Michael:
If you are refering to QLT's Phase III trials for ARMD, I believe they started in Sept. 97, after QLT announced successful completion of their patient accrual. From what I understand, it's about a 2 year approval process after Phase III begins, BUT, preliminary data can be analysed and subsequently released after the last patient has been followed for 12 months, ie., September 1998. I expect we'll hear about those preliminary results late this year or early '99. What I don't know is, whether the FDA can grant early approval on preliminary results, or if QLT will have to wait until the entire process is finished. If you or anyone else has any further insight, it would be worth posting. Also, I would think we'll see late stage cancer approved by the FDA later this year, as long as things go well at the March ODAC hearings.
Cheers,
Joe |
