NorthWest Biotherapeutics Inc (NWBO)

[Umibe5690]

IMHO, no not necessarily. They still might make some additional tweaks. Who knows with NWBO?

Anyway, this may have been an iterative process with give and take during the SAP drafting process. RAs may have made comments/suggestions along the way. Note that they have orphan status. This allows for frequent communications at least with the FDA which is the more important RA for NWBO. They may have presented the final draft already and may not expect any further commentary. Accordingly, after a short "grace" period to allow any final comments from the RAs, which they likely do not expect, they move forward.

I think "soon" has greater meaning and timing is pretty much in NWBO's control. I don't know if TLD will issue in 2019, but I am rather confident that it will issue prior to the ASM. Any day now, does not appear to be far fetched. I get the feeling they are confident of results and did not see the need to update blinded data. Why do it if TLD is just around the corner? I would be more concerned if they did do an update as this could possibly signal further delay in TLD revelation.

I finally think all is looking pretty good. Hope for a nice Christmas present--especially for patients with this dreaded disease. JMHO.