Thx for the analysis RMB My quick take Their pivotal trial failed to meet its primary endpoint because the most recent data shows DCCR tablets are most effective in those with severe hyperphagia ( insatiable hunger ) ...so if U enroll to many with low to moderate hyperphagia it would obviously be harder to get the stat sig results U need . Think of the R-IT trial being run with mostly primary prevention instead of the 70% secondary prevention patients actually used.
So this final short trial ...80 patients over 4 mths I'm sure they will try and recruit the most severe patients ....and may only get approval for this subset
The patent issue. Diazoxide is an oral suspension that apparently tasted horrible . DCCR are extended release tablets and apparently far more effective. In the Prader Willi population those with severe hyperphagia are often institutionalized ( group homes ) ....and care givers will want the best drug available to help control the often aggressive behaviors associated with this condition. Also the drug they can get these ( mostly kids / teenagers ) to take daily for at least a yr .
So Amarins Vascepa brand vs generic is not the best comparison .
Agree its very speculative ...but the FDA is under pressure from PW families to approve something for this condition ( currently theres no FDA approved drugs for PW ) ...and the severe hyperphagia indication with DCCR looks to be the best near term hope .
Short trial ...80 patients for 4 mths once fully enrolled. Once fully enrolled the Co get $10m from the investors with additional payments on trial success etc
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