Reply To: Supply for Inv Initiated Studies (IIS’s) or Inv Sponsored Trials (IST's)

[Anonymous]

Reply To: Supply for Inv Initiated Studies (IIS’s) or Inv Sponsored Trials (IST's)

Question 1- Typically C, fully labeled per CT country requirements. However, do provide in priority situation B.

Question 2- Typically A, order off that market for them and they apply the label. If we have left over supplies, if material is limited, that are already packaged we could rarely experience C as well. If the sponsor requests a blinded study, commercial material and placebo to match would follow option D.