That was not a submission for FDA review, and since we didn't get the material news PR RDGL was anticipating, we know 4th meeting didn't go as hoped.
RDGL needs to submit the containment report and request a meeting to get on review docket (then have to hope FDA says no meeting needed). Likewise with the ongoing dosimetry and response to comments on 2nd draft. Maybe MK is waiting to submit all three items at once? I hope not, as if there are problems on a submission, best to hear back from FDA sooner rather than later.
As of end April, MK had only begun writing containment report outline. Dosimetry remains ongoing, and it took MK over a year last time to respond to FDA comments on 1st draft IDE application. So no end in sight, and MK's off to middle of nowhere this July to talk about money losing IsoPet. Sad all of this could have been wrapped up years ago by competent management.
Praying MK can finally get serious and focus. Only Radiogel in human trials can save RDGL now. Yet the endless distractions continue.
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