Bioshares report on OSL, page-2

clinicaltrials.gov

Some interesting and conflicting information contained within the FDA clinicaltrials.gov registration.

Confirmed:

- Pilot safety / tolerability 1ry outcome study, defined by TEAEs
- Unresectable locally advanced pancreatic tumour excluding metastases and in absence of any other prior radiotherapy or chemo
- Single tumour implantation only
- 10 patients folfirinox
- 10 patients gem-nab
- Follow up 104 weeks (excepting death), post enrollment of last possible patient, before final analysis can be completed
- Enrolment estimated to take 12 months
- Estimated completion date of February 2020 (defined as final data collection date for primary outcome measure)
- Study to be "paused" (aka stopped) if one SADE requiring hospitalisation or device related death occurs within 4 weeks of implantation


So, exactly what results are going to be available in Q3 17? And what marketing approvals will these touted results support?

Could the "expected" timelines be a fabrication of the imagination?