Bioelectronics Corp (BIEL)

[GetSeriousOK]

Maybe this will help you understand.

Imagine a company named Bob's Electronics developing and patenting a PEMF device, going through the same trials and tribulations that BIEL went through to get five FDA clearances, the most recent in 2019. Poor Bob. What an ordeal. All the clinical testing was done with a certain device manufactured by Shenzhen CICD Technologies in China. Bob named this device "the ActivePatch."

Then imagine Bob's Electronics letting the patents expire in 2021.

Now imagine a little biotech named BIEL buying that same device from Shenzhen CICD with a different name and logo printed on it -- "the ActiPatch." They submit one 510(k) to the FDA in 2024 for full body OTC clearance, naming "Bob's ActivePatch" as the predicate device and including proof that this device is the EXACT SAME DEVICE MANUFACTURED BY SHENZHEN CICD TECHNOLOGIES AT THE EXACT SAME FACILITY, the only difference being the name and logo change.

The applicant could append all the independent research done with that same Chinese device, although it wouldn't be necessary. Forget all of BIEL's home-cooked studies and surveys because those were all BS, which is one of the reasons BIEL had so much trouble with the FDA over the years. (Other reasons: Andy's belligerent defiance, and his 2012 episode of selling the ActiPatch online without FDA clearance.)

You seem to think that BIEL would have as much trouble getting that generic device cleared by the FDA in 2024 as Bob had getting the original device cleared. You must think other generics suffer this fate.

And that is absurd. Getting a generic device cleared by the FDA is nowhere near as complicated, costly, or time consuming as getting the original device cleared. Surely you must realize that.

If Bob hadn't allowed the patents to expire, BIEL could not market a generic device in 2024. But Bob screwed up.

And if you still don't understand -- if you come back with some more head-scratching nonsense like the following -- then.... never mind.

You mean “slam dunk”….like the subsequent BS BIEL had to go through for all those additional clearances, for how many grueling years?

All those many years after BIEL’s first “device”, you know, the one allowed to be used for post-blepharoplasty surgery. Yes, the device allowed to be used after surgical repair or reconstruction of the eyelid. Last I checked, the eye and brain are in the same area, no?

Yes, all bureaucratic crap putting the company on a hamster wheel for a crapload of years! Treatment of ActiPatch for your back? Sorry, only cleared for the eyelid…near the brain. Try another day. That “slam dunk”?

Want to market your ActiPatch? Sorry, only approved for females and not males. Remember that? Another “slam dunk”! Only eye near the brain use was the menu

You want to go by 501k process BIEL? Ah, yeah, hmm, ah…Let’s see…umm maybe DeNovo, maybe this, maybe that process…. till that crap got put to rest. That “slam dunk”?