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exwannabe

02/28/23 8:09 AM

#571867 RE: X Master #571866

Agreed. And per that LP lied.
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dennisdave

02/28/23 8:14 AM

#571868 RE: X Master #571866

They are 2 process that can run concurrently but the MIA approval must complete first or at the same time.



Thats right. Unfortunately, Linda apparently thinks, given her statement at the ASM, the MIA needs to be concluded prior to MAA submission which is incorrect. I hope NWBO has submited the MAA already but I am pretty sure they would have PRed this. What I think and really hope is that after MIA NWBO will submit FDA/MHRA and EMA at the same time.