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Red_Right_Hand

02/21/25 4:27 PM

#750597 RE: sharpie510 #750595

Probably a change to something in Annex 1 or Annex 2, which are referenced but not publicly available.
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H2R

02/21/25 4:39 PM

#750599 RE: sharpie510 #750595

Sharpie,

Could the fact that it's the 'Human' (not the 'Investigational') Legal Basis be linked to the MHRA manufacturing inspection related to the approval process?
Senti and another MB member seem to indicate a 'delayed' inspection or such a bit earlier.
Cheers!

Best of luck to Patients, NWBO, and Longs!
Bullish
Bullish
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Lykiri

02/21/25 5:15 PM

#750607 RE: sharpie510 #750595

sharpie510,

I suspect that the Class C cleanroom has been fully completed and is now included in the updated MIA, and it is likely to be included in an updated GMP certificate as well.