Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

"The trial size for B-OM trial could kill the deal - the enrolling timeline from previous trial and fact that P3 trial needs many more patient could mean this will be a 2+ year trial"

Maybe there are reasons for a comparison being less than apples to apples (I know it's an infusion ) but the Galera Therapeutics trial started last month.
"The purpose of the phase 3, clinical study is to determine if GC4419 administered prior to intensity-modulated radiation therapy (IMRT) reduces the severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.The purpose of the phase 3, clinical study is to determine if GC4419 administered prior to intensity-modulated radiation therapy (IMRT) reduces the severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck."

Primary Outcome Measures:
1. Cumulative incidence of severe OM
From the first IMRT fraction through the end of the study treatment period, which is estimated to be 7 weeks.

Estimated Enrollment : 335 participants
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : October 2020 (Final data collection date for primary outcome measure))
Estimated Study Completion Date : October 2024
https://clinicaltrials.gov/ct2/show/NCT03689712?term=Galera+Therapeutics&rank=8

Can someone explain what is done between the Primary and Study Completion Dates that takes 4 years to do?

The trial is starting ahead of the Phase 2 trial's completion using the higher of the two doses tested in the Trial 2.

"Galera Therapeutics Raises $150 Million for GC4419 Phase 3 Trial and Pre-Commercialization Activities in Lead Indication"
http://www.galeratx.com/galera-therapeutics-raises-150-million-for-gc4419-phase-3-trial-and-pre-commercialization-activities-in-lead-indication