From Wilson HTM report before ODAC meeting:The ODAC review has...

From Wilson HTM report before ODAC meeting:

The ODAC review has flushed out inconsistencies in the way T315I testing was
handled in the trial; even though all tests were based on the familiar PCR
technique. This is new information that was not known before. FDA will push
ChemGenex very hard on this issue and could require a companion diagnostic
to accompany the product. This would not be difficult to obtain ? commercial
testing for T315I has been performed since 2006 and ChemGenex and a
diagnostic partner could pursue a Humanitarian Device Exemption through
FDA?s CDRH, which does not require clinical trials or effectiveness testing.