I just see the facts based on discussions held with EMA past...

I just see the facts based on discussions held with EMA past related very knowledgeable people.
If they tell me things, it is in the interest of this forum readers to know and make related questions. It is a fact that is hard from Australia to have a good perspective. Consultant and advisers exists just to make money, but do not share any responsabilities for any type of errors.
Consider as an example the substantial fees paid to advisers in Europe during Tissue Therapies times. As you are an old timer you know the truth about the EMA saga, appeals, outcomes and then the final EMA response. Dr. Mercer was led by the multitude of advisers that got paid, but in the end all these advisers led to a disastrous result in term of trial completeness. The EMA past referee that I have consulted clearly has advised that was silly not to follow the medical device path from the beginning considering the presence of the IGF-1 factor in the device.

We all have to be ready to be tested.
It is a fact that the wound care related field is very competitive and things can go odd very easily.
Was really a good idea to be compared to a placebo cured with a good standard of care?
Is the cause of a good placebo patient response to a too good dressing used in the standard of care?
What has been the rate of wound closure, rate of healing, carbon testing wound exudation test, quality of cicatrization of a no treatment and a Vitrogro treatment?