Replies to post #22426 on NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

Data is unlocked and delivered to the DMC (data monitoring committee), also called DSMB (data and safety monitoring board) at an interim analysis. They analyze the data and recommend to the Sponsor (such as NWBO) either to halt the trial (for clear futility or exceptional efficacy of treatment), or continue the trial until the next interim review, or if there is no other interim review, until the end of the trial.

Their recommendation is delivered to the Company (also called the sponsor, in this case NWBO), who nearly always acts on the recommendation. If it is to halt the trial for efficacy, they then begin the process of filing a BLA or NDA. This is submitted to regulators (in NWBO's case, the FDA and EMA). The regulator, after reviewing the application, either grants or refuses the request (if the latter, some explanation is included as to why and what would be needed to reverse their decision).

And now I have to say I'm somewhat afraid for you, Cancerfix, and hope this is the only biotech company you are invested in. At least until you fill in some of these gaps in your knowledge of the process ;). GL

[CaptainObvious]

Pyrr will be the authority on this, I just remembered something in an article I read some time ago. It had to do with the process of calling a trial early that involved only certain people being allowed to view the progress at certain points. In my scenario, it involved a data monitoring committee.