ANOTHER CRL !!!!!!

[anonymous]

https://www.businesswire.com/news/h...ives-Complete-Response-Letter-FDA-Apomorphine

Who is to blame this time?

Could it be related to that partner, Aquestive. They also got a CRL recently. Similar issues, maybe ?

https://www.prnewswire.com/news-rel...on-fda-for-tadalafil-oral-film-300752394.html

This sucks for us.
Biggie time

 

[anonymous]

That would be three CRLs in a row.

Pretty clear where the problem lies.

 

[anonymous]

That would be three CRLs in a row.

Pretty clear where the problem lies.

Apparently this is a loaded CRL with a lot of questions and 483 issued to both companies; allegedly until proven otherwise. Take a look at today's statements from both companies.

 

[anonymous]

Following the successful launch of Latuda its been one misstep after another. Horrendous purchases, bad strategies, and miscommunication. Chalk up another bust.

 

[anonymous]

Apparently this is a loaded CRL with a lot of questions and 483 issued to both companies; allegedly until proven otherwise. Take a look at today's statements from both companies.

I don't know what's in the CRL. But I do know Aquestive does not manufacture this product.

 

[anonymous]

I don't know what's in the CRL. But I do know Aquestive does not manufacture this product.

Who is Aquestive ?
Never heard of them