Replies to post #142616 on Biotech Values

[jq1234]

FDA advisory panel rejects PFE’s tafamidis by 13-4 vote:

This is not entirely true. They voted against clinical endpoint 13-4, but voted for surrogate endpoint with exact same 13-4 vote.

From PFE PR:

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) announced today that the United States Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee voted on Pfizer’s clinical data package for tafamidis meglumine. Tafamidis is a novel, investigational, oral therapy for the treatment of Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) in adult patients with symptomatic polyneuropathy to delay neurologic impairment. The Advisory Committee did not find substantial evidence of efficacy on a clinical endpoint. The Committee then voted 13-4 that the data provide substantial evidence of efficacy for a surrogate endpoint that is reasonably likely to predict a clinical benefit. This recommendation will be taken into consideration by the FDA when making its decision on Pfizer’s New Drug Application (NDA) for tafamidis as a treatment for TTR-FAP, a rare and fatal neurodegenerative disease.

http://www.pfizer.com/news/press_releases/pfizer_press_release.jsp?guid=20120524006494en&source=RSS_2011&page=1