Latest news for AB Science (OTC:ABSCF) Stock

AB Science is a France-based pharmaceutical company specialized in the research, discovery, development, and marketing of protein kinase inhibitors. It is engaged in targeted therapies through tyrosine kinase inhibitors for treating diseases with high medical factor in the field of cancer, chronic inflammatory diseases, neurological degenerative disorders and central nervous systems diseases in both human and veterinary medicine.

AB SCIENCE PARIS ORD by AB Science, Paris

AB Science

AB Science SA (OTC:<a class="ticker" href="/stock/ABSCF#OTC">ABSCF</a>) announces its decision not to pursue the re-examination procedure that the company initially requested for the marketing authorization application of masitinib in the treatment of amyotrophic lateral sclerosis (ALS). AB Science determined that the re-examination procedure would not be the most appropriate format to address all the pending concerns raised by the Committee for Human Medicinal Products (CHMP). AB Science will discuss with EMA the pathway forward to seek marketing authorization for the use of masitinib in the treatment of ALS. The marketing authorization 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. AB Science is therefore evaluating the possibility to resubmit the application based on the final results from study AB10015. As part of the resubmission, AB Science intends to submit: Final safety data. New sensitivity analyses on the primary analysis of the ALSFRS-R score for patients who stopped the study prematurely, applying recommended methods as per EMA guidelines in order to corroborate the results based on the LOCF method (last observation carried forward). New preclinical data reinforcing the mechanisms of action of masitinib, which is an important consideration in the context of an application based on a single pivotal trial. AB Science reaffirms its commitment to carry out the development of masitinib in ALS in order to provide a new treatment option to ALS patients.

News

Comments

AB Science

News

Latest news for AB Science (OTC:ABSCF) Stock

Monday, May 28, 2018

Thursday, March 12, 2015

Popular Channels

Tools & Features

Partners & Contributors

About Benzinga