Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-31

The last Quarterly - 31 Jul - stated that the Breakthrough Designation application had been submitted. But we don't know the date. Was it weeks before the 31st or just a day or so?

If it was close to 31 Jul, the 60 day assessment period would imply an outcome by the end of September.

But based on a recent assessment - at link below - it could be much sooner. Thirty days for Acoustiic (a medical ultrasound imaging device).

So, imo, we could - if FDA is happy with the submission and not requiring additional clarifications - get the announcement any day.

This blog is well worth a read for the simple explanation of the benefits of and the processes for securing BD - and the relatively minor implications of not getting it. That is, it is far from a binary situation.

https://www.fusfoundation.org/the-f...-at-obtaining-breakthrough-device-designation