I attended two roadshow meetings. I felt that FDA approval did not hinge upon the rechargeable battery project which was running parallel to the FDA submission.
Ok, thanks to Longreach’s communication with management we now know the lead connecting the transmitter to the (presumably) non- rechargeable battery requires specific abrasion testing. Will the lead hold up? If you think about it, this might involve an accelerated simulation test that mimics, say, 5 years of implanted activity. This kind of testing requires specialised equipment. And a very rigorous methodology.
I’m not disturbed by the delay…just a little disappointed like everybody else.
Ann: Update on Submission of Final Module to FDA, page-24
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