Replies to post #259725 on Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

"This may provide some helpful info (underlines mine)"
"Type B—Confidential between sponsor and the FDA."

Thanks for the link...it's more than I have time for but a quick search on a few terms turned up some interesting things (some of which we knew).

End of Phase 2 Meeting
The purpose of an End of Phase 2 (EOP2) meeting is to determine
the safety of proceeding to a phase 3 trial and evaluate the plans
for design of the phase 3 effectiveness trials [11]. It is critical that
the sponsor reaches agreement with the FDA at the conclusion
of the EOP2 meeting on key design elements of the pivotal trials.
The discussion can address issues such as (a) acceptable endpoints
for licensure; (b) study design, power,
confidence interval,
and other statistical considerations; (c) whether a single
study is sufficient or whether two independent confirmatory
studies are required; (d) the need for double-blind, placebo-controlled
randomized trials; (e) the control (placebo, standard of
care, or, if the standard of care is evolving, some active agent); (f)
consideration for crossover trial design if placebo patients progress;
(g) blinding/unblinding issues and impact on the statistical
analysis; (h) CMC-related issues such as adequacy of the potency
assay, product comparability assessment, product and process
validation, simulation of normal operating range and maximal
operating range considerations, and issues related to stability,
shipment, and delivery.
As with previous meetings, a TPP can be used to guide such
discussion and agreement. The proposed indication and dosing
regimen in the TPP will help determine the appropriateness of
trial design elements, including the primary endpoint(s), dose(s)
selected for testing, and inclusion/exclusion criteria. In addition,
the statistical analysis plan for the pivotal trials also needs FDA
buy-in to reduce the risk of its becoming a BLA review issue later
on. Statistical methods and analysis are often an important part
of the discussion. Key statistical considerations include statistical
methods, how to handle missing data/imputation method, potential
multiplicity adjustment, and prespecified interim analysis.
If agreements cannot be reached with the FDA at the EOP2
meeting, the sponsor must have follow-up discussions with the
FDA to resolve any issues before initiating the pivotal studies.

After the Meeting
Official meeting minutes will be provided to the sponsor by the FDA
within 30 days of the meeting. TheFDAwill summarize the following in bulleted form: important discussion points, decisions, recommendations,
agreements/disagreements, issues for further discussion,
and action items. Effective communication at this point will
improve the sponsor path later. If, after receiving official minutes
from the FDA, a sponsor or applicant needs additional clarification,
theFDAproject manager assigned to the meetingmaybe contacted
for guidance or to arrange a follow-up teleconference. If the sponsor
wishes to effect a change in the official minutes, a letter should
be submitted to the FDA citing the recommendations and rationale.
The sponsor’s concern will be taken under consideration by the review
division, and the project manager will issue an appropriate
response in writing. If the FDA agrees to change the official minutes,
such changes will be documented in an addendum to the official
minutes.


Your decision to underline here....
Type B—Confidential between sponsor and the FDA
...did what I guess you intended it to: it got my attention. You didn't say WHY you underlined it and I'll forego making an assumption about that, but I think that the term "confidential" simply means non-public (Table 3. Types of FDA meetings). As indicated above, and in every other document we've seen, the minutes of the meeting are to be and presumably were provided to the Company within 30 days after the meeting. The idea that we would hear more about the meeting wasn't dreamt up on this board, it was an expectation that was based on a Company statement, as you know: "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."

Your link is appreciated, of course, but the FDA provides Guidance of its own on these subjects:
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM590547.pdf

One of the things required ahead of the "confidential" meeting is:
"10. A list of all individuals, with their titles and affiliations, who will attend the requested
meeting from the requester’s organization, including consultants and interpreters."

On this very board it was suggested many times that a representative of the term sheet partner might be present at the "confidential" meeting.


I believe that the term "confidential" was simply meant to indicate non-public.

What was your purpose in underlining Confidential between sponsor and the FDA?

What was your expectation of what the "more details regarding planned Phase 3 trials of Brilacidin as a novel oral SOM treatment" might include?

[To infinity and beyond!]

sorry cannot follow. Are you saying that we company owners are not entitled to FDA meet info?

I am sure you are saying something helpful and more subtle-

Clearly there is a problem. BTD fails term sheet fails and now we are on to Europe- what aren't they rtelling us about the B OM data??

My guess is it is like P2a. They wanna hide the truth with misleading stats.

Pls recall your meticulous and amazing stat work on P2a and all the other psoriasis studies/competitors- so very commendable, but all for naught and it all added up to small trial numbers with IP pretending data meant more than they did.