6 was the bottom...see u at the top, page-17

Post of the day gsw - absolutely spot on. Those who have looked closely at the issues know that the filing is the big thing - that SBL and HGR management have been working closely with the FDA in preparing the documentation - dotting the i's and crossing the t's to ensure there are no unnecessary delays (calls for clarification/more information) during the assessment process. The key driver is the strategic marketing importance of being the FIRST to have FDA clearance and management is working to this end. A close inspection will also reveal that it is in the best interests of the FDA to expedite the assessment due to the somewhat compromised position it has placed itself in (in requiring an industry minnow to have clearance whilst giving biotech majors - for the time-being - a free hand). But this will change and I suspect that negotiations over ensuring a 'level playing field' in the market place are a key reason for the delay in filing the 510k clearance application.

I agree with gsw. The approval (as early as 30 days after filing) will be a formality. The filing - which I am sure will be announced - can, in effect, be interpreted as a sign that HGR has met all the FDA's requirements (due to the extensive negotiations and clarifications leading into it).

It would be nice to see the Mexican Government give the all-clear for the schools project in the same time-frame - to give a double boost to the SP in the short term.