Replies to post #54119 on US Stem Cell Inc (USRM)

[NoMoDo]

Is it possible to give full approval while reviewing for RMAT?

If I understand your question correctly, yes. RMAT has a few approval options.

They range from
1. Fast Track - requiring additional testing before they make a determination. May or may not include Rolling Approvals and/or Priority Review
2. Rolling Approvals - meaning they approve portions of the BLA as they get the information in,
3. Priority Review - which would involve assigning an FDA agent to meet with the company on regular intervals to help them along with the process of approval.
4. Conditional Approval - they are also calling this Phase 4. It gives the company the ability to market the product immediately. The company must report safety and efficacy of their drug or device as results come in. Generally the company will be required to report results for 6 months.

Fact Track would be very good, but Conditional Approval immediately makes the company golden.