NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

The order is normally.

1. Data freeze.
2. Data collection/scrub.
3. Data lock

Here, we see a little bit different way of explaining it by NWBO.

1. Apparently data freeze in November 2018.
2. Data collection/scrub apparently started in November 2018 and reached the middle by February 2, 2019.
3. NWBO has been simultaneously working on SAP finalization for four(?) regulators.
4. After submission they will await approval of final SAP before going to data lock. Ex states the regulator review stage is not supposed to take more than 30 days in the U.S..
5. Data lock apparently should occur sometime between April and June, 2019 according to their vague timeline. Although obviously could occur sooner or later depending on their progress.
6. (Normally) Topline would be almost immediately thereafter.

IMO, they should have been finalizing the SAP on the last scrub (the one that ended in October) if that could have been the last scrub. Apparently they never intended the October 2018 ending scrub to be the final scrub.

BTW that last collection/scrub took approximately 6 months (longer than a typical three month spring refresh) -- from probably mid April to probably mid October.

The likelihood is that very few events occurred between the last scrub completion and the new scrub data freeze, so that the new scrub/collection should be/have been very fast. The last one took longer than the three months they said normally occurs for spring refreshes, and that may be because they swept up (waited for) the very latest data for the 2018 SNO conference.

IMO they could have completed all this by now, but they have a different timeframe in mind. I by no means know, it's just a guess, but I suspect the earliest we will get topline specifics is at industry expert theater. After that there is ESMO in September and SNO next November. They could announce Topline success or failure before any of those potential conference appearances.

Everything they have done over the years, in hindsight, appears to have been centered around maturing the data way beyond anything they were publicly inferring. Therefore, because data maturation has been primary, they could be using SAP and all that to draw this out for more maturity on the additional blinded data that will be accumulating outside the data freeze before data lock. They say no to this and that they have the pedal to the metal, because right to try is no longer an option, and therefore they do not have the luxury, apparently, to draw this out in some fashion.