Replies to post #524612 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

the simple answer is Liau never said this:

"Liau has indicated that they do not have patient level data for the ECA and Medicenna's ACTUAL MEETING AND APPROVAL WITH THE FDA for their P3 with the hybrid ECA concluded that patient level data was needed for the hybrid ECA including those from external sources. Medicenna created a database with this patient level data for the ECA so they are convered"

She did say that when the FDA has not responded after 3 months after the SAP has been submitted that one can assume the FDA is on board with the SAP.