upcoming FDA meeting:
First off, I want to say much that is positive has happened since the last month or so, in particular the Dr.Scholl's nearly sealed deal, B. Braun wider roll out as part of their day surgery programme and TOTAL pathways solution are very positive. Equally important is the movement on FDA regulatory front - that the company has good clinical data for back and is exploring expanded indications and broad musculo-skeletal clearance.
However, I see that there is the idea floating around on this board that this clearance can happen in tommorrow's meeting. I think this is far-fetched. What they have is a pre-sub meeting, a standard practice before a formal submission to get feed back and guidance from FDA about your intended submission, to make sure the material being submitted is adequate, the best approach etc., to avoid costly delays. Also, there is no such thing as a supplement or amendment to a cleared 510(k) (unlike PMA). There is the so-called special 510(k) and abbreviated 510(k) meant for relatively minor changes, where you are not supplying new data but rather showing conformity with a cleared device. The new back indication being sought will not fall in this category and will need a new 510(k). Note also that this additional clearance is morphing into something much bigger - general musculo-skeletal use, this is indeed wonderful for BIEL - and thus would clearly not be something that will happen in the meeting. Having said that I do expect the FDA action will be quick, as they have already indicated that what they need is clinical data for a third indication to allow broad clearance and they are now well aware of the technology. Added to that is the quality of the data - the data that I saw in Dr. Sree Koneru's presentation is phenomenal with a p value of 0.006 - although this is for a composite efficacy index rather than for any individual end point in the trial. A level of < 0.05 is needed for clearance and I expect that the results for individual end points
is similar as the multiple end points are not uncorrelated. This p-value presented is better than the one in the Bagnato et al osteoarthritis study that the previous clearance is based on. I do expect an overall easy process.
I wanted to make sure that the expectations are not overblown, don't expect clearance tomorrow, rather some positive news about the prospects, if they do put something out. In my view more imminent news are the Dr.Scholls deal and the report on May 15 which *may* have a sales uptick due to the shelves that were stocked for the April NHS coverage start. We are now in more solid territory and we can continue to expect PPS uptick.
Will write in more on my thoughts for future in due course.
