"Ultimately – I believe – share prices are driven by the value...

"Ultimately – I believe – share prices are driven by the value of the enterprise which, in turn, is driven by revenue and profitability."

Well that's what a value investor says they think. But before that, investors look at opportunity and risk. As we have discussed ad infinitum, MSB has a JV which provides income on achievement of milestones. Once product approval is through, I would think one such milestone has been reached. Apart from that, you have the justifiable economics of putting in place manufacturing and marketing etc. It happens in that order.

"But if product validation is indeed one of the key strategic objectives, then in line with your questioning about Canada and New Zealand, one of the things I’ve never been able to understand is why MSB hasn’t already set up sales and distribution capability in Canada and NZ, where conditional marketing approval has been granted for a number of years now. "

What, you overlook is that the markets in Australia are relatively small compared with Japan and the US? You don't understand the diversion of resources involved? Or that FDA clearances are considered gold standard around the world?
Or that by Japan fast tracking clearances of stem cell technology, it sets a precedent that the FDA is likely to look at?

No, defying all commercial realities of what is involved in establishing the manufacturing facility and diverting resources, you want MSB to be focussed on sales and marketing distribution capability in Canada and NZ....and it doesn't make any commercial sense IMO.

"I would have thought that Canada and New Zealand, with their first world, western-style health regimes would provide as good, if not better, product validation as Japan."

"Well, he would say that, wouldn't he?" - Mandy Rice-Davies re Lord Profumo.

It's about market size and penetration and costs. For my reasoning, see above. You need to take into account market size and commercial realities and understand the strategies of the company deeper sense to be a really serious value investor. This is just playing at the edges IMO because as we both know, MSB is an emerging blue chip stock and the fast tracking in Japan is an indicator that everything may happen much sooner with approvals in the really big markets, than the supposedly "value investors" anticipate.