ema referral is redundant

A friend put me on to this. Looks like an amazing product. So much potential.

The regulatory delay concerns me though.

"However, it is possible that the MHRA review may result in a further referral to the European Medicines Agency (EMA) for a review of the VitroGro® ECM manufacturing process. EMA is the European Union health regulatory agency."

That's from the Annual Report. If referred to the EMA, it seems people are projecting a delay to late November - or even December.

According to the EMA Referral Procedure, found here:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000150.jsp&mid=WC0b01ac05800240d0

"There are a number of reasons why a referral may be started, ranging from concerns over the safety of a class of medicine to disagreements among Member States on the use of the medicine"

It doesn't look like there are any safety concerns, and I think 'use' is pretty straightforward, so I find it hard to believe the EMA would be interested in reviewing VitroGro. And it isn't really a medicine you ingest or inject in the conventional sense.

Very puzzling. As an outsider looking in, the whole delay is based on a minor technicality over classification and not any genuine issue requiring referral to a higher authority.

List of referrals can be found here:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/referral_search.jsp&mid=WC0b01ac05805c516f

VitroGro is nowhere to be found.