NorthWest Biotherapeutics Inc (NWBO)

[MI Dendream]

Hi DMB, We can be certain that they submitted the SAP to FDA and it was not rejected. Chiugray did a nice job transcibing for you.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168266043

This per company guidance occurred and had to occur before data lock. I guess we really can’t be certain they submitted. By what rational explanation would cause them to wait after building and validating the ECA model and receiving SAP “approval”. Now, perhaps FDA has been back and forth regarding the ECA and exact statistical analysis, but this would occur after submission and it is crazy talk to think they would wait a year to submit (the model was first presented in April 21). Maybe FDA just decided on a whim to look at the use of ECAs and publish in Annals of oncology and maybe it has nothing to do with DCVax.

It is actually quite a leap of faith to believe they have not submitted when all signs show that they have.