US Stem Cell Inc (USRM)

[NoMoDo]

No it isn't.

RMAT allows the FDA to approve with a range of support from fast track - commercialization generally within 6 months, to rolling approvals, and priority review, to finally BLA - allowing the company to market their product immediately and update the FDA with the results of the procedures as they come in (now also known as phase 4). Allowing USRM to market their heart procedure immediately would be the best of all worlds, but even fast track would save the company $10's of millions in further testing.

Myocell was in phase 2/3 when they stopped the trials due to financial constraints. They reopened those trials with the RMAT app, but they have not done anything officially with the trials since reopening. Any work they do outside the country or in RTT states can be used to support RMAT approval.

If USRM were to get fast track, they would likely be acquired by a BP. If they were to get phase 4 approval, they could have their choice of being acquired or they could go it alone as a major player.