Replies to post #708626 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

You just referring to a guideline or the FDA, just as Doclogic does, makes you an idiot. Put your money where your mouth is and start QUATION the FDA. Pock pock Pock pockPock pockPock pockPock pock chicken. from bcplatforms.com

Both the following quotes were in my post (with source):

Sponsors should finalize a study protocol before initiating the externally controlled trial, including selection of the external control arm and analytic approach, rather than selecting an external control arm after the completion of a single-arm trial

Sponsors must include in their marketing applications relevant patient-level data (i.e., data on each participant and patient in the externally controlled trial), as required under FDA regulations [21 CFR 314.50(f) and 601.2], for both the treatment and external control arm

Reading is not that complicated. You can spin these, but you cannot deny the FDA wrote them.

[wrt continuing trial after futility rec]Not if the sponsor plays by FDA rules which what NWBO did, you liar.

The FDA allows a trial to continue blinded even after the Sponsor has been informed by an efficacy IA of the primary endpoint futility. see this guidance

7.2.1. DMC Recommendations to Terminate the Study In almost all cases, a DMC is advisory to the sponsor; the sponsor decides whether to accept recommendations to discontinue a trial. FDA will rarely, if ever, tell a sponsor which decision to make.