When will AP26113 get FDA Approval?

AP26113 Will probably get FDA approval sometime around August of 2015.    This guesstimate is based on the mean number of days that 14 drugs which have received  FDA Breakthrough Therapy Designation (BTD) have taken to receive FDA approval.

That said, given the history of drugs that have previously received  BTD,  AP26113 could conceivably be approved  as early as January 2015.  This guesstimate is based on the fastest movement from BTD to FDA approval, which was 82 days (Eltrombopag: BTD on 2/3/2014; FDA approval on 26-Apr-14).

On the other hand, it might be as late as March, 2016.  This is based on the slowest movement (531 days) fromBTD to FDA approval (Ibrutinib: BTD 2/12/2013 FDA Approval 7/28/2014)

Breakthrough Therapy Designation Table          (Source for table)

So, now the disclaimers...

1. Double check my math (it's late, I'm tired, and...seriously, help me out here).

2. There were 58 drugs approved (one list says 68, but I'm only counting 58), and of these...14 have have been approved: I have NOT counted the days that unapproved drugs have been waiting for approval, so someone might want to calculate new intervals given these "not yet approved" drugs. I have treated FDA Approved and "NOT APPROVED" as apples and oranges because, well, see point 1 above.

3. Yes, I get that every drug is different and the path for one drug's approval need not predict the path of another. As such, who the heck knows when AP26113 will get approved....I'm just giving a RANGE of possible approval dates IF it gets approved.

4. And, yes, it may never be approved. There's no guarantee whatsoever the "BTD" leads, without fail, to FDA Approval.

Looking forward to your comments and quibbles.

Trading Cyclist.