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Biotech / Medical : VD's Model Portfolio & Discussion Thread -- Ignore unavailable to you. Want to Upgrade?

To: GregSL who wrote (6259)	1/15/1999 1:32:00 AM
From: Vector1	Read Replies (1) \| Respond to of 9719

Greg, submitting and NDA is a monumental task. AT HQ they said it would be filed in January and complete in the Q2. They expect an advisory committee in Q3 and approval in Q4. I guess we disagree on the results. The Phase III by design limited extremely ill patients. The protocol required that the patients have failed at least two prior courses of Chemo. Clear statistical improvement was shown vs chemo and from a safety and efficacy standpoint approval is in the bag. The only thing that could go wrong is manufacturing but I view that as low risk. In CLTR's stand alone phase II for previouly untreated patients CLTRs results were spectacular. 100% of patients responded with at least 50% tumor shrinkage and 79% had complete remissions. 64% were PCR negative and many of the patients from that trial continue to be PCR negative after 2 years. The side effect profile was relatively benign and the treatment is completed in less than a week. Those are spectacular results. CLTR is currently enrolling a study for post approval that will combine Bexxar with Chemo. For treatmetn naive patients that will in my opinion become the gold standard. I have not followed TCLN much for the past year. I looked at it when I did my inital due dilligence on CLTR. The company has a checkered past. If they are making progress thats great but my guess is there is a reason the stock is at about a buck a share. V1