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IntelGenx Technologies Corp. Message Board

  • eric_boc eric_boc Jul 8, 2014 8:45 PM Flag

    Can anybody link apotex to igxt

    I read the fda warning letter to apotex and it seems pretty horrendous. What I can't find is any relationship between apotex and igxt. Can anybody find the nexus?

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    • You won't find an explicit connection. You have to use a process of exclusion in deducing and identifying the manufacturer of the API (Active Pharmaceutical Ingredient) involved. When issuing 483 Warning letters the FDA does not link the third party manufacturer of the API (Apotex) to the host party (Intelgenx). Also the FDA masks and protects the identity of the actual API involved in the problem, in this case, rizatriptan benzoate, from public knowledge, to protect both companies proprietary intellectual rights, since the details of applications for new drugs cannot be made public domain knowledge before actual FDA approval for protection against preemptive lawsuits by competing companies. Warning Letters and Notice of Violation Letters to Pharmaceutical Companies are issued by the FDA's Office of Manufacturing and Product Quality, which are public domain documents and knowledge, and that is where you can start the process of exclusion to identify the third party manufacturer of the API involved. If you know some fundamental information about both parties, although there is no explicit link, you can deduce the third party manufacturer of the API with almost certainty as once you know some basic things about each company individually it is a relatively easy process of elimination as there are only a handful of Warning Letters from the FDA's Office of Manufacturing and Product Quality that are dealt specifically to Manufacturers of Active Pharamaceutical Ingredients (API'S) over the course of a year. In this particular case there have been only 9 of these letters issued since Jan 1, 2014 to the present of July 7, 2014. So you start to narrow it down from there. Most of the 9 choices are obvious exclusions when you read through each of their Warning Letters. So it narrows down quickly. Then you come to maybe 2 or 3 possible choices left. Upon further investigation of the contents of those Warning letters combined with your own investigative prowess, you can narrow it down to one. In this case the "smoking gun" was the fact that Apotex was the only company who manufactures rizatriptan benzoate which you would find that out by investigating each manufacturing companies products from their websites. Then oother things start to fall into place, like for example Apotex being the only Canadian company of all the choices, and upon further investigation, discovering that Nadine Paiement who is R&D Director of Pharmaceuticals at Intelgenx references Andrew Rodenhiser, Co-development Project Director at Apotex Inc., as a connection in her professional LinkedIn page, or another link such as a former Director of Intelgenx, David Coffin-Beach, Ph.D., was also the former President and Board Member of the U.S. division of Apotex Inc., etc. etc. SO you see what I am getting at here - you have to be an investigator to make these connections bewteen Apotex and Intelgenx that aren't explicit but very highly probable (approaching near 100%) based on the sum of all knowledge you attain in your investigation and the process of elimination/exclusion. So you see the investigative due diligence I did to reach my conclusion of Apotex is a bit out of the beaten path but highly reliable in the end when you look at the sum of the combined evidence as I just described. Hope this helps.

    • Same here but they did say back in June their supplier was going thru some discussions with the FDA so I am thinking Apotex? "The Companies further report that a supplier of raw material for the VersaFilm™ Oral Film Product is currently holding compliance discussions with the FDA, which are independent of RedHill and IntelGenx and are not specific to the VersaFilm™ Oral Film Product. The Companies are diligently working on a variety of options to ensure continued supply of the raw material regardless of the result of these compliance discussions."

      HH

 
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