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Posted On: 09/20/2018 4:39:51 PM
Post# of 72451
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.
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.
http://www.ipharminc.com/press-release/2017/1...-mucositis
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
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