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Biotech / Medical : ORTC Ortec International
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To: Lane Hall-Witt who wrote (256)2/24/2000 11:36:00 AM
From: Lane Hall-Witt  Read Replies (1) of 272
 
One thing I should clarify from the previous post is that ORTC will have exclusive commercial access to the EB, EM, TEN, and SJS markets for at least seven years, under the Humanitarian Device Exemption (HDE) that the company has already received from the FDA. That means ORTC will be the sole vendor within this $22 million/year U.S. market.

HDEs are granted under the Orphan Drug Act and are designed to encourage the development of treatments for conditions with small patient populations (4,000 patients per year, or less).
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