Bioelectronics Corp (BIEL)

[investordisciple]

@ Brabo

Let's break this down, shall we?

As far as I can understand, they tacked a heating device onto the PEMF device and (re-?)submitted it as a Class II heating device.
It's like putting an A/C in a car and then claiming it is a cooling device (thereby insanely hoping car safety tests can be avoided or something along those lines).

This is incorrect, BIEL isn't trying to classify that they are a heating device. They are trying to get the FDA to understand that their device conducts the proper amount of heat to fall under the product code category that would allow them Class II. In doing so, it is labeled as thermal for ease but it is not strictly a thermal device. Their shareholder letter precisely points out the level of heat. Please read that more carefully. Being a heat device and having a device that meets or exceeds the bare minimum of heat required to belong to a category are two very different things.

1/ the FDA is right in its refusal

This is in incorrect, as explained above. That of course, is why BIEL has filed an appeal. The FDA's ruling doesn't make sense and I agree with fuente in that they put BIEL's application under a stack of other things until they were recently prodded (as they do and has been proven over the years to happen to many company's). Taking 6-8 months and saying 'it's under review' is ludicrous even for the FDA.

2/ BIEL's submittal process is completely botched, takes on all wrong directions, has cost/is costing a lot of money and does not take us anywhere near approval. Same for the steps undertaken with the senator and the IG.

Again, this is actually not on BIEL's end this time. This is specifically because of the ineptitude that the FDA is displaying in not thoroughly reviewing all of the documentation and clinical trial research and seemingly forgetting their own rules for what kind of device must adhere to what set standard (a set standard they created). Addressing the Senator and IG is BIEL saying "we're not taking this bs, but we need assistance", to which they are getting. This to me, based on why they were given the no, is actually vastly closer to a yes than ever before. This single detail that the FDA is misclaiming would turn this around to a YES if corrected.

3/ What in the hell were they thinking: did they really think they could outsmart the FDA ?

This appears to be your assumption, to which I don't see your no foundation for argument. This was never about outsmarting the FDA. If BIEL was trying to do that, this long grueling process wouldn't have been so long. BIEL listed what the product code requires and what the FDA incorrectly labeled their product as. You can look the product code up online, it was easy to find.

4/ Being overly agressive with the FDA, while at the same time forwarding a botched submission for approval is not going to help their standing with the FDA at all.

Again, your take. BIEL is still confident (and apparently for the right reasons given the explanation) that their device meets and exceeds the minimum requires for the category and class level they have applied to. This is the problem with the FDA. Applications get passed from one person to another and they have so much paperwork that the necessary time isn't taken, hence the ridiculous amount of time wasted while they waited and were told it was under review.

Also you can wonder how long ago they knew about this letter. And if they were diluting in the mean time.

1. They couldn't have had this for very long. They themselves are clearly upset and are now taking action to fight rather than sit and wait.
2. They are always diluting regardless of any news. It's how they and a ton of other pennies run while they deal with the FDA. In fact, given this apparent recent information, it would make more sense that they weren't diluting so that they wouldn't have to deal with shareholders trying to take legal action for withholding something that would heavily effect the stock.

Hope they sell the patents soon.

I'd be satisfied with that, as that would most likely increase share price and earn me a pretty penny :)

Now, I have a martial arts tournament to go watch, hope everyone has a nice Saturday.