Replies to post #667581 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

MHRA has more staff and more accelerated paths in 2024. One way they expect to get high impact therapies done faster is to put veteran teams on throughout the process.

[Horseb4CarT]

Doesn’t the 150 day max apply?

And dcvax is a Promising New treatment, I think the first to be so designated.

For these reasons I think a year is off, and maybe I like koolaid but I feel a decision by March-April is coming!

[GoodGuyBill]

The MHRA will approve DCVax-L around mid-March, give or take two weeks!

[dennisdave]

please explain to me this then. As of Jan 1 2024, the MHRA has put in place a new 150 days +60 days clock stop = 210 days review process in place FOR NEVER approved drugs (if already EMA or FDA approved then the time span is actually within 60 days review)

The UK Medicines and Healthcare products Regulatory Agency (MHRA) expects to process all “priority and good quality dossiers that are compliant with legislative data requirements” within 150 days starting in 2024. UK statutory timelines give MHRA up to 210 days to process national applications for medicine approvals, but the agency has targeted a 150-day turnaround for some applications in recent years. At the end of 2020, MHRA published guidance on its offer of a 150-day assessment timeline for high-quality marketing authorization applications covering new and existing active substances and biosimilar products.

https://www.raps.org/News-and-Articles/News-Articles/2023/6/Euro-Roundup-MHRA-targets-150-day-turn-for-priorit

But then as you claim to make a complete ass of themselves (the MHRA that is) by taking x2 longer than 150 days? In other words, you are making 2025 up. The ONLY delay that could happen is IF NWBO would request a 60-day extension on the clock off RFI which btw the MHRA is very reluctant to provide.

So your 2025 is big BS and nonsense