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Biotech / Medical : Biotech Valuation

CRSP 50.19

+1.8%

Nov 21 9:30 AM EST

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To: IRWIN JAMES FRANKEL who wrote (4053)	6/7/2001 12:16:06 PM
From: Biomaven	Read Replies (1) of 52153

Here's the MEDX extract on manufacturing from their 10-K: In addition to our UltiMAb system, we have considerable experience in clinical supply antibody manufacturing. To facilitate the development and commercialization of antibody-based products for us and for our partners, we have assembled a team of experienced scientific, production and regulatory personnel. This team operates in our manufacturing facility, which complies with applicable FDA current Good Manufacturing Practice regulations, or cGMP. This facility currently has a capacity of 10 kilograms of monoclonal antibody production per year. Over the last five years, we have received regulatory approval to commence clinical testing of eight products in seven countries. Harold is the guy that knows all about this stuff. Peter P.S. Note that there are issues about changing the method of production mid-way through the clinical trial process. Just one of the issues that makes biologic manufacturing tricky.

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