Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

A grand total of ONE(1) person has asked why the transcript of the meeting hasn't been released. For you to focus on that issue is making a straw man argument. The issue has always been why, given the Company's assertion that it "expects to release more details regarding planned Phase 3 trials of Brilacidin as a novel oral SOM treatment", no announcement of the receipt of the minuutes has been made and nothing that could be described as further details about the trial have been provided.
These details were provided IN THE VERY SAME PR that the "expectation" was announced in:
"Both parties agreed to an acceptable Brilacidin Phase 3 development pathway, including studying Brilacidin oral rinse effects on SOM when cisplatin is administered in higher concentrations (80-100 mg/m2) every 21 days, and at lower concentrations (30-40 mg/m2) administered weekly as part of the chemoradiation regimen."

"BTW: we do know these items either from press releases or by inference:
1. Agreed P3 trial population: subjects having head and neck cancer undergoing IM RT with cisplatin Q1W or Q3W chemo.
2. Endpoints: SOM incidence, time to emergence of SOM, Duration of SOM
#1 is from the "expectation" PR.
#2 is your conclusion and not established by any Company statement in a PR or the recent 10Q.
Both may be reasonable but neither can be considered "more details" provided as a result of the receipt of the minutes.


"What has not been spelled out are precifics on trial size and safety, but those things seldom are included in press releases about EOP2 meeting."
Really. I know of at least one that did:
"In July 2015, at an End-of-Phase 2 Meeting, Cellceutix and FDA discussed data supporting advancement of brilacidin into Phase 3, as well as the basic elements of a Phase 3 program in ABSSSI. This is the first Host Defense Protein (HDP) mimic to advance through Phase 2. Because HDP mimics, such as brilacidin, represent an entirely new class of antibiotics, there is no potential cross-resistance with currently marketed antibiotics, and due to its unique mechanism of action, resistance to brilacidin is unlikely to develop. For this and other reasons, such as its high activity against methicillin-resistant Staphylococcus aureus (a leading cause of ABSSSI) brilacidin received designation as a Qualified Infectious Disease Product (QIDP) in November 2014. The QIDP designation was established as part of the Generating Antibiotic Incentives Now (GAIN) Act, passed by the U.S. Congress in July 2012, for the purpose of encouraging pharmaceutical companies to develop new antimicrobial drugs to treat serious and life-threatening infections. Receiving QIDP designation means that Brilacidin is now eligible for additional FDA incentives in the approval and marketing path, including Fast Track designation and Priority Review for development and a five-year extension of market exclusivity.

The Phase 3 ABSSSI program would include two Phase 3 ABSSSI studies, as required by FDA Guidance (October 2013), of approximately 700 subjects in each study. The two studies may enroll subjects simultaneously. In addition, the first study would include an interim analysis after a portion of the patients has been enrolled. This would provide an early assessment of both safety and efficacy."
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-files-form-10-q-quarter-ended-september-30-2015



When a Company makes the kind of statement this one did at a critical time (is there any doubt that IPIX is at a critical juncture?) it needs to follow up. This should have led to a press release describing the Phase 2 meeting in REASONABLE detail, reiterating any previously announced important facts and adding any new facts:
"Once official meeting minutes are received from the FDA, the Company expects to release more details regarding planned Phase 3 trials of Brilacidin as a novel oral SOM treatment."
You can do little dances around words like "confidential" and "expects" but IPIX's problems are in large part a result of a failure to keep the investor community fully informed about a cohesive plan (if there is one), resulting in a lack of confidence from which point one can draw a straight line to the share price.

"What I really wanted to do was to instigate somebody to search complete transcripts of EOP2 meetings made public in order to show how silly I am."
Why didn't you just say so? It would have been easy to make short work of that...I'm pretty sure it isn't done. I know that I sure didn't expect IPIX to do it.