We were on the verge of a slam dunk IDE last year. We also were under the impression that the team had been in regular contact with the FDA Panel, which was bogus as that only started through the sprint meetings. They were confident they would resubmit within a timely manner - we are at a year.
You have a publicized India trip whereby the ability to publish was apparently revoked right before the team arrived. You have hit and miss communication that sure picks up with an SEC complaint mention. If you aren’t treating this like the OTC, that’s on you.
Good news, if you buy on the lows and sell on the highs, your core shares should be free by now with leftovers. Replaced my roof and built my deck this summer (thank you RDGL)