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!!
TIS Price at posting:
39.0¢ Sentiment: Hold Disclosure: Held