Replies to post #92307 on Bioelectronics Corp (BIEL)

[shadolane]

There is a subtle message in your message....FDA is awaiting additional information.

There you go, that's why nothing has happened yet.

And you didn't hear what was being awaited and if anyone is working on getting it, or when.

So in my mind it still seems open loop.

Ad infinitum.

Nothing new seems to have been learned just a little more smoke.

[art2426]

Ok, that's what I thought might happen. Since they have stated previously they have accepted the data on the knee and foot (insole), I felt they just might give the clearance for sales on those two products first. Wait later for more statistics from Bioelectronics on the back pain studies and OK that use at a later date. This long delay gave me the thought that it was due to their in house decision to wait for that back pain information and give a 'one for all (uses)' OK. Since the products work on the same principle, I felt that was going to be the word from the FDA. Giving the OK on the insole and knee patch first is fine with me, if true, and maybe better as we get another boost afterwards with word of back patch approved. We will have to just wait and see

As far as prescription, they are all available as of now for just that if I am correct.

[60cent]

Dufresda thanks for clarifying - good info!

[Simpsonly]

Thanks for the clarification Dufresda
My personal philosophy for years has been'get whatever you can, when you can and chip away at the rest, as it will com. Word of mouth alone will be like booster fuel. FDA OTC USA Clearance will open the floodgates. The American people are not stupid. The foot bone is connected to the leg bone; knee bone; hip, bak, shoulder.....you know when

[User_347763]

I wouldn't be surprised if the FDA needed another year to evaluate the RWD, focusing on pro and contra of clearance based on the available data, and then taking another year to decide, while "forgetting" about the available clinical data on foot and knee.
I have been working for 4 different public services till now, albeit european.
Wouldn't it be better for BIEL to take control, forcing a decision on foot and knee?
That way they are half way,while they prepare to go the whole way.
Also I would check with BRAUN whether some pre-operation clinical data regarding the hip could be useful to convince the FDA.
I had excellent and consistent results with Actipatch for my hips.
The back is far more complex.RWD is certainly the way to go but before you realise it we will be unpacking the next christmas presents without Actipatch.