Replies to post #46473 on NorthWest Biotherapeutics Inc (NWBO)

[Tony888]

They are currently working with regulatory agencies through rolling review, and are awaiting a 74 day response that may occur any time between now and the end of February.

Why end of February? 74 days from mid September is early December, so we should hear something by end of next week.

[flipper44]

More recently in October she indicated the current estimate for reaching the primary end point is September/October 2016. -- Readyforbluesky

So, this is how I understand "reaching the primary endpoint." First though, look at one definition.

Primary Endpoint: The main result that is measured at the end of a study to see if a given treatment worked -- National Institute of Health.

As you know when a trial reaches the primary endpoint, it means the main clinical endpoint (e.g. PFS, OS, TTP, etc) reached statistical significance.

When a trial succeeds, companies often PR that their treatment reached it's primary endpoint.
When a trial fails, companies often PR that it failed to reach the primary endpoint.

So when, as you state,

"More recently in October she indicated the current estimate for reaching the primary end point is September/October 2016."

That is not inconsistent with the potential for an early interim halt. Why? Because as I understand it, an interim analysis allows a trial to reach its primary endpoint early, before the end of the study.

However, you do not expect LP to predict which interim analysis will succeed, that would mean she would be forecasting success or failure at a particular interim

So when LP states September/October 2016, she means potentially reaching the primary endpoint at the end of the study as it is classically defined. In other words, she is not predicting for us whether it will end at the first, second or final analysis.