good question. Not that long ago I posted here that I reckoned that an FDA approval realistically would not be much before 2025 (assuming a positive pivotal trial!) and based on their original 300 patient trial design communicated to market long time ago. For that everything would need to go well. My estimate based on educated assumptions about how long even just the set up can take and how long similar trials have taken. A few mocked, but it’s not difficult to look at facts, do the sums or ask those who work in trials for a living.. I’d stand by my assumptions (even then they could be optimistic- all comes down to how well recruitment goes) though how today’s FDA news changes that I’ve no idea. If they haven’t even started pivotal or have no confirmed new trial design by now well that’s a worry....
does make you wonder just say they get CE will they exclude running pivotal pancreatic cancer trial in Europe....otherwise potential commercial patients could be shunted into trial (free device, docs get paid) and so cannibalise possible sales.?? So run in US and risk poor recruitment again? . Well that’s company’s problem I guess, not ours!
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