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RequestNotes

Status

From the Rare Disease TAUG

1st IS.xpt

Rare Diseases Therapeutic Area User Guide, section 9.1, In Vivo Gene Therapy (Spinal Muscular Atrophy).

Status
colourGreen
titleResolved
  From the Rare Disease TAUG

  • Example added to the SDTMIG v4.0.



From Stefan Konermann.

2nd IS.xpt

  1. Email from Stephen on 2023-09-01.

    2023-09-07: 

    •  Team agrees to add ISTEST = Cytokine-secreting T Cells
    •  Team agrees to two ISCATs= VECTOR-INDUCED IMMUNOGENICITY and ANTIDRUG IMMUNOGENICITY.
    •  
      Status
      colourYellowGreen
      titleFollow-up NeededDone
      Action Item: Jordan to add this example to the SDTMIG v4.0. 

Status
colourGreen
titleResolved
 


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