Ok so we have clarity and a sense of direction now.- MHRA...

Ok so we have clarity and a sense of direction now.

- MHRA confirms classification as Medical Device Class 3, Device Rule 13.

- MHRA has decided EMA review of manufacturing & quality is required could take upto 210 days (key word upto)

- EMA is a desk review, no onsite inspections required.

- Eurogentec & Catalent are ISO, EU & FDA certified & licensed

- EMA examination will provide a definitive regulatory approval for all 27 EU member states.

- EMA submission is substantially complete, preparation work has been ongoing since August in case EMA review was required.

- EMA dossier is an international standard this format is understood by TIS and was used for the 1st clinical trial of VitroGro to Health Canada.

The real key in todays announcement is the following "The review start date will be advised to Tissue Therapies by the EMA" .. Ok what is the date ?

The news will come as disappointment and frustration to many no doubt. I guess TIS management 'rolled the dice' so to speak and got it wrong to pursue Device Rule 8 & will be held accountable for the judgement call made.

However I am in TIS as a long term holder and my judgement call 5 years ago to buy shares on the basis VitrGro will be a commercial product one day, has not changed. The length of time might have, however I will continue to ride the wave as I fortunately have time on my side.