Ariad Pharmaceuticals Inc fka ARIA

[Jesspro]

I really like this one guy from another board. He makes sense and the only one I read in there. For those interested, here's his latest comment...

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BRIG 2nd line approval date?

July 29, 2015 release by ARIA: "ARIAD is on track to complete enrollment in the pivotal ALTA trial of brigatinib in third quarter 2015...". So data collection for the pivotal trial should be just about to wrap up. FDA state "If a drug is designated as breakthrough therapy, FDA will expedite the development and review of such drug. All requests for breakthrough therapy designation will be reviewed within 60 days of receipt, and FDA will either grant or deny the request." FDA also advise NDA content. ARIA really should be able to receive the license in no more than one year.

The short median follow-up time on the registration BRIG trial means they pushed recruitment really hard at the end. hopefully pts/oncologists liked recent reports on BRIG. ARIA are necessarily conservative. 3Q2016 filing could mean July filing with FDA response no later than September. Looks like US approval in one year. EU shortly thereafter. Asia by end of year. 1st revenue by end of 2016. Put that in the short pipe and smoke it.
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posted by Mulanoom