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Re: TheDane post# 248373

Sunday, 11/11/2018 5:10:23 AM

Sunday, November 11, 2018 5:10:23 AM

Post# of 403025
"I’m still trying to understand what a successful “end of Phase II meeting” looks like."

Good question....I think they just enjoy using the "s" word (success, successful, successfully). Some version of it appears at least once in 94 of the Company's filings over the last 4 years and 47 times in the latest 10-K alone.

I suspect that what they may have meant in this case was that just having the meeting will be considered a success.


That said, I found a few references to successful meetings on the Company's website so maybe you can get an idea of what they meant by the phrase. The quotes from the PR's suggest that maybe by successful they mean they hope to come away from the meeting with a better idea of specifically how the FDA expects them to go forward clinically.


Company Reports Successful End-of-Phase 2 Meeting with FDA
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-to-start-brilacidin-phase-3-program-in-absssi?rq=meeting
"Dr. Daniel Jorgensen, Cellceutix’s Chief Medical Officer and leader of the team that met with the FDA, was pleased with the outcome of the meeting. “This was a collaborative meeting, and the FDA was extremely helpful in providing guidance on our clinical development program in ABSSSI. The plan for an interim analysis makes sense, as this is a brand new class of antibiotics.”"


Cellceutix Completes Successful Pre-IND Meeting with FDA for Cancer Drug
http://www.ipharminc.com/press-release/2016/10/27/cellceutix-completes-successful-pre-ind-meeting-with-fda-for-cancer-drug?rq=meeting
“FDA provided some very helpful comments on our study protocols,” said George Evans, CEO of Cellceutix. “We have incorporated their comments and now have the remaining studies underway, after which we will be able to go forward with our IND filing. This would be a very significant milestone for Cellceutix.”

But can it core A apple?
Yes Ralph, of course it can core A apple.

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