ive been following zgnx quite a bit and i think the case for approval is strong because it seems there might not be grounds for denial. the adcom for zohydro made it clear that they couldnt support bringing another opioid to market, and did not say that zohydro was worse than other drugs in its class. the primary concern was increased abuse potential, and Dr. Rappaport made it clear that class 2 existed solely for highly addictive substances, which negates the abuse potential argument. i think approval is very likely.
ODAC members recommended against approval and price tanked. FDA delayed approval so market took that to mean that FDA might actually approve, and pps soared. If you were able to buy when pps was 1.20, I would say go ahead and gamble. At current pps, big risk when pps may just go to 2.50 on approval. idk.