AI
Monday, June 15, 2015 8:42:17 PM
AAVL > Dew, a few questions if you don't mind...
1. Do you believe it's fair to claim AVA-101 significantly underperformed historical Lucentis data as many on twitter are pointing out given that AVA-101 subjects were heavily pre-treated with an avg of 10 anti-VEGF injections whereas the subjects in these Lucentis studies were treatment naive for the most part?
2. What do you make of the BCVA mean change of 11.5 letters from baseline vs. control with fewer rescue injections?... good enough to move on to the next phase?
3. Is the % of pts achieving 15 letter gain in VA a reasonable comparison metric when comparing AVA-101 to Lucentis when only around 30% of treatment naive subjects across all Lucentis trials met this standard?
4. It seems to me that AAVL will not be positioning AVA-101 to be a "one-shot cure" but there's quite a few investors that believe anything less than that is a failure. In AAVL's S-1 it was stated in preclinical studies AVA-101 expression has shown to last up to 17 months. Eylea has carved out >$2.5B in sales based on 8 wk vs. 4 wk dosing...Since AMD is a chronic disease with 3M ww and 150K-200K (U.S.) new cases annually and a large % of those pts stop treatment due to burden of injections... even if AVA-101 reduces those injections by 70%-80% while proving to achieve similar or higher VA vs. SOC.. wouldn't that still be a home run and become a multi-B$ drug?
1. Do you believe it's fair to claim AVA-101 significantly underperformed historical Lucentis data as many on twitter are pointing out given that AVA-101 subjects were heavily pre-treated with an avg of 10 anti-VEGF injections whereas the subjects in these Lucentis studies were treatment naive for the most part?
2. What do you make of the BCVA mean change of 11.5 letters from baseline vs. control with fewer rescue injections?... good enough to move on to the next phase?
3. Is the % of pts achieving 15 letter gain in VA a reasonable comparison metric when comparing AVA-101 to Lucentis when only around 30% of treatment naive subjects across all Lucentis trials met this standard?
4. It seems to me that AAVL will not be positioning AVA-101 to be a "one-shot cure" but there's quite a few investors that believe anything less than that is a failure. In AAVL's S-1 it was stated in preclinical studies AVA-101 expression has shown to last up to 17 months. Eylea has carved out >$2.5B in sales based on 8 wk vs. 4 wk dosing...Since AMD is a chronic disease with 3M ww and 150K-200K (U.S.) new cases annually and a large % of those pts stop treatment due to burden of injections... even if AVA-101 reduces those injections by 70%-80% while proving to achieve similar or higher VA vs. SOC.. wouldn't that still be a home run and become a multi-B$ drug?
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