Hi All
I spoke to PXS management and this is my take on the process going forward.
- Appeal documents were lodged after lots of open and frank discussions with the new rapporteurs. They believe it did not uncover any major issues and are happy with the submission.
- PXS will meet with the scientific advisory board late September / early October to discuss the CHMP questions. If the label were to change it is done after meeting the scientific advisory board and CHMP.
- PXS then meet the CHMP in October and they should vote again in the October meeting.
Cheers
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