Today's press release smacks of an impending RMAT designation for CHF in both advanced and end-stage CHF.
Meaning conditional approval and hence the words " .....accelerated entry of this product candidate into the market..."
The FDA, in its RMAT designation eligibility clearly states the following as one of the conditions:
"Preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition"
In other news, Mallinckrodt coughed up $80 million to acquire Infacare.
I am expecting (hopefully more) for MSB's GvHD:
http://www.mallinckrodt.com/about/news-and-media/2291927
This is not fluff
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