Universal thought of the day
There won't be a third CRL in this round. ( note my hallucination)
C.
Class 1 Resubmission - A resubmission submitted after a CR letter that
includes one or more of the following items:
1.
Final printed labeling;
2. Draft labeling;
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);
4. Stability updates to support provisional or final dating periods;
Center for Biologics Evaluation and Research SOPP 8405.1
Page 3 of 9
5. Commitments to perform Phase 4 studies, including proposals for such
Interesting- had not considered this- is this why SI gave so little info on adults in the Australian? studies;
6. Assay validation data; Requested , notified appears sufficient7. Final release testing on the last 1-2 lots used to support approval; @Phaedrus is this product about to be sold- you suggested a new assay?8. A minor re-analysis of data previously submitted to the application " After additional consideration" so the data has been considered already
(determined by CBER as fitting the Class 1 category);9. Other minor clarifying information (determined by CBER as fitting the
Class 1 category) such as a response to the CR letter that included only
compliance issues, stating that the applicant’s compliance status has been
updated to “acceptable” and requesting the clock be resumed for
completion of review for the application or supplement; and/or
10.Other specific items that may be added later as the Agency gains
experience with the scheme and will be communicated via guidance
documents to the industry.
D.
Class 2 Resubmission - A resubmission that includes any other item not
specified as a Class 1 item, including:
1. Any item that would require a presentation to an advisory committee.
NO- 9-1 vote2. A new manufacturing facility(ies) or would warrant a follow-up assessment
NO- no 483 received - manufacturing inspection doneand/or inspection of manufacturing facility(ies).
3. Any data other than minor assay validation.
Possibly- albeit they have had new assay data for months- so any additional product characterisation issues will hit this area 4. Any resubmission with large amounts of data such as data to support
Process performance? Probably NOprocess performance qualification.
Guidance from recent newspaper articles has the CEO saying pediatric data is sufficient for approval
Acceptance of the Resubmission is then the key that starts the engines ( if the CRL is not answered then they can't accept the resubmission, therefore a third CRL is highly unlikely unless something new is uncovered in the final process)
Short PDUFA date the spark for the ignition
Swami Reg
Ps Disclaimer - this image is not me- perhaps the tummy a tad.
Do not rely on Swami's for investment advice
(20min delay)