Mjschackl says May. That is only to meet SAWP about defining the...

Mjschackl says May. That is only to meet SAWP about defining the studies to produce the additional data. The data has to be produced after that ! Then another x days to assess the data is adequate. Its not around the corner.

Either this additional data was not provided or not asked for in the first place !

If it was not asked for then I think conspiracy/corruption on the part of the CHMP/EMA to keep a non-eurpoean co out of europe, because another european co has plans for a similiar product. There are alot of medical/pharma cos. in Europe.

If data was not provided then BSI should get the shaft pronto ! or at least a giant firecracker shoved up there ....

This whole thing really sucks !

But frankly withdrawing the request for a scientifc opinion is almost like saying we can't get a scientific opinion. That can't be good. Why would they redraw ?
Why would a doctor use it if it cannot be shown to work. The company needs to clarify this real quick.

I think the company is bitterly dissappointed. And a bit confused. I thought the CE mark was separate to the SO. But excerpt from announcemnt :

"Tissue Therapies (in consultation with the Notified Body, BSI) has withdrawn its
application for a Scientific Opinion in respect of VitroGro® ECM, but not the CE Mark
application. Consequently, the approval (CE Mark) of VitroGro® ECM for the European market will be delayed."

They have not withdrawan the CE mark application but the approval(CE mark) will be delayed. I thhought they were separate ! Ok so if they arent going for the CE mark without the scientific opinion ? Is the withdraw of SO temporary ? Havent they wanted a SO since the beginning ? Isnt it key really to the success of the product. Anyway it sounds pretty scrappy and they are confused and not sure which way to go and taking advice from BSI which is probably cause of all the problems in the first place !

Something has to change. Its not working.