Monthly Archives: December 2008

News You Can Use – Aflutter Over Twitter

This week, the Detroit News and the  Detroit Free Press announced that they were forced to cut back on printing their daily paper to three days a week of "dead tree" editions.  That should speak volumes. Newspapers and magazines are … Continue reading

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Speaking of Complete Response Letters

Here I am – speaking of Complete Response Letters.  What follows is a short tutorial on the communications aspects of CRLs.     NOTE ADDED OCTOBER 19, 2010 – There has lately been a great deal of interest in this … Continue reading

Posted in Approval Announcements, Complete Response Letters | 5 Comments

More on the Complete Response Letter Track Record and Stock Impact

Last week, I ran a chart on the track record of Complete Response Letters versus approvals from the FDA, demonstrating that the latter is losing in favor of the former.  Since then, the balance of power has changed even further. … Continue reading

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Weekly Roundup – 12/12/08

There are only 13 shopping days left until Christmas.  The lengthy process of building the scaffolding for the Inauguration continues.  The weather has been dreary and the economic forecast, humbling.   And here is a little bit of what happened … Continue reading

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Full Disclosure on Complete Response Letter by Targanta

Companies take various approaches to revealing the information that is contained in a Complete Response Letter from the FDA, but Targanta Therapeutics Corporation (NASDAQ:  TARG) was very thorough in its press release this week.  It is not uncommon for small … Continue reading

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