can find “little to disagree with” in the draft NPS.

 

www.transportxtra.com/magazines/local_transport_today/new...

Grit is often the single-most predictor of success

Jonah Lehrer

 

The grit it must have taken to succeed with a mine in Death Valley is unimaginable today. This image with the snow and starkness communicates that to a small extent. Lost Burro Mine, Death Valley National Park, CA Why it Works: Reference number: CA_1312_136

 

this was one of (maybe the first, i'm not sure!) video that i shot stills on. it's kaiser chiefs shooting the original video for I Predict A Riot in september 2004.

 

it was done at itch film in north london by charlie paul (he did some automatic/ ordinary boys stuff too, and is awesome) and generally invovled the band playing while lots of fans had a pillow fight.

 

finally got the photos up on my new site, so click here if you wanna go see them!

Investment pundits have been predicting the rise in price of silver for a while now. The white metal is expected to rise from its £11- £12 current spot price range in the near future. It could be an opportunity to build a sizeable stash of silver coins at the current price levels, allowing you to maximise the returns on your investment. But many investors are uncertain about the right coins to invest in. According to Daniel Fisher, founder and CEO of Physical Gold, one should never invest in obscure coins based on market conjecture. Well-known coins are a smarter choice simply because they enjoy a healthy secondary market and give you an opportunity to liquidate your investment when required within a short time span. One of the most well-known silver coins in the market is the silver Britannia.

 

The silver version was released by the Royal Mint after a decade of success enjoyed by the gold Britannia, which was released in 1987. The fame of the silver Britannia leapfrogged post 2013 after its purity rose to 99.9%. Coin investors don't always buy coins simply for the amount of silver that it contains. The motif and the design elements are of paramount importance to them. The silver Britannia is a winner on all these counts. Every edition of the silver Britannia portrays contemporary updated designs, which make all of these coins highly collectable.

 

A recent investor-focused informative video, released by Physical Gold about the silver Britannia is a great repository of information about the history, investment potential and attributes of this famous coin. In particular, the video emphasises the tax efficient nature of investments made in the silver Britannia. As legal tender in the UK, the coin enjoys a CGT free status which means profits that you make when selling your investments are tax-free up to a level. Physical Gold also sells the silver Britannia VAT free. The coin comes neatly packed into tubes of 25 or in monster boxes of 500.

 

There are fractional sizes of the coin available as well, which enhance divisibility in your portfolio. Reduced production costs ensure that the premiums you pay when buying the coins are kept to a minimum.

 

If you're a silver investor interested in putting your money on silver coins, do watch this video right away.

And so, as predicted, they nailed a wooden plank on the smashed window pane thus depriving our poor lot from the only sunlight we got in that section of the library. From now on, we'll need a flashlight to search for a book on the lower shelves...*sigh*

This afternoon I had to play the Ninja Librarian and drive out a bloke who was yelling - yes, YELLING - at his sweetheart: "JE T'AIME, MAIS SI, BON SANG, JE T'AIME" in the middle of the library. *rolls eyes*

I was paired with a chatterbox at the checkout, but I managed to finish "Narrow Dog to Carcassonne" by Terry Darlington. I enjoyed the book, even though I had to get used to the absence of quotation marks and the author isn't very kind to my country (I don't like Belgium. (...) The hole country has clearly come under control of aliens.)

I can't resist to share an excerpt with you:

Lucy, our eldest, rang at breakfast. Where are you? On the Rhône, down towards Avignon, I said. We are just getting ready to go through the Bollène lock, the second deepest in Europe. I am nervous, and your mother is nervous and we are being nasty to one another and we have made Jim [the whippet] nervous and he's whining. These locks are so big that one false step and you would never be found. Awful things happen on the Rhône. You don't know what has been going on here. We never know what to expect.

You know I just can't understand you, said Lucy. I was talking to Clifford about it and we really don't think it's good enough. I mean Cliff and I and Georgia gave you the best years of our lives. Whenever you needed us we were there. When you wanted advice we gave it, when your friends let you down we would comfort you. If you had bad luck in business or sport we would remind you what mattered was your own integrity, that bit of you inside that you know is good and no one can take away. We didn't ask for anything in return, only your love. And now we are getting old you leave us, you go off and do things against our advice. You don't care what we think any more. People ask Where are you, they have heard you are in trouble, and we say, We don't know, they probably are, they usually are. Grandmothers have evolved over millions of years so they can be back-up mothers, and grandfathers so they can put up shelves and build barbecues and give people money. Other grandparents babysit and tile their daughter's bathrooms but all you do is wander around and risk your lives and lavish your affection on a wretched dog that looks like a skeleton and steals things. You sit up drinking with people we don't know, dropouts and expats and bums and your grandchildren say Where are Granny and Grandad why can't they come to the pictures with us or take us to Chester Zoo and we say Last we heard they were being swept away down the bloody Rhône in a boat that was made for two feet of water with a dog that should be under the table in the Star or running around on the common chasing rabbits.

