Innovation Pharmaceuticals Inc (IPIX)

[BonelessCat]

Fast Track for B-OM was granted 15 months after the Phase 2 was started.

Yes. After I burial results were reviewed, fast track was granted. Then the choice became whether to modify the trial into a Phase 3, which they did, but the FDA wanted to see a much larger number of subjects in spite of fast track.

Another option would have been to modify the phase 2 under new fast track protocol, but the phase 2 was either finishing or finished. Either way, fast track meant delaying the continuation to revise the protocol or apply for an advanced phase.

Fast track only means increased review and increased access to guidance and meetings. It reduces the time for review and approval, it doesn’t alter the trial parameters once a protocol is approved.

Under the current emergency, there is still no effective treatment that is affordable, that won’t bankrupt the average patient. The treatment course the President took would have cost anyone else $50k to $100k. So, there is a huge need for cheap until there is vaccine-based herd immunity. Fast track means more now, but that doesn’t mean the protocol needed to include the parameters of fast track.

If you still are confused, maybe someone else can better explain why waiting for fast track prior to submitting the final proposal and protocol was the smart thing to do to save time.