Innovation Pharmaceuticals Inc (IPIX)

[oddone33320]

IMO the PR today shows that given IPIX thorough examination of comparative studies and competitors in this space, they REALLY want BTD and also an extremely compelling presentation for potential partners and investment firms. I have to imagine they waited to complete that thorough review before submitting for BTD so they could serve up a clear and easy to understand case to the FDA based on all the facts about their study and others, and why they have the best potential therapy on a multitude of fronts (ease of admin, patient and hospital time and cost savings, efficacy). Seems to me they hope to make it a no-brainer for the FDA to grant them BTD and that may explain the additional time needed to compile the necessary information to do so and request the end of Phase 2 meeting with the FDA.

Next PR could be that they have requested an end of Phase 2 meeting with the FDA???


"Incentives
Drugs that have been granted breakthrough status are given priority review. The FDA works with the sponsor of the drug application to expedite the approval process. This expedited process can include rolling reviews, smaller clinical trials, and alternative trial designs.[9]"

https://en.wikipedia.org/wiki/Breakthrough_therapy