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Biotech / Medical : VD's Model Portfolio & Discussion Thread

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To: Vector1 who wrote (7249)12/4/1999 9:33:00 PM
From: Bob L  Read Replies (1) of 9719
 
Earth to V1, earth to V1, ... enter safe mode ... switch to backup systems ... begin error diagnostics now ... reorient antenna towards earth ...

To me, the fact that Reuters played this as news story, rather than just a company press release, gives some support to the idea that there may be a pop Monday. Will it hold until the BLA is finally resubmitted and approved? That is still the big factor. The Reuters story did mention the BLA in the final paragraphs. The complete Reuters version follows.
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Saturday December 4, 10:45 am Eastern Time
Coulter's lymphoma drug shows promising results
NEW ORLEANS, Dec 4 (Reuters) - Bexxar, Coulter Pharmaceutical Inc.'s (NasdaqNM:CLTR - news) drug for treating lymphoma, showed promising results in Phase II studies when used in combination with conventional chemotherapy, according to a study on Saturday.

The study by Cornell University showed that all patients with low grade non-Hodgkin's lymphoma went either into complete remission or saw partial response when on a regime of chemotherapy agent fludarabine followed by Bexxar.

The Cornell study, funded by Coulter, said that following an initial five week treatment with only fludarabine, 14 percent of patients, or two out of 14, went into complete remission.

Three months into the study, following treatment with Bexxar, 43 percent of patients went into complete remission. After about six months, 71 percent of patients had the same result.

The remaining patients who did not go into complete remission saw a reduction in the signs and symptoms of lymphoma, such as a reduction in the number of cancer cells.

The study, which was released at the annual American Society of Hematology in New Orleans, included only patients who had never been treated for their disease.

Last summer, Coulter applied for U.S. marketing approval for Bexxar as a stand alone treatment for patients with low-grade lymphoma who have failed other therapies or who have responded and then relapsed.

The approval process has been delayed because of modifications in the marketing applications requested by the U.S. Food and Drug Administration.

Saturday's study is not related to the modifications request by the FDA. Bexxar is to be co-marketed with SmithKline Beecham Plc
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