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Re: TruthBeSaid post# 21483

Monday, 05/07/2012 11:16:05 AM

Monday, May 07, 2012 11:16:05 AM

Post# of 329701

I believe that the Allay and Actipacth De Novo requests were filed at the same time.



I don't believe that's true. If you read the investor update section of BIEL's site it states:

The FDA’s questions on our ActiPatch® device from the Center for Devices and Radiological Health, Division of Surgical, Orthopedic and Restorative Devices are very similar to the Allay™ questions. We elected to hold our response to the Center for Devices and Radiological Health, Division of Surgical, Orthopedic and Restorative Devices until we see if there are any questions or objections to our Allay™ response.Having received only a limited follow up question on our earlier response, we have gone ahead and filed our ActiPatch® research, bench testing and supporting literature to support the reclassification and new indication of use clearance request.



So Actipatch was definitely filed after Allay which would explain why the FDA has only responded on the first to date.