Acusphere Inc (ACUS)

[gfp927z]

SC, I listened to the June conf call, looked though the 10-K, etc.

Not only will ACUS need approx $15 mil to get to the Feb PDUFA date, these days the FDA routinely ignores PDUFA dates, or they just issue an approvable letter. If ACUS doesn't get full approval on the first try, they're toast.

Epix did four big Phase 3 trials on their imaging agent, and still got shot down by that division. Granted, some of the division's personnel have changed since then, but ACUS' trials could easily be found lacking. While both trials reached the accuracy endpoint, RAMP-1 failed in sensitivity, and RAMP-2 failed in specificity. The trials also seem to be on the small side. RAMP-1 was originally to be for 320 subjects, but efficacy data was only used from 285. Likewise for RAMP-2 (457 total, but only used efficacy data from 377).

The fact that the FDA quickly approved some other imaging agents recently is a good sign, and it looks like Imagify
could be a good product. But without a cash infusion of ~$15 mil, ACUS won't make it to the PDUFA date, much less survive longer if there are any delays. Maybe in the next 6 weeks ACUS can partner/sell off another pipeline program like they did with the paclitaxel product. Either that or they'll need to partner the remaining Imagify rights (ex-Europe). They have to do something in the next 6 weeks though.