NorthWest Biotherapeutics Inc (NWBO)

[highwayman4life]

Albeit from 2015, a very informative paper regarding the Clinical Trial Life Cycle and When To Share Data:

https://www.nap.edu/read/18998/chapter/2

There's alot of info available here and worth going through given it is directly applicable to where NWBO is right now with preparations for releasing data.

Sponsors want a quiet period for regulators to evaluate the entire body of evidence submitted to them, appropriate safeguards for intellectual property and commercially confidential information, and protections from invalid secondary analyses. Academic clinical trialists want time to analyze and publish the data they have collected and thereby gain appropriate professional recognition for planning, organizing, and running clinical trials whose data are subsequently used by other investigators.

This document also discusses that changing the SAP is quite normal and as long as it takes place while all parties are still blinded and there is communication with regulatory bodies...it's all good. There's alot of discussion on evaluating endpoints of a trial and ones with multiple endpoints.

On the path toward regulatory approval, life science and medical device company management will encounter difficult disclosure decisions surrounding clinical and regulatory events. Finding the right balance between the “duty to disclose” vs. “pressure to disclose” dilemma is not easy.

GLTA