Just got back in and saw the Relistor the news. The whole thing is a bit surprising because when the PDUFA decision was delayed 3 months ago, the FDA said there wouldn't be the need for additional clinical trials. Obviously I am disappointed but we can't say the extent of the problem until we get more information from PGNX/SLXP, which should be after they discuss the CRL with the end review committee. For now you have to figure a $2-$3 drop, which could increase or decrease deeding on what answers are coming. One possibility is they want to see patients in the current trial on Relistor for a longer period.
I would add that what is really puzzling is the whole need for the long-term safety study came from issues with Entereg from the now defunct ADLR. The primary safety issue which sank Entereg was an increased occurrence of neoplasia. To my knowledge this has never been seen with Relistor. Oh well, patience is a virtue.
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