yes placeboed, exactly! The only logical trial design is OSL...

yes placeboed, exactly! The only logical trial design is OSL device plus standard of care (best chemo) versus standard of care alone (best chemo). So basically their FDA randomised trial sitting on the shelf that was announced some years back. That’s the only way to decisively answer the one thing that matters: does device add any benefit over standard of care. The naysayers/doomsdayers obviously understand this! This trial design as somebody already pointed out is no different to some of the SRX trials eg Sirflox.

this can be debated endlessly but the fact is that although the MEDDEV 2.7 don’t say “ go do a randomised controlled trial” it’s explicit about what they do NOT approve. If they won’t accept a single arm uncontrolled combination trial (panco) compared with literature because of bias/confounding, then it should be bleedin’ obvious that only a trial with a control group built in will cut it!

@tinyteddy- interesting comments about CEO... maybe question to put to him and board is not “were you told to do randomised control trial” but “ did you consider MEDDEV appendix 6 before taking the approach you have”. If this is failed again for same reasons as last year by BSI , this may be the crux of the problem in which case somebody has really stuffed up.

@Suzuki- always good to read your beliefs about the data and what you think BSI believe...where do you get your facts from? But the comment “completing randomised trials would not offer any new information” is pretty remarkable and kinda flies in the face of a century of accepted medical and regulatory practice. Congrats. It needs its own meme!