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Momenta Pharmaceuticals Inc. Message Board

  • riffissimo riffissimo Jan 26, 2011 8:02 AM Flag

    Who the Heck Knows What a Minor Deficiency Letter Means?

    I don't think anyone can claim they know what a Minor Deficiency letter means. There just are not many examples of an ANDA Minor Deficiency letter. The most I could find were in reference to manufacturing warnings and devices, which isn't relevant.

    I think the best interpretation is that a Minor Deficiency letter means that when the FDA receives the revised application, they won't say, "Yes can I help you? Have we met before? What is this in reference to?". That is they won't need to review the whole application from top to bottom. It doesn't necessarily mean that the deficiency is easily resolved ("oh... we need you to initial each page at the bottom").

    This is what we need to live with when a company is trailblazing.

    As far as a positive from TEVA's perspective, the scenario of the FDA response letter saying, "Ha Ha... Ha Ha... Ha Ha...Are you Kidding?" is gone. And I have to say that was a slight possibility before the letter.

    As far as a negative for MNTA, I was hoping to get a 6-month window of certainty, which a major deficiency letter would have offered.

    Right now, I think we have at least a month of certainty. But I'm guessing much longer. I still don't think the FDA is at the point of site visits and supply-chain inspections. If they were at this point, I would expect TEVA to have more specific things to say about the application at this point of the review ("... the application is proceeding... we're having interactions with the FDA and they have visited our manufacturing facilities...).

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    • There is no "Approvable Letter" anymore. They received a Complete Response Letter, which Teva called a minor deficiency letter in their press release. The reason why you can't find any documentation about a minor deficiency letter is that it does not exist - it is simply PR.

      Only Teva knows what FDA is requesting in the CRL. It may be clarification, but it may need some additional data. My suspicion is that the lack of detail in the press release means that it will take about a year to resolve the issues.

    • MNTA's IR stated that the non-approvable letter contained "minor deficiencies" they had to make "minor amendments" too. The FDA doesn't use the term non-approvable letter any more. Therefore, you are the incorrect one.

    • Are you sure that it applies to already approved ANDA's? I'm not saying you're wrong, but reading it, it sure sounds like it applies to ANDA's that are under review (not approved). Here's a quote:

      "Minor amendments have a higher priority than major amendments because they often mean an application is close to approval and should, therefore, be given priority."

      I'm just trying to find hard policy documents (though I'd really be happy to find anything) that refer to this "Minor Deficiency letter" that Teva talks about. This document seems to be the most relevant I can find. My take is that Teva got a Complete Response Letter requesting a Minor amendment, as described in this FDA document. If you know of guidelines that fit better with what Teva describes, I would genuinely love to hear about them.

      Thanks.

    • I should caution you that your link to the FDA document is for amendments to approved ANDAs, which is not what they received.

    • As someone who works in the industry, I can tell you that what they received was a Complete Response Letter. Another poster said that it could take between 3 to 20 months to resolve, which is true from my experience. But it really depends on what is in the letter. My guess is about a year before it is approved.

    • Riff,

      I challenge you to find once ase where the FDA has issued a "major deficiency letter."

      Oh that's right, you can't because the FDA NEVER does.

    • This article discusses the Minor Deficiency letter and provides links to a couple of other articles on what Minor Deficiency mean for approval.

      http://seekingalpha.com/article/248738-misunderstood-news-offers-opportunity-for-deep-discount-on-momenta-pharmaceuticals

      My summary of what these articles say: we probably have 3 months minimum, 20 months would be normal, and it's very possible Teva never get approved.

      • 1 Reply to tek_jansen500
      • A minor deficiency designation is akin to a rejection letter by the FDA. It gives TEVA a chance to address the issues that the FDA puts in the letter which might include microbiology, GMP, labelling, master file issues that they encountered during their review. TEVA must respond or their application is permenantly rejected. Once they do respond the FDA has upto 60 days to respond. This could drag out a minimum of 6 months or years depending on what the minor deficiencies are; if it's GMP or micro related approval will be pushed back into 2012.

        Had it been a "minor" issue that the FDA could of cleared up easily they could of issued a telephone ammendment which is basically a phone call back and forth to clarify minor issues prior to drug approval. TEVA did not get this status and is spinning the rejection letter into something positive. By the way all this is on the FDA website for generic drug approval.

    • Hi Riff,

      Thank you for such an objective response.

      Will follow your posts.

    • Teva's answer to a few questions will consist of how they plan to address the immunogenicity issues. Its really back to square one for TEVA. 2 yrs minimum until approval.

 
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