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Started By
Message
1
Posted on 1/22/21 at 5:54 pm to bayoubengals88
quote:
sometimes Saturday.
If today is their PDUFA date, a decision will come down today.
quote:
PDUFA dates are deadlines by which the FDA must review new drug applications.
This post was edited on 1/22/21 at 5:54 pm
Posted on 1/22/21 at 6:05 pm to Chucktown_Badger
I may be wrong but doesn’t the company release the decision? Not the FDA
Posted on 1/22/21 at 6:32 pm to GAFF
How I am picturing people right now
Posted on 1/22/21 at 6:36 pm to castorinho
Please please please let there be a buyout announced with this approval. Why would they be taking so long?
Posted on 1/22/21 at 6:38 pm to HangingWithMrCooper
I interviewed with the company and turned down their offer. A friend of mine is employed there and he said it is now APPROVED!!!! They just got the email!!
Posted on 1/22/21 at 6:42 pm to tigerz3030
tigerz3030 - occupation pharmaceutical sales
Seems legit
Seems legit
Posted on 1/22/21 at 6:43 pm to HangingWithMrCooper
IF that’s true we won’t know what kind of price shift they’ll be until Monday pre market right?
Posted on 1/22/21 at 6:53 pm to tigerz3030
Show us some screenshots
Posted on 1/22/21 at 7:13 pm to tigerz3030
okay considering that as truth. are they just negotiating a buyout right now?
why else would they not release this news. I'm assuming the website was already ready to go with an approval makeover
why else would they not release this news. I'm assuming the website was already ready to go with an approval makeover
Posted on 1/22/21 at 7:20 pm to rocket31
quote:
okay considering that as truth. are they just negotiating a buyout right now?
That’s where I am in my mind. If you’ve got approval, likely with the label you want the only thing to do is release that...unless you are working on a BO or you don’t have the label
Posted on 1/22/21 at 7:21 pm to rocket31
What THE frick is going on?!? Superior margs only go so far!!!
Posted on 1/22/21 at 7:23 pm to bayoubengals88
y’all got me getting drunk and I’m not even in on this
Posted on 1/22/21 at 7:23 pm to GAFF
quote:
I may be wrong but doesn’t the company release the decision? Not the FDA
I believe they announce around the same time. I do know the company will likely have their press release up within an hour of knowing.
Posted on 1/22/21 at 7:23 pm to cgrand
Just got the Approval notification
Posted on 1/22/21 at 7:24 pm to beauxgus
Posted on 1/22/21 at 7:25 pm to bayoubengals88
Yeah this is ridiculous being the template for the PR was likely already done. BRCX (i think) released positive FDA news last month at 830 pm est... so still a chance we see it tonight.
Posted on 1/22/21 at 7:25 pm to bayoubengals88
congrats bud
Posted on 1/22/21 at 7:25 pm to tigerz3030
I was wrong
This post was edited on 1/22/21 at 7:30 pm
Posted on 1/22/21 at 7:25 pm to rocket31
quote:
why else would they not release this news. I'm assuming the website was already ready to go with an approval makeover
Yes, it's basically just flipping a switch. Their agencies, brand teams, and MLR teams will be pulling an all nighter. I worked on the launch of Trintellix, and when it got approved i put in back to back 20 hour days.
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