Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

No issue with sample size, FDA has approved BTD:s based on very small p1 trials. As to alternate doses, I think IPIX probably included mouse data from Polymedix to show that 3 mg dose should be near optimal. Anyway, approval of BTD application does not mean that FDA will go with initiation of phase 3. Maybe FDA asks to see first a dose ranging trial or a trial with different delivery method altogether. They can be ornery, sometimes. Although, the latter is more likely what the potential BP could be thinking.

From BP:s point of view the value and structure of deal depends significantly on what happens with BTD and end of phase 2 meeting.