QLT PhotoTherapeutics (QLTI) Message Board

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Biotech / Medical : QLT PhotoTherapeutics (QLTI)

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To: Ian@SI who wrote (57)	11/9/1996 10:36:00 PM
From: Joe Stephenson	of 1321

I believe in this case, these "Pivotal Studies" are the beginning of Phase III trials, which is the third and final stage before a company can apply to the FDA for approval of a drug. I think Phase III means that testing is being done on humans in a controlled environment They are "pivotal" because the FDA will review these test results to determine whether or not to approve the drug (BPD)for use in this application (AMD). If the drug goes through a normal approval process, it has been estimated that sales of BPD for this application will begin in 1999, so revenues for this treatment are still "down the road" a bit. More encouraging for QLT in the near term are Photofrin approvals expected late this year or early next year from Germany and Italy. Also, the company's filing with the FDA for early stage lung cancer (photofrin) which is expected this year, and the FDA decision within 6 months, thanks to the recent Cancer Regulatory Reform within the FDA. I wouldn't pay much attention at this time to "Pre-clinical" stuff, as this generally means the company is years away from revenues in this area. I have followed this technology (PDT) and this company for a number of years. Hope this helps.

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