You can deduct the dates as somewhere between May and August 2011
from their Pr release 23/5
The patent application relates to the use of radiofrequency induced, safe, inexpensive, convenient, 7-day or longer continuous deep heat treatments. The new thermal mechanism of action is in addition to the electrical field therapy, to provide a highly effective dual mechanism of action.
(...)
this additional product feature, when combined with our current patented pulsed treatment, will provide a compelling competitive advantage over drugs and hot and cold therapies.
and from the PR release of August 8th
(BIEL) has filed a response to the FDA concerns on the mechanism of action for the Company's Allay™, Menstrual Pain Therapy product. This response is predicated on additional physiological research, independent studies, and confirming bench testing to verify the working basis for the clinical results produced by its therapy. The research has established a unique patentable mechanism of operation and justification for moving the device into the FDA's lower safety Class II category. Additionally, the defined safety profile of the mechanism of operation demonstrates less risk than the FDA's approved Class I, over-the-counter heat products.
(...)
The energy emitted by the Allay device was previously thought to act as only an undefined non-thermal mechanism. We have provided the FDA with extensive performance data that establishes the physics and clinical efficacy of our exceptional therapy. The Allay device offers a simple way of providing dual electrical and continuous low-level, safe, deep heat therapy.
(...)
Last week we announced that we are expecting a near-term decision from FDA relative to our RecoveryRx™ surgical recovery product. Our FDA reclassification filing for our Allay Menstrual Pain Therapy product is a separate issue and thus we are now waiting for a second separate decision. We have approached both responses to FDA based on hard scientific facts and we believe we have supplied the examiners with a strong body of evidence in answering their questions. We are eagerly awaiting near term FDA's responses relative to both of these profound healing and pain relieving therapeutic agents."
As far as I can understand, they tacked a heating device onto the PEMF device and (re-?)submitted it as a Class II heating device.
It's like putting an A/C in a car and then claiming it is a cooling device (thereby insanely hoping car safety tests can be avoided or something along those lines).
If that's the case
1/ the FDA is right in its refusal
2/ BIEL's submittal process is completely botched, takes on all wrong directions, has cost/is costing a lot of money and does not take us anywhere near approval. Same for the steps undertaken with the senator and the IG.
3/ What in the hell were they thinking: did they really think they could outsmart the FDA ?
4/ Being overly agressive with the FDA, while at the same time forwarding a botched submission for approval is not going to help their standing with the FDA at all.
Déjà vu: BIEL once again messes up big time.
Also you can wonder how long ago they knew about this letter. And if they were diluting in the mean time.
Hope they sell the patents soon. Anything better than the present management that's only costing money, diligently working on ruining the chances of eventual success of the product.
