Replies to post #570043 on NorthWest Biotherapeutics Inc (NWBO)

[DrHigh]

I honestly do not believe he knows. Why would he need to know that? His job is to babysit retail investors.

[improving]

I'm wondering if a slightly sophisticated two option answering machine might not be able to replace DI

Now this is a rough draft, and certainly no pride of authorship, but i'm thinking along the lines of:

For Questions: Press 1 and record your question at the tone.
For Answers: Press 2 (and this is where it gets tricky) stone cold silence for the first 90 seconds (no need to do the music thing), and then if the caller remains on the line, a terse, expressionless "I can't answer that." Followed by a heartfelt "thank you" to the caller for calling, followed by a "and don't forget to vote at the annual shareholders meeting."

Just putting it out there.

[Doc logic]

reg2015,

An IND is for a new drug being proposed for investigation in clinical trials. A BLA is for approval to sell a product that has come to the end of trial(s).
Dave Innes can not disclose anything not already publicly stated about BLA/MAA progress with L or Direct unless NWBO releases that info to all publicly in a PR or similar.
Don’t feel put off. NWBO is in a very tight lipped and defensive situation right now with where they are at in “the process”. As you might have guessed, those of us on the message board that want to know where NWBO is at in “the process” are trying to tie bits and pieces of info together that might fit a given pathway. A rolling review pretty much puts everything of interest on the table at the same time as “in process” but as flipper44 has pointed out, a definition of when “in process” begins appears not to be specifically defined. My personal opinion is that once an approvable data set is presented ie top line data plus, and an approvable manufacturing process is presented (artisan method) that this would constitute an “in process” situation. This does not mean that any currently approvable manufacturing process is the final one that might be submitted with the final completed submission when L is approved for sale if an improved process can be validated prior to that decision point which is really what everyone wants. I believe Edens is in the process of catching up to an expected MAA approval based on the old artisan method and that the MAA is not being held up by Edens, rather Edens is trying to catch up to an “in process” rolling MAA based on manual manufacturing with the renewed Specials license acting as a kind of placeholder announcement for stockholders.
I could be completely off base but we all know that everyone wants closed system manufacturing and the U.K. wants this available to as many as possible as soon as possible with a price and manufacturing process that makes this possible. Blessings and best wishes.