1
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id
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o
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si
g
o
a
g
ir
so
b
re
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s
v
a
ri
á
v
e
is?
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3 5 F a s e I S u c e s s o 6 0 % -$ 4 0 E n tr a n a L ic e n ç a -$ 3 0 4 0 % F a s e I F ra c a s s o N ã o e n tr a n a L ic e n ç a $ 0 D a v a n ri k w o u ld b e a d m in is te re d t o 2 0 -8 0 h e a lt h y p e o p le t o d e te rm in e i f th e d ru g w a s s a fe e n o u g h t o c o n ti n u e i n to t h e e ff ic a c y s ta g e s o f c lin ic a l te s ti n g . P h a s e I w o u ld t a k e t w o y e a rs t o c o m p le te . It w a s e x p e c te d t o c o s t $ 3 0 m ill io n , in c lu d in g a n i n it ia l $ 5 m ill io n f e e t o L A B f o r lic e n s in g t h e d ru g . T h e re w a s a 6 0 % c h a n c e t h a t D a v a n ri k w o u ld s u c c e s s fu lly c o m p le te P h a s e I .P
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In t h is p h a se , D a va n ri k w o u ld b e g ive n t o 1 0 0 -3 0 0 p a ti e n t vo lu n te e rs to d e te rm in e i s e ff ica cy f o r tr e a ti n g d e p re ssi o n a n d /o r w e ig h t lo ss a n d t o d o cu m e n t a n y si d e e ff e ct s. T o co m p le te t h e e ff ica cy t e st s, D a va n ri k w o u ld h a ve t o d e m o n st ra te a st a ti st ica lly si g n if ica n t im p a ct o n p a ti e n ts su ff e ri n g d e p re ssi o n , o b e si ty , o r b o th . T h e M e rk t e a m e st im a te d a 1 0 % p ro b a b ili ty t h a t P h a se I I w o u ld sh o w t h a t D a va n ri k w o u ld b e e ff ica ci o u s fo r d e p re ssi o n o n ly , a 1 5 % p ro b a b ili ty f o r w e ig h t lo ss o n ly , a n d a 5 % p ro b a b ili ty t h a t it w o u ld b e e ff ica ci o u s fo r b o th d e p re ssi o n a n d w e ig h t lo ss a t th e sa m e t im e . L ik e P h a se I , P h a se I I w o u ld r e q u ir e t w o y e a rs o f cl in ica l te st in g t o co m p le te . P h a se I I w a s e x p e ct e d to co st $ 4 0 m ill io n , in cl u d in g a $ 2 .5 m ill io n l ice n si n g m ill e st o n e p a y m e n t to L A B . 7 0 % = 1 0 0 % -1 0 % -1 5 % -5 %3 7
