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Acorda Therapeutics is gambling $525 million on a Phase III-ready Parkinson's treatment, page-8

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k273

480 Posts.

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26/09/14

10:21

Post #: 14032464
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Originally posted by interestingtome ↑

The IMAGINE trial is still running and all we have are draft results from IMAGINE. We will likely see some more information from the extension if not before by end of March.

For HD, the next step is meetings with FDA about the orphan drug approval on how best to move forward. PBT2 will likely take one of four potential accelerated pathways. Either approval with no further trialing, approval with post approval conditions (i.e streamlined trial to provide additional answers), breakthrough or fast track the latter three provide Prana with FDA direction and improved review time frames.

The final annual report is due by the end of this month and that should provide some insight into the next steps.

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ITM,

Do you think that Prana will extend the Imagine trial for another 12 months to further evaluate PBT2 for efficacy and safety? Mainly to see if the anomaly of the placebo resolves into a result for or against the medication.
TIA K

PBT Price at posting: 24.5¢ Sentiment: Hold Disclosure: Held
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0 Great analysis

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