Replies to post #275558 on NorthWest Biotherapeutics Inc (NWBO)

[sukus]

Thanks Whitewater. May we know the thing that causes them to wait? How long will they wait? One month? Two months?

[exwannabe]

Is this Innes or your socks talking?

If DI said it, he is as bad as LG because it is total BS.

First, they might have to wait on something that happens before datalock, but you do not need to wait on datalock itself. If they are not waiting on the SAP, and have the data collected and scrubbed, then they snap their fingers and say "locked".

Second, if they are implying the first two steps (SAP and scrub) are done, that was never communicated. So I guess "communicate information when necessary" means they have no need to communicate.

[meirluc]

Innes response to question 6:

These milestones all have timeline ranges to them and we’ve done what we can to be ready. However, we can’t always control the timelines. We are waiting for data lock, unblinding, then top line. We plan to immediately communicate information when necessary

What timelines cannot be controlled by NWBO? As I understand it, if the SAP has been completed and agreement has been reached with all 4 regulators, all timelines are under NWBO's control and they can immediately move to data lock, unblinding etc.

This suggests to me that perhaps that concerning the SAP, there are still disagreements between NWBO and one or more RA's (FDA?). That makes me believe that questions 20 and 11 (status of the SAP) are very important and should definitely be on the list. If NWBO honestly states that there are still disagreement with one of the RA's pertaining the SAP, question 11 (status of the SAP) will not have to be asked since this has just been clarified.

Another question asked could be: Please clarify for us the nature of the timelines that are presently not under NWBO's control that will allow the company to proceed to data lock, unblinding and TDL?