You make me laugh!
"FDA must inform the sponsor7 or sponsor-investigator8 of its decision, or must notify the sponsor that the investigation may not begin, within 30 days from the date of receipt of the IDE application, or the IDE application will be deemed approved."
If OSL is speaking with the FDA, then it's generally a bad sign...
https://www.google.com.au/url?sa=t&...PfxrGCQaY0qxVylejU5COA&bvm=bv.110151844,d.dGY
You make me laugh! "FDA must inform the sponsor7 or...
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