Replies to post #26869 on Bioelectronics Corp (BIEL)

[fuente]

The comments to the proposed rule have nothing to do with the petition to remove BIEL from the ILX code and classify them as thermal.

This petition is only for those devices identified as non-thermal, as BIEL's is currently. It's nice to let FDA know that we'd like to have BIEL's devices classified as thermal and removed from the ILX code (by rule), and make them Class II OTC, but this petition is not for that.

That is what is being appealed with FDA right now.

The petition is to the proposed rule change to the docket, to make all WMD devices that are non-thermal in nature (in the ILX code) require PMA.

Whether this rule goes thru or not, worst case it can only affect RecoveryRx.

The comments associated with Actipatch and Allay have nothing to do with the petition.

[kidnova]

Does anybody else think it's a bit silly for a member of the board of the directors of the company to submit comments to that company's application? Shouldn't those argument have been expressed in BIEL's filing?

Regardless, if you read the other filings you'll see some of the issues the FDA are facing. Each one seems to point to a seperate mechanism of action for why PEMF work. The Regenesis letter argues the exact opposite of what BIEL is trying to argue in regards to heat being the cause for the therapeutic benefit. I know it's fun to bash the government, and the FDA in particular (I'm conservative so I do it all the time), but this really is a more complex issues than the one-sided arguments on this board often make it out to be.