Nothing is Guaranteed in the Markets and that is especially true in the OTCs. However, looking at the facts that have been provided:
* 5/24 FDA Meeting - "we met with FDA reviewer for our ActiPatch device, key management from the Physical Medicine and Neurotherapeutic Devices Branch, senior leadership from the Division of Neurological and Physical Medicine Devices, and a Regulatory Advisor, Office of Device Evaluation."
This was no ordinary FDA 510K meeting, "key management", "senior leadership". The FDA knew that this was a high profile meeting on an important 510k application.
* 5/25 FDA Meeting - "The Agency’s concern is the ability of the patients to determine the origin of the pain without a physician being present. Therefore,the agency representatives stated, the de novo classification pathway would be more appropriate for the ActiPatch than the 510(k)"
The FDA had made up their mind for De Novo going into the meeting. McLeod and AW refute the FDA argument with the OTC examples of Pepto-Bismol and TENS devices. BIEL lawyers give further examples of the 510k process being used for OTC, OTC ActiPatch use in other countries for years has resulted in no problems. FDA committed to review the information presented and advise.
* 6/8 - "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 advise regarding whether additional information is necessary."
This is the Turning Point, FDA moves from "De Novo is more appropriate" to "510(k) pathway may be available". The odds went from 80/20 in favor of De Novo to 60/40 in favor of 510k on 6/8.
* Between 6/8 and 6/24 - BIEL received and formally responded to the first set of FDA questions.
This is another positive for the 510k. The FDA could have come back and said De Novo Only but they said tell us more about X,Y,Z. The odds in favor of 510k go to 70/30.
* 6/24 - BIEL receives a 2nd set of questions from the FDA and schedules a 7/20 meeting.
It is extremely doubtful to me that the FDA would enter this Q and A process after the 5/24 meeting and say De Novo at the end. The odds in favor of the 510k go up again, 85/15.
So here we sit on 7/20 waiting for details on the meeting. I understand the reluctance of some to embrace the evidence of 510k approval. BIEL has had more than its share of false starts. This one feels much different with the Reclassification to Class 2, the level of openness regarding the FDA process and the involvement of Goodwin Procter. We should know for sure shortly.
