News: Manufacturer releases report that Makena (hydroxyprogesterone caproate injection) has failed to prove effective in post-approval trial

TL;DR Makena has not proven to be effective in its post-approval trials. You can talk to your doctor about the implications of this news if you are currently taking the medication.

I'm now 30w3d along with baby #2. I was prescribed weekly Makena progestin injections, since I ruptured early and had my first baby at 36w3d. This drug is intended to help prevent preterm birth when a history of one or more preterm singleton births exists. I am not high risk based on any other factors.

When going to refill my prescription online, I came across an article from March 8th (two days ago) released by the manufacturer that states that the drug has failed to prove effective in its post-approval trial. It was given accelerated approval by the FDA in 2011 and this trial was part of the approval commitment. Additional sub-group analyses will be conducted, as a spokesperson from the manufacturer notes that the majority of the subjects were enrolled from outside of the U.S. and therefore the difference between the outcome of this study and the initial study can be attributed to their demographics.

http://www.amagpharma.com/news/amag-pharmaceuticals-announces-topline-results-from-the-prolong-trial-evaluating-makena-hydroxyprogesterone-caproate-injection/

I have sent this link to my doctor to open discussion about whether or not to continue treatment, as I've never been convinced that it was necessary for me to commit the money and time (weekly doctor visits) to it. My daughter was born 4 days under the cutoff to qualify for the medicine, but was a normal healthy weight, had excellent APGAR scores, and has had no issues since (including during) birth. Anyway, just thought that if any other mommas on here are receiving this type of treatment that they may want to know about this.

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๐Ÿ‘ค︎ u/doppelgeist
๐Ÿ“…︎ Mar 10 2019
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Find out your DIY HRT horoscope!

Are you a crazy tranny who uses sketchy internet pharmacies to order grey market hormones from remote pacific islands instead seeing a doctor like a normal human being? Maybe your dad is Donald Trump. Maybe youโ€™re in Antarctica, 9 million miles from the nearest informed consent clinic. Maybe youโ€™re holding your body hostage so the FUCKING NHS has to treat you in the name of harm reduction. Whatever your reasons, look up your medications to see your horoscope.

โ€ข Estradiol: You think calling your hormones โ€œtiddy skittlesโ€ is funny.

โ€ข Spironolactone: You like to make pickle memes on /r/traa. You actually care about your health and that's why you donโ€™t use Cypro.

โ€ข Cyproterone Acetate: You feel a smug sense of superiority over people on Spiro cause youโ€™re on an antiandrogen that actually works. You secretly want to die so thatโ€™s why you donโ€™t care about the prolactinoma, liver failure, and blood clot risks.

โ€ข Bicalutamide: You like to think youโ€™re cutting edge. You had a smartwatch before it was cool.

โ€ข Progesterone: You read somewhere that Progesterone just might possibly theoretically maybe make your boobs the tiniest bit bigger and so you instantly ordered some.

โ€ข Estradiol Benzoate/Valerate: You (correctly) believe hormone injections are badass.

โ€ข Finesteride/Dutesteride. You naively cling to the hope that your hair will grow back. It wonโ€™t.

โ€ข Rectal Progesterone: Youโ€™re a horny bitch and you like sticking things up your butt.

โ€ข Lupron/Goserelin/Triptorelin: You are rich.

โ€ข Medroxyprogesterone Acetate: You secretly wish you were a cis woman so you could be a TERF. You read the blog Gender Apostates. Taking Depo-Provera shots makes you feel like a real wombyn with a uterus on birth control. You secretly hope it gives you a blood clot and you die.

โ€ข Hydroxyprogesterone Caproate: You watched a Kathoey beauty pageant once and everyone was so pretty. You know its what all the Thai girls use and you want to feel exotic.

โ€ข Tamoxifen/Raloxifene: As an enby you feel the need to prove youโ€™re a real tranny and not a pink haired snowflake trender who doesnโ€™t medically transition. What better way to do this than take synthetic hormones which will give you a blood clot and kill you. (/uj Tamoxifen and Raloxifene are for transitioning but not growing boobs, It's unclear if they actually work /j).

โ€ข Lenaโ€™s Homemade Estradiol Enthanate: You think it's totally safe. I mean she even sterilizes it in a pressure cooker in her kitchen/sket

... keep reading on reddit โžก

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LPCN (Lipocine) - Court case catalyst plus trial results.

I think LPCN is a strong dip buy amid this chaos in penny stocks.

