NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

In the case of IND submissions a 30 day period is established for FDA review, if they don't act in that time it's presumed to be approved. I don't know that this can be applied to a SPA, but if no dialog is underway with the FDA, perhaps doubling that to 60 days might be smart, but more than that would seem excessive. On the other hand when a BLA or NDA is submitted the FDA has 6 months if its got priority, and a year if it's not, so a case could be made for longer.

I hope they can speak, so no doubt is left as to the acceptance of the SPS, or modifications requested.

Gary