Now we know BTD was applied between 9/11 (10-K) and today.

Now we know BTD was applied between 9/11 (10-K) and today. We should get a decision by mid-November. I think IPIX is waiting for the decision before requesting a meeting because the development plan for B-OM could be different under BTD as opposed to Fast Track.

Quote:

Near-term strategic clinical priorities remain: to work closely with the FDA and other regulatory authorities to align on the remaining development plan necessary for Brilacidin in Oral Mucositis;

My take of “other regulatory authorities” could be drug agencies in Europe, Asia, Australia, and South Africa since patents have been granted in those areas.

Quote:

The European patent supplements other Brilacidin-OM patents that have been granted in the United States, Asia (Japan, Taiwan, China), Oceania (Australia) and South Africa. All currently issued patents have an expiration date of 2032. Additional Brilacidin-OM patent applications are pending in other key markets including Russia and South Korea.

http://www.ipharminc.com/press-release/2017/1...-mucositis