Replies to post #793331 on NorthWest Biotherapeutics Inc (NWBO)

[HappyLibrarian]

Per longs, they took extra time, and brought in a second set of consultants, to insure the MAA was perfect. They argued there would not be much (if any) time spent responding to RFIs.

And now it well over a year with LP on the clock.

Clearly there is a major issue.

It was also repeatedly pumped that NWBO had a good relationship with MHRA and that MHRA was eager to place the UK in the leading role on immunotherapies.

As with so much other positive speculation, this too has come to nothing.

At best, NWBO has been treated like any other company.

[QL300]

If there was a major issue, you would have seen a denial already. Is NWBO so special that they get to prolong a denial for close to 2 years? The longer this goes on, the higher the probability of approval. I think we'lll see an approval very soon. 

[dennisdave]

“MHRA has only been on the clock for 210 days”? That’s complete nonsense and a lie.

The MHRA doesn’t have a public clock like the EMA did pre-Brexit. Nobody outside NWBO or the MHRA knows how many assessment days have actually run and quoting “210 days” just shows you’re applying your rear end fantasy again.

LP already said the first RFI was delayed due to MHRA backlog. Every RFI cycle pauses and restarts the review. Three cycles (standard for a complex biologic) = easily 18-20 months total. That’s not “a problem,” that’s normal for first-in-class autologous therapies. If the application was in hot water the file would’ve been rejected long ago. The fact that the review is still active after nearly two years says the opposite MHRA is refining, not rejecting.

Had NWBO received a negative recommendation letter than they have to disclose that in the last 10Q and I have not read anything about that

Clearly there is a major issue.

It does not surprise me good luck with that