NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

If this is your primary question...

1. Were there prior efficacy IAs, and even though blinded, what was management allowed to know about the statistical comparison results between arms?

It's assuming that there was an efficacy IA. I think first, that question needs to be asked. And since they are sometimes so penurious about limiting the questions to one per person - which frankly I think is just wrong - perhaps ask that question like this...

1. Was there ever an unblinded efficacy IA done, and if there was, does management have any knowledge about the statistical comparison - or the extent of separation - between the control and treatment arms?

I only suggest this as this way (lol) you're able to get two questions into the one, and sometimes it's better to really spell it out, and make it super clear, what you're asking.

As for me, what I'd like to know pertains more to the timeline. I'd like to get a firmer commitment from them as to timing to data lock and top line. I'd want to know if we are going to be subject to some sort of an embargo on data due to an abstract submittal. So I'd ask this, if I were there:

Your November PR about SNO detailed a set of stages you were undertaking to reach the completion of this trial program. These included finalizing the SAP, final data collection, data validation, data lock, and unblinding and analyzing the data. I would like a range of months (lol not years!!!! - don't say that, haha) that it will take to reach data lock, and when you do, approximately how long after data lock will you be able to provide us with top line data?

I they can't answer it, then let them tell us they can't or won't. Of course, if it were me, and they refused to answer that question, then I'd insist that I be able to ask another. I mean, what good is getting only one question if they won't even answer it? So I'd be prepared with a back up or two, if someone attending wants to ask my question as their first one.

Another question I would love to know, so someone may want to ask it is...

You mentioned in your November PR that there is "no well established pathways". Could you explain to us further what you mean by that? And if it involves how you intend to approach the FDA in terms of an approval process, could you tell us what pathways you are considering as open to you?

By the way, I keep referencing the November PR as it's been said that Les refers people to the November PR and that everything we need to know is in it. So by referencing the November PR and what it's not stating points out to them that not everything we need to know is in it. And if others want to respond to my suggested questions, or improve on them, please do.

:)