Ann: BLA Filing Update for Renal Cancer Imaging Agent TLX250-CDx, page-64

Highlights Points from Webcast

Correct me if I have misunderstood what was said !!

* Area of Issue >> Membrane Filter Micron Filter >>> test for any bacterial potential say 2 weeks straight forward issue

* In parallels.. Investigation back office on why this happened !

* Single issue, straight forward mediation with FDA, timeline back dated not new start date !

* Whole process .. once TELIX ready .. FDA meeting expected to be granted quickly to finalize

* Have to resubmit the BLA, FDA then to review .. should be just a quality check only by FDA !

* CB calls it an " Unfortunate and a single issue only " NO other concerns indicated by FDA !


Onwards to FDA Approval in the near future

All Good