I must admit that my expectations were that the share price would be far higher after this announcement. Its a significant Milestone achieved, with the testing over and the submission now completed for all modules. And a bonus is that its still well within the Q3 2024 forecast by the Company about 10 months ago. Quite impressive.
Perhaps the market is aware that now we await the FDA signing off and confirms the submitted documents are sufficient to assess the suitability of the WISE device for PMA.
One step at a time . . .
Ann: EBR submits final PMA module to the U.S. FDA, page-6
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