Innovation Pharmaceuticals Inc (IPIX)

[kfcyahoo]

LR,

Well reasoned(I think).

Thought some might find the following interesting:

"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