Rather than expecting everyone to read through the 9 published...

Rather than expecting everyone to read through the 9 published reports from the EMA regarding ancillary medicinal substances in devices, I thought I would summarise for you what I believe will be the next steps and the next annoncement and when.

After the procedure starts (early September)the Rapporteur and co-rapporteur (the 2 people responsible for the first look at the review) will produce a report. If the VG procedure follows every other procedure this first report will be circulated to all CHMP members within 3 months.

It should be noted that for every single previous review of this type, the matter was dicussed at the regular CHMP meeting 4 months from the start date and that at that time a list of questions was submitted to the applicant.

IMHO we won't hear anything further until after the CHMP meeting at the end of December at which stage there should be an announcement that questions have been submitted.

As always DYOR. The above is based on historical data and there is always the possiblity that VG will move outside the norm.

Rev