Bioelectronics Corp (BIEL)

[kidnova]

I think Class II with special controls is a given at this point, although I suppose there could have been arguments made for Class III. However, if they impose the special controls that were recommended in that summary then it's not going to be a whole lot different than what is required for Class III. They will be required to present clinical studies for each indication.

Also, I don't think BIEL is at all confident that they have the necessary data to support an approval at this time. They stated in their PR that if they are required to submit additional clinical trials that they believe their molar extraction study will meet the criteria, however that study isn't even completed yet. If they thought their existing studies would be adequate for the FDA to approve the device then I'm sure they would have indicated that in their PR. Again though, if the FDA goes the direction they were leaning then that approval would be specifically for that procedure, and they would still need more data for additional approvals.

I am looking forward to reviewing the transcripts as well to see if there was anything extraordinary presented that might have persuaded the FDA to impose less restrictive special controls. I'm also hoping that the transcript is phonetic so that I can read Whelan's speech:

FDA: "Mr. Whelan, please present your case."

Whelan: "Uhh.....what? Oh, yeah, uhhhhhh, does that mean we are approved for over the counter sales now?

FDA: "That's not the topic up for discussion today. Do you have something to support the argument for ILX devices being moved to Class II?"

Whelan: "zzzzzzzzzzzzzz"

FDA: "Mr. Whelan!"

Whelan: "Huh? Ummmm...heat. Our device produces heat...ummmm wait...I think it does, right? Wait, that was yesterday...<mumble, mumble>ummm, something about nerves and stoking a resonator or something."

FDA: "Again Mr. Whelan, that topic is not appropriate for this panel. Do you have anything else to present that is on-topic?"

Whelan: "zzzzzzzzzzzzz"

FDA: "Okay, next up is the CEO for Ivivi Technologies..."