Replies to post #74899 on Innovation Pharmaceuticals Inc (IPIX)

[F1ash]

This may not answer the questions specifically but the next line was...

"This is consistent with the 2013 Food and Drug Administration (FDA) guidance for ABSSSI studies and is the same endpoint used in recent approvals for ABSSSI drugs."

[DrBones]

Primary outcomes are only for 48-72 hours, secondary outcomes are for later dates. I don't think it means we haven't met secondary outcomes.

Primary Outcome Measures:
Early clinical response [ Time Frame: 48-72 hours after first dose of study drug ] [ Designated as safety issue: No ]
The primary efficacy outcome, early clinical response 48-72 hours after the first dose of study drug, will be determined in the ITT population. A subject will be considered a Clinical Success if 1) the lesion area has decreased by =20% compared to baseline and 2) no additional systemic antibacterials that are potentially effective against gram positive organisms have been administered.


Secondary Outcome Measures:
Clinical Response [ Time Frame: Day 7-8; Day 10-14; Day 21-28 ] [ Designated as safety issue: No ]
For Days 7/8 and 10-14, a response of Clinical Success will be assigned if all signs and symptoms of infection present at baseline have improved and/or resolved and no additional antibiotics are considered necessary. Subjects who have a response of Clinical Success at Day 10-14 will be assessed for sustained efficacy at Day 21-28. A response of Sustained Clinical Success will be assigned if all signs and symptoms remain resolved and no additional antibiotics are considered necessary. If signs and symptoms of infection recurred at the original site of infection and require additional antibiotic therapy, a response of Relapse will be assigned.

Microbiological response [ Time Frame: 48-72 hours; Day 7-8; Day 10-14 ] [ Designated as safety issue: No ]
Microbiological responses for those subjects who had a relevant skin pathogen isolated at baseline (MITT and ME populations)

[TOB]

They announced the Primary Outcome Measure:

Can anyone help me to understand this:

,...when observed 2-3 days only,...?

Does that mean we do not know if we are equivalent at 28 days,..? -cabel

Here it is on the trial outline:

Primary Outcome Measures:

Early clinical response [ Time Frame: 48-72 hours after first dose of study drug ] [ Designated as safety issue: No ]

The primary efficacy outcome, early clinical response 48-72 hours after the first dose of study drug, will be determined in the ITT population. A subject will be considered a Clinical Success if 1) the lesion area has decreased by =20% compared to baseline and 2) no additional systemic antibacterials that are potentially effective against gram positive organisms have been administered. - Link

We have yet to hear on Secondary Outcome Measures, or the P-Value for statistical significance, or the specific numbers as noretreat pointed out.

PR was definitely a bit rushed.