You are incorrect MOT about it being years away...read the...

You are incorrect MOT about it being years away...read the presentation...


Development path shaped by orphan drug status and Somavert ?
development
?? Phase Phase II safety tolerability study with activity endpoints safety tolerability study with activity endpoints ((sIGF sIGF--II and and GHGH levels) levels)
? Phase IIa 12 week efficacy and safety study
o Somavert?
Phase IIa study (Trainer et al. The New Eng J Med April 20, 2000; 342(16):1171-7)
? 112 patients, 4 groups, 3 treatment arms: 10,15, and 20mg per day and placebo
? Primary efficacy endpoint: % change in sIGF-I reduction from baseline
? Phase IIb/III up to18 month efficacy and safety study
o Somavert?
registration study (Vander Lely et al. Lancet 2001, Nov 24:358 (9295) 175-1759)
? 167 167 ti t patients: 131 131 t t d f 6 th 90 f 12 th d 39 f 18 th treated for 6 months, 90 for 12months and 39 for 18 months
? Dosing started at 10mg/day, increased by 5mg/day up to 40mg/day to normalise sIGF-I
? Efficacy endpoints: sIGF-I,GH and diabetes markers including insulin and glucose levels
Orphan drug status allows ANP to follow the regulatory path of Somavert?which increases development certainty and speed, and with therelatively small patient numbers required for registration trials, reducesdevelopment costs.

In simple terms we are at most 2 years away.The important point here is that once we get thgough phase 1 ISIS in my view will fast track this with backing and that alone will soar the price of ANP in my view.This will in turn give ANP huge opportunity in itself to raise money at very decent levels turning the corner and fortunes of ANP.

Any manufacture being years away is totally incorrect MOT as Antisense are already manufacturing ATL1103 for clinical trials.
Robbsstttarrrr