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Posted On: 05/08/2019 1:59:17 PM
Post# of 149742
One thing I just noticed different with the ODD statements between the 20 Feb and today's PR is the initial one in Feb stated TNBC where today's said mTNBC. I wonder if this addition of metastatic means the previous request needed resubmitted?
Seems minor, especially since 95% of TNBC is metastatic, but may be important as they are pursuing MOA for all metastatic cancers and this may be required to distinguish the other 5% or the FDA is requiring for ODD approval?
Additionally, it would be nice if they would some of those creative and catchy terms like 'functional cure' to the HIV mono and/or cancer PRs (if/once clinical results are available).
Seems minor, especially since 95% of TNBC is metastatic, but may be important as they are pursuing MOA for all metastatic cancers and this may be required to distinguish the other 5% or the FDA is requiring for ODD approval?
Additionally, it would be nice if they would some of those creative and catchy terms like 'functional cure' to the HIV mono and/or cancer PRs (if/once clinical results are available).
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