The lead up to submission of a registrational trial involves multiple conversations between the company and FDA. These check-ins always involve overall study design. So for FDA to deny based on this is, among many things, an insult to all the sites and patients who participated in the trial.
11.02.2026 03:01 β π 1 π 0 π¬ 0 π 0
No more kicking or punting for the rest of the game
09.02.2026 00:27 β π 0 π 1 π¬ 0 π 0
Teams Message: hey did you see my email?
04.02.2026 20:44 β π 1 π 0 π¬ 0 π 0
Republican Senator X voted against lowering your health insurance costs and instead gave 75 billion MORE dollars to ICE
there you go democrat hopefuls, i better see this on every TV and in every mailbox this fall
31.01.2026 01:00 β π 363 π 84 π¬ 2 π 0
I receive constant reminders that some of the best things about America are our Mexican restaurants and that our funniest comedians are actually Canadian.
30.01.2026 18:50 β π 1 π 0 π¬ 0 π 0
Path Clearing
27.01.2026 23:28 β π 10 π 1 π¬ 0 π 0
Taunting should be encouraged in professional sports, not penalized.
26.01.2026 02:00 β π 0 π 0 π¬ 0 π 0
Iβm not sure which play youβre referring to but I agree and want it gone immediately.
25.01.2026 22:10 β π 0 π 0 π¬ 0 π 0
This makes it sound like you killed them
25.01.2026 22:07 β π 0 π 0 π¬ 0 π 0
Truly charming run for Caicedo and #chelsea who should have been an hour ago but instead draws a second yellow for his opponent
25.01.2026 15:33 β π 0 π 0 π¬ 0 π 0
Why are they able to track it?
24.01.2026 00:47 β π 0 π 0 π¬ 0 π 0
Life imitates art
22.01.2026 23:12 β π 0 π 0 π¬ 0 π 0
The guy has seen so much terrible football and I really hope he gets to call a winner
20.01.2026 03:23 β π 1 π 0 π¬ 0 π 0
Hell yeah. My idiot neighbors are all about to vote Vivek into office so Iβm all for new leadership!
20.01.2026 02:49 β π 1 π 0 π¬ 0 π 0
Nancyβs in Clintonville. Greasy spoon for breakfast all served from ~2x4β griddle. They made their own sausage and the breakfast potatoes were incredible. So many places now are just GFS frozen crap. They had a pool of money donated by guests to feed those who couldnβt pay.
19.01.2026 04:23 β π 1 π 0 π¬ 0 π 0
Football fans are soft at Soldier Field.
19.01.2026 02:49 β π 0 π 0 π¬ 0 π 0
Bo Nix breaks his ankle on a blunt force genuflect?
18.01.2026 15:58 β π 0 π 0 π¬ 0 π 0
Came here for this. Thank you
13.01.2026 22:58 β π 1 π 0 π¬ 0 π 0
Pay them
13.01.2026 02:21 β π 1 π 0 π¬ 0 π 0
12.01.2026 19:04 β π 2 π 0 π¬ 0 π 0
Iβm having a lot of trouble throwing away an old
garbage can.
12.01.2026 17:52 β π 0 π 0 π¬ 0 π 0
Ok it was a big victory but at a certain point, a single cityβs policies arenβt national news. Weβre good.
08.01.2026 23:55 β π 0 π 0 π¬ 0 π 0
Three universities with medical schools and NCI Designated Comprehensive Cancer Centers plus an SEC school
08.01.2026 18:24 β π 1 π 1 π¬ 0 π 0
bravoandy β’ 3h
Posted before reading the news. Wtf
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bravoandy β’
4h
Good morning !
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G5
Saving this screenshot from Threads as a new reaction image
03.01.2026 16:41 β π 14351 π 2070 π¬ 41 π 49
Except the game was sold out and the seats were full
02.01.2026 17:58 β π 0 π 0 π¬ 0 π 0
This was a very remarkable read
31.12.2025 03:52 β π 0 π 0 π¬ 0 π 0
Nancy just needs to string together a bunch of wins in front of HS football crowds lest Celtic not win their much coveted 56th title. The 56th title is the sweetest one.
27.12.2025 19:55 β π 2 π 0 π¬ 0 π 0
Straight from an Iannucci/Armstrong script, surely?!?
21.12.2025 19:11 β π 3 π 0 π¬ 0 π 0
Happens to the best of us cc: @robdelaney.bsky.social
21.12.2025 16:46 β π 0 π 0 π¬ 0 π 0
Texas A&M = Tottenham Hotspur
20.12.2025 20:19 β π 0 π 0 π¬ 0 π 0
In this house, shootouts are draws.
We are not PRO.
Regular season unless otherwise noted.
Abuse will not be tolerated.
"Disgracful" Person
What I have is a particular set of skills; skills that make me a nightmare for Nazi dickbags on the internet. I joke, and drive a Nissan Altima
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