Ann: Safety Outcomes of Alzheimer's IMAGINE Extension Trial, page-23

I'm sure he could do such a better job. Every scrap of what he says is untrue. Prana is still talking to FDA and Europe and likely Canada and Australia about moving the P3 trial forward. Here's something I came across relating to another drug yesterday - "In June 2008, an advisory committee for FDA unanimously recommended ustekinumab for this indication. However, a response letter issued by the FDA in December 2008 requested additional information, including a Risk Evaluation and Mitigation Strategy (REMS). FDA will issue another decision regarding whether ustekinumab can enter the US market in 2009. The product was approved for marketing in the 27 countries of the European Union in January 2009. In December 2008, ustekinumab was also approved in Canada, where it is being marketed by Janssen-Ortho Inc." The drug has since been approved by FDA also for plaque psoriasis.

Continuous 2 years of safety data at 250 mg is very important and will likely be instrumental in convincing FDA. However, they should be looking at other territories just in case.

I also wouldn't be surprised if they sneak in an orphan application for PBT434 in Europe and US in the meantime.