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Re: mcbio post# 97717

Thursday, 06/24/2010 4:11:32 AM

Thursday, June 24, 2010 4:11:32 AM

Post# of 252321
Your CYPB Call notes

That's pretty much what BiolineRx said with a few more details on:

1. Their view of the next trial - a bigger and longer (6-month) phase II/III, probably 3 doses, powered to validate data of phase IIb, could start before yearend. If succeeds - think one phase III will be needed.

2. On cognitive endpoints - BACS is only about 30 min test and MATRICS takes about 2 hours, very long time for a psychotic patient during the first 6 weeks of treatment while in hospital. CYPB will negotiate for an SPA with combined endpoint, perhaps the shorter test during the first month or so and the longer one later.

3. Why CYPB - perhaps this sounds like an excuse but they felt that a smaller and a hungrier company will do a better job developing this drug.

I have asked again about the trend seen with the lower dose and as I remembered the trend was there. I believe cognitive effect should be a lot better when correlates with BMI at the 10mg dose as it is underdose for heavier patients. I cannot say if they did such an analysis but my hunch is positive.

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