After re-reading the Q&A explanations again I ask the following.
The application of to the EMA has been basically refused because they have decided that the trial design was insufficient to deliver the information required for a scientific opinion.
I assume that the application was read in full, and understood. I assume the trial specifications were there in bold type as the backbone of the application.
Surely the EMA could/should have seen and said at the outset that "Your trial has insufficient parameters to provide the information needed to give an opinion."
Why did they ask the company a list of 30 complex questions, over several stages of the application when regardless how well they were answered there was never a possibility of a positive outcome.
Vindictiveness? Possible, after being forced to accept it as a device.
Incompetence? Possible, when you seemingly have no one to answer to.
I find it a little bit inconceivable that they have stretched the process to the absolute limit and then denied an opinion because of a fundamentally major issue that should have been apparent at the start.
Perhaps the EMA has flexed its muscle, and TIS is feeling pretty bruised and weakened from the affair and now is in a position of "yes sir, what ever you say sir". Instead of saying "If the trial design was not sufficient and never was going to be accepted, then why the F*** didn't you say so in the beginning, instead of having us waste all this time and money chasing something that was never attainable? See you back in court ****".
Of course we don't have all the detail and fine print of what has gone on over the past few years, but on the basis of what we have finally been told what has happened I'd say there is a pretty strong case of either purposeful prejudice, or incompetent prejudice.
Either way I would say they have a case to answer. Comments please.
TIS Price at posting:
8.8¢ Sentiment: Hold Disclosure: Held
