Please research FDA's link. Approval issue's been discussed previously to most investors satisfaction. Also see LQMT website medical anvil "photo of the day". Can you imagine what a less expensive to mfg., non-Beryllium, more durable alloy means now to the medical device industry especially with the so-called "Affordable Care Act" breathing down every health care related company's neck?
Your post "josh":
"FDA fast track approval is mostly related to "software upgrade".(sic)
Unknown Metal "replacement" is not exactly fast track....I truly hope not.(sic)
On technical front, new metal introduction in any system affect thermal characteristic which impact electronics which impact software.....etc." (sic)
"FDA classification of a device is determined by the amount of regulation necessary to provide a reasonable assurance of safety and effectiveness. Under the Medical Device Amendments...as amended by the Safe Medical Devices Act of 1990 devices are to be classified into Class I (general controls) if there is information showing that the general controls of the act are sufficient to ensure safety and effectiveness."
IMO "Covidien Medical" could do surgical staples on bench testing alone with biocompatibility testing. A class II 510(k) for clearance could be done in 6 months + 3- 6 months for testing first so less than a year total.
I think testings' already in progress 3-6 mos. approx. (again, see photo) so maybe 6-9 mos. additional from March IF a contract is signed.
No problem for "Substantially Equal"...IMO an "anvil"? It's a Class I item. EZ PZ
***Engineering, mold form(s), ENGEL / MTRN ingot prototypes, internal controlled lab / medical procedure testing cycle(s), physician testing and "sign-off", FDA submission, re-confirm mfg. equipment & supply chain, FDA board approval, procurement, marketing, mfg., delivery, revenues.
IMO: Revenues outside of APPLE are VERY important FY '14 and in the pipeline or we fall to .06 again.
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