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 video from investors of a company with a drug candidate that has received a CRL from the FDA.  A note of clarification about the video.  It was created for communications professionals to help understand the communications ramifications of the change from the old way the FDA responded to NDAs – with an approval, an approvable or no approval, to the way it is today – an approval letter or a complete response letter.  A CRL lays out a pathway for approval by stating the requisites the FDA wants to see fulfilled before it might grant approval.  Whether or not a company does, or even can meet those requisites, is another matter.  The company may find that the pathway laid out is not possible or desirable.  

And an approval …

Also, yesterday Abbott received FDA approval for Trilpix.  Trilpix (fenofibric acid) is a delayed-release capsule for use with diet to lower triglycerides and LDL cholesterol, raising HDL cholesterol in patients with lipid problems and is the first and only fibrate approved for use in combination with a statin.  

That updates our chart as follows:Approvals v CRLs12-16-08
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