I don't know if holders have seen the latest Bioshares report...

I don't know if holders have seen the latest Bioshares report that came out yesterday, it gives some insight as to what's happening. I'll put a few points below:

1. It talks about the rule 8 & 13 classification that everyone here knows all too well about.

2. It says that the MHRA confirmed with BSI's quationing that rule 13 applied, so the notified body requested a manufacturing data review from the EMA, rule 13 mandates such a review.

3. It then says that the EMA, "following an ‘informal survey’, replied that the majority of their committee members disagreed with the classification of VitroGro as a medical device, insisted instead that it was a medicine and refused to proceed with the manufacturing review"

4. It says that TIS however, had received in writing a statement from the European Commision legal unit saying the EMA is not a competent authority with regards to clarification of products.

5. It states that TIS are now applying pressure for the EMA to proceed with the manufacturing review so they can finally get the CE mark. They are in the process of demonstrating they have "exhausted all channels available to it to proceed, whereupon it will take action against the EMA in the European Court if they continue to refuse to proceed with the manufacturing review".

6. It says that TIS will be submitting an application for a large double-blineded pivotal trial next month with the FDA. It goes on to talk about the past trial results and that Mercer wants to exceed expectation of the regulators.

7. TIS has completed a healthcare economic modelling study in the UK showing a 51% cost saving against the standard of care, further studies are to happen in UK and Germany. It says the company is also looking at burns and consumer applications.

It's good to see they have done some of the studies because that is also, from my past understanding, needed to start sales in these particular regions. Still seems to be some way to go if the EMA don't do the manufacturing review.

Good luck holders.....