Out of all the BT applications in the last few years, how many (% of all applications will do) were for CVD and CKD?  And which ones of these applications were approved?  It appears to me that this designation has worked very well for rare diseases, but I don't know what the record for heart and kidney disease drug applications is.

Second question is re Apabetalone.  BT designation is given for an indication.  That suggests more than 1 BT designation is theoretically possible. But is that what happens in practice?  Does the FDA say...BT designation means you can now talk to us non-stop, so adding another BT won't change operating procedures.  Or does the FDA say...we will fast track your CVD AND your CKD indications since you got BT for both (I know we only have one so far), and this is critical for end drug approval.

Thanks!

Iconoclast