“If our results are stellar and nothing short of
Post# of 154183
(Total Views: 883)
Posted On: 06/27/2020 3:31:56 PM
“If our results are stellar and nothing short of the miracle of Lazarus we have about 10-15% chance to be approved for EUA.”
NP has said multiple times that the FDA helped design the 75 patient, phase 2 M2M trial. To what extent was this “help?” That’s a good question. NP said the safety of leronlimab assisted in lowering the number of patients required. How true is that? That’s a good question. Why is there 75 patients in the M2M but 395 in the severe trial? That’s a good question, too.
My hope it that the FDA did in fact give input into the development of the phase 2 M2M trial, especially the number of patients required for each. This would indicate that they could use the data from the M2M to make a approval decision from.
NP has said multiple times that the FDA helped design the 75 patient, phase 2 M2M trial. To what extent was this “help?” That’s a good question. NP said the safety of leronlimab assisted in lowering the number of patients required. How true is that? That’s a good question. Why is there 75 patients in the M2M but 395 in the severe trial? That’s a good question, too.
My hope it that the FDA did in fact give input into the development of the phase 2 M2M trial, especially the number of patients required for each. This would indicate that they could use the data from the M2M to make a approval decision from.
(0)
(0)