NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Marty, there has been a great deal of language saying the 150 day is from submission, I can't remember previously seeing validation as a starting date. I certainly can live with it if it is validation, it's roughly one month longer, but I still like the idea that we should know in just over a week, or less. Remember, 150 days is the last day they target to make the decision by, they frequently do it in less time than that.

If they made the decision by May 20th, we really couldn't say that they made it at about day 150, or was it actually day 120 based on a later start time. Perhaps they even met their newer 120 day guidance, but clearly from validation. All I'm suggesting is, the regulators just keep everyone guessing, and companies are no better when giving guidance, it's just not concrete, there is always wiggle room.

In the case of the FDA they set the PDUFA at 6 months after they accept a BLA or NDA, but I don't believe they say how long they spend in accepting, or whether they have precise guidelines on how much time they take. Al least once a PDUFA date is established, all know what their target is.

Gary