Replies to post #339857 on Innovation Pharmaceuticals Inc (IPIX)

[farrell90]

It is my understanding that a part of the IND process is reviewing, tweeking, and approving the proposed protocol.

The protocol for Brilacidin should be set in place now. I would be surprised if the FDA would make changes since they just approved the protocol a few weeks ago.

I do not believe we will have any more delays and the next PR should be to announce the human clinical trial sites.

GLTA Farrell

[loanranger]

"I said they needed the fast track included in the protocol before it was approved. If fast track is granted then the protocol must be modified and re-approved for accelerated chains of assessment. That means updating the staff on revised process."

I still don't get it.
Fast Track for B-OM was granted 15 months after the Phase 2 was started. Obviously it had to have been applied for long after the P2 started. Were they at risk for protocol modifications and a reapproval "for accelerated chains of assessment"? Did those things happen?




Did you notice this in today's PR?
"To date, Brilacidin has received Fast Track designation for three different clinical indications: COVID-19, Oral Mucositis, and Acute Bacterial Skin and Skin Structure Infection (qualifying for Fast Track under Qualified Infectious Disease Product designation)."

So they received Fast Track for B-ABSSSI except they didn't receive Fast Track for B-ABSSSI....they're eligible for it and need to apply, right?


The 10-K supports the fact that FT hasn't been received for B-ABSSSI: "Certain of our product candidates, such as Brilacidin for the indication of Oral Mucositis and Kevetrin for the indication of ovarian cancer, have been awarded Fast Track designation."
Where is B-ABSSSI?