This is not correct, FDA policy says that LJPC has 10 days to request a meeting. The FDA will then set a meeting within 45 days or less.
Hang in there longs, this drug works and it will simply take a bigger and better designed trial to show its significance. Lupus is too complex a disease with too many variables and random remissions and relapses so it takes either many patients or many years to do it properly. The mitigating factor of course was that both test and control groups were immuno suppressed with secondary medicines dampening the effect of Riquent. All these issues are dealth with in the next trial. In either case even both of the former smaller phase 3 trials showed positive improvement with statistical significance in the first year. Since this is the trial duration of the final trial it is simple to deduce that Riquent will be successful. So all longs just hang in there, don't take losses, all good things are worth waiting for, and those who believe in this technology will be rewarded in the end...
I have read most of the trial results and in the last one, I did not read anywhere that at 6 months or at the year they reached statistical significance. It was better, but still no statistical significance.
Can you please tell me where you read that at 1 year of the last trial they would have gotten statistical significance?