Ann: FDA Confirms Approach to Sofdra NDA Resubmission, page-73

The below is what the lawyer said during the 26/9, I think it’s better to quote him in full, to put his words into context… “We don’t have insight into what happened during this NDA review… these sorts of things are normally addressed during the review cycle. I will note that the FDA believes that the changes will require a human factors study, so we intend to get some more clarity at the type A meeting over exactly what the issues are… the specific changes that will make this resubmission complete. The usual process is you get information requests as the review proceeds about issues identified during the review of the NDA and the sponsor has a short period of time to respond in detail to those specific individual detail requests and in fact Botanix received several information request’s during the review and promptly responded on every occasion. The divisions are broken into different disciplines and those disciplines will have their own meetings during the review and then they all come together in the mid cycle review meeting where the division communicates to the sponsor if there’s anything critical at that stage that would hold up approval and Botanix mid cycle meeting was very clean and no critical issues were identified so it’s unusual that a sponsor would get all the way to the end of the review and have an issue like this with no discussion along the way, whether labelling changes during the review could have resolved the issue but that’s where we are. I was also surprised that the review ended this way… So, why 6 months? Under the PDUDA law in regulations a company’s response to a complete response letter can be classified as either a type 1 or type 2, type 1 can be reviewed in 2 months. This will likely be a type 2 resubmission, again because of the human factors study primarily that FDA will need to do and so FDA is committed under its agreement with congress to complete those types of resubmission reviews within 6 months. Can they do faster? Sure they can, but usually they take the full 6 months.”