Replies to post #673034 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

From the JAMA article.
Supplement 1.
Trial protocol.

”For purposes of the Secondary Endpoint #2, Confirmed Progressive Disease (cPD) is defined as:

Initial disease progression determined through independent review (unconfirmed PD), AND also either
(i) a new lesion or
(ii) any one of the following criteria (modified iRANO criteria):
* A further 25% increase or greater in the sum of bi-perpendicular diameters of enhancing tumor, occurring at least 4 weeks after the initial event of PD/PSPD;
* Significant increase in T2/FLAIR non-enhancing lesion attributable to tumor growth;
* Death (all deaths are counted as events).

A secondary analysis will, in addition to the MRI findings, take into account the clinical status of the patient, as follows:
* Non-temporary increase in steroid dose >2 mg/day not associated with the unconfirmed PD event;
* Significant clinical decline not attributable to other causes;”

https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847