Medizone Intl. (fka MZEIQ)

[Whatisvalue]

According to the following EPA publication, the EPA “will provide the applicant with a pre-decisional determination 2 weeks prior to the PRIA decision review time due date which specifies any label changes that have to be made in order to grant the requested new product registration. If the label issues cannot be resolved prior to the PRIA decision review time due date and if a PRIA due date time extension has not been agreed upon, then the Agency will issue to the applicant its regulatory decision with the specific label changes and supporting documentation on or just before the PRIA decision review time due date. At that time the applicant must either (a) agree to all of the label changes and submit a revised label that incorporates all of these label changes; or (b) does not agree with one or more of the label changes and request up to 30 days to reach agreement with the Agency and submit a revised label that incorporates all of the agreed upon label changes, which the Agency has 2 business days to review; or (c) withdraw the application without prejudice.”

http://www2.epa.gov/pria-fees/a540-pria-fee-category

http://www2.epa.gov/pria-fees/pria-fee-category-table-antimicrobial-division-new-products-and-amendments

http://www.medizoneint.com/2015/06/25/asepticsure-update-june-25-2015/

If I understand Dr. Shannon’s report on the topic, we should expect the EPA’s decision review date to be about the middle of this month. If so, MZEI should be hearing from the EPA this week. It might be just a tad early to speculate that the lack of communication (the normal) is a bad sign in this instance.