Yep, single issue with a small filter.
Routine study that is regularly performed needs to be performed and documented because its a biological product. They effectively have to swab it and see if any bacteria grows (not exactly but you get my drift).
The filter is widely used and is highly unlikely to cause any dramas, its just a study that needs to be completed and documented as part of the submission.
If anything, the call should have investors buying this morning. CB was frustrated with the minor hick up with third party reliance but stated the FDA has advised directly of no other issues and once resubmitted the "timeline for commercialisation is modest".
The 90 day push back should be worst case. They were careful to over quote on the lead time was the implication.
Ann: BLA Filing Update for Renal Cancer Imaging Agent TLX250-CDx, page-66
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