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Biotech / Medical : CLTR COULTER PHARMACEUTICAL
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To: kendall harmon who wrote (280)8/30/1999 9:38:00 PM
From: Bharat H. Barai  Read Replies (1) of 666
 
The data about response rates to Bexaar are simply superb. Even with best chemotherapy we rarely see 70% complete remissions.

Rituxan is a non radio labeled monoclonal antibody. In patients with Non Hodgkin's Lymphoma-low grade, who have been previously treated with chemotherapy, Rituxan produced 6% complete remissions and 36% partial remissions. Bexxar data if duplicated in real life, would be exceptional and would push the drug to 1st line use.

Idec, maker of Rituxan has gone from 30 to 130 in 12-18 months.

What FDA has asked is nothing but routine inquiries and I doubt it would delay the approval by more than few weeks at the best. It is possible that if revised data and analysis are submitted in next few weeks, the drug may still be approved by end of the year. FDA knows life of thousands of patients are at stake.

Radio active I 131 has been used for years in treatment of Thyroid cancer, without any significant harmful effects on the rest of the body. I 131 labeled monoclonal antibody should have similar safety profile.

Those who are willing to weather temporary turbulence, this may be a great entry point. You rarely get such opportunity. I was looking to buy into this company for sometime. I did buy some on Friday and a lot today morning. Make your own research and judgement.

Bharat H. Barai MD
Hematologist-Oncologist
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