Replies to post #250341 on Innovation Pharmaceuticals Inc (IPIX)

[MackG]

He already proved you wrong. More drugs approved last year WITHOUT BTD than with. No amount of tortured Logic will change that fact no matter how hard you try.

[To infinity and beyond!]

excellent points

[PlentyParanoid]

LR, you are absolutely right that my table does not address the whole picture. It was not intended to. I intended it to point out that not getting BTD is not end of the world for IPIX. Bad news, YES.

About those statistics you were asking. Here are some:

Fast Track Designation, Cumulative from March 1 1998 to June 30, 2018
Applied: 424
Granted: 283 (6 applications pending)
Designation approval percentage: 66.7 (pending applications assumed to be denied)
NDA/BLA Granted: ?
Marketing approval percentage: ?

Breakthrough Designation, Cumulative from 2012 to November 14 2018
Applied: 724
Granted: 264
Designation approval percentage: 36.5
NDA/BLA Granted: 125
Marketing approval percentage: 17.3

Unfortunately I could not find NDA/BLA percentages for fast track, my guess is that it is markedly lower than for BTD. Otherwise, numbers do confirm your contention, BTD is more difficult to obtain.

I am bit surprised with the differences in application numbers. It would be interesting to get breakdown by applicant size and business stage (development stage co, or not). That info might explain at least some of the difference in numbers.

Sources:
FTD
https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cber/ucm122932.htm
BTD
https://www.focr.org/breakthrough-therapies