So the problem lies in: "" So the delay has nothing to do with...

So the problem lies in:

""
So the delay has nothing to do with the actual trial but lies in the manufacturing process - what data are needed, how stabilty can be tested and how quickly an appropriate quality assurance method can be approved and implemented.
"
Good to know that the allusion to data, has nothing to do on clinical studies data on the trial size.
My question was related to the comparable US sample, that even if the two analysis are on different regulatory body, still are visible even from the EMA people.

Tissue Management is good too and capable, especially on the scientific side, but the world out there is complex and COSTLY and we have not unlimited energies.
We have not UNLIMITED FUNDS, and each month in a delay situation (i.e. we will seating with the scientific Commitee only in May to define the questions, and then we will have months for responding, and than we will sit again with them and see if it all OK, if not we will go back for testing and so on until MAYBE a CE decision day) take us to have less cash and in consequence increased business risk.
Does anybody know, what is now the certain time-frame path to approval? We are over the 210 days, and it looks now we are in the Purgatory of the indefinite time EMA process.
Does exist any material on the time frame in this EMA further analysis studies?

The issue here is NOT if the protein works and is stable, but the TIME that will be required (that is not certain) to eventually complete the process.
If we have somebody that will bring us by hand in this process, and with a large unlimited pocket full of cash, I would say NO PROBLEM, but with our SMALL MICRO size, I have to say WAKE UP!
We are no body in the market.