Bup Injection Approval

Rather doubt there will be any urgency by the FDA since it's a me to drug at best. Best case opportunity is 9 to 12 months. The government does not work on anyone's timeline.

 

No one is getting fired period. We’re all safe.

 

Ok... laid off. 2021 terrible year to launch with ALL the heath systems focused on the virus and vaccines.

maybe a small chance in 2022

 

The healthcare system can't even do the COVID vaccine. Do you think another me too is going to do well. Time to apply at Home Depot!!!

 

another CLR for Brixadi. Does anybody knows Braeburn's US based 3rd party manufacturer linked to continued quality related deficiencies that led to this CLR?

 

Any idea when they’ll actually launch?

 

Pharmaceutics International

 

how about never

 

I think we’ll launch sooner than later. Remaining hopeful.

 

That’s kinda sweet.

However, you may want to find out WHY the latest CRL was issued before you get your hopes up.

 

It was the manufacturing, not the product

 

Same issue as last time. We’ll launch within the next 2 months.

 

Riiiiiight. Sure you will.

Find out what those manufacturing problems were before you set your new target approval timing.

 

MMMMMmmmaybe somebody should turn off the LinkedIn job postings now?

 

I applied for the Atlanta position.

 

and did anyone get back to you?

 

I hear approval was held up for other products due to this same manufacturer. Anyone know the other products or what the specific issue is?

 

Anyone know how long they’re “held up”? Another year?

 

Hey dumbasses,

No one works there anymore. It’s dead move on.

 

Seems pretty dead... Strange thing is there is not any press release or even an acknowledgement from Braeburn regarding the latest CRL. After previous CRLs they at least communicated. Anyone with insights on what is going on there?