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 Research – Sagient 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 |
2007 |
2006 |
Change |
|
Approved |
64% |
73% |
-13% |
|
Approvable Letter |
28% |
20% |
40% |
|
Non-Approvable |
8% |
6% |
22% |
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.
2 Responses to Impact of Approvable Letters 2007 – Part 2