Replies to post #95710 on NorthWest Biotherapeutics Inc (NWBO)

[kabunushi]

I'm no FDA expert either, but Flipper posted link to an article discussing analysts talk about an AZN trial near completion where they could even be changing even their primary endpoint at a point rather close to the expected endpoint, which discussed the fact that as long as there have been no IAs for efficacy done and the sponsor is still blinded, a surprising range of flexibility in the statistical plan seems possible. This supports the theory that what is going on now with NWBO is final adjustment of the SAP plan. That matches conversations that my associate has had with LG. I believe that they may not be waiting for events but rather doing some final wrangling with the FDA about their analysis plan, possible only while they are still blinded to the data. This is no guarantee that the trial will succeed, but this is my understanding of what is possible (which I had not realized before Flipper's article) and matches some noises made by the company as to why the delay in the '2 weeks'.