No godsQuote:
Originally Posted by Steely Glint
No kings
ONLY MAN
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No godsQuote:
Originally Posted by Steely Glint
No kings
ONLY MAN
I just learned that the first bioresorbable stent got CE Mark in Europe in 2011, based on nearly nonexistent clinical efficacy data. That's crazy - the FDA only gave the first approval this summer and based on the latest clinical data that just came out they are reconsidering the whole thing. I can't imagine how many thousands of patients have had substandard stents implanted in them because regulators were way too permissive. For that matter, I'm still confused why anyone thought current designs were a good idea in the first place.
Which one is that? I'm interested and sure people at my work know about it.
We're also working on CE approval (and FDA in parallel) and it's not easy to get.
ABSORB is the name of the product; it is made by Abbott. New clinical data just came out in the last few weeks that casts yet more doubt on the efficacy and safety of the stent compared to the newest metal drug-eluting stents.Quote:
Originally Posted by Flixy
CE Mark is not easy to get, but in general the requirements are laxer than for the FDA - the FDA requires bigger, better clinical studies with longer timepoints (typically companies will get approval in Europe first and use data from the European roll-out to get FDA approval). There are exceptions, though, since each class of devices and drugs is regulated differently and there are some faster tracks available at the FDA. The clinical data available when this product got the CE Mark was just ridiculously small sample size and short term follow up. Given that the current gold standard treatment was pretty damned good (this was a non-inferiority design rather than a superiority design) there was no reason to fast-track approval for something so new and with so many serious questions about how it would work in the long term clinically. In this particular case, IMO it borders on negligence.
The FDA is sometimes to restrictive and cautious, and that is incredibly frustrating (and drives up costs). But we've seen far too many times that their caution is warranted when new classes of therapies come out and end up performing quite poorly.
Maybe it's because I'm busy getting drunk :D.....but that sounds just like the 2016 US Presidential election, where people are asking How the Hell did the results stray so far from 'the gold standard' of predictive models? Small sample sizes, bad data, aggregate data, questions about short-term vs long-term effects, unknown effects from fast-tracking, political strategy negligence, etc.Quote:
Originally Posted by wiggin
In the end, I think it boils down to money, and if SICI (that's my acronym for systemically important civic institutions) can compete against SIFI (systemically important financial institutions) for government funding, using tax dollars. Research is important and valuable, but it shouldn't be relegated to "freee market capitalism". The US Space program got us to the moon in the first place.
Today I learned that there used to be a primal scream room at our psych clinic. It was used for primal scream therapy but this practice was discontinued a while back. I expect this was because it was constantly occupied by frustrated staff and thus unavailable to patients :o
Florida woman. :o
http://www.bbc.com/news/world-us-canada-38080181
Today I came accross a piece that dealt with a news story I had seen a headline of only hours before. It's that story of the founder of Corona beer leaving his estate to the inhabitants of the village in Spain where he was born. Turns out he did no such thing, despite the 'news' bouncing around over the internet, including on presumably reputable news-sites. The man actually left his estate to his extended family, some of whom lived in said village, part-time. The villagers on the other hand were benefitting from his generosity while he was still alive.
How fucked up is that?
Just like that whole fake news bit about CNN showing hardcore porn for a half hour on Thanksgiving night. One person was tweeting about it, not even multiple people, and yet everywhere ran with that stupid story.
Yet another Florida woman. *headdesk*
http://www.whio.com/news/national/fl...NXtm7Z7njedEL/
Church collapses in Kenya and CNN has a report phoned in from Johannesburg.
"Africa-correspondent"Quote:
Originally Posted by Hazir
Ditto. That's probably their only remaining correspondent I'm Africa. This is a major issue in journalism.
https://i.imgur.com/A5V7svI.jpg
Is this fake news?
Unfortunately not.
http://www.cnn.com/2017/01/03/politi...re-resolution/
No I mean the part about not knowing that Obamacare = ACA
Oh, there are definitely people like that. And rather sad to say that I'm even related to more than a handful of such people.
The states won by Trump have the highest Obamacare enrollment. We have more than a few "dense motherfuckers" in this country.
http://www.vox.com/identities/2017/3...ves-immigrants
Ben Carson is for reals the weirdest person in US politics.
https://heatst.com/tech/he-will-not-...y-to-troll-it/
Weaponized Autism
And youth unemployment, as the author aptly pointed out.
