Replies to post #524515 on NorthWest Biotherapeutics Inc (NWBO)

[ahp123]

if that's the best reason then it doesn't look that positive... unless you want to start arguing that the FDA can't approve DCVax L without making it SOC.

[iclight]

What does global ramp capacity have to do with being:

approved in the US where manufacturing was established years ago and only needed a signature on a contract

Absolutely nothing. The best answer is the company will never submit a BLA because the data is not up to FDA standards.

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.