28 May 2018 - AB Science announces its decision not to pursue the re- examination procedure that the company initially requested for the marketing authorisation application of masitinib in the treatment of amyotrophic lateral sclerosis. 

AB Science determined that the re- examination procedure would not be the most appropriate format to address all the pending concerns raised by the CHMP. AB Science will discuss with EMA the pathway forward to seek marketing authorisation for the use of masitinib in the treatment of amyotrophic lateral sclerosis.

The marketing authorisation application was filed in September 2016 based on the interim results from study AB10015. The final safety data were generated in February 2018 and could not be inspected during the evaluation. New data cannot be presented as part of a reexamination procedure.

Read AB Science press release