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Re: DewDiligence post# 213320

Wednesday, 11/15/2017 10:34:29 AM

Wednesday, November 15, 2017 10:34:29 AM

Post# of 251709
ACOR -38% on safety problem in PD trials:

https://finance.yahoo.com/news/acorda-provides-tozadenant-development-program-120000127.html

Acorda Therapeutics today announced that it has increased the frequency of blood cell count monitoring for participants to weekly in its Phase 3 program of tozadenant for Parkinson’s disease. The Company took this action in response to cases of agranulocytosis, possibly drug-related, and in some cases associated with sepsis and death. Agranulocytosis is the absence of white blood cells, which fight infection.

The Company also has paused new enrollment in the long-term safety studies, pending further discussion with the independent Data Safety Monitoring Board (DSMB) and the United States Food and Drug Administration (FDA).

All told, seven patients on Tozadenant had sepsis, and five of those patients died.

Based on the above, it seems unlikely that this program can be resuscitated by altering the trial protocols.

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