Replies to post #70787 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Will the FDA people will take 10 months to analyze? Will saying the trial is complete in September be of significance until that analysis is done and approval granted?

The FDA does not analyse the trial upon completion, the company does.

If (and that is a huge if) the trial hits the designated point for unblinding in Sep, an approximate time-line would be:

2-3 months to scrub , lock and unblind the database.

PR for top line results follow almost immediately, so that would be Nov - Dec.

6 months to submit the BLA.

THEN the FDA goes to work. The PDUFA deadline would be 8 to 12 months form BLA submission (depending on priority review). So FDA decision in H1 '18.

Personally I think it is very unlikely to play out that fast, if at all.

[monentum2play]

10 months is a little on average 4 to 6 months. They could be working on it now Linda did say that the FDA has been asking for more data.