What will it cost you?

It might be a day. It could be days. And time is money, sometimes in a very big way.

What are some examples of Technically deficient? Here are some scenarios along with "nonbinding recommendations" that the FDA says are not for implementation. Still, they created them and put them up on the web so, decide for yourself, if you need to pay attention.

Here's how the date is set if you get it right:

An all electronic IND-- An IND in eCTD format arrives on October 1 via the ESG (Electronic Submissions Gateway). The submission passes technical validation on October 2. The receipt date will be October 1, the date the submission was received.

Here's how the date is set if your submission is "technically deficient":

All electronic BLA --- A BLA in eCTD format arrives on October 1 via the ESG. The index.xml file, a necessary component of the eCTD, is missing; therefore, the submission fails technical validation. The FDA notifies the applicant that the submission failed the technical validation check and requests a corrected replacement. The applicant submits a corrected replacement eCTD on October 4. The corrected replacement eCTD passes technical validation on October 5. The receipt date will be the arrival date of the corrected replacement eCTD, October 4.

All electronic NDA --- An NDA in eCTD format arrives on October 1 on two CD-ROMs. It passes technical validation on October 2. The receipt date would be the arrival date, October 1. During the filing review, the clinical reviewer notes that all 12 clinical study reports appear under one single incorrect heading, and all the subsections of the study reports are mixed up, making it impossible to determine which subsections correspond with which report. Therefore, the clinical section of the application is impossible to review. This technical error in assembling the eCTD was missed by the automated validation steps performed upon arrival of the CD-ROMs because it can be detected only by a manual review of the content of the NDA. The applicant is unable to correct the technical deficiency in sufficient time to permit completion of the filing review and the FDA will issue a refuse-to-file action.

Conclusions? They're self-evident.