This is like a loooong nightmare. You know, where you're running...

This is like a loooong nightmare. You know, where you're running through a tunnel but just when you think you're close to safety the opening recedes away again.

Back in mid-2012, "CEO of Tissue Therapies, Dr Steven Mercer said that the Company had answered in full all questions raised by BSI.”

Then later in 2012. "...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."

Even down to the meeting being shunted due to Xmas 2014 EMA staffing issues!

This must be driving Mercer & co crazy. Without hindsight, I still think it was the right move to go for CE Mark approval first. But I hate to think of the number of amputations that may well have resulted from non-healing diabetic ulcers that could have been healed in the last 3 years.