Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

I concur. You have a point. I based my opinion on the list of topics for EOP2 form this source:
https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM349907.pdf

on page 23 these topics are offered as example for EOP2

- Phase 3 trial design (including dose selection and endpoint selection)
- Adequacy of safety database
- Pediatric studies, including studies required under PREA and Written
Requests issued under the Best Pharmaceuticals for Children Act
- Additional information needed to support NDA/BLA
- Context for SPA submission
- Adequacy of supporting nonclinical data
- Adequacy of supporting clinical pharmacology data
- Adequacy of supporting abuse related data
- Use of data standards for submission

It seems that some reconciliation between your quote and my list is needed. Maybe FDA can give a conditional go ahead to phase 3. Something along the lines: "do these checks first and if no issues arises then you are allowed to start phase 3". Or maybe by expanding phase 3 trial protocol. Otherwise I don't see how one can address, for instance, a finding that current nonclinical data is inadequate. Dunno.