"IMO, the trial results are the least important of all upcoming major developments."
If the trial results are great, that will have a major effect on two on the "biggest impacts" that you mention. That is, the partnership - better results, a better deal (and a deal more likely) & the approvals - the bigger the benefit the easier it is to get approval.
As for being classed as a device, that is important of course. As all of the healing is done by the patients own cells, it's pretty safe to say it will be ok. There is no injection or oral delivery method, so it's similar to using a cream. It already has device classification in some countries.
The trial results will determine just how big a commercial product we have here. Will it be a $1b seller or a $10b seller?
Buy & hold
TIS Price at posting:
59.5¢ Sentiment: Buy Disclosure: Held