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Dynavax Technologies Corporation Message Board

  • imprvngmyavg imprvngmyavg Feb 25, 2013 7:38 PM Flag

    This taken from a transcript of a Conference call

    However, we believe the door remains open for a more focused label for HEPLISAV with the safety data that we currently have. Specifically, FDA has expressed their willingness and interest in continuing the discussion about what information is needed to support a more focused use of HEPLISAV, stating that the safety data required to support licensure will depend on the indication of HEPLISAV and a favorable risk-benefit determination associated with that specific indication.

    We will request a meeting with the FDA to discuss the CRL, and we believe the meeting can take place within the next 6 weeks. Our attack is to gain a better understanding of the specific issues and implement plans to address them. We intend to seek a path forward towards approval in a more focused population, which may be achievable without an additional clinical study. And these may include, once we gain clarity from FDA, pursuit of the chronic kidney disease population, adults over age of 40, and other groups that who have not responded well to currently available HBV vaccines, where HEPLISAV have been shown to provide significant benefit.

    Furthermore, FDA has asked to supervise additional data from our process validation program and to clarify information on our manufacturing controls and facilities related to the assurance of the quality of the commercial product. We believe this information is addressable, but until we meet with the -- meet with the agency, it is difficult to make any predictions about the exact timeframe for our response. Within the next few days, we will publish our financial results for the fourth quarter and the year, which end -- of 2012, once the audit is completed. We anticipate finishing the year with approximately $125 million in cash.

    Hope the members of this board find this info useful in determining their next moves GLTA
    Based on the work ahead of us, we anticipate maintaining a significant commitment to clinical, regulatory and manufacturing activities in the near-term. That said, we do not expect to establish a commercial organization until we are closer to approval. And it is certainly our goal to continue our annual spend levels consistent with prior years, which has been roughly $60 million a year, although we may need to adjust this once we have more definitive plans.

    As I mentioned earlier, Dynavax plans to meet with the FDA within the next 6 weeks to discuss the steps necessary for approval of HEPLISAV. Following this meeting, we hope to understand the types of indications FDA is willing to consider at this time, and be in a better position to estimate the time and resources necessary to satisfy FDA requirements for approval.

    We plan to do all we can to move the process forward in a swift and proper fashion, and we will put our full energy into addressing those issues.

    In closing, let me also take a moment to remind you that our marketing authorization application is under review by the EMA in Europe. We continue to pursue HEPLISAV approval and commercialization in Europe, and our timelines are proceeding according to plan.

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