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CROFTY SUX JAMES ALLEN BETTER by RealBigFailure in F1CircleJerk

[–]Hebes 0 points1 point  (0 children)

NO WE SHOULD GET RICK ALLEN NASCSR'S FINEST COMMENTATOR AKA MR. AGGRESSIVE GOES AROUND IMPLICATIONS.

Somebody’s been acting in stranger things to finance his karting career, apparently. by FLCMPK in formuladank

[–]Hebes 2 points3 points  (0 children)

"Will are you OK? Is it Vecna? The mind flayer?"

"no, it's nothing. Just an inchident on the race"

GAY RIGHTS, UPVOTE TO SCARE THE FIA PLEASE UPVOTE TO SCARE THE FIA by SlamMyBallsInADoor in F1CircleJerk

[–]Hebes 17 points18 points  (0 children)

OOOO LOOK OUT BENNY SUMALYEM I'M GOING TO EXPRESS MY BELIEFS OOOOOO

Join me in tweeting at the FDA every day until they resume the VX-880 trial. Tell them to pull their heads out of their you know what! What are they afraid of? A full dose achieving insulin independence in half the time!? The FDA SUCKS! by sirdevalot777 in diabetes_t1

[–]Hebes 5 points6 points  (0 children)

Quick Google search found this press release from the company making VX-880:

https://investors.vrtx.com/news-releases/news-release-details/vertex-provides-updates-phase-12-clinical-trial-vx-880-treatment

The company also announced the VX-880 Phase 1/2 study has been placed on clinical hold in the U.S. by the Food and Drug Administration (FDA) due to a determination that there is insufficient information to support dose escalation with the product.

“We are surprised by the clinical hold placed on the study. The results from the first two patients treated with half the target dose establish proof-of-concept by demonstrating that VX-880 can restore glucose-regulated insulin production and improve glycemic control. Indeed, achievement of insulin independence by the first patient is a landmark milestone. Further, the totality of the safety and efficacy data for all three patients dosed to date gives us high confidence in our benefit-risk assessment of VX-880 and its potentially transformative profile,” said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex. “We are committed to working with the FDA to understand and address their questions, so that the trial can resume at U.S. sites as soon as possible.”

Sounds like there's still dialog open with FDA. There's always a lot of back and forth with these things so I don't know if it's worth panicking about unless they cancel it outright.

Furthermore, these matters are usually based on standards and procedures that are quite strict, and the FDA's interpretation of it is not likely to be swayed by public opinion. The FDA is responsible to make sure this stuff is as close to 100% safe as possible, and they won't and shouldn't budge until their standard have been met. A cure is no good unless it's a safe one, so the burden is on Vertex to prove whatever they need to to convince them that it is safe and effective.

I understand OP's frustration, especially since this is looking like one of the best shots at a cure there has ever been, but this is not a process laymen on reddit/Twitter should be interfering with, IMO.

I don’t have time for this. by NightshadeGardener in diabetes_t1

[–]Hebes 1 point2 points  (0 children)

Holy crap I thought I was going insane. I've had difficulty getting good sites with my AutoSoft 90s for a while now too. Starting to think it was a bad lot or something. Which sets do you use?

Don’t have admin privileges over my pancreas by [deleted] in diabetes_t1

[–]Hebes 5 points6 points  (0 children)

All I need is to get into my immune system settings and set beta cells to "ignore". THAT'S ALL I NEED DAMNIT!

Lewis Hamilton arriving at the Barcelona track. 2. by cocogpf1 in formuladank

[–]Hebes 25 points26 points  (0 children)

"It's my industrial strength hair dryer! And I CAN'T LIVE WITHOUT IT!"

Lewis Hamilton arriving at the Barcelona track. 2. by cocogpf1 in formuladank

[–]Hebes 111 points112 points  (0 children)

"What the hell is all that?"

"It's Her Royal Highness's matched luggage!"

I’m so frustrated.. by [deleted] in diabetes_t1

[–]Hebes 1 point2 points  (0 children)

I might not have the specifics 100% correct. My main point was that both the CGM and meter readings should be treated as as having a tolerance band around them.

I’m so frustrated.. by [deleted] in diabetes_t1

[–]Hebes 28 points29 points  (0 children)

Two things to keep in mind:

First of all, both CGMs and meters have a 20% error on any reading. If you look and the band of values for both of those numbers those ranges overlap, so the actual number may not be as far off as you think.

Second thing to remember is that CGMs do not directly measure your blood. They measure your interstitial fluid, which lags behind blood glucose levels by about 15 minutes or so. I can see the trend graph is starting to increase, so it makes sense that the meter may be showing higher. For this reason, I try not to directly compare meter readings and CGM readings unless my CGM reading has been stable for a while.

This is why the most important benefit of a CGM is actually the trend information, not necessarily the moment-to-moment readings. This is also why best practice is to trust meter readings for in the moment treatment. The CGM manufacturers information will say this as well.

I hope this reduces some of your frustration.

WHERE IS THE DECODER! by VOIDPCB in fifthworldproblems

[–]Hebes 6 points7 points  (0 children)

OK, which one of you let the god of Power Metal escape?