(Total Views: 691)
Posted On: 11/05/2020 6:23:54 PM
Post# of 155037
Quote:
1) FDA "Firewall" (what's that?) has our Phase III s/c Interim analysis 195 data. So, what might they do with that and why did they want it? It would seem it must be to consider granting some type of immediate access to Leronlimab to treat covid-19 infected patient.
The "FDA statistician" refers to the statistician required by the FDA who operates with and reports to the DSMC. This is a requirement to keep the trial results blinded to the company. This is not a statistician that works for the FDA so the FDA still does not know any results of the trial.
(8)
(0)
