Impact of Approvable Letters 2007 – Part 2

Yesterday I posted about the impact of approvable letters and began by saying I have not yet been able to compare this year to other years, but my gut told me that it was a higher rate of approvables than ever.  Ask and ye shall receive. 

Today a release was issued by Sagient ResearchSagient Research is a publisher of independent research.  The release was about their research report which demonstrated a "significant decline" in FDA approvals during 2007 citing a 13% drop in 2007.  In addition, according to the company, the number of approvable letters increased by 40%:

Percentage Change in FDA Decisions: 2006 vs. 2007

Decision Type








Approvable Letter








Also according to the company, the average stock price change that was the result of an approvable letter dropped in 2007 to a 12.89% from 21.42% in 2006, which would mean that approvable letters are having less of an impact and that perhaps investors are adjusting to this new paradigm. 

This is not good news for the agency – especially one that is committed to bringing new drugs to market.  This, combined with a much lower rate of enforcement by the agency as expressed through a weak stream of warning letters indicates an agency, and hence and industry, that has much changed.   

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