sifting through the mess

Just thought I would briefly put into words my understanding of where we are currently sitting based on some research over the last couple of days.

The application to EMA was not about classification of Vitrogro as a device. VG had already been classified as a Class III device by MHRA. The application was about an ancillary medicinal substance incorporated into the VG extracellular matrix and was a final look into manufacturing process to ensure safety.

As per the announcement, VG was referred to a Medical Devices Group to look into whether VG could be classified as a device. Obviously this was unexpected as it had already been classified as such. As it was unexpected there was insufficient documentation before the Group to reach an informed decision and therefore they voted that it could not be considered as a device.

As per the announcement, BSI were informally notified of the result of the vote and this was passed onto TIS. There has been no formal decision by the EMA which has been transmitted at this stage.

I'll leave it to your imagination to conclude what steps TIS may have taken since being made aware informally of the vote. Suffice to say, if you can think of appropriate steps that could be taken in this scenario, then those steps have probably been taken.

We we are right now is playing a waiting game. It is pointless looking at what might happen 6 to 12 months from now because until a formal response is received from EMA, the next course of action is unclear. The response could be: 'we have decided VG is a medicine and not a device and therefore you need to conduct more trials to satisfy approval as a medicine'; OR 'we have decided VG is a device and the start date for dealing with your application is....'; OR 'please send us a submission regarding why VG should be classified as a device and noot a medicine'.

Therefore we wait to hear. It seems that responses from EMA are tied to CHMP meetings so it is possible we will hear something more formal and informative within a few days or we may have to wait until after the April meeting.

We've all been hit by the drop in SP but please also spare a thought for TIS management. I know there is a tendency to look for someone to blame but my belief is there is nothing which could have been done to prevent this latest red herring.

DYOR

Rev