- BPAX (click for stock research page) presented 10/21 at the BioCentury Newsmakers Conference (find webcast link and complete biotech webcast calendar on Upcoming Events page)
- Continue reading for my complete notes and updates from the presentation - 2 major catalyst timeline changes!
- We have a "quintessential binary event this quarter"
- slide: Bio-T-Gel PDUFA now listed as 2/14/2012 (NDA filed 1/2011, accepted 3/2011)...changed from Nov 14th. FDA asked Teva for additonal info, Teva has submitted this, and PDUFA date was changed. [This is of course not good news, but is pretty inconsequential for BPAX, and as some others have pointed out, will simplify the situation for those seeking to trade the LibiGel data]
- safety trial now have >4800 woman-years of exposure, average 15.7 months per women
- In efficacy trials - over 90% of events were reported as satisfying by the women in the daily diaries
- secondary questionare - given monthly. Of this, only one question (#13) is critical for SPA
- Intrinssa saw maximum effect at months 4-5, then levels off (but does not fall while on therapy)
- 15-20% of women in safety study are in their 70's. Anecdote- right after we closed the trial we had to turn down woman who was 92 years old
- We hope to have additional patent activity this year that will extend Libigel protection to 2026 [I need to look into this further]
- Warner-Chilcott abandoned testosterone patch because they as a company simply don't do these kind of big trials that would be required to build safety database
- 17 phase 1 and 2 cancer vaccine trials ongoing
- Today: 850k warrants expired at $2.75 unexercised
- $73.3m cash balance as of 8/31/11
- Libigel phase 3 efficacy data will be "in December time period"...no issues, but as we are gathering data from 141 investigators, can more and more define timeline
- topline safety data 3q2012..committed to submitting NDA by ye2012
- question and answer session was in breakout room