The court case has been delayed and new date should be announced very soon as a catalyst. In the pending suit against Clarus Therapeutics, Inc. ("Clarus") Lipocine isย alleging that Clarus's JATENZOยฎ product infringes Lipocine's U.S. patents: 9,034,858; 9,205,057; 9,480,690; and 9,757,390.

Lipocine Inc., a clinical-stage biopharmaceutical company, focuses on the development of pharmaceutical products for the treatment of metabolic and endocrine disorders. Its lead product candidate is TLANDO, an oral testosterone replacement therapy. The company's pipeline candidates also include LPCN 1111, an oral testosterone therapy product for once daily dosing that completed Phase 2b testing; LPCN 1148, an oral prodrug of bioidentical testosterone for the treatment of non-alcoholic steatohepatitis cirrhosis (NASH); LPCN 1107, an oral hydroxyprogesterone caproate product for the prevention of recurrent preterm birth; and LPCN 1144, an oral prodrug of bioidentical testosterone that is in Phase 2 Clinical trial for the treatment of NASH.

NASH biometrics and biopsy results, Tlando partnership news, and trial news should be any time soon to which hopefully the stock doubles.

The recent results of the 12 weeks MRI Lift Phase 2 NASH trial are very impressive. Fat reduction from start of study in subjects with liver fat >5% at start = 46.9% and Fat reduction from start of study in subjects with liver fat >30% at start = 63.2%.
If LPCN had enlisted more subjects with liver fat over 30% as some competitors did, their overall average would have been significantly higher. Very impressive. (from Yahoo).

Vanguard and Blackrock with the highest institutional holdings.

Analyst ratings is a strong buy. Low PT: $3 High: $10. Av: $5.33.

I'm holding for the whole year unless something drastically changes. But short term this is also great for the catalysts coming up.

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๐Ÿ‘ค︎ u/sanjaypark
๐Ÿ“…︎ Feb 19 2021
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SERIOUS: This subreddit needs to understand what a "dad joke" really means.

I don't want to step on anybody's toes here, but the amount of non-dad jokes here in this subreddit really annoys me. First of all, dad jokes CAN be NSFW, it clearly says so in the sub rules. Secondly, it doesn't automatically make it a dad joke if it's from a conversation between you and your child. Most importantly, the jokes that your CHILDREN tell YOU are not dad jokes. The point of a dad joke is that it's so cheesy only a dad who's trying to be funny would make such a joke. That's it. They are stupid plays on words, lame puns and so on. There has to be a clever pun or wordplay for it to be considered a dad joke.

Again, to all the fellow dads, I apologise if I'm sounding too harsh. But I just needed to get it off my chest.

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๐Ÿ‘ค︎ u/anywhereiroa
๐Ÿ“…︎ Jan 15 2022
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Blind Girl Here. Give Me Your Best Blind Jokes!

Do your worst!

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๐Ÿ‘ค︎ u/Leckzsluthor
๐Ÿ“…︎ Jan 02 2022
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This subreddit is 10 years old now.

I'm surprised it hasn't decade.

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๐Ÿ‘ค︎ u/frexyincdude
๐Ÿ“…︎ Jan 14 2022
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Dropped my best ever dad joke & no one was around to hear it

For context I'm a Refuse Driver (Garbage man) & today I was on food waste. After I'd tipped I was checking the wagon for any defects when I spotted a lone pea balanced on the lifts.

I said "hey look, an escaPEA"

No one near me but it didn't half make me laugh for a good hour or so!

Edit: I can't believe how much this has blown up. Thank you everyone I've had a blast reading through the replies ๐Ÿ˜‚

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๐Ÿ‘ค︎ u/Vegetable-Acadia
๐Ÿ“…︎ Jan 11 2022
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A thorough DD on $LPCN (Lipocine Inc)

What is $LPCN?

What is their main pipeline?

  • Their main pipeline/asset is:
  • TLANDO

What are their other pipelines?

What is TLANDO?

  • It is an oral testosterone replacement therapy product containing Testosterone Undecanoate that is designed to help restore normal testosterone levels in males for conditions associated with a deficiency or absence of endogenous testosterone.
  • It is meant to treat Hypogonadism
  • TLANDOย is designed to overcome many of the issues related to TRT products on the U.S. market.
  • TLANDO is being studied for both Primary and Secondary hypogonadism and is targeting the established chronic US TRT market.

What is Hypogonadism?

