USRM is currently awaiting RMAT designation which approved (And there is a 90% or higher chance it will) gives it similar qualities as Breakthrough Therapy, Accelerated Approval, and Priority Review. Basically, they can provisionally approve the drug or device for marketing and then provided the drug or device proves safe and reasonably effective, they will gain full approval - generally within 6 months. Other DD:
1. Institutional Loading
2. Multiple Patents
3. Nice ER that showed substantial profits
4. PreClinical Study Results Anyday
5. Form 4s filed by insiders
6. Uplistment
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