Thursday, October 29, 2015 2:11:14 PM
"Catalyst’s Firdapse contains the phosphate salt of 3,4-DAP. The phosphate salt form is more stable than the free base form of the 3,4-DAP that is available from Jacobus. Catalyst CEO Patrick McEnany stressed that their 3,4-DAP is produced under all requirements of cGMP. If there were an approved drug by the FDA, most patients would have easy access to this drug."
Also this about Jacobus: "Even more serious is the cGMP defects of Jacobus in the past. The FDA issued 483 inspection reports for the Jacobus facility in 2011 and again in 2012 (read them here and here)."
http://bit.ly/1jUJK1M
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