Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

LR, Thanks for posting your considerations - as usual I learned a lot. About treatment of serious adverse events during clinical trials. This is my understanding as succinctly as possible (pardon the convoluted language)

IND Safety Report:
1. Any suspected treatment emergent uncommon serious adverse event or
2. Aggregate of suspected treatment emergent serious adverse events occurring more frequently with treatment than in a concurrent or historical control group
must be reported to FDA and other investigational sites as soon as possible but no later than 15 days after determination. Immediately life threatening serious adverse events (category 4) and deaths due adverse events must be reported within 7 days.

How and when this could turn into a material and reportable event under SEC rules? Probably when FDA or sponsor takes an action based on IND safety reports. Halting or terminating a trial would qualify. I don't know if any trial protocol change would, probably not. Otherwise it is business as usual.