http://www.mineweb.com/mineweb/view/mineweb/en/page72068?oid=161110&sn=Detail&pid=92730
Showing posts with label inspection. Show all posts
Showing posts with label inspection. Show all posts
Thursday, November 1, 2012
Tuesday, September 7, 2010
ALXA and FDA inspection
This press release is potentially bullish for ALXA and AZ-004 FDA approval. Again, PDUFA date is October 11, 2010.
http://finance.yahoo.com/news/Alexza-Pharmaceuticals-to-prnews-2569073814.html?x=0&.v=1
See disclaimers in the side bar.
Disclosure: long shares of ALXA.
http://finance.yahoo.com/news/Alexza-Pharmaceuticals-to-prnews-2569073814.html?x=0&.v=1
"The PDUFA goal date for our AZ-004 (Staccato loxapine) NDA is October 11, 2010. During the past several months, the FDA has conducted and completed NDA-based inspections of our manufacturing facility, and several clinical and non-clinical sites, which appear to be part of the normal course of the ongoing NDA review," said Thomas B. King, Alexza President and CEO. "As we approach the PDUFA goal date, we expect continued interaction and contact with the FDA regarding our NDA submission. We are not planning on making any specific comments on the details of these interactions unless we feel we have material information that will impact our PDUFA date."
See disclaimers in the side bar.
Disclosure: long shares of ALXA.
Labels:
ALXA,
AZ-004,
FDA approval,
inspection,
manufacturing
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