Replies to post #236565 on Bioelectronics Corp (BIEL)

[The_Pro]

Very informative tutorial on the differences between

1. registered,
2. cleared and
3. approved.

Also note how many elect to go the 510k route versus the approved route. And the cost inhibitions of an approved route versus cleared. Well, this paragraph is the crux:

By the numbers, the vast majority of medical devices are cleared through 510(k) versus approved through the PMA pathway. Approximately 4,000 510(k) applications are submitted to the FDA each year compared to less than 100 PMA applications. The average cost to bring a medical device to market through the 510(k) pathway is $31 million compared to the PMA pathway with average costs of $94 million. The time and cost required to bring a device to market through 510(k) versus PMA makes the 510(k) pathway the popular choice, if available.

BioElectronics again did the wisest route possible for as much success/effect as possible.

What I really like about BioElectronics is:

1. Never a reverse split
2. Never any third party promoters.