- Moving forward with branding and payer research, conducting market research with key stakeholders
- NDA submission process--Engaged KOLs and moving forward with selection of a CRO with FDA portal access and using a common technical document approach as a basis for NDA and MAA filings.
- Multimodality approach is the future for a number of cancers, hyperthermia being a key component.
- On track for 700 patients by the end of Q2
- Approximately $2M to be paid to Hisun only after technical success (3 registration batches) and after unblinding of data. Registration batches expected to be completed "next year"
- Yakult remains enthusiastic and that initiation of bridging study will commence after successful HEAT data
- Ended first quarter with $24.6M dollars, sufficient to fund through Q3 of 2013.
- Phase 2 RCW will recruit 40 patients
- CRLM, RCW, bone mets, and pancreatic cancer trials will "give the oncology a community a snapshot of the broad potential of ThermoDox while it's approval is being considered"
- Securing multiple manufacturers important for supply continuity. Hisun has recently invested significantly in expanding capacity in China.
- Next DMC meeting likely in September (DMC meetings are every 3-4 months roughly every 100 patients)
- Progression and event rates are "substantially following what they consider consistent with a successful trial"
- Approval for ThermoDox in HCC as early as end of 2013
- sFDA China regulatory review period could be "cut by half" from 12-15 months, due primarily to the severity and umnet need in HCC. Hisun will support the regulatory process in China.
- Target number of patients for HIFU bone mets trial is "in the 20's"
- No presentations at ASCO or WCIO, first data to be presented will likely be data from RCW Phase 1 trial (my question was in regards to WCIO)
- Company cannot disclose the average lesion size in the trial (my question)
- The company would like a business card for "Odaat enterprises" (sorry, had to...that was quite funny...for those who don't know, Odaat is the individual from this blog post)
- As an FYI, this was the second time I noted both Cowen (Edward Nash) and Cantor Fitzgerald (Mara Goldstein) analysts on the call.
Let me know if you have any questions or if I missed something.