First, RMAT allows USRM to commercialize Myocell while conducting a phase 3 study. USRM, to this point did not have the funds. RMAT changed that.
USRM applies for RMAT but FDA says your trial is not active. You qualify but you need to be reactivated.
USRM applies for reactivation and FDA gives USRM reactivation status. (done)
Wait, FDA is concerned about the ability to fund phase lll.
USRM to FDA, we have a $5 million dollar commitment for the study and we are profitable. (done)
FDA, your approved to sell your product while conducting phase lll.
Just my speculation but everything makes perfect sense to me. We are talking about the government.
USRM has already proved safety and efficacy. USRM was already approved for phase ill/lll trial. (done)
Its all about paperwork, protocol and covering all bases.
This is the way I see the events regarding the FDA regarding one of USRM's protocols. We have more and have already broke ground in the middle east. So much happening here, 10 clinics being built over the next 3 years China partnership giving access to USRM therapies. Building a clinic in Kuwait city, Kuwait.
I could go on but this is the small picture I see. It only gets bigger.