That would be a very optimistic forecast even if test plan had already been submitted to FDA for their review, but tweet today confirmed test plan hasn't yet been submitted. Tweet also confirmed they need a 3rd FDA meeting just to discuss test plan before test start. That pretty much guarantees they'll need at least a 4th meeting after test results are submitted before FDA will green light IDE submission. Again, I hope I'm wrong but doesn't look like IDE approval is in the cards for this year. But heck, you now have plenty of time to increase position.
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