barda update, page-3

Argenbarx,

My take on this is rather positive, but some amount of delay in any award of a BARDA seems implied. On the other hand, the far more complex and technically challenging CCS is taken off the table for the BARDA effort leaving a far more straightforward application of BTM for third degree burns. This does in fact seem more in line with the need for a product stable in long term storage that can be mobilized quickly to treat the initial stages of serious burns during the triage stage. CCS is a longer term treatment that might be inappropriate in the context of first stage treatment of massive numbers of serious burns.

This development means the focus of the BARDA application can be narrowed, potentially speeding up the remaining review. It is difficult for me to imagine that the BTM product has not generated enormous interest at the US Dept. of HHS.

The other very positive element in this announcement is the news that the BTM product can be approved for sale in the United States (except for the treatment of third degree buns) on the basis of a 510 k) application. This is the same type of application planned for the VAC dressing, and is normally processed rather rapidly. Initially there was some indication that the BTM might not be eligible for a 510 k) process and that it would need a PMA - now seen as needed only for the third degree burn application.

This is great news.