Replies to post #685001 on NorthWest Biotherapeutics Inc (NWBO)

[Nemesis18]

It’s always everyone else’s fault, rather than NWBO’s !

Will it be the MHRA’s fault also if the MAA is rejected ?

[exwannabe]

You can argue about the approval of the Aduhelm drug against the advisory committee advice and that would be a legit argument. That also lead to investigations etc.

I can think of 3 controversial decisions in the last several decades.

The one you list where Biogen (a BP) had their drug conditionally approved.

The approval of Sarepta's (not a BP) Duchenes MD treatment for young boys

The approval of the "day after" plan B drug that was initially nixed by the political head of the FDA (who has never done so before AFAIK).

So, one political, one pro BP, one pro smaller company.

Out of thousands. While MHRA approved 8 new drugs last year that were not rubber stamps of EU approvals.

[skitahoe]

I may be mistaken, but I don't believe the tiny biotech's pay nearly as much as BP's do for filing, or other fees that are part of the system. The BP's have always been thought to have substantial influence over the FDA as they pay so much of its budget.

I don't know if, or how much NWBO must pay to file, if anyone does please let all of us know.

I don't believe that the cost of filing is delaying NWBO at all, I still believe they want the EDEN qualified to meet US commercial demand prior to approval, and their filing will be at a time they are reasonably certain that will be achieved. Remember, the PDUFA date is set 6 months after the BLA acceptance. If they felt certain their production facility would pass inspection 4 or 5 months after filing, they could do so before everything was deemed accepted. I also still believe that US production will probably be done by CRL, so that relationship would be formalized prior to submission, if I'm right.

Gary

[TTsr]

I believe filing with the FDA is around $3.2m, UK $150K… pay to play?