March 27, 2013

$PVCT's Breakthrough Therapy Designation Application

CUP data and Moffitt data will be included in Provectus' breakthrough therapy designation ("BTD") application. As such, I doubt a company PR about CUP would be issued until the application is submitted. I expect management is seeking accelerated approval for PV-10 for recurrent and metastatic melanoma under a widened label facilitated by successfully obtaining BTD. With April 8th being the date for Moffitt's poster presentation (and April 10th the date for Provectus'), I would expect data to be shipped to the FDA in early-April.

Some useful reading: FDA Breakthrough Designation and what it means for Pharma by Bioassociate.

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