Bioelectronics Corp (BIEL)

[TAZZER]

I realistically estimate 510K approval in 11 to 27 days expedited and 57 calendar days based on the normal timeline guidance.

Time line for statistical comparisons. FDA considers the start of the process the day they received a letter requesting guidance on a 510K. Usually takes 30 days before FDA gives guidance for submittal. BIEL had their review May 9th. So we are currently 67 days in the process. The numbers I suggest are reasonable. I am saying best case is 78 days worst case is 124 calendar days. In 2016 19% of 510Ks reached approval within 90 days from the beginning. Ours is expedited so hopefully we will be before 90 days.

https://www.emergobyul.com/resources/research/fda-510k-review-times-research

Refer to link for FDA 510K time guidance. Although it could be sooner given its an amendment to an existing 510K. Plus they already looked at the back study. Tick Toc...

Price will head towards at least a penny in next 27 Calendar days. GLTA!

Normal FDA 510K is projected to be completed in 60 calendar days once FDA approves 510K submission. BIEL received their approval on July 12 2018.

Just based on the regular not expedited we have no more than 57 calendar days till approval worst case scenario.

Expedited I would estimate 11 to 27 calendar days to approval would be my guess. Already day 2 so getting closer to approval.


https://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm408913.gif

https://www.emergobyul.com/blog/2014/01/us-fda-provides-510k-communication-timeline

https://www.fda.gov/AboutFDA/Centers