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wrinklesobw

04/26/22 8:09 AM

#146159 RE: HoneyBager #146158

We get ide approval this will pop really hard, how high it will pop who knows.
Also remember there’s 82 million shares that’s have been accumulated so that’s what about 25% of the share count essentially locked up. When news gets out there’s going to be a lot of chasing,
my opinion of course.

Are time’s coming, obviously they are being very serious about the information they are gathering for the fda, otherwise they probably would have turned something in by now. So not necessarily horrible that they are taking so long, more information they have the better chances they have any extra questions covered that the fda might ask in the next meeting.

SC8

04/26/22 9:48 AM

#146160 RE: HoneyBager #146158

Expecting an IDE progress update in May either in quarterly or released at same time as quarterly. But will likely be well short of submission. If on track, 2nd meeting was at least scheduled during 1st quarter and will occur in 2nd quarter. From Jan. 2022 update:

"We are currently strengthening our IDE based on their feedback. As per their suggestion we will schedule another meeting early in 2022 to focus on the details of the dosimetry calculations and to demonstrate that we have addressed their suggestions. The final IDE application will be submitted after the biocompatibility testing is complete and after the FDA comments are addressed.