Replies to post #435580 on NorthWest Biotherapeutics Inc (NWBO)

[HappyLibrarian]

It’s doubtful we’ll see TLD in February 2022 let alone approval.

[skitahoe]

Mi D,

While I wish what you were saying was true, if it were a PDUFA date would have been established by the FDA and other regulators. I'm uncertain about all of them, but the FDA's should be 6 months later, which would be in February. If that had been the case, it should be showing up in the FDA calendar.

I'm of the belief that they're still working on the BLA. Perhaps it's nearly completed, but I would suspect that they want the FlaskWork unit qualified before they make a submission of the complete document. Of course we're uncertain if they've been doing a rolling submission all along.

As I understand the BLA, the company would have needed substantial support from contractors in developing it. Dr. Bosch should be leading the effort. Dr. Liau on the other hand should be the lead author of the Journal submission, and as necessary would be supported by other clinicians, contractors, and certainly Dr. Bosch.

If we're truly near publication of the Journal, I would have to believe that complete drafts have been submitted, peer reviewers have requested changes, or clarifications, they've been made and submitted, and perhaps 98% of it is accepted. Dr. Liau, and perhaps Dr. Bosch, could be involved in finalizing that last 2%. I don't say this as an expert, purely my opinion of how these things are done. I believe the peer reviewers must be 100% satisfied before the Journal goes to press.

Gary

[Chiugray]

I share your feeling on this build up of events leading to a crescendo in late February. Thanks for laying out your view of the timeline and events. Counting months, it makes sense to me. I am into the rabbit hole.

[Doc logic]

MI Dendream,

BLA fees are zero for orphan indications but MAA fees or others related to manufacturing may be in play. Best wishes.

[Poor Man -]

I also strongly suspect the BLA was submitted. There is an indication that UK approval is what they’re first waiting on first. If that’s the case, the applications for each of the various RAs were likely prepared by outside consultants and submitted around the same timeframe.

By May, LL had presented the validated hybridization database twice and the SAP design once. There was a big June warrant exercise which could have paid fees and then the package acceptance. If this is how things played out, then it puts February in play for approval which may have opened the door for a coming soon campaign, beginning with the ABTA program