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loanranger

01/27/22 8:24 AM

#387569 RE: farrell90 #387563

"As you know the next step for IPIX is planning its end of Phase 2 meeting with the FDA."

I don't know that. You don't know it either. The Company has not said it.

You provide an unlinked quote purporting to describe what "End of Phase 2 Meeting" means.
Here's the wording of the law itself (it's not that different...my highlighting) :
"End-of-Phase 2 meetings - (i) Purpose. The purpose of an end-of-phase 2 meeting is to determine the safety of proceeding to Phase 3, to evaluate the Phase 3 plan and protocols and the adequacy of current studies and plans to assess pediatric safety and effectiveness, and to identify any additional information necessary to support a marketing application for the uses under investigation."
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=312.47

There is no mention of an end of Phase 2 meeting in the 3 links you provided or any other recent corporate communication.
There is no use of the phrase "Phase 3" by IPIX recently except in reference to a B-OM trial ("Development of an optimized Brilacidin oral rinse formulation is in progress, with potential to progress to Phase 3 OM testing in 2022.").

There's no mention of those things in your quote from the latest Company press release and there's obviously nothing in the "Shareholder Alert: Upcoming Update on Brilacidin in COVID-19" about them.

You're obviously free to hope for those things and help the Company with its carrot-on-a-stick dangling, but for you to raise carrots...expectations...that even the Company itself hasn't raised, is noteworthy.