It was Lucy, I said, wishing us luck with the Bollène lock.

 

Today I attended the first day of the Predict Conference 2015 at the RDS. I will not be able to attend tomorrow but I hope to return on Thursday.

 

The on-going conference Conference (organised by industry-leader Creme Global) is an interactive meeting. It will, over three days, feature leading international thinkers in the areas of Data, Predictive Models, Technology and Decision making. At the meeting, we will be discussing the latest progress in Predictive Modelling and its future - from Data to Software and Hardware technology, plus Predictive Modelling methods and the best examples of Data-driven Decision-making.

 

Talks from leading entrepreneurs, data scientists, technologists, investors, and decision-makers (from business and government) will include case-studies and hands-on workshops. This conference has a focus on Data and Predictive Modelling technology like no other.

This photograph shows an aphasic stroke survivor looking at images of his MRI brain scan showing the area of his brain damaged by his stroke. The scan was taken as part of the Predicting Language Outcome and Recovery After Stroke (www.ucl.ac.uk/ploras) research study. This research is identifying the locations of stroke damage within the brain that determine the expected recovery of language. The stroke survivor in the image is coming ‘face to face’ with the location of his stroke damage, the MRI images in a sense both providing a window into the future and enabling him to come ‘face to face’ with his stroke at a biological and anatomical level. The study’s findings are being developed into a new clinical tool to ‘predict language outcome and recovery after stroke’ which should enable future aphasic stroke survivors to be given individual and accurate information about their recovery to help set rehabilitation goals.

Louise Lim (concept) Julie Guerin (Photography)

Kenworth’s Predictive Cruise Control system becomes standard on the Kenworth T680 on-highway flagship beginning July 1, 2018. Kenworth Predictive Cruise Control combines GPS with cruise control to deliver enhanced fuel economy.

Very simple interaction: pee over the stick, plug it in and wait. The first easy pregnancy test. The design of the product was very refined, yet there were problems in reading out the results

Very nice doll, she needs more photos.

long time not doing videos, so thought id mix the 3 monsters together :)

honestly they do love each other :)

music by kaiser cheifs-i predict a riot :)

ADME & Predictive Toxicology, Nanomedicine, Barcelona 2013

Great night at London Predicts where we made our predictions for 2012. @tiredoflondon reads our predictions for the Olympics, Mayor Elections, Tube stuff, Diamond Jubilee and lots more. Thanks to Londonist for hosting the event.

Ryan Morhard, Project Lead, Global Health and Healthcare Industries, World Economic Forum, captured during the Session: Predicting and Forecasting Epidemics at the World Economic Forum - Annual Meeting of the New Champions in Dalian, People's Republic of China, July 2, 2019. Copyright by World Economic Forum / Ciaran McCrickard

With snow predicted predicted to fall from gloomy skies today, a little respite as we begin the slow progress toward the summer solstice. This is an adjacent series I made during my Wrought project from a few years ago. I have always liked the look of cross-processed slide film, the way is jacks up color and deepens saturation. Made with a Rolleiflex 3.5 equipped with Rolleinar close-up attachments. I like to think of these clover flowers as summer snow.

With scientists predicting major climate changes on the horizon, Hollister Knowlton feels urgency about her work, but also hope.

 

She shares an analogy she's heard, that humanity is like a caterpillar that devours a tremendous amount. When it has eaten enough, spontaneously "imaginal cells" appear in its body. They are a relatively small number of cells, but somehow they migrate until they find one another. It is only when the imaginal cells reach a critical mass that the caterpillar is transformed into a pupa, the stage before becoming a butterfly.

 

~ The Wisdom to Know the Difference, by Eileen Flanagan

 

augustocuginotti.com/imaginal-cells-caterpillars-job-to-r...

 

My favorite metaphor for the current world transition, first pointed out to me by Norie Huddle (Butterfly, 1990), is that of a butterfly in metamorphosis.

 

It goes like this: A caterpillar crunches its way through its ecosystem, cutting a swath of destruction by eating as much as hundreds of times its weight in a day, until it is too bloated to continue and hangs itself up, its skin then hardening into a chrysalis.

 

Inside this chrysalis, deep in the caterpillar’s body, tiny things biologists call ‘imaginal disks’ begin to form. Not recognizing the newcomers, the caterpillar’s immune system snuffs them as they arise. But they keep coming faster and faster, then linking up with each other.

