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
Highlights Points from WebcastCorrect me if I have misunderstood...
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