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Biotech / Medical : Ribi Immunochem (ribi)
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To: Grashopper who wrote (89)1/19/1999 12:28:00 AM
From: Douglas Nordgren  Read Replies (1) of 92
 
RE Melacine/FDA From the 11/13 10Q -

freeedgar.com

<Company representatives also recently met with representatives of the U.S. Food and Drug Administration ("FDA") to discuss preliminary information provided by the Company and to receive guidance as to the content of a BLA in preparation for filing with the FDA to market MELACINE in the United States. The FDA informed the Company during this meeting that the clinical data should be reorganized to provide data showing durability of tumor response and also requested additional manufacturing information. The Company is in the process of additional data analysis to comply with the guidance provided by the FDA and continues with its plans to file a BLA in the United States. This effort has delayed filing in the United States, which could be sometime toward the middle of next year. However, there can be no assurance that the Company will file the application in the United States and within the time frame stated. Additionally, there can be no assurance that regulatory authorities will approve marketing MELACINE for any indication or that revenues will be significant if marketing approval is granted.>

I've heard "Maybe in February at the earliest..." tied in with mnfg compliance completed for Canadian HPB inspection and approval.
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