Seems to me that the common sense of elapsed time has long passed.
The FDA turned down BIEL's applicatiosn for OTC sales capability in the USA for ALLAY and ActiPatch.
BIEL rightfully appealed and thereafter Senators, consumers, shareholders, all waded in.
The FDA hosted a twenty or so FDA employee ALLAY meeting with BIEL, I think, on June 8 2012.
Now, if the FDA decision prior to June 8 to deny approval on ALLAY had merit, does it not make sense that they would have simply gone to their files and released the specific reasons for the denial? Yes, unless BIEL introduced new truthful and accurate data.
Did BIEL not have another meeting with FDA people on the ActiPatch denial? Are the two applications not in the same limbo status of review?
Clearly BIEL followed the correct appeal process and the FDA is following its correct review protocol.
The FDA has not released specific, correct and therfor acceptable data to support its earlier denials. There are numerous other products/devices caught in the same mess. Indeed, nthere may be other devices which cause concerns. To my knowledge, there is no record of one adverse side effect of a BIEL product and RecoveryRx is already FDA approved for post-op opthalmic use by prescription.
By simple logic, I say something good is in the wind since no one, not the FDA, ex-employees, disgruntled shareholders, dissenting orgs, no one, has produced one reason why BIEL should not receive approvals, or such reasons would have been produced long ago. I know some of this is repetitive, but as time goes by, is the logic nt more sound? There is just nothing negative published about BIEL products leaving me to wonder how approval could possibly be denied. On what basis could the FDA produce a denial if they were incorrect first time?
