Trades line shows active algos so I assume they're betting on Class 2 response (within 6 months), whereas I'd figure a Class 1 (within 2 months) based on FDA guidance.
Class 1 would firm current levels and support upward creep to $bajillion. (say, 1.50) prior to approval/sadness.
If it's Class 1, (FDA response is based on resubmission content) the formal notification of Class 1 or 2 will be quick I would have thought.
On the other hand, I have absolutely no idea what I'm talking about.
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;
5. Commitments to perform Phase 4 studies, including proposals for such
studies;
6. Assay validation data;
7. Final release testing on the last 1-2 lots used to support approval;
8. A minor re-analysis of data previously submitted to the application
(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 forcompletion 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.
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.
2. A new manufacturing facility(ies) or would warrant a follow-up assessment and/or inspection of manufacturing facility(ies).
3. Any data other than minor assay validation.
4. Any resubmission with large amounts of data such as data to support process performance qualification.
(20min delay)