It's very likely that FDA will grant accelerated approval to AP26113 by October 2015 or could be earlier given Ariad AP26113 clinical response rate is better than Novartis's ceritinib. Below is the text from FDA website:
"... On April 29, 2014, the U. S. Food and Drug Administration granted accelerated approval to ceritinib (ZYKADIA, Novartis Pharmaceuticals Corporation) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) with disease progression on or who are intolerant to crizotinib.
On March 6, 2013, FDA granted ceritinib breakthrough therapy designation based on preliminary evidence of clinical activity in patients with metastatic ALK-positive NSCLC previously treated with crizotinib.....
BTW, how come Adam F. is so quiet lately given AP26113 clinical response is better than Novartis's LDK378 and received breakthrough therapy designation from FDA? His post on thestreet.com last March (03/26/14) in which he bashed Ariad's AP26113 as "significantly behind" Novartis LDK378?
I wonder what will happen to LDK378 once Ariad receives official approval for AP26113? Thanks!
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