Bioelectronics Corp (BIEL)

[JNdouble1]

Working with the FDA is not that simple

I don't think you appreciate how much work goes into a submission to the FDA. While I agree that this will be much simpler than the original submission, it is still not to be taken lightly. Even for 1 clinical trial, the paper work will run into the thousands of pages. The report that I am currently avoiding working on is just part of an appendix to an FDA submission, and it is 750 pages.

On May 9th, the agency "approved" of BIELS plan for the submission (with recommendations). BIEL will spend several weeks putting this all together, then a few more doing QC on the full package. I would like to think that BIEL will notify the investors, and the investment community at large that they have submitted the 510K for agency review. This is a major accomplishment in it's own right, and should be publicized.

If your right, and they had it all ready to go and only needed to run spell check and submit then I agree we should hear something soon. My guess is we see Q2 numbers first. In the mean time something official regarding Sweden would be helpful.