clarifying comment from rudy tanzi, page-28

Hi coattails,
It seems to me that there is nothing on the market today that is disease modifying for Alzheimer's Disease and PRAN's Pbt2 is the "only game in town" when it comes to having a statistically significant effect in a cognitive measure (of Executive Function) in a previous short (12 week) phase 2a trial. Given that therehas been no issues so far with safety, if the 12-month phase 2b trial also shows that it removes Amyloid-Beta deposits and some efficacy, then perhaps the FDA will pull the trigger early as they have done today with ICPT which just had its trial stopped by the FDA due to efficacy and the stock shot up $200 as of this writing. See News Release and links below:

7:33 am Intercept Pharma 01/09 announces NASH Primary endpoint met: FLINT trial stopped early for efficacy based on highly statistically significant improvement in liver histology (ICPT) : Co announced that the FLINT trial of obeticholic acid (:OCA) for the treatment of nonalcoholic steatohepatitis (NASH) has been stopped early for efficacy based on a planned interim analysis showing that the primary endpoint of the trial has been met. FLINT is a multi-center, double-blind, placebo-controlled clinical trial assessing the safety and efficacy of a 25 mg oral dose of OCA administered daily to biopsy-proven adult NASH patients over a 72-week treatment period.

The decision to stop FLINT has been based on the recommendation of the Data Safety Monitoring Board (:DSMB) which reviewed liver biopsy data from before and at the end of the treatment period in ~half of the 283 randomized patients, in accordance with a planned interim efficacy analysis. This analysis demonstrated that OCA treatment resulted in a highly statistically significant improvement (p=0.0024 on an intention-to-treat [ITT] basis) in the primary histological endpoint, defined as a decrease in the NAFLD Activity Score (:NAS) of at least two points with no worsening of fibrosis, as compared to placebo.

Link: http://finance.yahoo.com/news/inplay-briefing-com-055139997.html#icpt

Link: http://finance.yahoo.com/q?s=ICPT&ql=1

Intercept Pharmaceuticals, Inc. (ICPT)
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