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Biotech / Medical : ARIAD Pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?

To: jesspro who wrote (4352)	8/3/2016 10:35:01 PM
From: Biomaven	Respond to of 4474

>>s that not enough as a bargaining tool for the company to appeal for a 1st line case to the FDA? No, you need a proper trial to get a 1L label. There were 8 1L patients in the trial, but that's not enough to get anything on the label. Have to test against criz, the existing 1L drug.

To: jesspro who wrote (4352)	8/3/2016 10:56:01 PM
From: jaybe	Respond to of 4474

The appeal resulted in ALTA-1L, a potential frontline approval on only 270 patients (135 on briga). The sort of approval you're suggesting is seen only in diseases with NO available options, even chemo here counts as a viable alternative. What we don't know is what magnitude of benefit in mPFS over criz at interim (50% and 75% of events) could trigger early termination of the trial.