The following guidelines are from the FDA's website and I added my own comments (*)in caps, as to why I believe it should be a Class I review.
CLASS 1 RESUBMISSION A Class 1 resubmission is a resubmission that includes the following items only (or combination of these items):
1. Final printed labeling * FDA'S PRIMARY FOCUS FOR BYDUREON
2. Draft labeling * N/A
3. Safety updates submitted in the same format, including tabulations, as the original safety submissions with new data and changes highlighted (except when large amounts of new information, including important new adverse experiences not previously reported with the product, are presented in the resubmission it will be a Class 2 resubmission). *TQT STUDY WILL BE COMPARED TO QT STUDY. PLUS TQT HAS A PREAPPROVED PROTOCOL. THE FDA WILL HAVE NO CHOICE BUT TO ACCEPT FINAL RESULTS.
4. Stability updates to support provisional or final dating periods. *DURATION-5 RESULTS WILL BE COMPARED TO ALREADY REVIEWED DURATION-1 RESULTS. ALSO AMYLIN STATED THAT THE 2ND CRL NOTICE DID NOT MENTION ANY MANUFACTURING ISSUES.
5. Commitments to perform phase 4 studies, including proposals for such studies. *MOST LIKELY WAS DISCUSSED DURING INITIAL NDA REVIEW AND 1ST CRL SUBMISSION.
6. Assay validation data. * N/A
7. Final release testing on the last 1-2 lots used to support approval. *N/A
8. A minor re-analysis of data previously submitted to the application (determined by the Agency as fitting the Class 1 category). * BIOEQUIVALENCY RE-ANALYZED USING DURATION-5 AND QT STUDY RE-ANALYZED USING TQT.
9. Other minor clarifying information (determined by the Agency as fitting the Class 1 category). *N/A
10. Other specific items may be added later as the Agency gains experience with the scheme. These will be communicated through guidance for industry. *N/A
C. CLASS 2 RESUBMISSION A Class 2 resubmission is a resubmission that includes any other items, including any item that would warrant presentation to an advisory committee. Any submission that would warrant a re-inspection is considered to fall into the category of a Class 2 resubmission
I agree, but the 1st CRL notice issues as explained by Dan Bradbury obviously was not exactly what the FDA had in mind. I believe the Class II review for CRL #1 was appropriate, given the concerns the FDA had after completing their initial review of the NDA. Either the FDA's 1st CRL notice came as a total surprise to Amylin as they stated or Amylin just did not offer a full explanation or Amylin's head was under a rock and they refused to believe and accept the short comings of their regulatory strategy for Bydureon. I now believe all the chips are on the table and known by Amylin and if we accept what they stated about the FDA requests in the 2nd CRL notice as true, I believe a Class I is possible.