".............. ODD application didn't lapse,.........."Just had...

".............. ODD application didn't lapse,.........."
Just had a chance to see what Bard had to say re the application. According to Gemini ( for those who have any faith in AI info) the 90 days is not a statutory requirement but rather guideline brought about by internal review several years back in an attempt to streamline applications that at the time wer blowing out in timelines. Basically confirms that unless an application is outright rejected the original application carries but basically (as others have suggested) goes to the bottom of the pile to again work its way to the top. Only a little bit of bureaucracy involved in ensuring a big tick applied to timeliness of processing applications. would seem there is no advantage or disadvantage other than time to process. Bottom line is 90 days is a self imposed target so may be more or less. I can only guess that the additional info requested and supplied will ensure safe passage going forward.

".................The 90-day target for ODD applications remains in effect even if the FDA requests additional information. Here's why:The 90-day target is a benchmark, not a strict deadline. It allows flexibility for complex cases where the FDA needs more information to make a thorough decision.Once the applicant submits the requested information, the 90-day clock restarts. This ensures the FDA has a complete application for review and aims for a decision within 90 days of receiving the additional information.This approach balances the need for a speedy decision with ensuring a rigorous review process. It allows the FDA to ask clarifying questions while still aiming for a reasonably fast turnaround time for ODD applications................. "