News Focus
News Focus
icon url

j333

12/29/25 7:26 PM

#805301 RE: j333 #805300

"Kalinski is returning to Pitt, and it sounds like NWBO will be making DCs for his trials and using the Pitt facility as a hub for compassionate use cases across all solid tumors."

I do believe she also mentioned that Drs are requesting it as well. Just adding some seasoning to the prime rib.
icon url

learningcurve2020

12/29/25 7:28 PM

#805302 RE: j333 #805300

Everyone here already did their dd on that a year plus ago and came up empty. Also consider the large majority of biotechs / pharma submit to the FDA or EMA first, so MHRA pushes them right through. She’s talking out her —-
icon url

SkyLimit2022

12/29/25 8:00 PM

#805314 RE: j333 #805300

j333,

That’s a very good question…

Here’s one recent example for EMA/MHRA approval:

Biogen’s MAA was accepted for review by the EMA in 2022 & the company received authorization for exceptional circumstances in 2024, followed by MHRA approval in 2025.

Biogen Press Release Dec 5, 2022

MHRA Approves Tofersen July 28, 2025

Bullish
Bullish