If the FDA examined the data and is looking for statistical relevance, it by definition means they are attempting to prove/dis-prove an anomaly. Meaning the early data is outside of the bell curve for established treatments. From that one could infer that the early results were not only good, but game changing. If the additional patients confirm this, well, the rest will be history. Best of luck to you all, and most importantly to all of those patients in need who may very soon have a life changing option.