Deficit accumulated during the development stage (29,174,401)
they have worked miracles in that most companies spend well over $100m to get their first FDA cleared device
Nothing has been ill-gotten the Agency is in a bind now and getting more and more annoying - read the restrained and professional submission form the BIEL attorney which around pages 21 and 22 is calmly pointing out the fact that the agency is just making stuff up and exaggerating at all turns.
here is an example:
Again, the hyperbole and exaggeration contained in the Division's Brief is outside the limits of permissible advocacy and unnecessary to the case.