Replies to post #240012 on NorthWest Biotherapeutics Inc (NWBO)

[TiltMyBrain]

Nonsense

[H2R]

Hi Umibe,

I have chatted with DI a couple times in the last month, reviewed the video from ASCO 2019 (Dr. Bosch) and I find a consistent 'road to unblinding' story: See p. 28 of the ASCO 2019 PDF presentation or listen to the presentation https://vimeo.com/340029244 starting at 35m16s. I've heard the same steps from DI, again, twice, while pushing him on it both times.

The Road to Unblinding
• Generation of the draft Statistical Analysis Plan (SAP)
• Presentation of the draft SAP to regulators – Obtain feedback – Finalize the SAP taking the feedback into consideration In parallel …
• Checking and validation of the data by the CRO – Review case report forms: hundreds of pages per patient, for 331 patients – 100% source document verification – Resolution of queries
• Database lock (all data is held by an independent CRO)
• Unblind the trial data

While this has taken way too long for my own taste, I do not see the unblinding as beholden to any event, SNO, ASCO, ASM, or other.

It will happen on its very own timetable. I don't even know if they received all the comments from the FDA, if they finalized the SAP, if they filed it, if they are in the final data collection... you can put your own interpretation on it and come up with whatever you feel makes sense. I won't. But it is not on a timeline for any particular event, of that, I'm am very confident.

Best of luck to Patients, NWBO, and Longs!