Actually, I have, in the past, tried to do this several different ways and there seems to be no short cut to take in releasing the bulk of my information on this subject. So many things must be told about clinical trials that no longer exist in the public domain simply because they are too revealing for 3M, Graceway, and all the others to continue allow floating around for all to see. Bad for business, you know... Then you have, in my opinion, simple fraud on the FDA, a U.S. government agency, which the last time I checked is a criminal offense. Fifteen years has passed since Aldara was approved by the FDA. During this time, the fraudulent data has been used in the approval process and still no one has been punished except all of us thousands of innocent injured victims who had nothing whatsoever to do with the 3M's dirty approval process.
Such activity, by law, allows the FDA to void the original application for Aldara due to the fact that fraudulent data was presented to the FDA for approval of the drug.
It would further require that all other generic products that are fundamentally relying upon the use of the IQ molecule as an active ingredient be removed from existing consideration for FDA approval because the FDA approval process for New Drug Applications or NDA's for IQ generic's are going forward based upon this prior, 1997, 3M flawed data for IQ and Aldara.
Then there is the matter of whether or not Graceway and the others were privy to this same information I am about to release when they along with others paid $Billions for 3M Pharmaceuticals products and licensing arrangements during their purchase of the same.
SHORT BACKGROUND ON THE DEVELOPMENT OF ALDARA & IQ:
the 1950's the 1H-imidazo[4,5-c]quinoline ring system was developed ,
and 1-(6-methoxy-8-quinolinyl)-2-methyl-1H-imidazo[4,5-c]quinoline was
synthesized for possible use as an antimalarial agent. Subsequently,
syntheses of various substituted 1H-imidazo[4,5-c]quinolines were
reported. For example,
1-[2-(4-piperidyl)ethyl]-1H-imidazo[4,5-c]quinoline was synthesized as a
possible anticonvulsant and cardiovascular agent. Also, several
2-oxoimidazo[4,5-c]quinolines have been reported.
Certain 1H-imidazo[4,5-c]quinolin-4-amines and 1- and 2-substituted derivatives thereof were later found to be useful as antiviral agents, bronchodilators and immunomodulators. Subsequently, certain substituted 1H-imidazo[4,5-c]pyridin-4-amine, quinolin-4-amine, tetrahydroquinolin-4-amine, naphthyridin-4-amine, and tetrahydronaphthyridin-4-amine compounds as well as certain analogous thiazolo and oxazolo compounds were synthesized and found to be useful as immune response modifiers (IRMs), rendering them useful in the treatment of a variety of disorders.
JOHN F. GERSTER, Ph.D., the inventor of imiquimod, received a patent for imiquimod August 25, 1987. Gerster immediately assigned his patent to the corporation Riker Industries, Inc. of St. Paul, Minnesota. 3M later purchased Riker Industries, Inc. and the full and exclusive rights to Gerster's related inventions in the deal. In the deal, Gerster went to work with 3M and retired in 1999 as a corporate scientist at 3M. He continues to consult for the company on a part-time basis. Gerster received a Ph.D. in organic chemistry from Arizona State University in 1965.
JOHN F. GERSTER
For the next couple of decades, after the 1987 issuance of his patent, Gerster's invention became the catalyst for 3M developing more chemical compounds based upon Gerster's parent imiquimod family of molecules described in his first patent. Now, all are "immune response modifiers" (IRM's) tweaked by design to perform immune system activities that run parallel to his first imiquimod molecule patented in 1987. There are various reasons why 3M continues to research and patent so many variations, or analogues of imiquimod as they are called .
My opinion is that there is and has been concentrated efforts first by Gerster and later by 3M and now Graceway to identify as many of these active analogues as possible in order to protect their future interest in the imiquimod family of compounds as a whole. Their investments will be protected only if patents are in place for each immuno-active analogue. If one is missed and a competitor were to hit upon the missed analogue combination it could mean that existing markets would be needlessly diluted by one or more new drug competitor(s). Another reason might be that these compounds or analogues will also be sold off under future licensing agreements by 3M at a later date, at least that will remain an option for 3M so-long as they are successful at retaining all of the known active analogues in-house.
But enough of the of the history on IQ, let's get down to the business of actually seeing some proof of all that is being alleged.