Innovation Pharmaceuticals Inc (IPIX)

[BonelessCat]

Benefits diminish after approval of phase 3. There are still many options for acceleration that apply to phase 3, but need to be addressed during the end-of-phase 2 meeting to be included in a Phase 3 trial design. Again, “ideally” the BTD is submitted before the end-of-Phase 2. For example both OM and UP had one human data prior to the small Phase 2 trials. If a BTD is approved, the FDA is unlikely to require another phase 2 as it would without a BTD, as the FDA is also likely to shorten Phase 3 to a single smaller trial, as it is likely to do with a BTD in place. Still lots of benefits.