Question uno - what is the difference between IUO and RUO. At 1st blush, Gerald was prognosticating LymPro as an IUO device for months-on-end. We've now changed horses to RUO mid-stream. Why? Is there a difference - and what pricing effects does it ultimately have on the switch-up, as Gerald is the proverbial 'gatekeeper' over Jason Napodano's FY15 $1-Mil. / FY16 $3.5-Mil. revenue 'math.' However, he unequivocally refused to address Jason's Blog 'math' during the last CC - when he had a 'clean green' to tee off and provide a well articulated rebuttal...
FDA Issues Final Guidance Regarding Research Use Only and Investigational Use Only Products
http://www.insidemedicaldevices.com/2013/12/2...y-products
Question deux - do you encumber LymPro with a JV Agreement, or keep it unencumbered for spin off purposes? Licensing is yet another revenue center which can work in conjunction with/or separate and apart from the aforementioned
Question tres - will Geneva be the proverbial LymPro 'gateway' for expansion in Europe, and more importantly Asia, with lax regulatory hurdles...