Biotech Values

[DewDiligence]

FDA tells Miravant to conduct additional clinical study in AMD:

[The PR says the company is “pleased” with the FDA’s approvable letter. Total nonsense, of course.]

http://biz.yahoo.com/bw/040930/305762_1.html

>>
Miravant Receives FDA Approvable Letter for SnET2 PDT for Macular Degeneration

Thursday September 30, 4:15 pm ET

SANTA BARBARA, Calif.--(BUSINESS WIRE)--Sept. 30, 2004--Miravant Medical Technologies (OTCBB:MRVT - News), a pharmaceutical development company specializing in photodynamic therapy (PDT), today announced that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for its proprietary drug SnET2. The letter outlines the conditions for final marketing approval, which includes a request for an additional confirmatory clinical trial. SnET2 PDT is a drug-and-light procedure that is being developed to slow the progression of wet age-related macular degeneration (AMD), the leading cause of blindness in older adults.

Gary S. Kledzik, Ph.D., chairman and chief executive officer, stated, "We are pleased with the approvable designation [uh huh], which reflects positively on the results achieved in phase III clinical trials. The Company will work with the FDA to address the issues needed for final approval. We expect that this guidance, coupled with the knowledge we have gained about wet AMD through the phase III studies, should enable us to efficiently fulfill the requirements. We remain committed to serve the large elderly population with wet AMD, and we again thank the investigators and patients who participated in these important clinical trials."
<<