Innovation Pharmaceuticals Inc (IPIX)

[Justfactsmam]

Your erroneous "conclusion" could only be drawn from a failure to apply simple logic to the announced protocol of the trial and FDA dictum on the subject:

Logically:

Reporting on "efficacy" in the middle of a Trial would necessarily require a full and complete breach of the "data-lock", required for the Double-Blinded full trial, thereby negating the entire "Double-Blinded" protocol requirement upon which FDA authorized the trials.

FDA Dictum:

The FDA (as noted by two prior posters...one directly in response to your prior posts) clearly indicated (BEFORE) the IPIX/Brilacidin Clinical Trials that a sponsor put into its FDA approved protocol the process of interim (in IPIX "safety" for the extension of dosing from 3 to 5 days) BEFORE the trial, using an independent DMC!:

"...releasing interim results could have
ramifications on the integrity of the ongoing trial and the ability to collect reliable and interpretable data needed to support regulatory decision-making. If sponsors intend to conduct interim analyses, FDA recommends they consult the guidance for industry Adaptive Designs for Clinical Trials of Drugs and Biologics, prospectively plan these analyses, and incorporate processes to maintain the integrity of the trial (e.g., using an independent DMC)"

"FDA strongly discourages disseminating data from ongoing trials. Knowledge of accumulating data by trial investigators and patients can adversely affect patient accrual, adherence, and retention, as well as endpoint assessment, compromising the ability of the trial to reliably achieve its objective in a timely manner.

Issues with trial conduct caused by knowledge of interim results are difficult to predict and generally impossible to adjust for in statistical analyses. Therefore, releasing interim results could have
ramifications on the integrity of the ongoing trial and the ability to collect reliable and interpretable data needed to support regulatory decision-making. If sponsors intend to conduct interim analyses, FDA recommends they consult the guidance for industry Adaptive Designs for Clinical Trials of Drugs and Biologics, prospectively plan these analyses, and incorporate processes to maintain the integrity of the trial (e.g., using an independent DMC). FDA recognizes there may be exceptional circumstances in which a
sponsor determines it needs to disseminate results for safety or other reasons. In such situations, the sponsor is strongly encouraged to discuss with FDA before releasing such results." Page 9 4th paragraph (3rd bullet).

Source: https://www.fda.gov/media/137926/download";

and as another poster further reminded the board (which does not fit your narrative):

"(the link below)...explains why interim data analysis for efficacy will likely not be performed as “releasing interim results could have ramifications on the integrity of the ongoing trial and the ability to collect reliable and interpretable data needed to support regulatory decision-making.”

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/covid-19-developing-drugs-and-biological-products-treatment-or-prevention

This article above which I quote below contains recommendations about the conduct and design of clinical trials on COVID from the FDA and explains why interim data analysis for efficacy will likely not be performed as “releasing interim results could have ramifications on the integrity of the ongoing trial and the ability to collect reliable and interpretable data needed to support regulatory decision-making.”

One can also see that our trial design appears to be following these recommendations for trial design and analysis to a T, hopefully facilit
ating

EUA up on release of great results."

The repetitive questioning of why no "efficacy" data has been releases...when it is abundantly clear...???

IMO Just another STRAWMAN question!