InvestorsHub Logo

loanranger

01/27/22 10:54 AM

#387582 RE: farrell90 #387577

I thought we were discussing facts, not known procedures.

The fact is that both of these things are true:
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.

I'm not surprised at this opinion and haven't expressed any disagreement with it:
"IMO application to an ACTIV trial would require a end of phase 2 meeting with the FDA."


I shouldn't have to point this out again, but....
You provided this quote from the PR issued the day after the failure announcement:
"Complete analysis of trial results already has begun, with the aim to potentially identify positive trends in the data that could support Brilacidin for inclusion in larger COVID-19 platform trials, such as the U.K.’s CTAP program and the NIH’s ACTIV program. The purpose of these programs is to prioritize development of promising COVID-19 therapeutics."

I highlighted the hedging language used in the quote.
It's intent was plainly to get investors to believe exactly what you went ahead to believe. It's an expression of hope on his part. Hope that data that he didn't have at the time would reveal itself at some future time, allowing an application for consideration for a future trial.

Spending a lot of ink on what might be and what process might ensue if his and your data dreams come true is a fine use of IPIX's press releases and this board, but it is the data that must come first and it's just not here.

Let me know when Leo announces that the submission requirements for an end-of-Phase 2 meeting have been made and THEN we can discuss the process.

TheDane

01/27/22 11:46 AM

#387589 RE: farrell90 #387577

Excellent info!