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Biotech / Medical : CLTR COULTER PHARMACEUTICAL -- Ignore unavailable to you. Want to Upgrade?

To: Vector1 who wrote (478)1/13/2000 1:08:00 AM
From: biowa  Read Replies (1) | Respond to of 666
 
V1,

Despite my rumored cynicism, I agree that I feel much more comfortable with the BLA situation because of today's clarification. Hopefully when the company gives its guidance as to the BLA filing, they will be able to provide further assurance that the FDA is now satisfied.

To clarify: NO COMPLETE REMISSIONS for Zevalin in Rituxan-failed patients. Hopefully (for patients and investors) the Bex in Rituxan-failures data will have a significant CR rate.

I think this will differentiate Bex from Zev, but what I heard today was CLTR putting the pieces in place for Bex or Flu+Bex first-line. Thus failures are secondary to the primary positioning.

biowa



To: Vector1 who wrote (478)4/25/2000 1:10:00 PM
From: GregSL  Respond to of 666
 
It has been 239 days since we found out that the FDA wanted the data reformatted for the BLA. Non-Hodgkins Lymphoma kills 71.5 people per day. 17,089 people have died waiting for re-formatted data. All because the FDA wants to try a new electronic filing method. 17,089 deceased. Somebody should be held criminally liable.


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