Kinda crazy.Quote:
Originally Posted by Ominous Gamer
For my Italian Restaurant as marketing I regularly take photos of the food and post them on Facebook and Twitter. Today I posted a collage of four meals with a caption of their names but after I posted it, Facebook decided when showing it to me to "translate it to English" which was gibberish. It was translated from Italian. Except the names are correctly in Italian and what they should be called in English. Plus it was capitalised as a proper noun.
I don't want all my customers who follow the restaurant to see gibberish English translations of names of meals that's dumb. Even if the translations were accurate it would still be improper to translate them, you don't translate names.
That'll teach you to put Spaghetti alla puttanesca on the menu :o
LOL!
Technology is not my friend this week it seems. My phone has had a software update and it has completely screwed up my predictive text. It is not just autocorrecting typos to the wrong word it is in fact replacing correctly spelt words with incorrect ones. It is also taking correctly spelt nouns and randomly capitalising the first letter of them for no clear reason. It's like every third or fourth word in some sentences. Keep having to go back and replace they capitalised letter with a lower case one manually.
Samsung S7 Edge.
Change keyboard settings including autocorrect, clear keyboard app data or switch to a better keyboard app of which there are dozens :o I've been using SwiftKey for about a million years
:haha:Quote:
Originally Posted by Aimless
I must say that sometimes it does get a bit silly when all dinners are called exactly what's in there except in Italian to make it sounds nicer. Up to a point it's nice but some places push it a bit too far :p
The ban on bigger electronic devices. I can't say I am very surprised because I have noticed over the last few months that my iPad consistently was the subject of closer inspection at the security checks in both Amsterdam and Istanbul, but it would still be annoying if I'd have to check Luggage just for my iPad, as I usually travel back to Holland without checked baggage in order to not have to wait till kingdom come for my Luggage to arrive on the belt. With Luggage it takes me about 2 hours after touchdown to get home. Without it's usually 1 hour.
https://www.wsj.com/articles/port-au...48449?mod=e2fb
America's finest :bulb:
Front page of today's Daily Mail :|
https://static.independent.co.uk/s3f...12/legs-it.jpg
I mean, using an exclamation mark to denote a question. Come on!
Nice example of blatant sexism.
That's right Daily Mail, just like the text overrun the blue box onto the photo on your stupid-ass, vile, sexist headline, it's not like that's the front page of a national newspaper or anything.
Like, did they farm the front page out to an intern that day or something?
At least they weren't asked what type of knickers they prefer.
http://news.bbc.co.uk/1/hi/uk_politics/4420760.stm
Overslept this morning and was app not awake and in a hurry i managed to put in two different shoes without noticing:bulb:
American Immigration
So. On thursday I am off across continental France on a 6-day road-trip from the UK right down to Nîmes near the French south coast, with a buddy of mine, to dress up as barbarians and fight gladiatorial combat against Roman gladiators, as part of a 3-day annual Roman re-enactment spectacular involving around 2,000 participants. Don't ask.
My buddy's partner is also good friends with my partner, so while we're behaving strangely in the South of France, they've booked a trip together to New York on a shopping and sightseeing jolly.
I have just found out that while filling out the online ESTA application form for entry into the US, my buddy's partner inadvertently ticked a box stating that she has a conviction for drug dealing. Yes, really.
After recovering from fits of laughter, I hear that her ESTA application has been rejected, and she cannot enter the US, as you would expect.
She now has the tricky, most likely impossible task of somehow explaining to US immigration authorities that she has no convictions of any sort, let alone drug dealing, and this was just a complete and utter accident. Wrong box ticked. Now my buddy, her partner, is an immigration lawyer, working out of a small practice in London. So he knows the intricacies of immigration applications as well as anyone, so we're hoping he may be able to wrangle through this. She has been to the US many times before, both business and pleasure, which may stand her in good stead.
If no joy, then she's going to be kicking herself for years to come, and I suppose may face the prospect of being permanently barred from entry into the US.
And my partner will be off to NY on her lonesome self.
Timbuk, if you accidentally tick off the wrong box, there's an email address to contact, and they're actually pretty good at straightening things out.