Given the slow news and previous questions about where we are at...

Given the slow news and previous questions about where we are at I thought I'd post this example of a different application which is following the same procedure as VG.

This was reported in the CHMP Agenda a couple of days ago:

An ancillary medicinal substance used in a medical device which is currently seeking a positive opinion is Thrombin which is, in some way, being used in surgical procedures. This product is ahead of VG in the process. The "List Of Questions" for the device was adopted by the CHMP on 19/9/2013. Our list of questions was adopted on 23/1/2014 (4 months later).

Whatever company owns the device submitted responses to the questions shortly before 22/2/2014 so it took them 5 months to get their stuff together. We can only hope that it takes TIS and BSI less time than that.

On the other hand, the company which owns the other device now has to contend with a "List of Outstanding Issues". I would hope that TIS and BSI are diligent enough in their answering of questions that there won't BE any outstanding issues for VG.

So the other company has to now spend time addressing the issues and dealing with further delays of months duration.

Not news that is positive for us in any way but hopefully gives a realistic possibility for what could be coming our way so no-one is taken by surprise.

Rev