- This event has passed.
BCLI – Type A Meeting with FDA
January 11 @ 8:00 am - 5:00 pm
A “Type A” meeting, in this case, to discuss the contents of a refusal to file letter previously issued regarding the company’s New Biologics License Application (BLA) for NurOwn® for the treatment of ALS. While this event is not one that would normally include a “runup” and an “event” type trade, the “Afterglow” traders here might find something worthwhile.
If, for example, the FDA agrees to schedule an Advisory Committee meeting, that would be a path towards a new PDUFA date. Future implications of that can be discussed in a separate entry in the Catalyst Calendar, if the FDA were to schedule an Adcom, there would be a new runup trade (which is the same as an Afterglow trade for this event).