Replies to post #220168 on Elite Pharmaceuticals Inc (ELTP)

[no2koolaid]

Indeed, we should expect it will…

FDA SOPP 8405.1: Procedures for Resubmissions of an Application or Supplement
• The review team and division director will determine whether the resubmission constitutes a complete response that addresses all deficiencies in the complete response letter (THIS SHOULD MAKE IT CLEAR THAT ANY ISSUES THE FDA HAS WOULD BE IDENTIFIED OR THEY ARE NOT CONSIDERED ISSUES TO BE ADDRESSED. IT IS FOR THIS REASON THAT ELITE’S TECH CAN BE PRESUMED NOT AN ISSUE).
• If the resubmission is considered a complete response (THIS IS WHY IT IS CALLED A COMPLETE RESPONSE LETTER – THE RESPONSE IS FROM THE APPLICANT NOT THE FDA), the review team and the division director will classify the resubmission as Class 1 or Class 2.
o The regulatory project manager will issue a letter to the applicant within 30 calendar days, acknowledging receipt of the resubmission.
o If CDER does not agree that the submission is a complete response addressing all deficiencies in the complete response letter, CDER will inform the applicant in the letter and the review clock will not start until a complete response is received.
o If CDER agrees the submission constitutes a complete response, the letter will state the classification and provide the due date for action.
o CDER will complete the review and act on Class 1 resubmissions within 2 months of the receipt date. If determined to be a Class 2 resubmission, it will review and act within 6 months.
o A Class 1 resubmission includes one or more of the following:
1. Final printed labeling
2. Draft labeling
3. Safety updates that addresses changes to the previous safety information or labeling

Class 1 Does not require a presentation to an advisory committee

The FDA acts on Class 1 within the 2 months 95% of the time. They act on Class 2 within the 6 months 85% of the time. Based on the FDA guidelines for resubmissions, it appears that SequestOx will be a Class 1 resubmission.