NorthWest Biotherapeutics Inc (NWBO)

[StableGenius]

Does anyone have a rational explanation why Breakthrough Treatment Designation was not sought in 2018 when the preliminary trial results were published? Results could have been unblinded at that point, and the FDA would have provided a date certain for action on a BLA. The explanation provided as to why NWBO has waited so long to lock data, namely, people were living so much longer than anticipated, does not explain why it did not unblind in 2018, provide TLD and seek Breakthrough Treatment Designation (BTD). They could have followed the same population and had the same data they have now, and possibly brought the treatment to market many years earlier. I would appreciate others' views as to whether this was possible. The BTD Program definitely existed in 2018, and as I pointed out, other immune treatments have been granted BTD based on similar, but less, data.