Replies to post #415250 on NorthWest Biotherapeutics Inc (NWBO)

[Maverick0408]

I hope I am wrong! It’s certainly different than what I am accustomed to with ISO and other regulatory audits, but we will find out in the next week or two.

[exwannabe]

I would normally agree. However, in this case with the HTA approval, and the almost concurrent inspection by MHRA, the approval will be faster. There is some cross-over in standards for these certs, I believe.

Yes, but the HTA does not look at manufacturing at all, and cGMP is heavily on that. So only a modest percent of cGMP has been vetted by the HTA cert.

More significantly is the slipped timeline by NWBO. The inspection was delayed by 6 weeks. But the NWBO estimated date slipped by 2 months. It also had a subtle language change in that they are are only estimating the time to respond to the report, and not the time to get approved.

Sounds like they have some feedback that implies no-trivial corrective actions.

I will be surprised if they are certified by EOY.

[biosectinvestor]

I believe you are correct and that the one certification reenforces those crossover issues unless something completely unrelated would come up.