Replies to post #406988 on NorthWest Biotherapeutics Inc (NWBO)

[CherryTree1]

OK I won't disagree with that danielboog.
I think the closer all of that is aligned:
TLD, journal article and approval the better.
Is that what you think the delay is waiting for approval or at least until the FDA Biologic License Application as been accepted?

[martyDg]

I call it Bull crap! Before we're only waiting for TLD and then Publication and now BLA approval to release TLD. Come on guys. Adding a new objective on top of the unfinished objective just to justify the delay is another bull crap.

[Doc logic]

danielboog2,

The other validation route is to wait for manufacturing certification with BLA waiting with fill in the blanks for prior art and closed system options available to insert. Either way, certification starts increased Specials manufacturing output and that brings validation too.
NWBO pointed to initial treatments being done under the old method but if there has been a safety push by regulators then maybe they can get certification with Flaskworks done before the BLA submission. Will the national priority designation help in this regard? I don’t know but maybe. Best wishes.

[Fireman02360]

This is one of the most absurd things I have read on any message board.

BLA and Peer-reviewed data in a Journal are two very different things (while I agree fundamentally they can be similar in the contents and they can happen simultaneously) A Company tying one to another to "create" credibility for a peer-reviewed Journal publication is ludicrous thinking. Do you have examples of this ever being done before?? If so I would love to see it. My bet is you dont, and your just grasping at straws here. I know of zero cases of such. Regardless if a BLA is filed, if the Lancet is the chosen publication for release of peer-review, this stock rockets if the "Conclusion" portion is good. GBM is deadly in almost all cases. If peer-review is good it will be approved shortly thereafter. But the Company (or journal) holding up one for the other is flat-out absurd. The Lancet doesn't have to prove anything to anyone. Its the cream of the crop in terms of credibility and trust. Nice try though.

The truth is nobody know, it could happen tomorrow or next year. But your reasoning isn't one of them.

-Fireman

[antihama]

Your thought process is so wrong w regards to BLA and TLD.

[biosectinvestor]

Typically they'd not go in that order, but I do see your point.

[biosectinvestor]

I could not see it accepted and pending approval before TLD announcement, but if they were working it simultaneously that would be great. Challenge is, it is said to take substantial resources to prepare and it definitely is not mentioned as part of the process pre-TLD. I could see them wanting to be discussing the process with regulators as they are working now on manufacturing and probably, as per their financial filings, getting fast track or priority status of some sort.