Explanation and Expectation, page-46

Hi Pixie,
I quite agree, considering the company's comprehensive answers to the questions! It's almost like the regulators are doing everything possible to hold us up. Anyway, that's my little rant! As far as the outstanding issues go, they can only relate to the answers we gave (or perhaps extension of the use by date on existing stock). No new questions are permitted. I wouldn't expect a lengthy delay in our response unless all the questions require clarification which imo is unlikely. The clock stops until we respond to the outstanding issues and then the CHMP must make a decision within 30 days. This could stretch out a bit though if we miss the cut-off for the monthly meeting schedule.

Looking at past decisions it seems quite normal for the process to take the full 210 days with clock stops at 120 and 180. The good news is that this year there have been 59 positive decisions compared to only 3 negative. Mind you, this applies to new medicines whereas our product is a device with ancillary medicinal substances, but I think it indicates that they are much more likely to issue a positive rather than a negative decision. I'm a bit biased of course

Have a good weekend, and hopefully we'll have some news on Monday!

Cheers,
vango