Replies to post #145812 on Bioelectronics Corp (BIEL)

[DewmBoom]

To give some background on why I think BIEL deserves an expedited clearance within 30 days, take a look at my post below from October, 2016.

Biel met several times with the FDA during the original 510K submittal. In that submittal, the FDA reviewed Biel's Real World Data for Back pain, but finally, refused to accept the real world data and clear the Actipatch for knee and foot in February 3, 2017.

How Long it took for the first 510K?

Submittal: August 10, 2015
Approval: February 3, 2017
Number of Months: 17 Months

So. It took 17 months to approve the Actipatch for knee and foot and deny them approval for back pain, requiring a clinical trial.
Then, they denied them full body muscle and joint approval, requiring one more clinical trial on back pain. As you can see from this example, the length of time it takes is not as simple as waiting in line and your line comes and you are approved. It is much more complicated than that. Thus, the average time reported in the report you shared is almost meaningless, as it is skewed by more complicated cases. The 17 months that Biel took for approval can skew the data big time.

The 510K approval includes multi facet reviewes related to the product mechanism of action, safety, labeling, clinical data review, and many other details. Those other details are already reviewed by the FDA over 17 months period during the first approval.
Essentially, the FDA is familiar with the product and know that the product has no issues. All they care about for the upcoming approval is the back pain clinical trial. However, during the pre-submission approval meeting with the FDA on May 9,
the FDA had access to the data and a significant part of the discussion was focused on statistical analysis, as reported by the CEO.

In Summary, this application is expedited because of the circumstances and as expressed by Dr. Koneru after the FDA pre-submission approval meeting.

Dr. Koneru, who led the discussion, expressed confidence in the FDA’s constructive feedback. “We are pleased that the FDA viewed our data and statistical methods favorably. They have provided guidance on how to combine the back-pain study results, along with our previously cleared 510(k), into a single 510(k) submission for obtaining expedited expanded market clearance.”, he said

DewmBoom Member Level Saturday, 10/08/16 01:05:24 PM
Re: None 0
Post #
85915
of 145856
CHRONOLOGY OF THE RECENT SUBMITAL OF THE 510k FOR ACTIPATCH THERAPY OTC CLEARANCE....IT HAS BEEN OVER A YEAR NOW

1. BioElectronics Files FDA Premarket Notification for ActiPatch® Therapy-AUGUST 10, 2015

2. BioElectronics Responds to U.S. FDA’s Comments on its Market Clearance Application-MAY 10, 2016

3. BioElectronics Company Update – June 8, 2016

US FDA Meeting On May 24, 2016, we met with FDA reviewer for our ActiPatch device, key management from the Physical.....

"On June 8, an FDA representative notified company counsel that the agency believes that the 510(k) pathway may be available for the ActiPatch device, the agency staff is reviewing the company’s data, and the agency would be back to the company shortly with its pathway determination and advice regarding whether additional information is necessary."

4.BioElectronics Company Update – July 22, 2016

Pending U.S. FDA Market Clearance for Over-the-Counter Sales We had a second status meeting with the FDA on Wednesday, July 20, 2016. Senior Management from the Neurology and Physical Medicine Group, 4 examiners, the Head....

5.BioElectronics Company Update: August 22, 2016

"Our knee and plantar fasciitis studies, and our explanation of our unique mechanism of action have been accepted as indicative of musculoskeletal pain relief. The examiners have also agreed to review our UK Registry back pain data to accommodate our broad relief of musculoskeletal pain indication of use request. We have excellent data on approximately 4,500 back pain users, as well as well as observational study data on 100+ subjects demonstrating the durability of the therapy over 6-months."