Innovation Pharmaceuticals Inc (IPIX)

[BonelessCat]

It comes out of the document linked below. Under the most current FDA interpretation of regulations regarding rapid approval for critically needed drugs, K can be approved for limited market based on a Phase 1 trial with an efficacy measure in the secondary out comes and if the drug shows the outcomes are backed by same or similar expectations shown in pre-clinical studies. K could be (emphasis on could) approved for Stage 4 cancer patients with solid tumors of the types that showed high efficacy in the Phase 1 study and no DLTs at effective therapeutic doses.

I'm only laying this out as an answer to Gov's what if of Cohort 9 and still no DLT. As I keep saying, let's get to Cohort 7 first, but it can be fun to speculate on a what if.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf