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Tuesday, May 14, 2024 10:18:14 AM
Yes the assessment timetable for new active substances and biosimilar products or existing active substances will begin after the validation of the application.
However, that date is January 24, 2024 and NOT as you falsy claim the date NWBO received news of the application has been validated March 7
Now the question is if NWBO has received an RFI. Yes or no. If they have received an RFI then they received it on April 13 2024 (80 days + Jan 24 2024)
In that case the date for approval news will be 210 days + Jan 24 2024= aug 20 2024. Most likely Scenario 1
From everything that NWBO and Les are communicating it seems that they have not and never will receive an RFI in that case the date for approval news will be
at Jan 24 2024 + 150 days = June 24 2024 Best case scenario 2
If the MHRA would still send an RFI today or this week, well than we are looking at fall 2024. Worse and most unlikely scenario 2.
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