Bioelectronics Corp (BIEL)

[shadolane]

How is this study relevant to what the FDA has in front of it regarding consideration clearance of BIEL products?

Are you suggesting that this study is part of what the FDA needs to make a decision?

If so, then data omission existed.

If not, then it seems relevant perhaps but not part of the FDA process.

Significant time has passed since reclassification initiatives by the FDA was announced.

Since then they (FDA) either had sufficient submission info to consider and decide clearance or they didn't.

If they did then the decision is far overdue.

If they didn't then I assume that there would have been dialogue between the FDA and BIEL.

Looking for comments.

Thanks