As per Dewmboom on IHUB:

As per the FDA website:

Below is a screenshot of the recently updated FDA web page for Bioelectronics Corporation (BIEL).  It indicated that the proprietary names of the BIEL products covered include the ActiPatch, Allay, and Recovery X.

Allay deserves a special mention–this means the FDA is correctly treating menstrual pain as muscle pain, and correctly indicating Allay is a safe product for women to use. It is covered by the same basic regulations as the ActiPatch. This is how I interpret this, and I am probably either right or fairly close to right.

Recovery X–might it be possible the May 29th FDA meeting will just be a brief formality to announce approval for this? If so, I will use some incipient psychic ability to detect the hidden hand of BRAUN in this again. That process has flowed too smoothly for a BIEL solo effort. Andrew Whelan discussed selling this company quite seriously in the past, but because the FDA shot down Full General Clearance, this never came to fruition.

I’m a little bit stunned by this development. Initiates into the convoluted story of BIEL will share this moment, a bit awe-struck. It seems it is time to unleash the Beast that is BIEL. Might not happen Monday, but the FDA classing Allay and Recovery X with the ActiPatch, with the implication that all can use the original ActiBand as the Substantially Equivalent predecessor…

I do not notice new comments instantly, but do welcome them. Let me point out that over the course of time and learning about this technology, I have also gained some familiarity with the FDA process as well. I have spoken with well paid experts, people with jobs that FDA experts get, and in certain areas, in a hands on kind of way, I was the SME for them. They studied the stuff for a class, I had money at stake.  So, while I have never really lent myself expert status, in this instance I do.

That screenshot below represents several huge milestones. It is impossible not to understate the significance of this–it is as if months of possible regulatory stumbling blocks have just been swept away. Again, my interpretation.

Oh, and Allay has the potential to generate billions of dollars.

The last unresolved question is will the Migraine application appear listed with these names in the not too distant future? Another billion dollar product.

Screenshot 2018-05-19 at 10.45.29 PM - Edited

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