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Biotech / Medical : Texas Biotech (TXB)
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To: David D. who wrote (349)10/11/1997 5:48:00 PM
From: Joe Senesac   of 834
 
Smithkline is not doing the manufacturing. From the company's last annual report:

"Mitsubishi further agreed to supply the Company with its requirements of NOVASTAN(R) throughout the term of the Genentech Agreement for TBC's clinical testing and commercial sales of NOVASTAN(R) in the United States and Canada. In the event Mitsubishi should discontinue the manufacture of NOVASTAN(R), Mitsubishi, Genentech and TBC have agreed to discuss in good faith the means by which, and the party to whom, NOVASTAN(R) production technology will be transferred. The transferee may be a person or entity other than Genentech or TBC. At present, Mitsubishi is the only manufacturer of NOVASTAN(R). Should Mitsubishi terminate or default in its supply commitment, there can be no assurance that alternate sources of bulk NOVASTAN(R) will be available to the Company at reasonable cost, if at all. If such alternate sources of supply are unavailable or uneconomic, the Company's results of operations would be materially and
adversely affected."

This is what I was referring to. TXB has performed a clinical trial on another company's drug here, not one they developed on their own. Approval of a drug is as much based on the manufacturing process and facility as it is on the clinical results.
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