EARLY ROLLOUT POSSIBILITY.
That's what I was referring to, as well.
Yes, they explicitly mentioned the did not proceed with phase 3, and want to work on a rollout(maybe limited) process, based on holding the RMAT approval, and that is the definition of RMAT. (FDA acknowledges taking the risk, when the benefit weighs out)
If it doesn't workout, they will move on with a strategic partner, and who doesn't want to partner up with a gold mine...
Again, the mgmt know they have the ACE card, and not willing to sell it for cheap, that's likely why they are negotiating with FDA, prior to partnering up.
So, to recap.
They are looking for a early rollout. and IMO, FDA may give them a green light this year to give approval after safety results available in Feb 2018, and by early Q2 next year this is a few Billion Dollars company, upon approval.
And yet this is the beginning. They will sell worldwide in the next 5 to 10 years. Both MACI and X...
Most of my retirement is in this fund. My kid's fund is right here too.
We hit the jackpot. It just takes patients.
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