Wednesday, September 12, 2012 9:55:49 AM
Here from their last filing:
The company's current proprietary product offering is the Shasta Genstrip blood glucose diagnostic test strip for at-home testing. Shasta Genstrip is a product conceived and designed by Shasta Technologies LLC, and fits into a diagnostic product niche and will sell into the world-wide self-test (home test) market of $22.5 billion. The company has been involved with Genstrip since early 2010. Products like Genstrip require FDA approval but travel toward this approval through a well defined albeit slow and unresponsive regulatory process. The company believes that all regulatory hurdles have been addressed and satisfied, but as of April 30, 2012 Genstrip has not received final regulatory approval or disapproval from the FDA.
In March 2012, representatives of the company and Shasta Technologies LLC met face-to-face with the FDA in an effort to ask and respond to questions in an effort to complete the FDA review process.
Based on this reading, I would assume, if the FDA hat further questions or question it company would have replied by now and if no further questions would come forward or have been come forward the FDA should give the go ahead.
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