PDUFA date this Sunday for 20,000IU vials and spray kits, per today's webcast.
Other upcoming milestones:
Recothrom: completion of P3B in 2H08
Not giving sales guidance yet.
Atacicept: P2/3 study in SLE to start in this quarter. P2 just started in MS.
Complete enrollment in P2 RA studies in 2H08
IL-21: Complete enrollment in P2 RCC study in 2H08
Interim P2 data from RCC/melanoma studies in Q408; look for this data at EULAR in October
Interferon lambda: P1b ongoing, data from first part of study (I'd guess safety and viral load numbers, PK) in 2H08. Good tolerance in terms of acute tox relative to ifn alpha, i.e. thrombocytopenias, flu-like symptoms, and so on; good antiviral activity in this single dose study (1.5mg). If greater than a 1 log reduction, part two will be in combo with ribavirin.
IL-17RC: IND filing in Q408
Currently evaluating debt financing to avoid dilution. Since they have no debt at this point, and are becoming a product company, this seems logical in terms of capital structure.
Q&A not webcast.
Currently, I am holding my ZGEN shares unhedged, as I expect a positive outcome from the FDA shortly. After that, I don't see drivers until earnings, so I might write calls against the summer doldrums after the PDUFA news is out.
Cheers, Tuck |
