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FeMike

01/26/24 11:55 AM

#667356 RE: dennisdave #667354

I'm confused, are you arguing with me? What is your stance here? I feel like we agree with each other....

150 days from the day NWBO submitted so (probably) from Dec 21st.

FeMike

01/26/24 12:02 PM

#667361 RE: dennisdave #667354

I mean, I agree with you. I was just saying I found a different, more clear source back on January 4th. Which thankfully Flip just reposted.

The links you keep giving contradict themselves, because that same guidance (150 Day Assessment guidance) also says very specifically:

The assessment timetable for new active substances and biosimilar products or existing active substances will begin after the validation of the application.



So Gov.UK contradicts the hell out of itself.

But the Common Issues: Validation link is very clear in what it states, which is that the clock starts upon receipt of the application, not validation.