US Stem Cell Inc (USRM)

[NoMoDo]

The company is applying for RMAT designation. It doesn't take the 3 phase process other drugs will take. If granted, it will have similar qualities as Breakthrough Therapy, Accelerated Approval, and Priority Review.

RMAT is different - and much better than Fast Track designation. It will provide for Intensive guidance on efficient drug development, Orgainzational review, and other actions to expedite review.

Unlike Fast Track, they can use nonclinical information to support clinical evidence - information that USRM already has and would have submitted.

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.

Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Alternatively, they can approve portions of the drug or device or if needed, they can involve senor managers and cross disciplinary project lead for the review team to facilite an effcient review of the drug development program. In other words, if the drug or device looks promising, but they aren't sure whether they should provisionally approve, they will designate FDA people to work with the company to expedite the review.