NorthWest Biotherapeutics Inc (NWBO)

[User-840664]

Ex... Any truth to this? In your opinion.
“No matter what anybody says, NWBO cannot get approval until they run the pediatric trials. This is from the EMA - same rules apply MHRA

"All applications for marketing authorization for new medicines in the EU must include the results of studies as described in an agreed pediatric investigation plan, unless the medicine is exempt because of a deferral or waiver."
NWBO submitted a SAP for pediatric trials, which has been accepted. But until they run - or start to collect enough data to make a case - they are dead in the water. No matter what, they have to run pediatric trials .