FDA have told Telix that there are no issues in the non clinical and clinical data, the sole issue is in the filter sterilisation validation on dispensing the product as party of a larger piece of equipment.
This is great news, once they resubmit (with the new data on the filter) you could almost consider this one approved and gaining the data on the filter is standard stuff.
Cheers
Ann: BLA Filing Update for Renal Cancer Imaging Agent TLX250-CDx, page-65
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