those 28 little words

"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."

A possible additional barrier mentioned by SM in the announcement, but not explained or given any context.

Another review of the manufacturing process??

Under what circumstances? How likely? How long?

SM should be asking these questions now so he can be prepared for the worst.