Ann: US FDA advises further data needed for MEBsleep approval, page-9

Unfortunately, I am a bit disappointed too. MEB's FDA consultant is not doing a good job. The MD said something along the lines of assessing the merits of a resubmission. This could mean waying the cost vs the benefit of obtaining additional clinical data to validate MEBSleep 510(k) application. One question that could arise would be; should we just focus on the MEB-001 De Novo application which would have a larger clinical data set that could be used to validate both MEBSleep and MEB-001? This approach will save us the cost of pursuing the 510(k) but would delay the commercialisation of MEBSleep in the US market. Otherwise, more money (which we are running low on) will be required to close out this application that was celebrated as under-budget back in April.

The positive is that there is an ongoing clinical trial in Ohio sleep clinic (and one other state) which I believe could be scaled up easily if required. It is also somewhat reassuring/comforting that the FDA is not outrightly throwing out our applications but is only requesting more information or clarifications. In the case of the 510(k) could be interpreted as 'yes I find with your claims interesting and based on information submitted appears to be true but I'd like you to convince me by providing a larger data set'. MEBSleep is NOT a dud. Also, this outcome should not have any effect on our CE Mark application and I can only hope a trend of 'shoddy' or more likely, incomprehensive applications is not confirmed here. So looking forward to the CE mark being granted and a meeting held with FDA to address concerns with 510(k) and BDD, if necessary. Also, keeping my fingers crossed for an update on the Compass deal and the ilumen mobile app development in the coming weeks. The market seems to be expecting some positive news too if the market reaction is anything to go by. Short term speculators out? Too early to call?

IMO, it's still worth buying/holding as we are closer to our goal than from where we started on the regulatory front. Patience required here to reap the gains imo.