First up - RENE are selling a stem cell kit (through a subsidiary of the US co. Millipore) as a diagnostic tool - for drug companies to use when testing there products. Secondly, RENE are not producing a drug as such - this is a new 'industry' - biogenics. RENE are doing genetic engineering using a stem cell source. They have a patented procedure to multiply stem cell cultures multi-fold (from one to millions). The FDA clearance is for the use of ReN001 (a stem cell line derived using RENE's patented process) in so called 'phase 1 trials'.
... and to continue, the FDA approval will be tacit - in other words as I understand it, trails can proceed if RENE don't get a negative from the FDA. The key date (we think) is the 5th Jan. 07.