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Biotech / Medical : ARIAD Pharmaceuticals
ARIA 23.990.0%Feb 17 4:00 PM EST
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To: jaybe who wrote (4033)12/12/2015 11:15:56 AM
From: kenyonn  Read Replies (3) of 4474
 
They need to file an NDA before the FDA will consider approving the drug, priority review or otherwise. Ariad has stated they intend to file in the 3rd quarter of 2016. Unless they're lying to us, I don't see approval happening before end of 2016/early 2017.

Frankly, I find the delay in reporting early results from the ALTA trial concerning. I suppose it could simply be that they didn't get enough patients enrolled and mature data points in time to be ready for ASH. But pushing them all the way to ASCO 2016 doesn't make much sense to me. There's been speculation that this is because they are privately showcasing those early results to suitors, but that makes little sense either. If they're good, why not go public? It won't matter one way or another to negotiations--in fact, with the rise in share price that would undoubtably occur, it could strengthen price negotiations.

Has anyone heard any rumblings of continued issues with the pulmonary side effects of the drug? At least publicly, Ariad has been pretty adamant that they have them under control. But I'm not inclined to believe everything they say. I don't want to end up in another situation where the FDA disagrees with Ariad's assessment of risk, and us small investors are caught in the crossfire.
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