  • Hypogonadism typically refers to a permanent deficiency of sex hormones rather than a temporary deficiency that may be related to acute/chronic illnesses or other medical, personal, or environmental factors.
  • Primary hypogonadism describes disease states that intrinsically affect the gonads. Examples of these include the genetic disorders, Turner syndrome and Kleinfelter syndrome
  • Secondary hypogonadism refers to disease states that affect gonadal-related structures such as the hypothalamus and pituitary gland that directly impact the development of gonads and as such the release of testosterone and other sexual hormones
  • Hypogonadism affects upto 20million men
  • Close to 6million are diagnosed & only 2 million are being treated

TLANDO Market Opportunity

  • Since 2015, the TRT TRx yearly market has been growing exponentially with 2019 having the highest ann
... keep reading on reddit โžก

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๐Ÿ‘ค︎ u/PradoMV96
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What starts with a W and ends with a T

It really does, I swear!

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๐Ÿ‘ค︎ u/PsychedeIic_Sheep
๐Ÿ“…︎ Jan 13 2022
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What is a a bisexual person doing when theyโ€™re not dating anybody?

Theyโ€™re on standbi

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๐Ÿ‘ค︎ u/Toby-the-Cactus
๐Ÿ“…︎ Jan 12 2022
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Geddit? No? Only me?
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๐Ÿ‘ค︎ u/shampy311
๐Ÿ“…︎ Dec 28 2021
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I wanna hear your best airplane puns.

Pilot on me!!

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๐Ÿ‘ค︎ u/Paulie_Felice
๐Ÿ“…︎ Jan 07 2022
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E or รŸ?
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๐Ÿ‘ค︎ u/Amazekam
๐Ÿ“…︎ Jan 03 2022
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What did Spartacus say when the lion ate his wife?

Nothing, he was gladiator.

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๐Ÿ‘ค︎ u/rj104
๐Ÿ“…︎ Jan 15 2022
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Pun intended.
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๐Ÿ‘ค︎ u/Sharmaji1301
๐Ÿ“…︎ Jan 15 2022
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No spoilers
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๐Ÿ‘ค︎ u/Onfour
๐Ÿ“…︎ Jan 06 2022
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Covid problems
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๐Ÿ‘ค︎ u/theincrediblebou
๐Ÿ“…︎ Jan 12 2022
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These aren't dad jokes...

Dad jokes are supposed to be jokes you can tell a kid and they will understand it and find it funny.

This sub is mostly just NSFW puns now.

If it needs a NSFW tag it's not a dad joke. There should just be a NSFW puns subreddit for that.

Edit* I'm not replying any longer and turning off notifications but to all those that say "no one cares", there sure are a lot of you arguing about it. Maybe I'm wrong but you people don't need to be rude about it. If you really don't care, don't comment.

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๐Ÿ‘ค︎ u/Lance986
๐Ÿ“…︎ Dec 15 2021
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I had a vasectomy because I didnโ€™t want any kids.

When I got home, they were still there.

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๐Ÿ‘ค︎ u/demotrek
๐Ÿ“…︎ Jan 13 2022
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What did 0 say to 8 ?

What did 0 say to 8 ?

" Nice Belt "

So What did 3 say to 8 ?

" Hey, you two stop making out "

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๐Ÿ‘ค︎ u/designjeevan
๐Ÿ“…︎ Jan 03 2022
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Spi__
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๐Ÿ‘ค︎ u/Fast_Echidna_8520
๐Ÿ“…︎ Jan 11 2022
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I dislike karma whores who make posts that imply it's their cake day, simply for upvotes.

I won't be doing that today!

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๐Ÿ‘ค︎ u/djcarves
๐Ÿ“…︎ Dec 27 2021
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The Ancient Romans II
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๐Ÿ‘ค︎ u/mordrathe
๐Ÿ“…︎ Dec 29 2021
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I'd like to dedicate this joke to my wisdom teeth.

[Removed]

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๐Ÿ‘ค︎ u/ThoughtPumP
๐Ÿ“…︎ Jan 14 2022
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I did it, I finally did it. After 4 years and 92 days I went from being a father, to a dad.

This morning, my 4 year old daughter.

Daughter: I'm hungry

Me: nerves building, smile widening

Me: Hi hungry, I'm dad.

She had no idea what was going on but I finally did it.

Thank you all for listening.

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๐Ÿ‘ค︎ u/Sk2ec
๐Ÿ“…︎ Jan 01 2022
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How do you stop Canadian bacon from curling in your frying pan?

