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Biotech / Medical : BIOTECH & TECHNOLOGY INVESTING *UNDERVALUED*{T/A F/A & V} -- Ignore unavailable to you. Want to Upgrade?


To: BRAVEHEART who wrote (28)1/27/1999 8:26:00 AM
From: CPAMarty  Read Replies (1) | Respond to of 423
 
Questions. questions, questions
It looks like Phase approval of IMCL's C225 product is imminent. Would you be out of IMCL until approval is announced? Also i have heard that a company cannot announce Phase III approval until it signs up the first patient for the Phase III trial, is this true? Where does one go for information on approval of clinical trials and new drugs?



To: BRAVEHEART who wrote (28)1/29/1999 5:40:00 PM
From: BRAVEHEART  Read Replies (1) | Respond to of 423
 
SCIO UPDATE:

Well once again my buddy is right. SCIO gains an approval letter. Wish I had bigger Ahem. Anyway this is great news for SCIO investors who could risk FDA rejection. I would guess the stock will trade above $15 on Monday.

"FDA Advisory Committee Recommends Approval of Natrecor(R) for the Short-Term Management of Congestive Heart Failure"

"Natrecor, developed by Scios, is the genetically engineered form of the naturally occurring cardiac human hormone, b-type natriuretic peptide (hBNP), which is secreted as part of the body's natural response to a failing heart."

"The key pivotal Phase III efficacy study was a multi-center, randomized, placebo-controlled, double-blind clinical trial. The clinical studies focused on measurements of two key hemodynamic markers. The study outcomes included:"

* A decrease in pulmonary capillary wedge pressure (PCWP), a measure of the blood pressure in the heart that when elevated, forces fluid into the lungs causing respiratory problems (the primary endpoint).

* An increase in cardiac index, a measure of how much blood the heart is putting into circulation for the body's organs (secondary endpoint).

A dose-related decrease in blood pressure was the most commonly observed side effect in the clinical trials.

"Roughly five million Americans suffer from CHF, however, only half are diagnosed with the condition, which may go undetected because the body often compensates for many of the symptoms."

biz.yahoo.com

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