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Dynavax Technologies Corporation Message Board

  • ctic_neutral ctic_neutral Feb 23, 2013 3:04 PM Flag

    Why it'll be at least a non-inferiority CKD approval

    As posters who know ALOT (notably jspoetry) pointed out in the past, these people all know each other, and they talk/communicate. By these people that means FDA, advisory committee, various vaccine experts, etc. It's a very small 'club' and everyone knows everyone.

    FDA (& DVAX) nevertheless were stung by a committee vote steered into the weeds by Dr. Doom. How does the FDA follow up? Do they hunker down for several months just chitter-chattering amongst themselves, and issue a CRL based on their fearful internal chitter chatter?

    No. They exit the committee meeting and begin formulating plans B, C, D, etc. Ultimately that results in conversations with committee members, for example the key government players that I think 'Soup' noted made comments to the effect that they'd have voted YES except the indication presented to the committee was too wide.

    Down at the bottom of the plan B, C, D ... chain is the most minimal CKD non-inferiority indication. Keep in mind DVAX has already achieved a superiority endpoint in a small PIII trial for CKD and has been preparing a BLA for this separate indication. Further, since committee meeting FDA has had ample opportunity to look at these results.

    Thus in conversations that must have occurred, FDA has conveyed to committee members various possibilities, perhaps including this minimal one. And given committee members wish for a thinner indication, giving the nod to a non-inferiority indication for CKD-only is a virtual gimme, it's possible even Dr. Doom himself might be amenable to that, not that he has to be part of these follow-on conversation.

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    • "Thus in conversations that must have occurred, FDA has conveyed to committee members various possibilities, perhaps including this minimal one. And given committee members wish for a thinner indication, giving the nod to a non-inferiority indication for CKD-only is a virtual gimme, it's possible even Dr. Doom himself might be amenable to that, not that he has to be part of these follow-on conversation."

      I like your logic and the resulting premise, but the problem, as you noted, is that the NDA was for healthy adults, and the understanding was that there would be a follow on NDA to cover the at risk populations. I just do not see FDA approving a drug for an indication for which there is not an NDA on file. If they want to limit the indication they can use the data showing age related improved efficacy over existing standard of care and use that limited approval to collect the REMS data for a subsequent broader approval. Or they can CRL the thing, accept the CKD NDA, and then rule on it without another adcomm. The European application is for adults 18-70 and CKD patients, so your scenario would work in that jurisdiction.

      • 1 Reply to erniewerner
      • Ok, you've alluded to something here I've heard before, but assumed likely not true. And that is that if since this NDA was not specific to CKD, then the FDA cannot or will not approve only for CKD.

        But you then seem to contradict yourself with "If they want to limit the indication they can use the data showing age related improved efficacy over existing standard of care and use that limited approval...".

        But there is not an NDA on file for any age group other than 18-70, so by your logic how can data be used for limited age-based approval but not used for limited CKD-based approval?

 
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