Innovation Pharmaceuticals Inc (IPIX)

[BonelessCat]

The BTD request is filed before the end of phase 2 meeting (ideally, not requisite). It’s not required to file before end of phase 2. How can a sponsor file a BTD before data is in and fully analyzed? Indeed, an advanced reading comprehension test.

From the last paragraph: “Ideally, a Breakthrough Therapy designation request should be received by FDA no later than the end-of-phase-2 meetings...” (emphasis mine)