I wasn't convinced enough to post my personal European status...

I wasn't convinced enough to post my personal European status assessment following review of the strangely phrased March 1 ANN ... so I solicited wider expert opinion from a group of European and other colleagues. To summarise the collective feedback;

- 3 memos closed out yet questions still remain = significant (show-stopping) regulatory compliance issue(s)

- Lack of approval 6 months post "fast-track" review is highly unusual, the picture isn't pretty

- Publically available information plus an understanding of the current regulatory environment points to deficient clinical data as a likely significant issue
Note: BSI, Health Canada and TGA are currently recommending (i.e. mandating) RCT's as standard for class III devices with no established predicate

The following thought-provoking general/regulatory process-related points were also raised;

- It is most curious that prior to additional information being filed, a face-to-face meeting is deemed necessary to discuss the (as yet unfiled) material and (as yet unasked) questions ... ?

- It is most interesting that the complexity/complications/time delay have been attributed to seeking PC and HCC indications at the same time. This hints strongly of an outright rejection of at least one indication.

- NB's, particularly BSI NEVER schedule face-to-face meetings to discuss issues. Question - management time-buying exercise?

- Stated confidence of CE approval being granted in the near future is incomprehensible - prior to BSI review of currently unsubmitted material ... ? Question - deliberately misleading?

Overall conclusion

Available clinical data and OSL ANN's indicate insufficient clinical data exists to achieve CE approval. It is most likely an RCT will be required.