Dont know much about them millertime, what I do know is thier...

Dont know much about them millertime, what I do know is thier lead application trial phase 2/3 The FDA recommended they conduct another trial that was in the last half of 2013............... Gamida Cell announced today that while the current single arm Phase II/III study, incorporating a historical cohort as the study control, provides evidence of activity of StemEx®, the FDA has advised Gamida Cell to conduct another trial – a Phase III, randomized, controlled clinical study.
Indeed we had expectations that the completed Phase II/III study will support a BLA submission and allow us to launch the product in the market in a couple of years. Nevertheless, we know from the Phase II/III study data as well as the FDA’s recommendation, that the StemEx® study provides evidence of activity that warrants an additional clinical trial for registration,” said Gamida Cell CEO Dr. Yael Margolin. “We will now regroup and determine how to proceed with our clinical development program of StemEx®. We will also continue to advance the clinical development programs of NiCord® for hematological malignancies as well as for sickle cell disease and thalassemia.”
.............Vin