Cytodyn Inc (CYDY)

[Midasbro]

Very important to understand

The FDA updated guidance today (originally released in May 2020) entitled ‘COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry’.

The guidance states the following:

‘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.25 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’

https://www.fda.gov/media/137926/download

It’s available for all to read.