JohnCohen- I hear you, you've raised some important questions...

JohnCohen- I hear you, you've raised some important questions about probity and competence, concerns I share. I also find myself concurring with the sentiments of some others on this site regarding the impression of the OSL company taking some substantial liberties with how it has communicated regulatory progress and trial data over these years. But I also take the view that personnel can come, go or are removed.

Regarding this breakthrough designation it looks like others have answered some of your good questions but it's worth knowing some metrics. From information posted to the RAPS.ORG website (18th Jan 2019) FDA data shows that since this breakthrough device programme was authorised in late 2016, 110 devices had received breakthrough designation. So it isn't rare. One of those is V WAVE shunt that another person mentioned on a post recently- it received FDA breakthrough designation around middle 2019 but is still undertaking a 500 patient RCT in heart failure, due to complete 2025 (clinicaltrials.gov). Although this designation is a good outcome for OSL with upside, as a holder I think it could be argued why was this not obtained sooner. I understand no data are required for this designation (it is based on expectation of or potential benefit), the programme has been around a few years which OSL's regulatory team and leadership should have known and FDA provides decision in 60 days. Imagine how much further this company could have been with its US strategy with a designation a year ago for example.

Milsha77- agree with your logic about plausible timelines for a pivotal RCT in locally advanced pancreatic cancer. From company releases we know Panoc trial recruited first patient March 2017, and last recruited /implanted patient looks to be around July 2018. So it took approx. 16 months to get 42 patients, involving 12 hospitals in 3 countries (hospital info from clinicaltrials.gov). If my maths is correct that works out as each participating hospital recruiting on average one patient every 4 -5 months, just over 2 per year. According to company releases, the US trial recruited 9 patients, using 4 hospitals, with first patient recruited in Feb 2018. The company announced it had shut recruitment in US in Jan 2019 so it seems 9 were recruited over approx. 10-11 months, at those 4 hospitals in US. So a similar performance to Panco. I think these metrics highlight the scale of the task ahead.