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

To: Gordon James who wrote (241)	8/20/1999 1:17:00 AM
From: Vector1	Read Replies (2) \| Respond to of 666

Gordon, welcome to SI. I actually tried to post a response over the past couple of days but the new SI had inadvertently suspended my posting privileges. They must have found out I posted on the yahoo CLTR thread. VBG. First I am not concerned about the BLA filing being accepted. The FDA granted CLTR priority status after the filing and the company now has over 100 centers approved for the early access program. Hardly sounds to me like a BLA that is going to be bounced. No one should forget that SKB did an enormous amount of due diligence on Bexxar before signing the deal with CLTR and indeed SKB's sign-off on the BLA was one of the reasons for the delay. The main reason for the delayed BLA filing was paper work and documentation in connection with the manufacturing process. CLTR made a strategic decision that they wanted two separate antibody manufacturers. The most dificult part of the process of course is the radiolabeling. Nordian is a well respected company but we are on new ground in the use of a radiolabeled MAB for therapy as opposed to simply imaging. While I agree that the company has not handled the hot v cold trial info flow well I am not concerned about the results. SKB was not worried either. Three events will drive the company to record highs over the next 6 months. First, probably in November Bexxar will be reviewed by an advisory panel. Second in December CLTR will have a number of major presentations at ASH. The most interesting will be the results of the Bexxar/Fludarabine phase II in first line patients. If the results are as strong as I suspect (I have no info just my gut)there will be tremendous patient demand for the drug. What a lot of people seem to be missing is that the big advantage that Bexxar has over Chemo, Rituxan or the combo is not the percentage of responders but the DURATION of response. This is where Bexxar blows away Rituxan and it is absolutely critical. NHL is a recurring disease which gets worse with each occurrence. Bexxar has a duration of response that is 2 or 3 times that of Rituxan. In this disease duration is the key. Third of course is FDA aproval which should occur in late December. For a great thread discussing short tactics take a look at exchange2000.com V1