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Friday, March 16, 2018 2:09:03 PM
IPIX would benefit of getting at least SPA out FDA before starting p3. One thing a small biotech does not need is FDA saying after commercialization filing: "Sorry, we don't agree with your targets and methodology. You need to do this over."
I would try to get FDA committed for Kaplan-Meier style efficacy evaluation for incidence rate and onset combined plus mean count of days with SOM. That would put some needed intellectual rigor in SOM clinical trial business and probably would benefit B also. I bet they could get support for it from health insurance industry; they like to get their hands on better measures for cost estimation.
One can always dream.
Recent IPIX News
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- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2023 08:15:25 PM
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