You're spot on malmanu. BSI will await results of FDA initial 20 patient safety assessment before even reconsidering CE approval. Denial will most certainly have been informed of this by BSI. Continuous statement of "near-term" expectation of CE approval is entirely disingenuous and misleading, IMHO of course.
Should 5 x US sites actually be interested in such a high-risk safety run-in study, and should recruitment be successful, adverse events/stopping criteria will be heavily scrutinised real-time by both FDA and BSI. Given the underwhelming existing safety profile - approx. 40 pts across 2 clinical indications - the potential for patient deaths and trial failure can't be underestimated.
The last 4 projects my clients tried to get past NB's without adequate clinical data ended the same way. "Come back when the IDE is successfully completed and we'll take another look at the data then". But they couldn't be told!! My regulatory opinion - CE approval will not be issued for OncoSil prior to IDE success.
So, IDE approval, whilst a mandatory regulatory process step, is really quite insignificant where the bigger PMA approval picture is concerned, and has a direct link to CE approval (or not) prospects
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