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Biotech / Medical : QLT PhotoTherapeutics (QLTI) -- Ignore unavailable to you. Want to Upgrade?

To: Ian@SI who wrote (1163)	2/5/2001 8:42:01 AM
From: Alan Caley	Respond to of 1321

Hi Ian, Ed, Just a word of caution on the 6 month deadline. If I remember correctly the original application for Visudyne was also given priority review status, but took nearer 8 months than the expectation of 6 months. In other words, do not be dissappointed if this date is not met. It is more a statement of intent than a hard and fast rule. Kind regards, Alan NB. for Ian - my resonse rate has now increased by a further 50%!! :-)

To: Ian@SI who wrote (1163)	2/5/2001 2:07:11 PM
From: Alan Caley	Respond to of 1321

It appears the FDA is moving forward towards an acceptance. I have just retrieved the following statement from the Novartis web site (partner to QLT). Alan ******************** Basel, 5 February 2001 — Novartis Ophthalmics, the eye health unit of Novartis AG, and QLT Inc. today announced that the US Food and Drug Administration (FDA) has issued an approvable letter to expand the currently approved use of Visudyne™ (verteporfin for injection) therapy beyond the treatment of predominantly classic subfoveal choroidal neovascularization (CNV) caused by age-related macular degeneration (AMD) to include additional ocular conditions caused by other macular diseases. CNV is a growth of abnormal blood vessels under the central part of the retina or macula. The additional conditions characterized by CNV for which approval is sought include pathologic myopia and ocular histoplasmosis syndrome (OHS). A supplemental new drug application (sNDA) was submitted last August. An FDA approvable letter typically indicates that the agency intends to approve the application. In the letter, the FDA states that it has reviewed the application and requests further clinical information relating to OHS, which is expected to fulfill the necessary criteria to obtain the broad supplemental indication for Visudyne therapy. The additional information has been submitted to the agency. Final approval is expected to be issued in the next few months. "This is a significant development in our effort to capitalize on Visudyne's tremendous potential," said Dr. Julia Levy, President & Chief Executive Officer of QLT. "And, as in AMD, Visudyne may well represent the only hope for many patients around the world affected by these other conditions. We are hopeful that the FDA will review this new information quickly."