NorthWest Biotherapeutics Inc (NWBO)

[aesop1]

I would say 6 months is the normal timeframe for nda/bla submission and 12 months would be considered slow. And yes that timeline applies even if it is personalized immunotherapy. You can go check the historical timeline on Dendreon wikipedia. 1 year from top line data to US FDA approval. (top line in April 2009, FDA BLA submission in November 2009, and FDA Approval in April 2010). The sad part is the investors are used to the company missing timelines and now having no timelines. This is why there is all this speculation on where things stand.