NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Interested in DMC Protocol on Early Termination for Strong Efficacy?


Review Section 7.2.1

http://www.fda.gov/downloads/Regulatoryinformation/Guidances/ucm127073.pdf

Note: I've never seen an announcement where a sponsor or a company decides to continue a trial for more data once the DMC recommends stopping the trial for strong efficacy. It could be that the DMC would agree to withdraw its recommendation if the sponsor or company felt more data was needed. Or it could be a positive DMC recommendation would be announced, but the company would state it needed to continue so that it could get enough data for the FDA.

However, its my view that the interim analysis for this phase 3 trial has predetermined stopping points for efficacy that were agreed upon by the sponsor, company and the FDA back on May 17, 2012. So I do not see the sponsor, NWBO nor the FDA wanting more data if the DMC recommends early termination for positive efficacy results in line with predetermined stopping points -- if indeed those stopping points exist and are achieved. IMHO