change in medical device classication?, page-14

As a result, the MHRA has decided that a European Medicines Agency (EMA) review of manufacturing
and quality data is required and this will take up to 210 calendar days. The review start date will be
advised to Tissue Therapies by the EMA. The EMA review is a desk audit; no on-site inspections are
required.
The management of the Company is confident in the VitroGro® ECM quality and manufacturing data

this review may only take a week but might not start for 6 months.

is there a chance that that after 210 days they wont be happy with the data?
thats my fear!!