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Biotech / Medical : XOMA. Bull or Bear?
XOMA 32.18-0.3%Nov 28 12:59 PM EST
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To: Robert K. who wrote (16516)12/7/2003 3:35:13 PM
From: Bluegreen  Read Replies (3) of 17367
 
Bob, as long at it is bio-equivalent ANYONE or ANYPLACE in the USA can make it as long as it has permission from the patent holder and the FDA. Listen, DNA wanted to use their NEW form of Raptiva NOT the form made by Xoma by the old manufacturing process. Changes were made in the manufacturing process. They were hoping the NEW form by the new manufacturing process would be bio-equivalent. It wasn't therefore the new trial to PROVE the new form was just as good and safe as the old. Xoma can start making the NEW form of Raptiva AT ANY TIME if agreed upon by DNA and the FDA. All Xoma would have to do is copy the DNA NEW manufacturing and then test their batch for bio-equivalence. Some morons thought it had to do with Xoma NOT being able to manufacture a good product BUT in reality it was the CHANGES made for the NEW manufacturing that gave patients higer levels thus the new trial. I hope this clears it up once and for all.
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