Guys, if you can sift through the crap above (I am guilty too)...

Guys, if you can sift through the crap above (I am guilty too) and read my last post just above. Many of you will know (apologies), but if you didn't, not only is there the perhaps unexpected completion of the prerequisite FDA 501K study, there is some really important information on the third page. Read above (or just re-read the release thoroughly if you haven't) but essentially the company is considering an alternative more lucrative pathway with the FDA:

"De Novo, Pre-Market Approval pathways and expedited programs allow for increased interaction with the FDA and provide the opportunity for the Company to gain a stand-alone approval for a novel nerve repair device, based on the unique clinical benefit delivered by that device. These pathways also allow the Company to leverage the evidence generated in the studies to support FDA approval and maximise the value ultimately paid by US payers for the new product, rather than referencing the existing price for currently marketed products. This would potentially allow Orthocell to reap the benefit of the significant patient and economic advantages generated by using CelGro® in nerve repair applications, and take a larger, more profitable share of the nerve repair market".

This is well worth discussing. Given the passage of CelGro Dental already and the low hanging fruit of animal studies for this CelGro Nerve 501K approval this study completion was great news. This development makes it very interesting news.