When the company files a BLA the FDA will set up a PDUFA date 6 months after they accept the filing. It's very possible that they could approve in 4 months or more, but if it goes down to the last day it's probably equally likely to be a CRL. The company would need to comply with whatever is in the CRL and then resubmit and get a new PDUFA date. I join others in believing that once we have UK approvals the others will concur once everything is properly filed. In that I believe the EDEN unit will be used for commercial production here, having it ready for the entire production facility to be inspected may be the key to when a BLA can be filed. I believe that at least initially, the CRL Memphis facility will be where NWBO licenses for the production of DCVax-L in the US.
While the company might receive more if their case went to trial, it could take substantially longer, and of course the attorney's will get a greater percentage if they go to trial. If a settlement was agreed to before NWBO had sales revenue building up it could give them the funds needed to accelerate many things.
Gary
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