 

Eventually the caterpillar’s immune system fails from the stress and the disks become imaginal cells that build the butterfly by feeding on the soupy meltdown of the caterpillar’s body.

 

It took a long time for biologists to understand the reason for the immune system attack on the incipient butterfly cells, but eventually they discovered that the butterfly has its own unique genome, carried by the caterpillar, inherited from long ago in evolution, yet not part of it as such (Margulis & Sagan, Acquiring Genomes 2002).

 

If we see ourselves as imaginal discs working to build the butterfly of a better world, we will understand that we are launching a new ‘genome’ of values and practices to replace that of the current unsustainable system. We will also see how important it is to link with each other in the effort, to recognize how many different kinds of imaginal cells it will take to build a butterfly with all its capabilities and colors.

 

– Elisabet Sahtouris, Ph.D., evolution biologist, lecturer and author of EarthDance: Living Systems in Evolution

 

www.butterflymysteries.com/imaginal-cells.html

 

"The caterpillars new cells are called 'imaginal cells.' They resonate at a different frequency. They are so totally different from the caterpillar cells that his immune system thinks they are enemies...and gobbles them up--Chomp! Gulp! But these new imaginal cells continue to appear. More and more of them! Pretty soon, the caterpillar's immune system cannot destroy them fast enough. More and more of the imaginal cells survive. And then an amazing thing happens! The little tiny lonely imaginal cells start to clump together, into friendly little groups. They all resonate together at the same frequency, passing information from one to another. Then, after awhile, another amazing thing happens! The clumps of imaginal cells start to cluster together!.., A long string of clumping and clustering imaginal cell, all resonating at the same frequency, all passing information from one to another there inside the chrysalis."

  

Les prédictions technologies, médias, télécommunications de Deloitte Canada à Montréal ont eu lieu le 19 janvier 2011.

 

www.youtube.com/user/DeloitteCanada#p/c/0899C16A89DAA853/...

 

Les Prédictions TMT 2011 de Deloitte sont les résultats de recherches, d'informations et de points de vue avant-gardistes en technologies, médias et télécommunications des quatre coins du Canada. « Les Prédictions de 2011 seront axées sur le thème global de la diversité, notamment pour tout ce qui touche à l'utilisation des différentes formes de médias, mais aussi aux plates-formes technologiques toujours plus nombreuses sur le marché », explique Robert Nardi, leader du groupe Technologies, médias et télécommunications de Deloitte à Montréal.

 

How to predict the future with big data: Thomas Nørmark at TedxVennelystBlvd

 

In his talk Thomas Nørmark introduces us into the secret mechanisms of future predictions. This has nothing to do with fortune telling but patterns in big data. He illustrates how big data allows us to look into the future and even predict our individual future lives. He shows why you should see this inevitable development as an opportunity rather than a threat.

Thomas Nørmark is the head of innovation at itelligence Nordic. With his team he works on solutions using predictive analysis. He developed a “time machine” consisting of systems and solutions for predicting the future using social media data, object recognition and predictive analysis algorithms. One of his recent programs is to predict the movement of fish along Australia's coast. He hold a Master's degree in Computer Science from Aarhus University and gained extensive experience as SAP software consultant. When he was only nine years old, Thomas ran eight marathons and won bronze medal at The National Chess Championship.

 

Photo: Sugar Cube Studios & Greg McQueen: Photographer

Trying to get pregnant? While conceiving requires a number of things to line up just so, you can take some of the guesswork out of it if you know how to track ovulation correctly. www.mamaxpert.com/blogs/post/how-to-track-ovulation

ADME & Predictive Toxicology, Nanomedicine, Barcelona 2013

Predictive analytics can help improve shopify stores.

www.msn.com/en-us/health/medical/new-data-shows-mercks-ex...

 

New data shows Merck’s experimental covid-19 pill is less effective than early results predicted

 

Drugmaker Merck and its partner Ridgeback Biotherapeutics released data Friday showing their experimental pill to treat covid-19 is less effective than early clinical trials predicted, a finding that emerged as the Food and Drug Administration raised questions about the drug.

 

Molnupiravir, a pill that could be taken at home, had shown promise in cutting the risk of hospitalization and death by half among high-risk patients in data released by the company in October. But according to the latest findings Merck presented to the FDA, the pill reduced the risk of hospitalization and death only by 30 percent.

 

The study by the drugmakers found that, among participants receiving the pill, just one participant died during the trial, compared with nine deaths in the placebo group, the companies said in a news release Friday.

