NorthWest Biotherapeutics Inc (NWBO)

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Like all points raised by 'ex' this is another waste of time on a technicality in his mind or as part of his waste people's time plan.

In advance this is my opinion stuff based on experience.

There is history to the SAP doc in general and I am not sure when it became a separate doc from the trial protocol as all this clinical world has evolved greatly in the last couple of decades nor am I sure when/whether FDA requires the original SAP to be filed, but what I can say is that FDA requires (and it is common sense) all studies of all kinds have an approved protocol which includes the data plan prior to initiation. Data collection during any type of study is driven by what data is required to address the reason for the study. And the data collection will always include the specifics of what will be measured, how it will be measured and how it will be analyzed. This all being said NWBO knew what their initial trial data plan was and modified it appropriately within the boundaries of GCP's or Good Clinical Practice and FDA guidance on clinical studies. There may or may not have been a separate SAP filed with FDA originally. NWBO modified the plan and submitted the final version of the SAP to FDA prior to datalock, when it is required to be.