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

To: Andrew H who wrote (5958)	11/16/1998 11:57:00 PM
From: Vector1	Read Replies (3) \| Respond to of 9719

Andrew, The good news is that approval is all but assured. The fact that Panretin was not approved as a first line treatment is not a huge issue as the docs will make that decision. What concerns me is that the reviewer at the FDA reached the conclusion that Ligand erroneously found evidence of meaningful reduction of KS in half of the responders. The FDA areviewer based his assesment on pictures taken of the patients which must be very difficult to analyse and far less accurate thatn actual inspection. It appears that the FDA was not willing to accept the clinical judgement of the docs who treated the patients. Something does not smell right here. Either the FDA is paraniod or they thought there was some kind of consiracy. My gut is the reviewer suffers from pananoia. Does anyone else think this is strange. V1

To: Andrew H who wrote (5958)	11/17/1998
From: Vector1	Respond to of 9719

From the DJ report: 11/16 12:38P (DJ) FDA Panel Backs Ligand's AIDS Tumor Gel, Panretin FDA reviewer Dr. Robert White told the panel that Panretin's benefits can't be compared to those of an internal treatment, which attacks the disease and not just the visible lesions. When FDA panels review therapies, the company and FDA reviewers present assessments of the study data. Then the panel votes on whether or not to recommend approval of the product. White said the FDA asked Ligand for photos of patients' lesions to help the agency review the Panretin application. Based on the pictures, White said, the FDA reviewers disagreed with Ligand's assessment of some patients as Panretin responders. The FDA reviewers disagreed with half of the patients Ligand considered responders. White also said Ligand's two Panretin studies had different criteria. One study required patients have at least six lesions, with at least three of those raised. In that study, body photos were taken of all participants. The other trial, which the FDA reviewers said was less rigorous, required only three raised or flat lesions for studying. The trial didn't require global body photos. The frequency with which the medicine was applied also differed between studies, White said. When the panel discussed Panretin, panelist Dr. James Krook said he didn't see evidence to recommend the drug as a first-line, or first-option, therapy.