US Stem Cell Inc (USRM)

[NoMoDo]

VCEL did not get RMAT approval, they got fast track approval and they were in phase 2 when approved. That means that VCEL would potentially save 10's of millions in trial costs, but they still need to get through phase 3 - albeit a faster phase 3 with priority review. It is quite possible that a company getting fast track will not get through phase 3 because of the costs.

With RMAT, there is a range of approvals from fast track to rolling approvals, priority review, to conditional approval (now called phase 4). Phase 4 allows a company to start marketing their product and then report the results that they get.

If USRM gets fast track, the stock will see $5-8 immediately since they were almost done with phase 3 when they applied. With RMAT they are allowed to use non-clinical data - meaning that they can use the results from outside the country. They could realistically commercialize within 3 months after fast track.

If USRM gets phase 4 approval, the stock will see $12-18 immediately because they will be able to schedule the heart procedure that very day in the clinics that are already located throughout the US and there are plans to open 10 more clinics which will also be able to handle the procedures.

These are not made up numbers and may actually seem conservative. Look at PPS spikes for cancer drugs as there is a plethora of information showing PPS after FDA approval. USRM is attempting to solve the number one cause of death with their product and there is no competition currently. The major difference between cancer drug approval and USRM stem cell therapy is that this therapy has little or no side effects. The cancer drugs all have a ton of side effects that might seem worse than the cancer.

The q after receiving BLA, the PPS could be as high $30 - based on additional revenues and the plan for growth that the last K and the recent q outlined.