Ariad Pharmaceuticals Inc fka ARIA

[zuize]

TC, you forgot one huge detail. Full enrollment of the '113 trial is expected to be completed by Q3 2015. How can you expect it to be approved in August 2015? This is straight from Harvey himself.

Ever hear of "Accelerated Approval", or "Fast Track Approval"?

On 03/06/2013 FDA granted Novartis's Ceritinib BTD (Breakthrough Therapy Designation). A year later, on 04/29/14 they granted Accelerated Approval to the drug. Detailed info on this can be found via FDA website: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm395386.htm

Now Ariad's AP26113 (with much better clinical data than Ceritinib/LKD378), received FDA Breakthrough Therapy Designation on 10/02/2014. Also according to this article which someone posted here a couple days ago about the possible change in FDA procedure for faster approval.

Can you figure out when AP26113 will receive FDA Accelerated Approval?