Not Allowed to Market in US!

From FDA: Not allowed to market in the US??? So we are all out of a job?? WTH

 

Why?

 

Indivior lawyers grasping at straws again...


"With the tentative approval, Brixadi has met all regulatory standards of clinical and non-clinical safety, efficacy and quality for US approval. However, final approval of a monthly depot is according to the FDA subject to the expiration of an exclusivity period granted to Sublocade™. The restriction period may not last longer than November 2020, but both the scope and duration could be reduced if successfully challenged.

 

This sucks. How could the company Not see this coming??

 

Indivior has been granted exclusivity by the FDA for their once-monthly injectable. exclusivity not to exceed 11/2020. However, Braeburn could challenge and possibly shorten the timeframe.

 

Maybe they will challenge and if not successful, go forward with launching the weekly.

 

These patients dont want a freakin shot every week!

 

Second time trying to launch this damn thing. So new hires get sent home again?? For the second time??

 

Doesn’t say we can launch the monthly?

 

I don’t understand how this was never looked at as an obstacle moving forward.

 

FDA's tentative approval of a drug product is based on information available to FDA at the time of the tentative approval letter (i.e., information in the ANDA and the status of current good manufacturing practices of the facilities used in the manufacturing and testing of the drug product) and is therefore subject to change on the basis of new information that may come to FDA's attention. A new drug product may not be marketed until the date of approval.

 

It actually says cant launch a depot period. Says nothing about monthly or weekly.

 

They’ll challenge and win!

 

This thing is dead in the water. No way in hell this patient type would even go for a weekly injection let alone treatment beyond that. It is hard enough getting these patients in for treatment when there are so many other highs they can get on the street for less money. There is also another factor that goes with approval for this product. Patients will have to show up for weekly counseling and addiction therapy by an approved addiction specialist. Good luck with that when most of these patients will be impossible to get to those counseling sessions.

 

Challenge and Win? How in the world can we challenge and win this. It will cost 100's of thousands of dollars to challenge this and if I'm not mistaking, we are still being funded by a group of investors or hedge fund. Have you looked at the stock market lately? There isn't revenue rolling in right now and who will pay for these court costs? Commercialization of this product is what the investors are banking on to start bringing in capital. Mark my word, these investors will start to bail. Time to cut the losses.

 

Can still do the weekly

 

Camurus has $$. They’ve got skin in the game just like us.

 

Weekly???? Good luck with that. Half of this patient population don't want the help and those that do will have to rely on caregiver services or that of a gov't / outreach organization to get them to a treating physician on a weekly basis. How long will that last? Those in long term treatment centers won't be able to afford or are already on less expensive treatment options.

 

What now?

 

You’re never gonna get a patient into the office for a weekly injection. Good luck.