Replies to post #192558 on Biotech Values

[biocqr]

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?

[biocqr]

AAVL > There was a loss of 9.3 letters in the control but only 4 rescue injections over 10 mos...seems odd. I'm guessing a large part of the declines in the control group came towards the end of the trial. Plus we don't know what baseline was of the pts prior to starting their prior anti-VEGF therapy...or who knows what their prior therapy response was...or how many had become refractory etc.

[GrthzGd]

My takeaway regarding the AAVL call was of execs not so much disappointed with the phase 2a trial results as eager to get on with incorporating what they had learned into the phase 2b trial.

[DewDiligence]

AAVL gives up on existing AMD program:

http://finance.yahoo.com/news/avalanche-biotechnologies-inc-reports-second-200500978.html

…after further analyses of results from a previously reported Phase 2a trial of AVA-101 for the potential treatment of wet age-related macular degeneration (wet AMD), it will not initiate a Phase 2b clinical trial in the second half of 2015.

Instead, Avalanche will conduct additional preclinical studies to investigate optimal dose and delivery of AVA-101 and AVA-201 versus standard of care anti-VEGF protein therapy to select the best gene therapy product candidate for wet AMD to advance back into the clinic.

Don’t hold your breath for additional news on this program; the above sounds like a longwinded way of dancing around the reality that the program failed and the company is moving on.