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Re: DVAX post marketing plan - Reply to questions from DVAXTo these questions I sent via emial to Ryan Spencer of DVAX, his reply to me below: Ryan: How are you? Exciting days ahead! I'm a shareholder and was hoping you could answer 3 questions:
REPLY: We do not plan on announcing any of the interactions with the agency regarding the post marketing study during their review. They have received the general design of the study as part of the BLA submission. A better way to categorize the continued interactions is that we are providing more details surrounding the study design to address specific concerns raised at the VRBPAC meeting. This is not a situation where we submit a final plan and get a yes or a no. It is an iterative process to agree on the details.
Regards, Ryan |
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Msg # | Subject | Author | Recs | Date Posted |
773 | Re: DVAX post marketing plan - Reply to questions from DVAX | EatYourTomatoes | 0 | 9/21/2017 12:51:44 PM |