Does anyone know the PDUFA date for Calcitriol?
It is already FDA approved. Rockwell is seeking manufacturing approval. On the call they said it was expected within the next 2 months.
Wait a minute, why exactly do they need manufacturing approval? Is this a special case that I am unaware of or do all companies need manufacturing approval after regular drug approval?
They said approval is expedited "fast tracked" "excelerated approval".... For what it's worth. The call sounded great. He did mention they are in a stage of doing what's best for shareholders- hasn't said that in the past
Sentiment: Strong Buy