Replies to post #252799 on NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

And as usual whatever little management says is always vague . Why couldn’t they at least say which month was it submitted if not the exact date .
Several steps and each being a multimonth process basically has bought them several years of wiggle room
Honestly if it took them almost a year for SAP ( and I can’t fathom a reason why they shouldn’t have been writing it last year ) , do you think it will take any less time to write BLA for 4 RAs ?

[hyperopia]

Thank you senti. Your table is so much better than mine. ; ) I thought I read somewhere (maybe Ihub) that it was a 30-day review, so knowing that it is actually a 60-day review, it makes what David Innes said about whether to wait a little longer make more sense. No, we don’t know exactly when it was submitted, but we can probably narrow it down to a couple months. (AUG/SEP) And thank you for pointing out that the manual is outdated (2013) so the part I copied below may not (but probably still does) apply.

Presently, CDER does not have the resources to meet all listed timelines, and must balance this work with other responsibilities, including NDA/BLA review and oversight of postmarketing safety. Meeting all the dates specified in Tables 6 and 7 cannot be accomplished at present.