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Cayston PDUFA Feb. 13th.

|Includes: Gilead Sciences, Inc. (GILD)

Will FDA approve?    Feb call buyers on 2/5/2010 believe it will get approved.  Do you?

The inhaled antibiotic is designed to treat a lung infection associated with cystic fibrosis.  In CF, the patient's lungs produce too much thick mucus which is not cleared away. The excess mucus encourages the growth of bacteria. In patients with CF, P. aeruginosa infections usually start in the first 10 years of life and can cause long-term lung problems.

CAYSTON binds to certain P. aeruginosa proteins and causes the cell wall to break apart and destroy the bacteria.  Lower levels of bacteria should improve lung function.


1.  FDA Advisory committee voted 15 - 2 for its approval in Dec. 2009.   FDA has gone against the committee in the past, but it is a good sign.

2.  Europe and Canada gave conditional approval in 2009.

3.  Oprhan Drugs for un-met medical needs face lower hurdles with the FDA and Insurance Companies.

4.  FDA required additional studies vs.  NVS's TOBI

5. Risks: Allergic reactions

Benefits of Approval to GILD

1.  $200m mkt, very profitable because it requires a small sales force.

2.  Better dosing, better delivery mechanism Altera Nebulizer System, better efficacy, easier on parents...all need to be proven in the real world, but have shown positive signs so far.

Disclosure: Long GILD