NorthWest Biotherapeutics Inc (NWBO)

[notbrad]

I attended the ASM (it was held a few blocks from my office) and essentially nothing new to report. A few quotables from Linda:

"Cannot be specific on exact timing of unblinding".

"SAP to be developed and submitted to regulators. This is a ginormous (her word) effort. Lots of complexity to SAP; lots of decisions to be made".

"Doing things in parallel where we can. Final data collection ongoing; CRO physically visiting 81 trial sites; some case files can be more than 100 pages long; every discrepancy generates a query; and every query needs to be resolved".

I had to wait for the last question:
Question: While the SAP is being developed, are you in active dialogue with the regulator? Will you unblind only after regulator signs off on SAP?

Linda:
"I'll answer the second part first. Yes, we will unblind only after regulators sign-off on the SAP. Note that it's not just the FDA, but a total of 4 regulators. On the first part, we cannot comment about any dialogue with the FDA. The SAP will be a formal submission to FDA for sign-off".

My takeaway: It seems the SAP sign-off by regulators is the biggest rate-limiting factor. LP hedging her statements about time-line because she does not know how long the FDA will take to sign-off on SAP.