Replies to post #32562 on Bioelectronics Corp (BIEL)

[investordisciple]

I'd take it, assuming the buyer paid for the shares too. :P

Still waiting to hear from fuente.

[fuente]

I feel compelled, based on my history on the board.

I will not comment on the increase in pps as I no longer hold a position. I can easily see what is happening here..but that's not the issue at hand.

The change by FDA eliminates (or may eliminate) a hurdle for BIEL in that Allay and Acti may be able to be sold OTC...depending on what the 'special controls' are and if BIEL's device can meet those requirements.

The benefit is really for any manufacturer who had an cleared product classified in Class III...if they meet the special controls they can then sell OTC. They would need to re-submit their 510K's but presumably the road would be smoother as those product were cleared already - so efficacy and safety were already demonstrated.

For manufacturers such as BIEL who do not have a cleared product (Allay or Acti), they would need to re-submit their 510K apps and if approved, and if they meet the special controls (which are yet to be defined) they would be granted Class II clearance.

But, remember, BIEL already submitted 510K's for both products...and both were rejected. They went as far as to get a member of Congress involved, took it on to appeal, etc. All rejected. To say the FDA does not appreciate this is like saying Superman only mildly dislikes Kryptonite. You think politics were in play before? Just wait.

Reason would have it that if they submit the same clinical data, they would get the same result. It's not really even a question. This is what would happen....FDA would not even grant them a review. The FDA development does not raise or lower the bar...you still must show efficacy and safety, and based on history, BIEL has not been able to accomplish that with FDA.

So, if they have new data, and it does show safety and efficacy, and they re-file..then they have a chance. But it's a long way off. They get no special treatment, no fast track (there is no such thing in the med device world anyway). They have to get in line with everyone else. All of this costs money of course.

If you have any questions concerning the process, please feel free to message me.

Congrats on the day.