You take away their little brooms

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๐Ÿ‘ค︎ u/Majorpain2006
๐Ÿ“…︎ Jan 09 2022
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It this sub dead?

There hasn't been a post all year!

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๐Ÿ‘ค︎ u/TheTreelo
๐Ÿ“…︎ Jan 01 2022
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School Was Clothed
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๐Ÿ‘ค︎ u/Kennydoe
๐Ÿ“…︎ Jan 08 2022
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Letting loose with these puns
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Couch potato
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Baka!
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๐Ÿ‘ค︎ u/ridi86
๐Ÿ“…︎ Jan 09 2022
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All dad jokes are bad and hereโ€™s why

Why

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๐Ÿ‘ค︎ u/LordCinko
๐Ÿ“…︎ Jan 13 2022
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My name is ABCDEFGHIJKMNOPQRSTUVWXYZ

Itโ€™s pronounced โ€œNoel.โ€

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๐Ÿ‘ค︎ u/beef_fried_rice
๐Ÿ“…︎ Dec 25 2021
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concrete ๐Ÿ—ฟ
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๐Ÿ‘ค︎ u/Fast_Echidna_8520
๐Ÿ“…︎ Jan 07 2022
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Why are people so surprised and angry about Djokovic being an anti-vaxxer?

After all his first name is No-vac

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๐Ÿ‘ค︎ u/hangryman23
๐Ÿ“…︎ Jan 06 2022
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If Korean pop is shortened to Kpop and Korean Drama is Kdrama...

What, then, is Chinese rap?

Edit:

Notable mentions from the comments:

  • Spanish/Swedish/Swiss/Serbian hits

  • French/Finnish art

  • Country/Canadian rap

  • Chinese/Country/Canadian rock

  • Turkish/Tunisian/Taiwanese rap

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๐Ÿ‘ค︎ u/hootanahalf
๐Ÿ“…︎ Jan 09 2022
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Thatโ€™s Michelle
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๐Ÿ‘ค︎ u/FLEXSEALBREAKER
๐Ÿ“…︎ Jan 10 2022
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Is this sub still active?

There hasn't been a single post this year!

(Happy 2022 from New Zealand)

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๐Ÿ‘ค︎ u/DonStimpo
๐Ÿ“…︎ Dec 31 2021
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What did the ocean say to the beach?

Nothing, it just waved

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๐Ÿ‘ค︎ u/hackerboi1198
๐Ÿ“…︎ Jan 13 2022
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My 9 year old son just asked me to pretend I was a police officer arresting him for downloading the entire Wikipedia. Me: Young man, you're under arrest for downloading the entire Wikipedia!

Him: I can explain everything!

(It's his best joke yet I think)

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๐Ÿ‘ค︎ u/MrPJ2020
๐Ÿ“…︎ Jan 14 2022
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is Isn't
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๐Ÿ‘ค︎ u/mordrathe
๐Ÿ“…︎ Jan 11 2022
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@u/mordrathe - remix
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๐Ÿ‘ค︎ u/SpydrRydr
๐Ÿ“…︎ Jan 12 2022
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What do you call a guy with no arms and no legs in a hot tub?

Bob

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๐Ÿ‘ค︎ u/4fuchssake
๐Ÿ“…︎ Jan 05 2022
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My WIFI password is 2444666668888888

Just to clarify, 12345678

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๐Ÿ‘ค︎ u/az1m_
๐Ÿ“…︎ Jan 03 2022
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I named my dog "5 miles."

So that I could frequently say, "I am going to walk 5 miles now."

Edit: My most popular post on Reddit! ๐Ÿ˜€ Thank you for the awards.

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๐Ÿ‘ค︎ u/javacafe
๐Ÿ“…︎ Jan 10 2022
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Possibly the greatest Snap Reaction dad joke I've ever told (it even got me a POWERFUL groan and vehement FU from my wife)

Me grabbing a soda from my (what I thought was) half full 12pk...

Notices there's only 2;

Me: "Awe man... This is a damn bird box!" Her: "What the hell does that mean?!" Me: (Pulls both cans out & shows them to her) "It's only got Toucans."

I'm not ashamed to admit the look on her face was glorious.

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๐Ÿ‘ค︎ u/AKhakiNerfHerder
๐Ÿ“…︎ Jan 10 2022
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I can't believe I was arrested for impersonating a politician...

I was just sitting there doing nothing.

๐Ÿ‘︎ 9k
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๐Ÿ‘ค︎ u/ENJOYblet
๐Ÿ“…︎ Jan 05 2022
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