As another broken shareholder of long standing, I'd put an...

As another broken shareholder of long standing, I'd put an immediate clamp on any expenditure on FDA. i.e NIL, until EMA is totally fixed with the European market established & profitability understood.
Euro market is 300M population, but with that stamp, many other countries will permit its use or turn a disinterested blind eye to its importation. Say Asia & Africa?
It depends on how much cow-towing TIS wants to do to maintain an image of scientific integrity for its staff, by having immediate bragging rights to " USA's FDA approval".
Sure that will attract a buy-out, but up to my neck in crap, I can wait for FDA to be achieved on the back of profits from EMA
Will they bend over for their shareholders and relax the rules? Let our patents be sufficient.
The other side of the world - USA - can wait, till we've broken the back of widespread proof of safety & efficacy in the rest of the world. South America & Canada will likely accept EMA, anyway,IMHO.
Put our cash towards developing markets that do not need FDA approval. They are huge.
I think there is also a likelihood of developed countries relaxing the use of non- final- approved "drugs" in life threatening situations. USA has already begun. Surely chopping off legs is life threatening?
My fear is that we are still in the hands of scientific bureaucrats, lacking any entrepreneurial flair.
Cheers, Japes.