 

“It’s still a 30 percent effect, which is still good for a high-risk population,” said David Boulware, an infectious-disease physician and professor of medicine at the University of Minnesota Medical School who was not involved in Merck’s research. “It’s better than zero, and it’s a starting point, but it’s a little bit more modest.”

 

The FDA on Friday asked a panel of expert advisers to weigh the benefit of reduced hospitalizations and deaths in high-risk patients against potential risks associated with the drug. Because Merck and Ridgeback presented new clinical trial data to the agency after FDA scientists completed their review, regulators said their analysis may change ahead of a Tuesday meeting to consider the scientific evidence on the drug.

 

“The review issues and benefit/risk assessments may therefore differ from the original assessments provided in the briefing document which was based on the interim analysis,” an addendum to the FDA briefing materials said.

 

Merck and Ridgeback are seeking emergency-use authorization for their covid treatment, which would become the first easy-to-use pill to thwart the virus. The FDA advisory committee is expected to make a recommendation Tuesday, and agency officials typically follow the guidance of the advisers.

 

The agency reviewed data presented by the companies and determined that the clinical trial identified “no major safety concerns” related to adverse events. The most common side effects were mild-to-moderate diarrhea, nausea and dizziness. Still, the FDA identified several areas of concern, including potential risks for pregnant people and the possibility the drug could cause the coronavirus to mutate.

 

The FDA’s Antimicrobial Drugs Advisory Committee is scheduled to meet Tuesday to consider the scientific evidence on molnupiravir and weigh in on how the drug might safely be used to stave off severe infections.

 

The FDA could authorize the drug for use in treating patients at higher risk of hospitalization or death because of age or underlying health conditions such as obesity and heart disease. The agency’s review suggests that regulators may limit the drug’s use in people who are pregnant, hospitalized and vaccinated.

 

Merck’s pill works by interfering with an enzyme that the coronavirus needs to replicate itself and by changing the virus’s genome.

 

Unlike existing treatments — including monoclonal antibodies and the antiviral drug remdesivir — molnupiravir could be prescribed to patients and taken at home without a doctor’s direct supervision.

 

High-risk patients with covid-19 would start taking the pills within five days of developing symptoms and would continue using the drug twice a day for five days. The ease of use could make the treatment a powerful tool in preventing the worst outcomes by keeping mildly ill covid patients from getting worse and landing in the hospital.

 

While the drug could play a role in tamping down the toll of a pandemic that has killed more than 775,000 people in the United States, it is not a magic bullet. Some study participants, all of whom were unvaccinated and considered high-risk for serious infection, still ended up in the hospital with covid-related complications.

 

The FDA review suggests the pill will not be recommended for patients who are already sick enough to be hospitalized.

 

Because the medicine is not a perfect fix, experts have emphasized the continued need for people to get vaccinated to prevent serious covid infections.

 

The pill also carries potential risks, particularly for patients who are pregnant. Merck did not include in its clinical trial participants who were pregnant, and it required participants who could become pregnant to use birth control while taking the drug. That reflects concerns that the antiviral drug could disrupt the healthy development of a fetus because of the way it interferes with the virus’s genes.

 

The FDA proposed several ways to restrict the drug for pregnant patients because of the risk of birth defects and other potential problems.

 

“One approach is not to authorize [molnupiravir] for use during pregnancy because there are no clinical scenarios where the benefit outweighs the risk,” the agency’s review said.

 

A less restrictive approach would be to provide information about the risks and not recommend the pill during pregnancy, but allow doctors to prescribe the drug “at their discretion in certain clinical scenarios where the benefits were thought to outweigh the risks.”

 

Advisers to the FDA may also suggest precautions for women of childbearing age who take the drug, such as pregnancy tests and birth control.

 

Regulators also raised the question of whether vaccinated people should receive the pill. Because the vaccine offers robust protection against severe infection and death, the agency asked its advisers to evaluate whether vaccinated people would benefit sufficiently from the drug to justify the risks.

 

Merck’s pill was authorized for use in Britain this month for people older than 60 or with at least one risk factor for developing severe covid-19.

 

Regulators in the European Union gave member states the go-ahead to approve emergency use of the pill last week, as several countries in Europe contend with another wave of infections and enact new shutdown measures.

 

The FDA is expected to soon consider another antiviral pill — this one, Paxlovid, developed by Pfizer — after the company requested an emergency-use authorization last week. Pfizer’s drug, when taken within three days of symptoms, reduced the rate of death and hospitalization among high-risk patients by 89 percent, according to data from the company.

Jornada “Mejores prácticas en mantenimiento predictivo de transformadores” impartida en las instalaciones de IK4-TEKNIKER.

 

Más información en www.tekniker.es/es

  

ADME & Predictive Toxicology, Nanomedicine, Barcelona 2013

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