Question uno - what is the difference between IUO
Post# of 30066
Posted On: 01/02/2015 12:16:51 PM
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...
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...
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