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Biotech / Medical : Biotech Valuation
CRSP 56.87-2.3%Dec 5 9:30 AM EST

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To: Biomaven who started this subject11/9/2003 9:24:36 PM
From: IRWIN JAMES FRANKEL  Read Replies (1) of 52153
 
ESPR CC

I missed the beginning but did get Steve Nissen's discussion of ETC216 and the Q&A. Audio was very weak but I had a decent set of earphones that helped.

- about 40 people in the world express the ApoA1 Milano gene and all are related to one person who lived in 1760
- PK Shah study using the mouse model for atherosclerosis showed regression of atheroma in 5 weeks froming the basis for this study
- IVES is the most accurate way to track plaque and being used in all current studies seeking to reverse plaque
- The proceedure measured the plaque in 30MM of artery and took 88 to 100 measurements as the device was withdrawn bya motor at a constant speed.
- It is the high number of measurements per pt that accounted for the power of the study
- All 4 study endpoints were statistically significant
- On average 49% of the artery was filled with plaque
- On average 4.2% of the plaque was removed in the treatmetn arm
- 30 of 36 patients treated had reductions in plaque
- I would go straight to a PIII measuring morbidity/mortality. (Cited that he has patients dying who need this treatment.)
- Talking about the statistical workup: "We tried everything we could to make the P-value go away or get smaller - and we couldn't".
- "Even if you assume that every dropout received no benefit, we had a statistically significant result."

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