we have done a terrible job with the application (most likely)
That's an ignorant perspective. It is one of a kind....comparable to no other app. You don't know if it's good or bad. Possibly a 1.7M pages of never seen before data and you say....WHAT....YOU'RE STUPID
Everyone has an opinion. I've seen everything from the MHRA being bought off by big pharma to we are going for tissue agnostic. In a vacuum of information, its understandable. My opinion is just what George Zavoico said, its taking longer because it is completely new. However, I do think its disgraceful of the MHRA to take this long since they have real world (compassionate care) info at their fingertips and should be able to see no side effects and its effectiveness. But I am not a doctor and not completely cynical yet. I believe it will be approved 100%
It’s hard to believe they did a terrible job with the application when they took over 3 years to submit and hired some of the best consultants to pretty much do the job for them.
The likely reason is that the data is messy and NWBO is unable to address all of MHRA’s concern. However, MHRA continues to give NWBO extra leeway given the political and clinical community pressure. At some point in 2026, the MHRA may be left with no choice but to send a rejection letter.